[Federal Register: October 28, 1997 (Rules and Regulations)]
[Page 55902-55951]
From the Federal Register Online via GPO Access

[[pp. 55902-55951]] Quality Mammography Standards

[[Continued from page 55901]]

[[Page 55902]]

to restrict continuing education credits for radiologic technologists
to Category A courses.
    (Comment 256). One comment stated that a limit should be placed on
the number of times credit could be earned for teaching the same
course. NMQAAC, when discussing this issue, recommended that no credit
should be given for teaching. FDA recognizes, however, that a great
amount of study and learning is required to successfully teach a
course, especially the first time it is given. The agency will continue
to permit personnel to earn credit towards the continuing education
requirement by teaching, but has added a new provision that limits the
times a particular course can be counted towards this requirement to
once in any 3-year period (see Sec. 900.12(a)(2)(iii)(B)). This is
consistent with similar provisions for interpreting physicians and
medical physicists.
    (Comment 257). A number of comments on this section were based on
misunderstandings. One comment expressed the belief that this
requirement actually meant that an individual would have to earn 15
units every 2 calendar years in order to meet this requirement. Another
comment, incorrectly assuming that implant imaging was a mammographic
modality, assumed that 6 hours of implant imaging training would be
required every 3 years. Other comments mistakenly concluded that 5
credits on implant imaging would be required every year, that the
requirement to average 5 credits a year was being increased to 6, or
that 5 credits were being required each and every year.
    All of these comments opposed the requirement based on their
misunderstandings. As FDA develops educational materials to help
personnel understand how they may comply with the new regulations,
special attention will be focused on correcting such misunderstandings.
Changes in the wording of Sec. 900.12(a)(2)(iii)(A) from the proposal
are intended to emphasize that the basic continuing education
requirement is to earn 15 credits over 3 years and to clarify options
for calculating the time period to be used to demonstrate compliance
with that requirement. The agency hopes that these changes will
eliminate confusion about whether 5 units must be averaged per year or
earned per year (the unit requirement is an average) and provide
radiologic technologists and the facilities that employ them with some
flexibility in maintaining and documenting compliance with this
requirement. Both of the changes parallel similar changes made in the
wording to the interpreting physician and medical physicist
requirements.
    Only two comments were received on proposed
Sec. 900.12(a)(2)(iii)(B) (now Sec. 900.12(a)(2)(iii)(C)), which
requires a technologist to have some continuing education for all
modalities used by that technologist. One comment stated this was a
``great revision.'' The other expressed concerns about the availability
of the training.
    FDA believes that if a new mammographic modality is introduced,
training will be available initially from the originators of the
mammographic modality because those originators will have a high
interest in ensuring that the mammographic modality is used properly.
FDA acknowledges that training with a disappearing mammographic
modality, like xeromammography, may be more difficult to obtain.
However, FDA has concluded that the possibility of detriment to the
public health that could result from personnel not maintaining their
skills must override this concern.
    (Comment 258). FDA received four comments on proposed
Sec. 900.12(a)(2)(iii)(C) (now Sec. 900.12(a)(2)(iii)(D)), which
describes requalification procedures for technologists who failed to
meet continuing education requirements. One comment agreed with the
provision and two comments went further to suggest that there should be
some sort of penalty for not meeting the requirement on time. The
authors apparently did not realize that the penalty was not being able
to perform mammography except under direct supervision until the
requalification was completed (see previous discussion related to
interpreting physician). The fourth comment supported the requirement,
but expressed concern about who would approve the training and keep the
records of completion.
    FDA has found the mechanisms used under the interim regulations for
approving training, which involve the participation of professional
groups, are adequate. These same professional groups ordinarily provide
documentation of completion. Under the interim regulations, it has been
the responsibility of the facility to obtain and maintain such records
and this will continue under the final regulations.
    (Comment 259). The three comments received on proposed
Sec. 900.12(a)(2)(iii)(D) (now Sec. 900.12(a)(2)(iii)(E)) opposed the
requirement that a technologist receive training in use of a
mammographic modality for which she was not previously trained before
using that modality. One comment stated that the requirement would be
an undue hardship and two stated that it will be difficult to obtain
the training. FDA believes that the value of being trained in the use
of a mammographic modality before beginning to use it on patients
overrides the hardship concern. As discussed earlier, FDA also believes
that availability of training will not be a problem and that the
definition of qualified instructor (Sec. 900.2(oo)) provides for an
adequate number of teachers. The proposed requirement has been retained
unchanged.
    Continuing experience is the second of the general requirements
intended to ensure that the technologists maintain their skills. As
proposed, Sec. 900.12(a)(2)(iv) required that technologists perform a
minimum of 100 examinations during a 12-month period. This requirement
was intended to parallel the continuing experience requirement for
physicians.
    (Comment 260). Eight comments supported a continuing experience
requirement for technologists, explaining that a technologist's
positioning skills improve with additional mammography examinations.
Nine comments opposed the requirement. Several of these suggested
alternative measures, such as a ``lengthy appraisal (at least 3 days *
* *) * * *'' by the chief technologist and radiologists or a
certification program similar to that used by the American Heart
Association for CPR certification.
    While these suggestions have merit, they are a form of proficiency
testing and, as discussed elsewhere, large numbers of comments provided
valid reasons to conclude that it is premature to require such testing.
    (Comment 261). Another comment opposed the requirement on the
grounds that ``if you can do a mammogram, you can do it, period.'' The
author's basic assumption seems to be that you never forget how to
perform mammography. FDA notes that the purpose of continuing
experience requirements is to ensure that technologist skills are
maintained at a level that is likely to produce accurate and reliable
mammograms. In view of the complexity of the examination and changes in
technology, FDA believes that the optimism expressed by this last
comment is unwarranted.
    (Comment 262). Proposed Sec. 900.12(a)(2)(iv)(A) set the continuing
experience requirement at the performance of at least 100 mammography
examinations in a 12-month period. One comment stated that this was a
``very acceptable requirement,'' but two believed that it

[[Page 55903]]

should be higher. One of these recommended that the number should be
the same as the 480 interpretations a year required of radiologists.
Four comments supported the level of the requirement, but asked that
the averaging period be longer than a year to allow technologists to be
absent for longer periods and still be able to meet the requirement.
Two of these comments noted that physicians are allowed a 24-month
averaging period for their continuing experience. Ten other comments
suggested that the number be lowered, with 50 or 75 a year being the
most common suggestions.
    FDA has concluded that the number of 100 per year, which was first
suggested by NMQAAC in February 1994, and supported by them at their
January 1997 meeting, is the most reasonable compromise between the
need to establish a requirement sufficiently high to maintain skills
and the need to avoid disqualifying large numbers of competent
technologists. The agency notes that as few as two examinations per
week will be sufficient to meet this requirement.
    FDA does agree with the suggestion that the averaging period be
lengthened to 24 months and the wording of the regulation has been
changed to require the performance of 200 examinations in a 24-month
period. A clarification of how to determine the 24-month period was
also added, which parallels similar provisions for calculating such
time periods for interpreting physicians and medical physicists.
    (Comment 262a). Seventeen comments identified specific groups that
they believed would have difficulty meeting this requirement. These
included individuals, such as mammography supervisors, instructors, and
technologists in sales, who had made career choices that would make it
difficult for them to meet this requirement.
    FDA understands the desire of these individuals to keep their
options open in case they wish to return to the performance of
examinations, but the agency believes that higher priority must be
given to maintaining technologist proficiency. FDA also notes, as
discussed later, that a requalification procedure has been provided for
technologists in this situation.
    (Comment 263). A related concern was expressed in the 13 comments
that indicated technologists in rural hospitals would have difficulty
meeting this experience requirement. As explained previously, FDA
recognizes that rural facilities face special challenges but believes
that it would be contrary to the MQSA goal of assuring women a uniform
minimum level of quality of mammography nationwide to establish lesser
standards for technologists practicing in rural areas.
    As proposed, Sec. 900.12(a)(2)(iv)(B) stated that technologists who
fail to meet the continuing experience requirement can re-establish
this qualification through the performance of 50 mammography
examinations under direct supervision.
    (Comment 264). Ten comments stated that this number of examinations
was too many and suggested that it be reduced, with 30, 25, and 20
examinations all being proposed. Another comment urged that there be a
penalty for failing to meet this requirement, apparently not realizing
that the penalty was not being able to work independently until
requalification was completed. One comment urged that proficiency
testing be used instead of an experience requirement, while another was
concerned about how the performance of these examinations would be
documented.
    As discussed above, FDA has reduced the number of examinations that
have to be performed under direct supervision as part of the initial
training from 50 to 25. The agency has no reason to require the
requalification figure to be higher than the number of examinations for
initial qualification. Accordingly, the agency has similarly reduced
the requalification requirement from 50 to 25 examinations.
    d. Medical physicist (Sec. 900.12(a)(3))
    Section 900.12(a)(3) establishes the requirements that must be met
by medical physicists who conduct surveys of mammography facilities and
provide oversight of the facility quality assurance program. Initial
qualifications, alternative initial qualifications, continuing
qualifications, and the reestablishment of qualifications are all
covered. No major changes have been made in the final regulations from
what was proposed. Some changes have been made in the survey experience
requirement and in the averaging time for the continuing qualifications
requirement. The comments received on the final regulations in each of
these areas are discussed in below in connection with the specific
provisions.
    (Comment 265). One comment stated that the proposed rule is very
positive, ensuring that only properly trained and adequately qualified
professionals perform medical physics surveys. Another comment
concluded that the medical physicist qualifications were appropriate
and reasonable.
    The initial qualification requirements for medical physicists
include board certifications or State licensure or approval; masters
degree or higher in physical science with 20 semester hours in college
or graduate level physics; 20 contact hours of training in mammography;
and survey experience.
    The proposed initial qualifications requirements generated a wide
spectrum of comments. Views varied greatly on the value of State
approval or licensure in ensuring that physicists were properly
qualified to perform mammography services.
    (Comment 266). Ten comments expressed doubt that State approval/
licensure provided a sound basis for establishing competence. One
comment recommended that the State approval option be deleted, while
another suggested that State approval be accepted only after FDA
investigation. One comment stated that State approval/licensure should
be part of alternative criteria with additional appropriate training
and experience requirements. Three comments argued that State approval
or licensure should be specific to the State where the professional
practice will occur, unless a State reciprocity mechanism is in place.
One comment stated that the proposal was unclear as to whether State
approval was sufficient or additional requirements would need to be met
after October 1997. On the other hand, seven comments stated that State
approval, like board certification, was adequate by itself and that
additional requirements were not needed.
    Five comments stated that board certification should be required
for all medical physicists. Several other comments urged FDA not to
accept board certification without requiring a special certificate for
mammography. Two comments recommended deleting the master's degree
requirement and argued that course work in college level physics and
supervised experience should be adequate. One comment contended that
the issues of degree, training, and curricula are unnecessarily
complicated in the proposed regulation. Another comment stated that the
requirement of board certification or State licensure unfairly excludes
physicists who are otherwise well qualified to test mammography
equipment on the basis of their actual experience in this field. One
comment stated that these requirements are appropriate.
    FDA considered all of the comments received concerning initial
qualifications requirements for medical physicists. Because the MQSA
expressly establishes State approval or licensure

[[Page 55904]]

as an alternative pathway (42 U.S.C. 263b(f)(1)(E)(i)), FDA could not
eliminate this route for initial qualification, even if the agency
believed it was desirable to do so. The agency is aware that not all
States have adequate minimum qualifications standards. Concern has also
been expressed that some board certified physicists do not have
adequate experience with mammography equipment. Therefore, as proposed,
FDA added additional educational and experience requirements for all
physicists, regardless of which initial route they follow to become
qualified under the MQSA. These additional requirements are: (1) For
initial qualification, masters degree or higher in physical science,
with a minimum 20 semester hours or equivalent in college or graduate
level physics, 20 contact hours of training in mammography, and
experience of surveying 1 facility and 10 units; and (2) for
alternative initial qualification, bachelors degree or higher in
physical science, with a minimum 40 semester hours or equivalent in
college or graduate level physics, 40 contact hours of training in
mammography, and experience of surveying 1 facility and 20 units.
    (Comment 267). A number of comments suggested that additional
subjects, such as mathematics, biology, nuclear physics, and radiologic
technology should be added as acceptable fields in which the degree may
be obtained. Some comments wanted the reference to physical science to
be changed to medical physics. One comment stated that physicists who
are not board certified should be required to demonstrate a stronger
educational background than currently required. In response to the
agency's discussions in the preamble section of the proposal about the
possibility of requiring all 20 semester hours in imaging physics (61
FR 14905), two comments stated that such a requirement would not be
appropriate because the mammography equipment evaluation would require
more than training in imaging and limiting 20 semester hours to imaging
physics would not provide the physicist with the education needed to
adapt to constant changes in technology.
    The agency has decided to keep the requirement of physical science
as the field in which the degree must be obtained and believes that its
definition of physical science (Sec. 900.2(jj)) sufficiently covers the
wide range of subfields that can provide adequate initial training to
enable an individual with 20 semester hours of physics to understand
the basics of mammography physics. The agency believes that this would
not be the case if other fields, such as biology, were added to the
definition.
    (Comment 268). Sixteen comments stated that board-certified
physicists should not have to demonstrate compliance with the
additional educational requirements of Sec. 900.12(a)(3)(i)(B)(1) in
the proposed regulations, but should demonstrate experience conducting
mammography surveys. Because the MQSA establishes board certification
and State licensure/approval as equivalent pathways for qualifying
medical physicists, FDA has not issued different additional
qualifications for each of these groups. Accordingly, the agency has
retained this requirement as proposed. However, if a designated board
confirms that its certification in an accepted speciality always
requires the minimum of a masters degree in physical science with at
least 20 semester hours in physics, the agency may not have to verify
the degree and semester hour requirements during annual inspections for
those physicists certified by that board.
    Another initial requirement is that physicists have 20 contact
hours of documented training in mammography. Several comments requested
further clarification of contact hours. Some comments urged FDA to
accept self attestations of contact hours for experienced physicists
who have worked in the field for a long time but do not have any
documented contact hours. Ten comments stated that, if the medical
physicist is board certified, the contact hours requirement should not
apply.
    After considering these comments and consulting with NMQAAC, FDA
has retained contact hour requirements for all physicists, regardless
of which initial route they followed to become qualified. FDA will
accept self attestation of any contact hours received before October
1994. The agency has also provided a more detailed description of
contact hours in Sec. 900.2(m).
    Under the proposal, an additional initial requirement was that
medical physicists shall have the experience of surveying at least 5
facilities and 10 units.
    (Comment 269). About one hundred comments opposed the requirement
for multiple facility surveys for in-house physicists and stated that
in-house physicists who are employed by hospitals and medical schools
are often contractually prohibited from performing surveys at outside
facilities. Several of these comments suggested that FDA should instead
base its requirement on number of unit surveys.
    In response to these comments, the agency has revised this
requirement so that physicists qualified under Sec. 900.12(a)(3)(I)
will be required to have initial experience of one facility and ten
unit surveys. FDA did not eliminate the facility requirement entirely
because the agency strongly believes that having experience with
complete surveys of facilities, including oversight of all QC records,
is necessary. Evaluations of units only cannot provide a medical
physicist with the same experience and knowledge as the survey of a
facility. Although the amended regulation does not mandate survey
experience with more than one facility, the agency encourages all
physicists to perform additional facility surveys when possible to
expand their experience. FDA believes that it is also advisable to gain
familiarity with a number of different mammography units because much
of the educational benefit is lost if the same unit is surveyed
repeatedly to meet the experience requirement. In order to address this
concern to some degree, the regulation now provides that no more than
one survey of a specific unit within a period of 60 days can be counted
towards the total mammography unit survey requirement.
    The initial experience requirement also stated that, after the
effective date of these regulations, the initial survey experience must
be acquired under the direct supervision of a qualified medical
physicist.
    (Comment 270). One comment stated that direct supervision would be
very difficult to arrange. Another suggested requiring two surveys
under direct supervision and the rest under indirect supervision. The
comment stated that indirect supervision with telephone consultation
and advice is more valuable than the direct supervision.
    FDA has retained this requirement because the agency and NMQAAC
consider it important that new physicists entering the field acquire
initial experience in conducting mammography surveys under the direct
supervision of a qualified medical physicist, who can correct any
mistakes made during the learning process before they pose to a threat
to patients. Because this provision does not take effect until the
effective date of the regulations, the agency believes that it will not
disrupt the availability of experienced medical physicists.
    Alternative initial qualifications were established in
Sec. 900.12(a)(3)(ii) to provide a way to permit medical physicists who
have been successfully providing mammography physics services for some
time, but who lack a masters degree, to continue to practice

[[Page 55905]]

without lowering quality standards in any manner that would jeopardize
public health. In general, in order to qualify by this alternative
qualification route, an individual must have qualified under
Sec. 900.12(a)(3) of the interim regulations and maintained his or her
licensure, approval, or certification requirement as required under the
interim regulations. The physicist using this alternative route is also
required to have a bachelors degree or higher in physical science, with
at least 10 semester hours or equivalent in college level physics, 40
contact hours of training in mammography, and survey experience of 10
facilities and 20 units.
    (Comment 271). Several comments opposed the alternative pathway for
initial qualifications and considered the proposed educational
requirements for these medical physicists to be inadequate. On the
other hand, a larger number of comments shared FDA's concern for
existing medical physics service providers and the facilities they
serve. These comments supported this alternative qualifications route
and recommended that experienced individuals who have previously
qualified and who meet continuing education and experience
qualifications should be allowed to continue to practice. Five comments
stated that the alternative initial qualifications should be a
permanent option. One comment claimed that the proposed alternative
qualifications criteria were too restrictive to permit many State
licensed physicists to qualify.
    A number of comments suggested increasing the requirement of
semester hours of college level physics for this alternative route from
the proposed number of 10. Some comments suggested that the credit
hours requirement for this alternative route be increased from 10 to 15
or 20 hours by including subjects such as biology, radiation biology,
radiation science, and chemistry. Other comments expressed concern that
this college level physics requirement would bar a number of presently
qualified physicists from continuing to provide mammography services.
Two comments stated that the requirement for semester hours in physics
should be removed, and that physicists qualified under the current
interim regulations by the State licensure or approval process should
not have to meet additional educational requirements. One comment
stated that 10 hours of physics is reasonable. Another comment stressed
that formal training in physical science is necessary and stated that
this standard should not be weakened.
    In the preamble to the final regulations, the agency explained its
reasons for proposing the alternative initial qualifications route for
physicists with bachelors degrees who are currently performing
mammography physics services under the interim rule (62 FR 14905).
Based upon discussions with NMQAAC and the Conference of Radiation
Control Program Director's Task Force on Medical Physics Criteria, the
agency proposed the requirements for course work in physics, contact
hours, and experience included in this alternative route. The agency
believes that the combination of all these requirements provides
adequate protection for the public health, while permitting most
practicing physicists to continue to provide mammography services under
the final rule.
    Moreover, the agency considered it to be unfair to individual
physicists and potentially detrimental to facilities and the public to
exclude many currently practicing physicists by withdrawing the
alternative initial qualifications route or by increasing the
educational credit hours requirement for these individuals in the
absence of evidence that such physicists are providing inadequate
services. The agency was concerned that such an exclusion could cause a
possible shortage in the availability of physics services for some
period of time.
    Several comments supported the views expressed in the preamble to
the proposed rule. In addition, the agency's experience and data
gathered from its inspection data base affirm that many currently
practicing medical physicists with bachelors degrees, adequate course
work in physics, and substantial experience are performing quality
medical physics surveys in mammography facilities with care and
competence.
     The agency continues to believe that it is very important to have
at least 10 semester hours in college or graduate level physics. The
other subjects, suggested by some comments, will not necessarily
provide an individual with the necessary background and training to
understand the basics of mammography physics. However, because at least
a bachelors degree in physical science is also part of the educational
requirement, the credit hours in other related subjects, suggested by
the comments, may be associated with fulfilling the degree requirement.
Although the agency believes that a minimum of 10 hours of course work
in physics is necessary to gain proper physics background, it also
believes that requiring more credit hours in physics, as some comments
and some members of NMQAAC suggested, will exclude individuals other
than physics minors or majors or those with graduate degrees. For these
reasons and those previously stated in the proposed rule (61 FR 14905),
the agency has retained, as proposed, the minimum requirement of a
bachelors degree with no less than 10 semester hours or equivalent
courses in physics in its final rule on alternative initial
qualifications.
    The agency agrees, however, that enhanced educational
qualifications are necessary in order for physicists entering the field
in the future to have the required background to understand the
technology of the future as it becomes increasingly intricate. As
previously proposed, therefore, FDA is limiting the use of this
alternative pathway to only those physicists who have met its
requirements by the effective date of the final regulations.
    (Comment 272). Several comments opposed the contact hours
requirement, while some supported it.
    The agency has previously stated its justification for retaining
this requirement for initial qualification route. For the same reason,
the agency will retain the requirement for the alternative route.
    (Comment 272a). A large number of comments stated that the proposed
initial experience requirement of 10 facilities and 20 unit surveys for
the alternative route in Sec. 900.12(a)(3)(ii)(B)(3) would be
impossible to achieve for many in-house physicists and suggested
eliminating the reference to the number of facilities.
    In order to be consistent with the initial requirements for
physicists under Sec. 900.12(a)(3)(i)(B)(3), the agency has revised
Sec. 900.12(a)(3)(ii)(B)(3) to change the required initial experience
from conducting surveys of at least 10 mammography facilities and 20
units to conducting one facility and 20 unit surveys. Again, no more
than one survey of a specific unit within a period of 60 days can be
counted towards the total mammography unit survey requirement.
    (Comment 272b). Two comments stated that the experience component
under the alternative initial requirement should have to be fulfilled
under the direct supervision of a qualified medical physicist, as
required under Sec. 900.12(a)(3)(i)(B)(3). Another comment suggested
changing the effective date of this regulation to the effective date of
this section because there is more than one effective date in these
regulations.
    The agency points out that Sec. 900.12(a)(3)(i)(B)(3), which will
take effect 18 months after these regulations

[[Page 55906]]

are published, will affect only new medical physicists entering the
field. Because Sec. 900.12(a)(3)(ii)(B) establishes that the
alternative pathway is only available until the effective date of the
final rules, the direct supervision requirement does not apply to the
individuals qualified through the alternative pathway, because no one
will enter the field through that pathway following the effective date
of the rules. In response to the comments about varying effective dates
in the proposed rule, FDA points out that, except for some of the
equipment standards and equipment QC tests, all sections of the final
rule will be effective 18 months after publication. This is clearly
stated in the final rule.
    The continuing qualifications requirements for medical physicists
have two components: Sec. 900.12(a)(3)(iii)(A) continuing education,
which requires the physicist to earn 15 units over 3 years; and
Sec. 900.12(a)(3)(iii)(B) continuing experience, which requires the
physicist to survey 2 facilities and 6 units over 24 months.
    (Comment 273). One comment questioned FDA's authority to require
continuing education at all.
    In response, FDA observes that the MQSA is designed to provide the
government with authority to issue and enforce standards to ensure
safety and accuracy of mammography in the United States. The section of
the statute relating to quality standards lists a variety of
requirements for each group of personnel associated with mammography
practice. Although only the requirements relating to interpreting
physicians expressly includes a reference to continuing education,
these requirements are not an exclusive or limited list of standards to
be established by the agency. They represent only the minimum
requirements that Congress mandated that the Secretary must ``include''
among those issued to ensure safety and effectiveness of mammography
(42 U.S.C. 263b(f)(1)). Just as FDA has determined that continuing
education is necessary to maintain the skills and expertise of
radiological technologists, the agency has concluded that continuing
education requirements are also essential for medical physicists, who
play a critical role in guaranteeing the safe operation of equipment
and effective quality assurance systems.
    (Comment 274). One comment stated that these requirements are
appropriate. Two comments asserted that self training by reading and
studying should qualify. Other comments asked that continuing education
units be better defined. Another comment stated that the language was
too prescriptive. One comment stated that most medical physicists would
have completed rather than taught continuing education units and
another opposed giving repeated credit for a course taught several
times. One comment maintained that no CME has been available for those
who have tested Xerox systems for the last 5 years, and that such
courses are unlikely to be available in the future.
    FDA notes that the final rule establishes that the units earned
through teaching of a specific course can only be counted once towards
the 15 education units requirement. A new definition for continuing
education unit or credit has been added in Sec. 900.2(l). The agency
will accept only the continuing education credits offered by
professional organizations whose training is shown to be relevant and
acceptable for medical physicists. Language clarifying the options for
calculating the 3-year period has also been added. The agency
understands that sufficient training opportunities may not be available
in xeroxmammography. However, because only 0.5 percent or less of the
facilities use xeromammography, the agency believes that the majority
of physicists, if not all, will need only continuing education related
to screen-film mammography. When other mammographic modalities, such as
digital mammography, become available, medical physicists will need
continuing education in those areas. The agency believes that such
training will be increasingly more available as the technologies
develop. The agency advises the facilities that use xeromammography to
contact the manufacturer of this system to provide or arrange for
training in xeromammography.
    (Comment 275). One comment recommended that the second and
subsequent 3-year periods begin to run from the original date that the
physicist was required to meet the continuing experience qualification.
    FDA decided to use a floating 3-year period for all mammography
personnel, instead of a fixed 3-year period as suggested by the
comment, for two reasons. First, as explained previously, a fixed
period actually allows an individual to go much longer without
continuing education than the length of the period itself. With a 3-
year fixed period, for example, if an individual received training near
the beginning of one period and near the end of the next period, he or
she would go nearly 6 years without continuing education, which is
entirely too long in a changing field such as mammography. Second,
because inspections are annual, if an inspector found that an
individual had not met the continuing education requirement during the
previous fixed period, that individual might have provided services to
the facility for almost a year before the failure was discovered.
Depending upon the circumstances, the actions needed to correct the
consequences of using the services of a noncompliant individual could
require a considerable amount of time and money on the part of the
facility.
    (Comment 276). Two comments stated that persons providing
continuing education should meet the qualifications of a medical
physicist as described in the proposed regulations and that the
instructors should be in active practice.
    FDA disagrees. The agency believes that many scientists, university
professors, and equipment manufacturers can provide training in
different aspects of mammography physics.
    (Comment 277). Another comment claimed that it is excessively
bureaucratic to require that a physicist send a copy of his or her CME
to include in the operating manuals, as was insisted upon by an
inspector at their facility.
    FDA believes that the author of the comment misunderstood the
reason why the information on CME was required to be sent to the
facility. The reason was not for inclusion in the facility's operating
manual but to enable the facility to demonstrate that its medical
physicist met the continuing education requirement. All interpreting
physicians, radiologic technologists, and medical physicists providing
services to mammography facilities have to document that they meet the
continuing education requirement.
    (Comment 278). One comment stated that there should be some penalty
for failing to meet the continuing education requirements.
    The consequences of failure to maintain these requirements is the
inability to work independently as a medical physicist. As stated with
respect to other mammography personnel, the agency believes this
penalty is the most effective means to guarantee that physicists
maintain qualifications and to protect the public health.
    Under the proposal, FDA would require medical physicists to
maintain their skills through the survey of at least 3 mammography
facilities a year.
    (Comment 279). More than 50 comments opposed this requirement. As

[[Page 55907]]

expressed in related comments, in-house physicists may be contractually
prohibited from surveying outside facilities. Many of these comments
suggested deleting the reference to the number of facilities.
    In response to these comments and in order to establish consistency
with revisions to the initial experience requirement discussed above,
FDA has revised the proposed continuing experience requirement. The
requirement will be for surveys of two facilities and six units in a
24-month period. The same facility can be surveyed twice. However, as
with the initial experience requirement, no more than one evaluation of
a specific unit within a period of 60 days may be counted towards the
requirement. In addition, while the same facility may be surveyed twice
within this 24-month period by an individual physicist in order to meet
this requirement, the two surveys by this physicist must be at least 10
months apart. This restriction does not prohibit the facility from
having surveys more frequently than once every 10 months, if it wishes
to do so out of quality concerns or for other reasons. The restriction
only limits the number of surveys of that facility that an individual
physicist can use to meet his or her continuing experience requirement.
The reduction in the number of facilities will address the concerns
that were raised about in-house physicists.
    In order to be consistent with the equivalent physician and
technologist requirements, the continuing experience requirement for
physicists is now based upon a 24-month period. This will now make it
more feasible for physicists who are out of the field for a time, e.g.,
on maternity or sabbatical leave, to maintain their qualifications. The
requirement has also been amended to explain options for identifying
the 24 months that will be used to determine compliance. This change
parallels similar changes in the requirements for radiological
technologists and interpreting physicians and is intended to provide
personnel and facilities with additional flexibility for monitoring
compliance with these standards.
    Section 900.12(a)(3)(iii)(C) requires physicists to be trained to
do surveys of a mammographic modality for which they have not
previously received training before independently doing surveys of such
units.
    (Comment 280). A number of comments correctly pointed out that the
reference to mammographic ``examinations'' should actually be to
mammographic ``surveys'' or ``evaluations.''
    FDA has corrected this error by replacing the word examination with
survey.
    (Comment 281). Several comments opposed the requirement for 8 hours
of training in a new mammographic modality prior to doing a survey of
such a modality. One comment expressed concern that this will keep
physicists from surveying new modalities. Another comment suggested
that length and degree of training be commensurate with the specifics
of the new modality. Two comments stated that the requirement
overestimated the complexity of new modalities and undervalues the
physicist's capability of adapting to new modalities in medical
imaging. One comment stated that this rule is unnecessary because a
qualified physicist will be able follow guidelines developed by ACR and
AAPM when a new modality, such as digital mammography, begins to be
used by the facilities. One comment stated that 8 hours of training in
a nonscreen-film modality would be difficult to complete, while another
comment stated that only expert instrument manufacturers would be
qualified to provide such training.
    The agency continues to believe that the proposed requirement of 8
hours of training in a new mammographic modality before a medical
physicist may begin performing surveys independently in that type of
modality is reasonable and necessary. Training prior to practice using
a new mammographic modality is required for all critical personnel
(interpreting physicians, radiologic technologists, and medical
physicists) because FDA has determined that the benefits to patients
from such prior training outweighs the cost to individuals and
facilities. The agency recognizes that training in a new modality may
not be widely available and agrees with comments that have observed
that equipment manufacturers would and should be able provide such
training. The agency will encourage manufacturers of a new mammographic
modality, such as digital mammography, to provide or arrange for such
training when the modality is commercially marketed.
    Section 900.12(a)(3)(iv) describes measures medical physicists may
take to reestablish their qualifications if they have failed to meet
their continuing qualifications requirements.
    (Comment 282). Two comments stated that the surveys of facilities
and units required for reestablishing qualifications should be
consistent with the experience requirement for initial qualifications.
The authors believed that, if a medical physicist is not actively
involved in mammography facility surveys for an extended period of
time, performing the proposed three surveys may not be enough to regain
the required expertise. They recommended that the requirement for
requalifying be increased to five supervised surveys. One comment
supported the qualification's supervision requirements. Another comment
questioned why physicists are not allowed to perform surveys without
the supervision of a qualified physicist, while such supervision is not
required for physicians and technologists.
    The agency notes that this provision has been amended to be
consistent with similar provisions relating to physicians and
technologists. In order to reestablish qualifications, physicists must
perform facility and unit surveys to bring their total up to the
required survey of 2 facilities and 6 units in the previous 2 years.
This change also makes the requirements for continuing experience
qualification more consistent with the experience requirements for
initial qualification, as suggested by some comments. Any survey
performed by a physicist to bring his or her total up to the
requirement must be under the direct supervision of a qualified medical
physicist. Contrary to the assumption in one of the comments,
physicians and technologists who fail to meet their continuing
experience requirement are also required to reestablish their
qualifications under direct supervision and cannot resume working
independently until the requalification is complete.
    e. Retention of personnel records (Sec. 900.12(a)(4))
    The provision on retention of personnel records Sec. 900.12(a)(4)
is intended to describe the personnel records that must be kept by the
facility to establish that their personnel meet the MQSA requirements
and to indicate how long such records should be kept.
    (Comment 283). Ten comments disagreed with the proposal by FDA to
allow records to be discarded following the next annual inspection and
the resolution of any personnel problems discovered during that
inspection. These comments urged that records be required to be kept
for longer periods, with ``as long as the person is employed at the
facility'' being the maximum suggestion. Four more comments suggested
that FDA also establish requirements for how long records of staff
members who have left the facility should be kept. One comment noted
that the list of the people for whom records were required in the
proposal included darkroom personnel and pointed out there were no
specified qualifications for such individuals. Two

[[Page 55908]]

comments suggested that, if mammography is performed at various sites
under the same ownership, the records be kept only at one site and be
sent to the separate facilities as needed. Finally, one comment
expressed the opinion that keeping personnel records was an unnecessary
burden, but made no suggestions as to how personnel qualifications
could be verified without documentation.
    FDA has made a number of changes in this requirement in response to
the comments. First, to address the concern about inclusion of darkroom
personnel, the list of activities performed at a facility has been
replaced with a reference to those personnel for whom quality standards
have been issued. The wording was further changed to clarify that, as
long as an individual is employed at a facility in one of these
capacities, records must be available to show that the individual meets
all qualifications. Records for individuals who have left the facility
may be discarded after the next inspection has occurred and FDA has
determined if the individual met the requirements. Although nothing in
the MQSA or these final regulations precludes the facility from
retaining these records for longer periods of time, FDA does not expect
to have further need to review such records following the subsequent
inspection. In response to comments suggesting that multi-site
facilities retain personnel records in a central location, FDA notes
that such a practice would be permitted but is not required under the
final rule. Because the MQSA inspections are typically announced in
advance, a facility could store its records at one site and bring them
to the other sites as needed for review during the inspections there.
2. Equipment (Sec. 900.12(b))
    The requirements were intended to establish specifications to
ensure that each facility would have equipment that is capable of
producing quality mammograms. FDA made a number of significant changes
in the equipment requirements that were proposed. These changes include
removing several of the requirements proposed for phase-in 5 and 10
years after the publication of the final rule and moving several
requirements from Sec. 900.12(b) to the quality assurance paragraph in
Sec. 900.12(e). Most of the test procedures that would have been
required under the proposal have also been deleted. Each of these
changes will be discussed below.
    a. General comments on equipment
    (Comment 284). A number of comments raised issues that did not
address specific provisions proposed under Sec. 900.12(b), but were
directed generally toward the entire package of regulations governing
equipment. These included two comments that expressed a blanket support
for the regulations proposed under Sec. 900.12(b).
    One comment stated that it would be useful to have a better
delineation of responsibility for ensuring that units meet particular
standards under the MQSA. The comment recommended that the facility
medical physicist be designated as the individual responsible to ensure
that a facility's equipment is in compliance.
    FDA believes responsibility for compliance with all the MQSA
requirements rests ultimately with the facility. Within the scope of
each facility's individual operations, responsibility can be
apportioned as the facility wishes, so long as this is consistent with
the regulations. The suggestion made by the comment is not inconsistent
with the regulations. Under Sec. 900.12(d)(1)(iv), the medical
physicist is designated as the individual responsible to oversee the QC
requirements, though no provisions specifically require routine QC
testing to be performed by the medical physicist.
    (Comment 285). Three comments suggested that FDA cannot anticipate
future changes in mammographic equipment technology sufficiently well
to be able to determine all appropriate requirements in this area over
this extended timeframe. One of these recommended that FDA review the
equipment requirements on a continuing basis to recommend and propose
modifications that are recognized to promote quality mammography. One
comment suggested that FDA simply require all mammography X-ray units
to be replaced every 8 to 10 years in order to keep facilities upgraded
with standardized equipment.
    FDA agrees that it cannot anticipate all changes in mammography
equipment over the next 10 years and has not attempted to do so. In the
proposed regulations, FDA simply incorporated specifications of current
equipment that experts had deemed desirable for quality mammography
systems. The goal of the proposal was to ensure that, 10 years in the
future, each facility would be using equipment that was considered
state-of-the-art in today's market. FDA approached this goal by
phasing-in the requirements over various time periods. Equipment
requirements considered most fundamental to the delivery of quality
mammography would be required first, followed by those specifications
considered useful but which, because of cost impact, could be delayed
for a period of 5 years. The third phase under the proposal included
``nice to have'' features that are not absolutely necessary to the
production of quality mammograms and would not be required until the
end of a 10-year period. However, based on the uncertainty surrounding
the need for the phase three requirements, consultation with NMQAAC and
industry representatives, assessment of the costs associated with some
of the proposed 5-year phase-in requirements, and consideration of the
public comments, FDA has determined that this goal is inconsistent with
efforts to keep the costs associated with the delivery of mammography
services at a manageable level. The agency has, therefore, decided to
eliminate many of the requirements that had been proposed for both 5-
and 10-year phase-in. FDA has previously stated that it plans to
periodically review the regulations for necessary revisions in response
to new technology and remains committed to that effort. The agency
intends to and will revisit these areas in the future to reassess the
need for additional regulations.
    Although the revised equipment standards do not mandate that each
facility have all the equipment features the agency originally had
proposed, FDA believes the final regulations establish basic
requirements that ensure that every facility meets the baseline
equipment standards necessary to perform safe and accurate mammography.
In response to the comment that recommended requiring new equipment
every 8 to 10 years, FDA does not believe that the costs associated
with the arbitrary replacement of mammography equipment every 8 years
to 10 years is justifiable. In addition, the agency notes, too, that
the alternate standards provisions, included in the regulations under
Sec. 900.18, provide the flexibility needed to ensure that new and
innovative advancements reach the market without unnecessary delay.
    (Comment 286). Two comments recommended that all detailed testing
procedures be eliminated from Sec. 900.12(b) to allow flexibility for
qualified medical physicists to determine the appropriate testing
methodology.
    FDA has, in large part, adopted this approach in the final
regulations. In doing so, the agency has placed responsibility on the
medical physicists to be able to justify the procedures that they
utilize to perform testing of equipment in any particular facility.

[[Page 55909]]

    (Comment 287). One comment suggested that the X-ray tube companies
are ``planning for early tube retirement so they can replace the tubes
frequently at high cost to the facilities.'' The comment asked FDA to
address this issue immediately in an effort to keep mammography costs
down.
    FDA does not control the pricing of equipment in the marketplace.
The agency is, however, interested in equipment problems that may
indicate a unit does not meet its specifications and/or aspects of
compliance that it is certified as meeting. Specific information about
manufacturers should be submitted to the Office of Compliance in FDA's
Center for Devices and Radiological Health, 2094 Gaither Rd.,
Rockville, MD 20850.
    (Comment 288). One comment suggested that there should be a lock-
out and/or alarm mechanism preventing a mammography technologist from
exposing the patient to radiation without placing film in the
equipment. Another comment suggested a requirement for an interlock to
prevent a second exposure until the cassette is changed, and two more
comments recommended a requirement for an interlock to ensure the
presence of a cassette in the bucky/film holder. These comments noted
that such incidents have occurred, needlessly exposing patients to
radiation multiple times because the technologist forgot to insert or
change the film.
    Although FDA is aware that some manufacturers include interlocks
that ensure the presence of a cassette or that cassettes are changed
after each exposure on their equipment, FDA is not considering such
requirements at this time. FDA believes that, unlike equipment
performance, this is an aspect of the mammography process that is
within the complete control of the technologist and that the
technologist must assume responsibility for preparing the system for
each exposure. In facilities where more than one technologist uses the
equipment, a check list of items should be followed and this should
most certainly be one of the items on the list. If the technologists
adequately follow standard procedures, incidents such as those
described in the comments can be prevented without incurring the
considerable expense involved in requiring the suggested interlocks.
    (Comment 289). One comment asked the agency to consider requiring
special grounding devices to protect operators and patients. The
comment also suggested a prohibition against carpeting in the
mammography room, and a requirement for the use of static mats around
the mammography machine.
    Although these items might be desirable they do not impact the
quality of the mammography image and are beyond the scope of these
regulations.
    (Comment 290). One comment suggested that a requirement
establishing a maximum distance from the surface of the patient support
to the sensitive part of the image receptor should be incorporated in
Sec. 900.12(b).
    FDA is not aware, and the comment did not offer evidence to show,
that this represents a problem for current mammography systems.
Accordingly, the agency is not planning to regulate this aspect of
equipment performance.
    (Comment 291). One comment suggested that the maximum allowable
photo-timed exposure for mammography applications should be specified.
The comment stated that the backup limit of 2,000 mA's (from 21 CFR
1020.31(a)(3)(iii) in the Performance Standards for Diagnostic X-ray
systems and their major components) was clearly selected based on prior
technology, i.e., much slower screen-film systems or, perhaps,
industrial X-ray film where exposures were typically on the order of
5,000 milli Roentgen (mR) for an average breast.
    FDA notes that the regulations under 21 CFR 1020.31 presently set a
limit of 2,000 mA's for automatic exposure control equipment when
operating with a peak tube potential under 51 kVp. This regulation is
not specific to mammography, but applies to any diagnostic X-ray
equipment operating with a peak tube potential under 51 kVp. In
previous draft regulations presented to NMQAAC, a lower value of 600
mA's was proposed for mammography systems. The committee was of the
opinion that 600 mA's was too low and FDA planned to increase the value
to 800 mA's. In the meantime, FDA received comments from industry
pointing out that some systems have variable SID capability. This
variability in current equipment undermines an approach that relies on
the maximum mA's concept because the mA's required at a longer SID may
be significantly greater than that required at a shorter SID, although
the dose delivered might remain constant. Because FDA was faced with
setting dose limits for the termination of the exposure or
unnecessarily limiting equipment SID, the agency decided that the
maximum allowable photo-timed exposure should not be prescribed in the
regulations at this time. This decision was presented to NMQAAC, which
had no comment. FDA may revisit this area in future proposals.
    (Comment 292). One comment noted that the time between exposure of
the film and photographic processing is critical because the latent
image on all film decays with time.
    FDA had considered this aspect of the imaging process for
regulation but, based on comments from the public and NMQAAC, decided
not to propose requirements at this time. This area may be revisited in
the future when more is understood about the requirements and practices
in the mobile mammography community, where film processing often must
be delayed for a significant period of time after exposure.
    (Comment 293). Several comments recommended that FDA set standards
for batch variability of film, stating that this variability is often
greater than that proposed for the equipment standards.
    FDA recognizes that the variability of film may be a potential
problem but believes that facilities can control this, to a significant
degree, through their purchasing specifications and selection of
suppliers. FDA will monitor this problem closely to determine if future
regulation is required.
    (Comment 294). Twenty-five comments recommended that FDA include
requirements for the viewbox and/or the viewing conditions for the
physician and technologist.
    FDA agrees such standards would be beneficial, but does not believe
that enough is known, at this time, to set appropriate specifications
for viewing conditions. The guidelines recommended by ACR are excellent
and the agency encourages facilities to follow them. FDA will consider
this subject for future regulation and all relevant comments will be
reconsidered at that time.
    (Comment 295). Thirty-nine comments expressed concern that the cost
of some or all of the equipment regulations would cause facilities to
close and thereby restrict access for patients. Many of these comments
urged that the equipment requirements should be made to apply to
manufacturers of equipment for items manufactured after the specified
effective date of the regulations. A related comment suggested that the
current interim rule, which requires only that equipment be
specifically designed for mammography, is working well and that further
regulation proposed under Sec. 900.12(b) will serve only to stifle
invention, add cost, and ``overly rigidify'' this important aspect of
providing the highest quality mammography services at the lowest cost
to the public.

[[Page 55910]]

    FDA can understand why the last comment believes the interim
regulations are far less extensive than what was proposed. The interim
regulations address the equipment aspect of mammography quality
directly by listing four criteria that all X-ray systems used for
mammography must satisfy: (1) The X-ray equipment must be specifically
designed for mammography; (2) it must be certified to meet the
performance standards in 21 CFR 1020.30; (3) it must have a removable
grid; and (4) it must have a compression device. In addition, however,
the interim regulations required each facility to undergo an annual
survey in accordance with the standards specified in the 1992 or 1994
ACR QC manuals (see Sec. 900.12(d) and (e) of the interim regulations).
These manuals outline extensive requirements for the equipment
associated with the mammography process. In the final regulations, FDA
has not referenced these manuals although NMQAAC strongly advised their
continued use and has instead included specific requirements that were
part of the ACR standards under final regulations at Sec. 900.12(b) and
(e). Although they appear as new regulations, many of these new
provisions merely restate requirements that previously had been
referenced through the ACR manuals but are now reformatted as
regulation.
    FDA is also concerned about all costs associated with the
regulations under the MQSA, including those incurred by the purchase,
upgrade, and repair of equipment. However, FDA's authority under the
MQSA relates to the user of the equipment rather than the manufacturer.
Under authority granted to FDA by provisions of the act (which
incorporates the Radiation Control for Health and Safety Act of 1968),
FDA is pursuing a parallel path to generate standards for new equipment
under Sec. 1020.30. This process will take some time and regulations on
new equipment only gradually affect the installed base. The agency
concluded that regulations directed at new equipment only, and not the
installed base, would have inappropriately delayed the benefits of the
improvements provided by the new equipment for millions of women for a
number of years.
    For these reasons, FDA determined that equipment standards
implementing the MQSA should be directed to the installed base to
ensure that all women, not just those that utilize facilities with new
equipment, receive an adequate and equal baseline of care. Based on
facility inspection experience with the interim regulations, FDA does
not expect a large reduction in providers and anticipates no access
problems solely as a result of the equipment regulations. In addition,
FDA has provided mechanisms for alternate standards in Sec. 900.18 to
allow for innovation and flexibility under the final rule. The agency
has no reason to believe that the regulations will cause stagnation in
the market for new and useful equipment.
    (Comment 296). One comment asked if it was necessary to attempt to
codify and regulate equipment standards that, in the respondent's
opinion, will evolve anyway through competition in the market.
    Again, the agency responds that the introduction of new products
into the market place can be a slow process and waiting for
manufacturers to manufacture and market and for users to purchase would
not produce the change in minimum national standards that FDA perceives
is needed. Additionally, in FDA's experience, certain segments of any
market are often driven by price concerns rather than features or
performance. FDA believes that regulations are the only mechanism that
will provide the impetus to achieve the desired baseline of care in a
reasonable time.
    (Comment 297). One comment supported phasing in the equipment
standards over the next 1 to 10 years, as discussed in the preamble to
the proposal (61 FR 14909). Two comments stated that 5 years is not a
sufficient amount of time to require the purchasing of new equipment
and maintained that it would be more appropriate to allow a longer
phase-in period, for example, 10 years.
    Five comments offered a contrary point of view, suggesting that the
majority of the mammography equipment presently in use meets most of
the proposed standards in Sec. 900.12(b) and that many of the
timeframes proposed in Sec. 900.12(b) are excessively long. One of
these comments expressed concern that there are some facilities where
the machine limits the ability to do adequate imaging and the facility
will not get newer equipment if not forced by law to do so.
    FDA appreciates these comments and recognizes that some facilities
will not upgrade their equipment until the last possible moment,
thereby using equipment that has become inadequate by current
standards. The agency must balance these concerns with cost concerns
that facilities, patients, and FDA all share. The decision to require
certain equipment standards to be phased in relatively quickly and
postpone others represents the agency's efforts to balance these
competing concerns.
    (Comment 298). One comment suggested that there should be
regulations for needle biopsy systems in Sec. 900.12, including
provisions that address misalignment of the biopsy cross-hair. The
comment stated that the cross-hair assembly, if not accurately aligned,
may lead to inaccurate localization of lesions during needle
localization, increasing the possibility of morbidity. FDA recognizes
the need for regulation in this area and has raised the issue with
NMQAAC in the past. As a result of discussions with NMQAAC and opinions
offered by the ACR, the decision was made to delay regulations for this
aspect of breast radiography until community consensus can be reached
on all aspects of the process. As discussed earlier, FDA is currently
working internally on possible regulations for interventional
mammography, while awaiting the results of collaborative efforts
between the ACR and the American College of Surgeons to reach consensus
on recommendations for standards in this area.
    (Comment 299). One comment recommended that the equipment
specifications proposed under Sec. 900.12(b) should not be included in
the final regulations and that the entire section should be issued as
guidance rather than a binding regulation.
    FDA has considered this approach, but has determined that, because
the guidelines would not have the force of law, they would not achieve
the widespread results necessary to meet the goals of the MQSA.
    (Comment 300). Nine comments expressed concern that the proposed
regulations under Sec. 900.12(b) were not specific as to whether all
equipment in a facility must comply and one of these comments
questioned if existing mammography units must be redesigned and/or
upgraded to all the standards by the effective dates.
    FDA intends that all facilities performing mammography shall meet
each of the final regulations by the effective date of each
requirement. In the case of equipment, all equipment used for covered
mammography procedures must meet the requirements in effect at any
given time. If equipment must be repaired, replaced, or upgraded to
achieve this result, then such actions must be completed by the
effective date or the facility must discontinue offering mammography
services with the nonconforming equipment until compliance is achieved.
    (Comment 301). One comment stated that the equipment standards
sometimes

[[Page 55911]]

give very specific descriptions of testing equipment and procedures.
For example, in proposed Sec. 900.12(b)(4)(iv), FDA specifically
described a 12 cm diameter acrylic disc 1.5 cm thick. The respondent
was unsure why 12 cm was specified instead of 10, and why 1.5 cm was
specified instead of 1 or 2.
    FDA notes that in each case where test procedures and/or test
objects are specified in these final regulations, the objects or
procedures are usually based on established test protocols. In some
cases where the test object itself could be variable, the
specifications are identical to an object used in another required test
in order to reduce the number of items required for the entire survey
or inspection. In cases where the test or the test object is new, the
details of its design are beyond the scope of this document. FDA
intends, whenever possible, to issue guidance documents that will
address the use of such new procedures and equipment. The particular
example cited in the comment has been deleted from the final
regulations.
    (Comment 302). One comment stated that the proposed rules are not
entirely consistent with the guidance document developed by ACR and
CDC. The comment recommended that every effort should be made to ensure
consistency with the ACR guidance document.
    FDA is, of course, aware of the ACR/CDC document and, in fact,
adopted many of its requirements for these final regulations. However,
the ACR/CDC document was written as a guideline for new equipment and
not as a regulation for installed equipment. As a guideline, its
wording would not readily transfer to regulation and, as a
specification for new equipment, its scope was not sufficiently broad
to address the range of the installed base or the cost concerns
associated with upgrade and replacement of equipment. The agency also
notes that the recommendations in the ACR/CDC guidance represent an
attempt to describe an optimal system. NMQAAC and members of the public
have stated that some of the features, while desirable, would generate
costs not justified by the expected benefit, especially when applied to
the installed base. In those cases where the agency believes the
benefit does not warrant the cost, FDA has not made particular features
regulatory requirements. Within these limitations, FDA has generally
made efforts to remain consistent with the ACR/CDC guidance where doing
so is appropriate.
    (Comment 303). One comment suggested that a section in
Sec. 900.12(b) or (e) should address the issue of screen placement in
the cassette. The comment noted that, because the screen is sometimes
not positioned with its edge in contact with the inside wall of the
cassette at the chest wall, the film edge is underexposed or unexposed.
The comment suggested that ``such cassettes should be rejected and the
screens remounted.''
    FDA agrees that such conditions should not exist, but believes the
annual survey and normal QC procedures will identify and correct such
problems and is not considering regulations to address this concern at
this time.
    (Comment 304). One comment recommended that the proposed equipment
regulations in Sec. 900.12(b) be rewritten to correspond more closely
with existing international standards.
    In certain aspects of equipment related requirements, FDA has
attempted to conform to both national and international precedent.
However, in some cases, those guidelines are inappropriate or do not
address the specific concern being considered under the MQSA.
    (Comment 305). One comment suggested that the proposed requirements
of Sec. 900.12(b)(17) through (21), which do not relate to X-ray
equipment or film processors, should be included as part of the annual
physics survey and need not be specified by regulation. FDA believes
that this respondent misunderstood these provisions because the core of
the annual physics survey is, in fact, set forth in these regulations.
Some of these regulations have been modified and/or transferred to the
quality assurance section of the final regulations, while others have
been deleted. The remaining requirements may be checked as survey or
inspection items, verified by documentation provided by the
manufacturers, or established through normal QC procedures performed by
the facility. Although the agency has not expressly prescribed how
these requirements should be met in all cases, FDA has determined that
the facility is responsible for establishing compliance with these
standards rather than trusting that they would be included in all
medical physicists routine surveys.
    b. Prohibited equipment (Sec. 900.12(b)(1))
    This paragraph prohibited the use for mammography of general
purpose equipment or equipment designed for special nonmammography
procedures.
    (Comment 306). Seven respondents recommended that the use of
xeromammographic equipment should be prohibited or phased out.
    FDA considered taking this action but believes that the unique
characteristics of the xeroradiographic process may provide a valuable
tool in the diagnosis of some cases. Records obtained during the first
year of facility inspections under the interim regulations indicate
that there are an extremely small number of these units in service and
it is believed that the number will continue to decrease as their use
falls out of favor with the community. FDA has concluded, therefore,
not to ban their use.
    c. General (Sec. 900.12(b)(2))
    This paragraph, as proposed, required that all equipment be
designed for mammography and certified under Sec. 1020.30.
    (Comment 307). One respondent suggested that a definition of
``specifically designed for mammography'' be included because some
units may be used for imaging of extremities.
    FDA does not believe that this is necessary because the
manufacturer's labeling, along with the FDA device approval process,
ensures that the design is appropriate for mammography. FDA recognizes
the fact that the characteristics of mammography radiographic equipment
make it useful for other radiological examinations and does not intend
to restrict such applications if the product has also been approved for
that use.
    d. Motion of the tube-image receptor assembly (Sec. 900.12(b)(3))
    This paragraph proposed that the gantry be capable of specific
rotation, that the angle of the gantry be indicated, and that the tube-
image receptor assembly remain rigidly fixed in any position where it
was designed to operate.
    (Comment 308). Two comments noted a citation error in the proposed
regulations. One comment recommended the deletion of the entire
section, with the possible exception of requiring the system to remain
fixed when placed in an operating position. Three other comments
supported the proposed requirements, although one suggested that only
one unit at each facility need meet the requirements. NMQAAC supported
the proposed requirements, with the recommendation that they be
applicable only to equipment acquired 5 or more years after the
publication of the final regulations.
    FDA has determined that NMQAAC's recommendation to require
compliance only on equipment acquired 5 or more years after publication
of the final regulations presents major problems with respect to
enforcement. Such an approach would produce a situation where two
distinct levels of quality would be in place for different facilities

[[Page 55912]]

and often within the same facility, based on when equipment was
acquired. After reviewing the public comments and assessing the
possible cost impact of the requirements, FDA decided to remove the
provisions detailing the range of gantry motion and angle indication.
If this area is considered for future regulation, all comments
submitted on these sections will be reconsidered in the process. FDA
has reworded the provision that requires the tube-image receptor
assembly to remain fixed in its designed operating positions and this
requirement remains under Sec. 900.12(b)(3) in the final regulations.
The citation error has been corrected.
    e. Image receptor sizes (Sec. 900.12(b)(4))
    This paragraph requires that all mammography systems have, at a
minimum, both a 18 X 24 cm and 24 X 30 cm screen-film receptor and
matching grids, and that the grids should be removable. This section
also proposed that grid motion should not be impeded when a breast is
subjected to compression in the system.
    (Comment 309). Seven comments supported the proposal regarding the
image receptor sizes and matching grid requirements proposed in
Sec. 900.12(b)(4)(i). Two comments opposed the specification requiring
both a large and a small image receptor system in the regulations. One
of these misread the proposal as being applicable to xeromammographic
equipment and suggested that the regulation might prohibit the use of
such equipment because such systems may not provide multiple image
receptor sizes. The other comment supported the concept of requiring a
large and small image receptor combination, but opposed a provision
specifying the actual dimensions of these receptors. A related comment,
while not actually opposing the proposal, expressed concern that
requiring multiple image receptor sizes for screen-film systems might
establish difficult precedents for future technology.
    FDA believes that, for the present and foreseeable future, the
dominant film sizes used in screen-film mammography will remain 18 X 24
and 24 X 30 cm and has not been persuaded to revise the provision that
requires systems to have both sizes with corresponding grids. The
agency believes that the last comment is concerned with digital systems
currently under development and the concern that large or multiple
sized image receptors would be prohibitively expensive with such
systems. FDA has not formulated an opinion in this area and will wait
to see what final technology and configurations evolve for digital
systems before addressing this issue in regulation.
    (Comment 310). One comment, while neither agreeing nor disagreeing
with the requirement for multiple size image receptors, stated that the
use of smaller image receptors, even on large breasts, results in
clearer, sharper images and noted that larger areas compressed all at
once do not provide the sharpness and detail needed to pick up very
small cancers. The comment stated that, even though more films are
taken when a smaller film size is used to image a large breast, the
benefits of finding a life-threatening cancer far outweigh the minimal
increase in radiation exposure to the patient.
    FDA recognizes this practice as essentially the ``spot
compression'' of the entire breast in multiple exposures. Although
``spot compression'' can yield improved images, it is not a recognized
or accepted procedure in screening mammography. Interpreting physicians
who deem such studies necessary will order them to be performed, but it
is not standard practice for routine screening. The agency also notes
that the regulation merely requires that the two-image receptor sizes
be available; their use in any particular case is left to the judgment
of the mammography personnel involved.
    (Comment 311). One comment proposed that the requirement for
multiple image receptor sizes be restated to require at least one unit
at the facility to provide the multiple sizes, rather than requiring
each unit to have both receptors. Experts on NMQAAC recommended that
the requirements of Sec. 900.12(b)(4)(i) not be weakened by permitting
a facility to satisfy this equipment standard by having only one system
with the multiple cassette sizes. The rest of the committee agreed. FDA
has accepted this advice and retained this requirement under
Sec. 900.12(b)(4)(i).
    Section 900.12(b)(4)(ii) requires facilities to have systems with
moving grids matched to all image receptor sizes provided.
    (Comment 312). One comment commended FDA for requiring both an 18 x
24 and a 24 x 30 bucky for each unit. Another recommended that the
regulation read: ``Systems using screen-film image receptors shall be
equipped with separate moving grids matched to all image receptor sizes
provided.'' FDA does not believe that the suggestion was a significant
improvement and did not make the change.
    (Comment 313). One comment recommended the inclusion of a
requirement in Sec. 900.12(b) that specifies the image receptor support
device shall match the cassette size.
    The agency does not believe this additional requirement is
necessary. By requiring the system to have both a large and small image
receptor and corresponding sized grid assemblies, FDA is confident that
most technologists will select the appropriate receptor and cassette
size for each patient.
    Section 900.12(b)(4)(iii) requires the grid to be removable for
systems used for magnification.
    (Comment 314). Three comments requested clarification regarding
applicability and intent of this provision.
    FDA notes that the final regulation was drafted to clarify the
interim rule. Section 900.12(b)(4)(iii) simply states that the system
must be operable with the grid removed from between the source and the
image receptor when the technologist is performing magnification
procedures. This could be accomplished in various ways, including
actually removing the grid mechanism, substituting a nongrid film
holder for the grid film holder assembly, or any other mechanism that
ensures that the grid does not interfere with the image or the
automatic exposure control, if one is used.
    Under Sec. 900.12(b)(4)(iv), FDA proposed that the grid motion not
be impeded when the breast is compressed and also proposed detailed
requirements for verifying compliance.
    (Comment 315). Seven comments supported the proposed requirements
for assessment of grid related artifacts, while 14 comments supported
the concept of evaluating grid related artifacts, but opposed both
listing the requirement in regulation and the test procedure outlined
in the proposal on the basis that the test method was unproven and
objective standards for evaluation of the seriousness of the problem
were lacking. In April 1996, and again in January 1997, NMQAAC
recommended removing Sec. 900.12(b)(4)(iv) regarding the grid related
artifacts.
     FDA has accepted NMQAAC's recommendation and removed this
paragraph.
    (Comment 316). Twelve comments requested justification,
clarification, or suggested modifications for the test procedure
proposed under Sec. 900.12(b)(iv). If the issue is revisited for future
regulation, the comments to this section will be reconsidered at that
time.
    f. Beam limitation and light fields (Sec. 900.12(b)(5))

[[Page 55913]]

    This paragraph covers devices for limitation of the X-ray field and
specifies light localizer characteristics.
    Under Sec. 900.12(b)(5)(i), FDA proposed that all systems ensure
that the X-ray field can extend to or beyond the chest wall edge of the
image receptor.
    (Comment 317). Two comments interpreted this as a requirement that
the collimator must provide separate adjustability on the chest wall
edge and suggested that such adjustability is unnecessary.
    FDA accepted these comments and reworded Sec. 900.12(b)(5)(i) to
clarify that the intent is not that the collimator be adjustable, but
that the collimator allow complete coverage of the image receptor at
the chest wall edge unless it is the intent of the operator to not do
so. This requirement has been moved to the quality assurance section
and appears in Sec. 900.12(e)(5)(vii).
    Section 900.12(b)(5)(ii) proposed that any system with a light
field that appears to approximate the X-ray field must approximate the
X-ray field to a specified tolerance and that the light must produce a
minimum specified brightness. Four comments supported the alignment
recommendations with the observation that, in the respondents'
opinions, the alignment was more important on the chest wall edge.
    (Comment 318). Two comments expressed disagreement with this
requirement. In Sec. 900.12(b)(5)(ii), FDA also proposed a definition
for the mammographic source to image receptor distance (SID) that was
changed slightly from the definition used for more general purpose
radiographic systems in order to be more consistent with the actual
usage in mammography. Two comments supported this change, two opposed
it, and one respondent expressed concern that the definition of SID in
this section might be confusing.
    After reviewing the comments, FDA has determined that the
requirements for the alignment of the light field and X-ray field and
the definition of SID are adequately addressed by existing regulations
in Sec. 1020.31, and has deleted the proposed requirements from this
standard. A QC test to verify alignment now appears in the quality
assurance section at Sec. 900.12(e)(5)(vii).
    With respect to the proposal that the light provide a minimum
illuminance, two comments supported the requirement and four comments
opposed it.
    FDA notes that this proposed requirement is the same as that
currently required for general purpose systems covered by Sec. 1020.31.
Thus, it already applies to such collimators using such light
localizers on mammography systems. FDA has chosen to restate the
specification here to eliminate any confusion and to clarify that the
general requirement also applies to mammography equipment. The
restatement now appears under Sec. 900.12(b)(5)(ii) in the final
regulations.
    Under Sec. 900.12(b)(5)(iii), (iv), and (v), FDA proposed a phase-
in of additional requirements. The first stage required all mammography
systems to incorporate such a light localizer 5 years after
publication. The second stage required that 10 years after publication,
all mammography systems were to prevent X-ray production unless the
correct combinations of field size and image receptor were selected and
to prevent any exposure with an X-ray field exceeding the size of the
image receptor support device.
    (Comment 319). Three comments supported the requirement for the
light field as proposed, with one of these urging that it be instituted
at the earliest date the regulations become effective. One comment
agreed that a light field, as proposed, may be a desirable feature but
thought properly trained personnel are able to position the breast
correctly without a light and suggested that the requirement should be
deleted because, in the respondent's opinion, the cost would be too
high to justify. NMQAAC supported the requirement for a light field, as
proposed. Four comments supported the proposed requirements in
Sec. 900.12(b)(5)(iv) and (v) but one of these suggested that a means
to override the interlocks should be provided. One comment opposed both
proposals.
    FDA has reevaluated these proposals and concluded that they raise
safety concerns related to X-ray systems in general rather than image
quality concerns. For this reason, and the cost concerns discussed
previously, the agency has decided to delete both Sec. 900.12(b)(5)(iv)
and (v) from these regulations and to develop such requirements under
the authority provided in the act for regulatory products subject to
the Radiation Control for Health and Safety Act of 1968. Accordingly,
FDA is discussing relevant changes to part 1020 with its Technical
Electronic Product Radiation Safety Standards Committee.
    After the revisions to the proposal were completed, there remained
only two paragraphs in this provision: Sec. 900.12(b)(5)(i), requiring
beam limiting devices that allow the useful beam to extend to or beyond
the chest wall edge of the image receptor; and Sec. 900.12(b)(5)(ii),
which establishes the illuminance requirement.
    g. Source-image receptor distance (SID) (proposed
Sec. 900.12(b)(6))
    FDA proposed requirements for a minimum SID for mammography systems
and specified that the SID must be displayed. The agency also proposed
an accuracy specification for that display. In Sec. 900.12(b)(6)(i),
FDA proposed that all mammography systems have a minimum SID of at
least 55 cm.
    (Comment 320). One comment recommended that FDA include a
definition of ``contact mammography'' as used in Sec. 900.12(b)(6)(i)
to eliminate confusion about its meaning. Another comment supported the
minimum SID as proposed, and six comments supported the concept but
recommended that the minimum SID be reduced to 50 cm; NMQAAC supported
the proposal as published.
    In considering these comments and other more general comments
relating to avoidance of unnecessary specifications that may limit
future technology, FDA has decided that other requirements in the final
regulations (dose, resolution/focal spot condition, and system output)
make issuing this requirement unnecessary. Therefore, the limitation on
the SID has been removed from the final regulations. In the future, if
the agency determines that regulations covering this area are required,
all relevant comments will be reconsidered at that time.
    In Sec. 900.12(b)(6)(ii), FDA proposed that each system should
provide a visual indication of the SID, accurate to within 2 percent.
    (Comment 321). One comment stated that the actual SID needs
definition or that there should be specification of an acceptable
method of verifying the SID or location of the focal spot. Other
comments were concerned with uncertainties in determining the end
points of the SID. One comment noted that the indication of the SID
proposed in Sec. 900.12(b)(6)(ii) might differ between systems because
of differences in interpretation of the location of the image receptor.
Conversely, another comment suggested that the concept of an indication
of the SID, as proposed in Sec. 900.12(b)(6)(ii), is ambiguous for
those systems having multiple focal spots and anode tracks because all
focal spots are not at the same location on the anode. The comment
further suggested that the ``source'' be defined as the average
location of all focal spots.
    Another comment noted that the standards in IEC 601-1-3(point
29.203.2) specify a tolerance of 5 percent for the SID indicator and
requested that FDA consider adopting that specification rather than the
2 percent proposed. One comment suggested that FDA might wish to

[[Page 55914]]

consider recasting the proposal of Sec. 900.12(b)(6) as an outcomes
specification. Another comment recommended that the proposed
requirement in Sec. 900.12(b)(6)(ii) for indication of SID be restated
to require the indication only for variable SID units. NMQAAC
recommended that the section be deleted because they believed that it
would add to the equipment costs with little benefit to the quality of
mammography.
     FDA has accepted the NMQAAC recommendation and deleted
Sec. 900.12(b)(6)(ii). If this issue is revisited, all comments will be
reconsidered at that time.
    h. Magnification (Sec. 900.12(b)(6) (proposed Sec. 900.12(b)(7)))
    As proposed, this paragraph required that systems used for
procedures beyond basic screening mammography have magnification
capability available to the user.
    (Comment 322). One comment suggested that the proposal was unclear
as to the intent of ``available to the user.'' One comment incorrectly
assumed that, because there was no implementation date for the
requirement, all diagnostic equipment installed presently have
magnification capability and will meet the requirement. One comment
expressed concern that this requirement made his facility's equipment
obsolete and stated that most diagnostic mammography does not require
magnification.
    The radiologists on NMQAAC stated that magnification is needed for
noninterventional problem solving mammography. The committee debated
whether to recommend to delete or change these provisions and decided
not to recommend such actions.
    FDA has retained the provision, but reworded parts of the proposal
to clarify the intent. The changes include replacing the term
``diagnostic mammography'' with ``noninterventional problem solving
mammography.'' This change was necessary because there is no general
consensus as to the definition of ``diagnostic mammography.'' ``Problem
solving mammography'' refers to mammography requiring techniques beyond
those utilized in standard mammography of asymptomatic patients and
``noninterventional'' indicates that the procedures are noninvasive in
nature. The term ``available to the user'' simply means that any
attachments or accessories necessary to allow the X-ray system to
perform magnification procedures must be present with the system and
available to the technologist to encourage and facilitate the use of
the feature.
    (Comment 323). Four comments recommended that the specification be
reworded to require the facility to have the capability to provide
magnification instead of requiring that each system provide the
feature. However, the experts on NMQAAC stressed the importance of
requiring the feature in each system used for such procedures and FDA
has retained the requirement.
    In Sec. 900.12(b)(7)(ii) of the proposal, FDA specified that at
least one magnification setting should be in the range of 1.4 to 2.0.
One comment suggested that the use of magnification greater than 1.5 is
questionable and that limits for the image quality and average
glandular dose should be set for these conditions.
    FDA agrees, in principle, with this comment. Generally,
magnification for these procedures is accepted within the range
specified by the requirement and most sources seem to agree that
magnification at approximately 1.5 is optimal. FDA believes that by
requiring the equipment to provide magnification in the optimum range
the facility will then be able to adequately perform the procedure.
Some systems currently used for magnification will not meet this
standard. This will not, in itself, however, force the replacement of
the equipment because the unit may still be used for the general
population ``screening'' of asymptomatic patients so long as it meets
the other requirements.
    (Comment 324). One comment noted that ``magnification setting'' as
used in the proposal was not defined. Another comment stated that the
method of determining the magnification, along with acceptable limits,
should be specified or referenced. FDA has removed the word
``settings'' from the requirement because it might be confusing but has
not added a definition of ``magnification'' to Sec. 900.2; FDA believes
that the term is generally understood to be the ratio of the source-to-
image receptor distance to the source-to-object distance.
    Because the proposed SID requirements were moved, proposed
Sec. 900.12(b)(7) Magnification has been codified as Sec. 900.12(b)(6).
    i. System resolution (proposed Sec. 900.12(b)(8))
    This paragraph proposed requirements for the system resolution for
both contact mode and magnification mode mammography.
    (Comment 325). Nine comments requested that a test procedure be
specified for the contact mode requirement proposed in
Sec. 900.12(b)(8)(i). One comment suggested that a specification of the
appropriate resolution target should be included along with a
specification of its position in the test plane, and a requirement for
an absorber in the beam to lengthen the exposure times, because very
short exposures may introduce interference from gridlines.
    FDA agrees with these comments and has included a description of
the test conditions in the final regulations.
    (Comment 326). One comment correctly noted that the requirements in
proposed Sec. 900.12(b)(8)(i) and (ii) attribute failure to meet
resolution requirement to problems with the focal spot when, in fact,
the cause of observed low resolution values may be some other component
in the imaging chain.
    FDA agrees with this comment and has rephrased the requirement.
    Based on recommendations from NMQAAC, FDA has removed this
requirement from the equipment standard and established a QC
requirement for system resolution that is codified under
Sec. 900.12(e)(5)(iii).
    In Sec. 900.12(b)(8)(ii), FDA proposed regulating the system
resolution in the magnification mode. Based on guidance received from
NMQAAC, FDA has moved this requirement to the quality assurance
provisions in Sec. 900.12(e)(5)(iii), and has designated it for phase-
in after 5 years. If, in that time, other values are determined to be
more appropriate, the regulations will be modified accordingly.
    Thus, proposed Sec. 900.12(b)(8) System resolution, no longer
appears among the equipment requirements.
    j. Focal spot selection (Sec. 900.12(b)(7) (proposed
Sec. 900.12(b)(9)))
    As proposed, this provision included several requirements for
indication of the focal spot selected for use in examinations,
interlocking of the focal spot with selected kVp, and alignment of the
focal spot with the image receptor. FDA also proposed that the system
indicate which focal spot and, where applicable, which focal spot
material is selected prior to exposure. The proposal also recognized
that some systems may automatically select the focal spot during the
exposure and required a post exposure indication of the focal spot used
during such exposures.
    (Comment 327). Three comments, including that of NMQAAC,
recommended that the requirements proposed in Sec. 900.12(b)(9)(ii) and
(iii), concerning indication of the target material, be linked with an
``or.''
    FDA did not accept this recommendation because it would essentially
eliminate the requirement for post-exposure indication of the machine
selected focal spot. The agency believes that the change would modify
the

[[Page 55915]]

requirement in a way the agency does not intend or desire because it
would permit the equipment to display only the initial preselected
focal spot and never indicate the actual focal spot used.
    (Comment 328). Two comments supported the proposal in
Sec. 900.12(b)(9)(iv) that the system be interlocked to prevent
exposure with improper or incompatible combinations of kVp and target
material. One comment opposed this requirement, two requested
clarification, and one requested a test procedure. NMQAAC recommended
that the initial clause in the proposal be deleted.
    After further consideration of this requirement, FDA concluded that
the requirement was already adequately covered by requirements relating
to diagnostic X-ray systems in Sec. 1020.30(m) and has deleted proposed
Sec. 900.12(b)(9)(iv).
    k. Focal spot location (proposed Sec. 900.12(b)(10))
    This paragraph proposed a requirement that the focal spot be
located in a specific geometric relationship to the image receptor.
    (Comment 329). One comment supported the requirement, five
(including NMQAAC) opposed it, believing that it was unnecessary, three
requested clarification on its testing, and one, recognizing its
relationship to the compression paddle alignment, recommended that the
provision be moved to the section on compression paddle alignment.
    FDA accepted the NMQAAC recommendation and deleted this requirement
from the final rule.
    l. Filtration (proposed Sec. 900.12(b)(11))
    This proposed paragraph contained a statement requiring mammography
systems to comply with the beam quality standards for half-value-layer
(HVL) codified at Sec. 1020.30(m)(1).
    NMQAAC recommended that the section specifying the HVL requirements
should be moved to the QC section. FDA accepted this recommendation and
codified the requirements for filtration under Sec. 900.12(e)(5)(iv).
    (Comment 330). One comment suggested that the proposed rule in
Sec. 900.12(b)(11)(i) was too vague and subject to arbitrary
interpretations. Another comment recommended that more precise rules be
used to determine the required HVL and suggested that existing dose
tables could be used to determine the desired limits. The respondent
based this position on the fact that Sec. 1020.30(m)(1) requires the
interpolation or extrapolation of HVL values in the mammographic range.
One comment noted that filtration is not the same as HVL; the HVL
measure indicates the filtration that is in the X-ray system, but it is
not an actual measurement of filtration. Two comments noted that the
proposed regulations refer to Sec. 1020.30(m)(1) for the minimum
filtration requirement and incorrectly interpreted this as a lack of
specification for kVp's not listed. They asked what FDA is planning to
do concerning the perceived lack of regulation of filtration for kVp's
below 30 kV since the table of HVL specifications does not list any
values below 30 kV. One comment stated that some realistic values for
expected HVL at ranges of 25 to 30 kVp should be given. One comment
stated that Sec. 900.12(b)(11)(i) seems less specific than current
requirements for filtration and another comment suggested that the
requirement in Sec. 900.12(b)(11)(i) should be referenced to the most
recent ACR physics manual instead of Sec. 1020.30(m)(1).
    FDA believes that the comments indicate that relationship between
filtration and half-value-layer (HVL) in the mammographic energy range
and the concept of mathematical extrapolation and interpolation may not
be fully understood by some members of the mammography community. It is
generally understood that the first HVL is an indirect measurement of
the filtration in the X-ray beam. In the kVp range up to 50 kVp, the
values specified in Sec. 1020.30(m)(1) represent a beam with an
inherent filtration equivalent to 0.5 mm of type 1100 aluminum. FDA
notes that, although the standard relates the HVL in terms of type 1100
aluminum, it does not specify that the same alloy be used to measure
the HVL. Therefore, the measurement of the first HVL and the comparison
of the result to the specification indicate whether the system has
sufficient filtration in the beam; if the first HVL is less than the
number specified in the table, there is insufficient filtration because
the HVL is a function of the filtration and the energy of the X-ray
beam (kVp).
    In response to the comments, FDA has provided a table of the
extrapolated values of HVL in the mammography kVp range under the
quality assurance provisions in Sec. 900.12(e)(5)(iv). Values not shown
may be derived by interpolation. FDA believes that providing these
values, which are derived from the Federal performance standard at 21
CFR 1020.30(m)(1) and are serendipitiously identical to the ACR
recommended values when the paddle is not in the beam, makes it
unnecessary to reference the ACR manuals or any other external source
of HVL values.
    (Comment 331). Five comments supported a specification of a maximum
filtration requirement in Sec. 900.12(b)(11)(i) and another comment
recommended that a maximum HVL, specified as a function of kVp, be
added for each known combination of anode and filter materials. One
comment noted and agreed with the deletion of the upper limits for HVL
that had been proposed in previous drafts of the proposed regulations.
    FDA deleted those upper limits because it had concluded that other
aspects of performance and image acceptability will serve to limit the
maximum filtration. Comments to the proposal have not persuaded the
agency to reverse that position.
    (Comment 332). One comment noted that Sec. 900.12(b)(11)(i)
references Sec. 1020.30 and questioned the need to repeat the
requirement. The comment also found the proposal ``redundant with
Sec. 900.12(b)(2),'' which requires equipment to be specifically
designed for mammography. FDA does not agree that the references are
redundant and has concluded that the restatement in this regulation
serves to clarify and reinforce the Sec. 1020.30 specification.
    One comment suggested that the regulation be recast in terms of
desired outcomes and offered this example: ``The type and quantity of
filtration interposed between the source and the breast entrance
surface shall be such as to provide the maximum subject and image
contrast consistent with limitations on dose (Sec. 900.12(c) of the
interim regulations) and minimum half-value layer
(Sec. 1020.30(m)(1)).''
    FDA believes this suggestion would introduce an unacceptable level
of subjectivity into the evaluation process without eliminating the
need to reference the specification in Sec. 1020.30(m)(1).
    FDA also reconsidered the requirements in Sec. 900.12(b)(11)(ii)
for variable filtration systems, which proposed interlocking the
filtration with the target material. Upon further review, the agency
concludes that requiring equipment to meet standards that ensure that
the minimum filtration required in Sec. 1020.30(m)(1) is in the beam
during each exposure is sufficient to ensure proper filtration and has
deleted Sec. 900.12(b)(11)(ii) from the final regulation.
    m. Compression (Sec. 900.12(b)(8) (proposed Sec. 900.12(b)(12)))
    This paragraph proposed a number of requirements concerning the
application of compression. The basic proposal was

[[Page 55916]]

that each mammography unit should have a compression device.
    (Comment 333). Five comments and several members of NMQAAC
supported the proposed requirement. One comment suggested that FDA
should go further and require the use of the compression device.
    If the compression device is present, most technologists will use
it responsibly and also recognizes that the use of an item is difficult
to enforce. FDA, therefore, has rejected this suggestion.
    Under Sec. 900.12(b)(12)(i) FDA proposed that, 5 years after
publication, each system would be required to be equipped with an
initial, foot controlled, power driven compression and also be required
to allow the user to control additional ``fine adjustment'' of the
compression. The proposal required that both controls be operable from
each side of the patient.
    (Comment 334). Two comments stated that power-driven compression by
foot control is unreasonable or unnecessary. One comment stated that
FDA should delete the requirement for fine adjustment controls and the
specifications on how the compression controls should operate because
they will increase the cost of new equipment while providing little
benefit. Another comment stated that no requirement beyond one that the
system ``be capable of maintaining a force of 25 pounds for 15 seconds
and have a maximum force no greater than 40 pounds when used in
automatic or power driven mode'' is necessary.
    In contrast, twenty-eight comments agreed that ``automatic'' power
driven compression should be required of all facilities but stated that
it should be put in effect immediately, not 5 years from now, as
proposed. Several of these comments expressed the opinion that the
technologist needs to have both hands free to optimize the breast
position. Five comments stated that manual and power compression
controls, as called for, are essential for quality mammography. The
comments further noted that manual controls are needed for finer
adjustment and that the two controls complement each other, although
one comment expressed the respondent's belief that the fine adjustment
should be a manual control because that type of control was reassuring
to some patients. One comment recommended that the reference to ``foot
controls'' be deleted since the goal of ``hands-free'' application of
compression may be achievable by some mechanism other than a foot
operated control.
    FDA has accepted the last comment and modified the requirement
accordingly. However, FDA believes that this ``hands free'' application
of power compression and the fine adjustment control are basic to the
delivery of quality mammography care and is retaining the requirements
in the final regulations. FDA appreciates that this will have a cost
impact on the installed base; however, the agency believes that the
benefit to public health outweighs this cost and also notes that most
of the current equipment can be brought into compliance with
modifications that are far less costly than total replacement.
    (Comment 335). One comment suggested that FDA might wish to recast
the proposal in terms of the desired outcomes, for example:
     Means of applying compression to the breast shall be provided
that; (i) allow the technologist to use both hands to position the
breast while applying compression, (ii) facilitate positioning from
both sides of the patient without removing hands from the patient,
(and) (iii) allow a slow, final adjustment of compression.
    While FDA appreciates this suggestion, the agency believes that
such terms as ``allow'' and ``facilitate'' require too much subjective
evaluation in the interpretation of compliance. Under some design and
use conditions, certain technologists may be able to demonstrate that
the equipment meets these requirements, while others may not. FDA
believes that establishing reasonable standards for the equipment
allows the majority of technologist the greatest opportunity to achieve
optimal positioning for even the most challenging patients.
    (Comment 336). One comment stated that a number of different types
of mammography systems in use either do not offer automatic compression
or have only automatic compression with no manual compression knob. The
comment suggested it would be worthwhile to retain maximum flexibility
in the final regulation to allow evaluation of this type of retrofit
system, so long as the intent and specifications of the final
regulations were met. A second comment stated that the ``fine
adjustment compression,'' as proposed, would place a costly burden on
some facilities that do not have manual compression. Another comment
indicated that when requiring all units to have a power driven
compression paddle activated by foot controls, as proposed, it is also
necessary to have a manual compression mode as well. One comment
suggested that final compression should always be done using a hand
control knob, which the technologist can easily control with direct
tactile feedback. One comment agreed that it is necessary to have power
driven compression, as proposed, but noted that it was not necessary
that the fine adjustment control be power driven. One comment noted
that the proposed requirements do not preclude the equipment from
having a manual compression provision.
    Many of these comments resulted from misreading the proposed
regulations. The proposal does not require the fine adjustment
compression be a manual operation. The fine adjustment is usually a
``manual'' adjustment in that it is applied by a hand operated
(``manually operated'') control. This does not imply or require the
provision of a direct linked drive dependent only on the input force
provided by the operator. Many of the ``manual'' knobs are actually
servo-driven power compression devices that are under a more closely
controlled incremental advance than that provided by the foot control
and, in these cases, the ``tactile'' feed-back sensed by the
technologist is not necessarily related to the force applied to the
patient. As the regulations are written, the design of the equipment
can provide a truly ``manual'' control for the fine adjustment, or can
provide a slower power driven application that may be adjusted by a
hand control or other suitable means. FDA believes that most equipment
with power-driven compression already provides a fine adjustment
control and that the cost impact on those facilities not presently
meeting this requirement will be outweighed by the advantages to
positioning and improved image quality.
    (Comment 337). Five comments suggested that a requirement for
maintaining compression for a specified period of time should be added
and one suggested that this specification should be established for
both automatic and fine adjustment compression.
    FDA proposed the criteria for application of compression without
stating a specified time for maintaining the compression. This means
that FDA expects the compression to meet the criteria in the
regulations until the compression is terminated, either by an automatic
release at the end of the exposure or by operator intervention during
or after the exposure. Therefore, it is not necessary to expressly
establish a time limit for maintenance of compression.
    NMQAAC discussed these provisions at some length and several
committee members spoke about the importance of compression to the
overall quality of

[[Page 55917]]

mammography. The committee recommended that the requirements for power
driven and fine adjustment compression become effective immediately but
that the requirements for the maximum force in the initial power drive
remain a 5-year phase-in requirement. The agency considered the
recommendation to move forward the effective date for the power driven
and fine adjustment controls, but has determined that the cost
considerations associated with accelerating the implementation of these
requirements cannot be justified based on the expected improvements.
Therefore, FDA has reworded these requirements to address some of the
above comments, and has retained the effective date that was proposed.
    Section 900.12(b)(12(i)(C) proposed limits on the compression force
required for the automatic power compression mode.
    (Comment 338). Two comments stated that the proposed requirement
for 25 to 40 pounds under power driven compression was excessive and
may result in patient injury.
    Based on input from NMQAAC, ACR, and the general comments provided
by manufacturers, FDA believes that 25 to 45 pounds is an appropriate
range and presents little risk of injury to patients when applied by
trained technologists.
    (Comment 339). One comment observed that the proposal only limits
the compression under power driven control and recommended that an
upper limit be set for the maximum compression under manual control.
    Although FDA had considered such an upper limit, the idea was
opposed by NMQAAC because they felt that it was unnecessary. FDA is not
proposing such a limit at this time.
    (Comment 340). One respondent was concerned that there may be units
designed to achieve the proposed compression forces but that have user
adjustable controls that allow adjustment to values below the minimum
proposed specification.
    FDA agrees that such equipment may exist or be introduced into the
market place. The agency notes that under the regulations, as codified,
the requirement is for values attainable by the user. If the user has
direct control over any such system adjustment, then this adjustment
must be used in testing the system. If such adjustment is only
available through service or installation configuration, then the unit
should be tested only to the limits adjustable by the operator. Under
these circumstances, the respondent's concerns are adequately addressed
because any user adjustable controls must be utilized in determining
the compliance of the system with the standards. FDA has moved the
requirement for the range of acceptable power driven compression to the
quality assurance section under Sec. 900.12(e)(4)(iii).
    Under Sec. 900.12(b)(12(ii)(B), FDA proposed that each system have
a means for manual compression release in the event of failure of other
decompression mechanisms.
    (Comment 341). One comment questioned if the wording meant that
compression must be maintained in the event of power failure and, if
so, must the required display of override status also be maintained
after power failure.
    FDA intends that the compression be maintained after a power
interruption. However, the display of override need not continue in
such circumstance because the fact that the patient is still under
compression would serve as adequate indication that manual release is
required.
    (Comment 342). One comment noted that there were many designs
currently on the market that allowed for the manual release of the
compression without the presence of a specific device as called for in
Sec. 900.12(b)(12)(ii)(B). The comment requested that the proposal be
reworded to emphasize the desired outcomes rather than a specific means
of obtaining those outcomes.
    FDA believes that the wording in the proposal does address outcomes
and does not intend the provision to require any specific release
design. Any mechanism that allows the manual release of compression
would meet the requirement. The requirements for the compression forces
and decompression have been moved, as recommended by NMQAAC, to the
quality assurance section of the regulations and are addressed in
Sec. 900.12(e)(4)(iii) and (e)(5)(xi).
    In Sec. 900.12(b)(12)(iii)(A), FDA proposed that systems be
equipped with different sized compression paddles matching the sizes of
all full-sized image receptors provided and that compression paddles
for special purposes, including those smaller than the full size of the
image receptor (for 'spot compression') could be provided. FDA did not
require that these special paddles be provided but included the
reference to clarify that these paddles could be included in the system
and are exempt from certain parts of the requirements applicable to the
full size paddles.
    (Comment 343). Three comments supported the requirement in
Sec. 900.12(b)(12)(iii)(A) as written. One comment recommended that the
proposed requirement be expanded to require that facilities have the
``spot compression paddles'' available. NMQAAC supported the proposal
as published.
    FDA has done some minor rewording in this paragraph and renumbered
it in the final regulations under Sec. 900.12(b)(8)(ii)(A).
    In Sec. 900.12(b)(12)(iii)(B), FDA proposed that the compression
paddle be flat and parallel to the patient support and not deflect from
parallel by more than 1.0 cm at any point when under compression.
    (Comment 344). Nine comments opposed the proposed requirement.
Three of these suggested that this is not the best way to compress the
breast because it ignores the anterior tissues and the often thicker
tail of the breast. One comment stated that nonparallel paddles are
useful for compression of very large breasts in the MLO view. Another
comment noted that one manufacturer's equipment does not meet the
proposed requirement, suggested that the subject does not need
regulation, and recommended that the section be deleted. This comment
maintained that the exemptions available for alternate devices would be
``much too difficult to use to allow possible improvements.'' One
comment responded to FDA's request for comments on the nonparallel
``alternate design'' compression paddle by supporting the concept of
allowing such a configuration under the proposed regulations. The
comment further noted that some manufacturers are investigating the use
of compression paddles that apply compression in nonparallel geometry
and that these paddles would have difficulty complying with the
regulation as proposed. One comment suggested that the proposed
requirement was too restrictive, stating that several manufacturers
have measured the paddle deflection on their units and found that the
requirement may be difficult to meet on the 24 x 30 cm paddles. One
comment suggested that the proposed specification could be improved if
the tolerance were loosened, if the measured compression force were
reduced, or if the allowable flex were expressed as a function of the
applied force.
    Two comments asserted that the proposed regulation in
Sec. 900.12(b)(12)(iii)(B) places too great an emphasis on the position
of the compression paddle, but does not address the position of the
film in the patient support. These comments recommended that the
regulations

[[Page 55918]]

address the film location with respect to the edge of the patient
support and relax the requirements for the compression plate. Three
comments suggested that the description of the test method as proposed
in Sec. 900.12(b)(12(iii)(B) should be deleted and that testing
procedures should be left to the medical physicist to determine, or be
included in a companion manual prepared by FDA. Fifteen comments
neither supported nor objected to the proposed requirement, but were
concerned with the test procedure as proposed and suggested
modifications or requested clarification of the procedure.
    NMQAAC discussed this section at some length. Some members and
consultants were concerned that the specifications in the proposal
would limit the introduction of new equipment and, even though the
regulations provide procedures for obtaining approval for alternate
standards, wanted to modify the requirement. Experts on the committee
stressed that the purpose of this regulation was to eliminate those
worn and faulty compression devices that were intended to be flat and
parallel by design but which, through use, now flex unacceptably. After
consideration, the committee recommended that the requirement remain
but that a new provision be added that addressed those paddles that by
design were not intended to remain straight and parallel under
compression. They also recommended that the test procedure described in
this section be deleted as a requirement because it could be determined
by the physicist during the survey.
    In response to the public comments and NMQAAC recommendations, FDA
has made changes as outlined below. FDA is deleting the provision that
established a test procedure for this section. The requirements have
been modified and renumbered as Sec. 900.12(b)(8)(ii)(B) and a new
Sec. 900.12(b)(8)(ii)(C) requires that all paddles intended by the
manufacturer's design not to be flat and parallel under compression
must meet the manufacturer's design specification and maintenance
requirements. The agency will revisit and modify its proposal for the
test procedure for this section in the future and all comments
regarding the procedure will be considered again in that process.
    Under Sec. 900.12(b)(12)(iii)(C) and (D), FDA proposed that the
chest wall edge of the compression paddle should be straight and
parallel to the edge of the image receptor and that the chest wall edge
of the compression paddle should not interfere with the chest wall edge
of the image.
    (Comment 345). Two comments requested clarification on how straight
and how parallel the requirement intended the chest wall edge of the
paddle to be. One comment agreed with the intent of the proposed
regulation, but expressed concern that varying interpretations of the
written regulation will lead to confusion in enforcement. This comment
recommended that, if such specifications are included in the final
regulations, there should be some tolerance specified that is both
affordable and effective in the improvement of mammography.
    FDA notes that the intent of this section is to eliminate the older
style compression paddle that had a curved chest wall edge. The agency
believes that the words straight and parallel are well understood but
will address concerns raised by the comments through issuance of a
guidance on this paragraph that contains a test procedure facilities
may utilize. The description of this procedure should also clarify any
confusion regarding FDA's interpretation of the regulation.
    In Sec. 900.12(b)(12)(iii)(D), FDA had proposed that the chest wall
edge of the compression paddle should be bent upward.
    (Comment 346). One comment recommended that the proposed regulation
include a requirement that the chest wall edge of the paddle be
perpendicular to the surface of the compression plate. Another comment
stated that the use of ``should'' in Sec. 900.12(b)(12(iii)(D) has
little meaning and is unenforceable.
    NMQAAC discussed both paragraphs and did not recommend any changes.
FDA notes that this provision was not intended to establish a mandatory
requirement but to clarify that such a design, intended to enhance
patient comfort, was permissible. This requirement has been codified
under Sec. 900.12(b)(8)(ii)(E) in the final regulations. The word
``should'' has been replaced with ``may'' in the final rule. FDA does
not agree that it is advisable to require the chest wall edge to be
perpendicular to the surface of the compression paddle since this could
lead to sharp edges that might cause patient discomfort.
    Under Sec. 900.12(b)(12)(iv)(A), FDA proposed that, 5 years after
the publication date of the final regulations, the edge of the
compression paddle shall align with the chest wall edge of the image
receptor to within 1 percent. Proposed Sec. 900.12(b)(12)(iv)(B)
further restricted the alignment to within 2 millimeters 10 years after
publication and Sec. 900.12(b)(12)(iv)(C) proposed a test procedure for
the requirement.
    NMQAAC recommended that the Sec. 900.12(e)(12)(iv)(A) be moved to
the QC section of the final regulations and that the requirements
should go into effect at the earliest opportunity. NMQAAC also
recommended that the requirement under Sec. 900.12(b)(12)(iv)(B) and
(C) be deleted because the committee believed the proposed 2-millimeter
requirement was too stringent. The proposed 2-millimeter requirement
and the test procedure have been deleted and the final regulation
regarding compression paddle-image receptor alignment was moved to the
quality assurance section and is codified under
Sec. 900.12(e)(5)(vii)(C) where it will become effective at the
earliest effective date.
    (Comment 347). One comment recommended caution in specifying these
alignment requirements because they might limit design in some areas of
new technology. The comment recognized that these proposed
specifications are only applicable to film-screen systems, but
expressed concern that the concepts might carry over into new
technology areas.
    FDA assumes that this comment was directed toward the issue of
image receptor size for digital systems, but does not anticipate any
conflict.
    (Comment 348). Eleven comments agreed with tightening the tolerance
for alignment as proposed in Sec. 900.12(b)(12)(iv) but suggested that
only a positive misalignment should be allowed.
     FDA agrees and accepts these comments.
    (Comment 349). Eight comments noted a typographical error in
Sec. 900.12(b)(12)(iv)(A). FDA has corrected this.
    (Comment 350). Three comments recommended that the ``October 1,
2000'' effective date be deleted and that the requirement go into
effect in the earliest phase because, in the respondents' opinions, the
vast majority of systems already meet this requirement.
    FDA agrees with these comments and has accepted this recommendation
to move the effective date forward.
    (Comment 351). Six comments expressed concern regarding the test
for this paragraph.
    These comments will be reconsidered when FDA publishes its
guidelines for the QC test.
    Under Sec. 900.12(b)(12)(iv)(D), FDA proposed that the alignment
criteria for the contact mode should also be applicable to the
magnification mode 10 years after the publication of the final
regulations and proposed a test procedure.

[[Page 55919]]

    (Comment 352). Five comments suggested that the requirement was
unnecessarily restrictive and should be dropped. Four comments
supported the proposed requirement, believing it serves to ensure the
accuracy of the alignment of the edge of the compression paddle with
the edge of the image receptor. One comment recommended a rewording for
the requirement. Two respondents expressed concern regarding the test
procedure. NMQAAC suggested that the requirement in the magnification
mode was unnecessary and should be deleted.
    After reviewing the comments, FDA has accepted the NMQAAC
recommendation and deleted the requirement for paddle alignment in the
magnification mode.
    Under Sec. 900.12(b)(12)(v), FDA proposed that, 5 years after
publication of the final regulations, all systems should display the
compressed breast thickness. The proposal also established a test
procedure for the requirement.
    (Comment 353). One comment pointed out that current indicators of
compressed breast thickness are grossly inaccurate for a number of
reasons, including paddle and compression arm flex, lack of uniformity
across the breast, and differences in the location at which various
manufacturers determine the breast thickness (since there is no
agreement where the breast thickness is to be measured). Two comments
recommended that the word ``correct'' be inserted between ``the'' and
``compressed'' in Sec. 900.12(b)(12)(v). One manufacturer requested an
exception for its product because the measured breast thickness read
out could be off by 0.6 to 1.0 cm for their paddle. One comment
expressed concern that there was no clear specification to the accuracy
of the indicated value proposed in Sec. 900.12(b)(12)(v)(A). NMQAAC
discussed this provision at its April 1996 meeting and recommended that
the requirement for a display remain but that no accuracy specification
be associated with the display. NMQAAC revisited the issue at its
January 1997 meeting but did not change its recommendation. Another
comment suggested that the proposed requirement should apply only to
equipment that uses the compressed breast thickness in an algorithm to
determine technique factors. One comment supported the proposed
requirement in Sec. 900.12(b)(12)(v)(A) because it is especially
important for implant patients, but recommended that it go into effect
5 years after the effective date of the regulations rather than 10
years after, as proposed.
    FDA has reviewed the comments and reassessed the need for this
requirement. The practical application of the information provided by
the display to the mammography process appears to be questionable and
the concept of having a display that has no associated accuracy is of
debatable value. FDA has decided to remove Sec. 900.12(b)(12)(v) from
the final regulations in accordance with the agency's desire to
minimize costs, as discussed previously. All comments requesting
clarification or suggesting modification to the test procedure will be
considered again if FDA revisits this requirement.
    The portions of proposed Sec. 900.12(b)(12) that have been retained
in the equipment provisions were codified under Sec. 900.12(b)(8).
    n. Technique factor selection and display (Sec. 900.12(b)(9)
(proposed Sec. 900.12(b)(13)))
    In this paragraph, FDA proposed requirements for the selection and
display of technique factors.
    FDA proposed in Sec. 900.12(b)(13)(i) that every system shall have
the capability for manual selection of mA's or, at least, of mA or
time. No public comments addressed this issue. NMQAAC discussed the
proposal at both the April 1996 and the January 1997 meeting and
supported the proposal. FDA reworded the requirement slightly before
codification to clarify its intent. Because of the deletion of
paragraphs listed earlier in the proposal, paragraph Sec. 900.12(b)(13)
has been codified as Sec. 900.12(b)(9), and this paragraph became
Sec. 900.12(b)(9)(i) in the final rule.
    Under Sec. 900.12(b)(13)(ii), FDA proposed that all technique
factors be clearly displayed at the control panel prior to exposure. At
Sec. 900.12(b)(13)(iii), the agency proposed that such factors be
preindicated in the AEC mode.
    (Comment 354). One comment recommended FDA clarify that the
specification in Sec. 900.12(b)(13)(ii) applies only to the manual mode
of operation. A comment on Sec. 900.12(b)(13)(iii) requested
clarification of which technique factors were intended to be covered by
this requirement. At its April 1996 meeting, NMQAAC also expressed some
confusion regarding the same issue. Another comment recommended that
the requirements of Sec. 900.12(b)(13)(iii) and (iv) be combined.
    FDA believes that requirements for preindication and postindication
of the technique factors should be presented under separate paragraphs
and has not accepted this last comment. FDA did clarify
Sec. 900.12(b)(13)(ii) and (iii) and combined them into a single
provision at Sec. 900.12(b)(9)(ii).
    Under Sec. 900.12(b)(13)(iv), FDA proposed that, after AEC
exposure, the system should indicate the actual kV and mA's used during
the exposure.
    (Comment 355). Two comments recommended that this requirement be
deleted or its implementation date be delayed because the replacement
or retrofit of many older units might be costly. Another comment stated
that a mA's readout, as proposed in Sec. 900.12(b)(13)(iv), has not
been proven necessary. NMQAAC discussed this issue and the cost
concerns related to retrofits to provide the postexposure mA's
indication. The committee supported the requirement but requested some
wording changes to clarify the meaning of mA's indication.
    FDA has retained this provision because it concluded that the costs
associated with the possible retrofits are not significant enough to
outweigh the benefits and has included it in the final regulations
under Sec. 900.12(b)(9)(iii).
    Under Sec. 900.12(b)(13)(v), FDA had proposed that each unit
provide an indication of kVp that was accurate to within + 5.0 percent
of the actual kVp.
    (Comment 356). Five comments agreed with the proposed five percent
accuracy specification, but another comment suggested that the
requirement for kVp accuracy of + 5.0 percent was not justified because
there was no definition of what kVp really means and no calibration
available for kVp meters. Another comment stated that ``5 percent of
the actual kVp as proposed in (b)(13)(v), is a very large
discrepancy,'' noting that 5 percent of 30 kVp allows 31.5 kVp, which,
in the respondent's opinion, presently is considered to be
unacceptable. The comment further suggested that Sec. 900.12(b)(13)(v)
be changed to read: ``All indications of kVp shall be within 1 kV of
the actual kVp.''
    In Sec. 1020.30 FDA defines kVp to mean the maximum value of the
potential difference across the X-ray tube during an exposure. FDA
agrees with the comment that the + 5.0 percent accuracy is a large
discrepancy and notes that it is the same specification currently
established by the most recent revision of the ACR manuals. The agency
intends to provide additional information regarding compliance with
this requirement.
    (Comment 357). Three comments, including one from NMQAAC, noted
that there was a conflict between the kVp accuracy specification at
Sec. 900.12(b)(13)(v) and at Sec. 900.12(e)(5)(ii)(A). NMQAAC also
recommended that the requirement be moved to the quality assurance
section

[[Page 55920]]

and that the + 5.0 percent accuracy specification be retained. FDA has
accepted these recommendation and the requirement now appears in the
final regulations under Sec. 900.12(e)(5)(ii) and includes the + 5
percent accuracy specification.
    In Sec. 900.12(b)(13)(vi), FDA proposed that, 10 years after the
publication of the final regulations, each X-ray unit used for
mammography would be required to have a specific range of kVp and mA's
selection and that adjacent selections of the kV selection and adjacent
selections of the mA's should not vary by more than a prescribed
amount. The public comments regarding this section were overwhelmingly
against including these proposals in the final regulations. NMQAAC
supported the proposals but only marginally so, with many opposing
opinions. FDA has reconsidered the advisability of including these
specifications in the final regulations, based in part on the public
comments and in part on the difficulty in predicting the necessity for
these limitations 10 years in the future and has deleted all
requirements proposed under Sec. 900.12(b)(13)(vi) from the final
regulations.
    o. Radiation output (proposed Sec. 900.12(b)(14))
    This paragraph proposed setting a minimum value for radiation
output per second of mammography X-ray equipment, with an increase in
that minimum value to occur 5 years after publication. This section has
been codified in the quality assurance section of the final
regulations.
    (Comment 358). Two comments agreed with the requirement proposed in
Sec. 900.12(b)(14)(i), with one urging that the requirement be fully
implemented at the earliest possible date rather than being phased-in.
One comment suggested that the proposed requirements in
Sec. 900.12(b)(14)(i) and (ii) might actually be in conflict with each
other. FDA reviewed these provisions and does not see a conflict
because clause (i) specified an exposure rate and (ii) specified a time
over which that rate must be met. However, in response to other
concerns, as outlined in the preamble to the quality assurance section,
FDA has modified the requirement to clarify that the specification is
to be an average over three seconds and not an instantaneous rate
measurement.
    (Comment 359). One comment suggested that the proposed requirement
in paragraph (b)(14)(i) be replaced by the equivalent air kerma
expressed in milligray (mGy). The guidelines followed by FDA in the
writing of regulations specify that all numerical limits, where
applicable, be expressed in terms of the International System (SI) of
Units, the internationally accepted standard, followed by the more
common equivalent in parentheses.
     In the proposed regulations, FDA had represented radiation limits
in terms of exposure expressed in the SI unit of coulomb per kilogram
(C/kg). Although C/kg is the correct SI unit for exposure, it is an
awkward unit for the actual operating ranges of exposure (10-4 C/kg) of
mammography systems. FDA believes now that it would be more
advantageous to specify radiation limits in terms of the alternate
quantity air kerma expressed in the SI base unit of gray (Gy). Air
kerma, which is defined at Sec. 900.2(d), is the sum (per unit mass of
air) of the initial kinetic energies of all the charged ionizing
particles liberated by the X-rays. At the X-ray energies typically used
in diagnostic radiology and mammography, values for air kerma are
practically indistinguishable from values of absorbed dose in air. Air
kerma is increasingly accepted in the international community as the
quantity preferred in the specification of radiation delivered, and it
is being proposed to replace exposure in amendments in 21 CFR part
1020. Because amendments to those standards are not final, the units
were not used in the proposal. However, FDA is replacing the quantity
exposure with the quantity air kerma in these final MQSA regulations
because it anticipates that parallel changes will be made in the
international standards and part 1020.
    (Comment 360). One comment suggested that FDA recast proposed
Sec. 900.12(b)(14)(i) as a performance objective, such as: ``The
radiation output, in terms of exposure rate, at clinically useful kVp's
shall be sufficiently high to avoid exposure times of such duration
that loss of resolution due to motion or excessive dose due to film
reciprocity failure is expected to occur.''
    FDA appreciates the benefits of adopting performance standards when
appropriate but believes that in this case the suggested wording
introduces an unacceptable level of subjectivity into determining
compliance.
    (Comment 361). One comment recommended that the test procedure
proposed to measure radiation output in Sec. 900.12(b)(14)(iii) specify
the position of the compression paddle during the measurement.
    FDA assumes this comment is expressing concern regarding the
scatter contribution to the reading and its variability depending on
the distance the paddle is located from the detector. FDA recognizes
the possible effects of scatter on this measurement but does not
believe the contribution is of sufficient concern to warrant the
prescription of paddle position relative to the detector. In clinical
use, the paddle is obviously in contact with the breast. If a facility
wishes to test with the paddle in a similar position, FDA has no
objection. Similarly, if the paddle is moved nearer to the focal spot,
FDA would find this acceptable. FDA does, however, require the
compression paddle to be in the X-ray beam between the source and the
detector as was specified in Sec. 900.12(b)(14)(iii).
    (Comment 362). One comment suggested that FDA require that
compliance with Sec. 900.12(b)(14) be determined ``with the phantom in
the beam and that the exposure be completed within 2.5 seconds.''
    FDA believes that placing any phantom in the beam during this test
would not improve this test and that the three second exposure proposed
is both reasonable and appropriate for this requirement.
    (Comment 363). Two comments suggested that compliance with
Sec. 900.12(b)(14)(i) should be determined at a routine clinical kVp
instead of the proposed 28 kVp. FDA notes that 28 kVp is used
clinically for mammography, although not as frequently as other kVp
values. It was selected first by the American Association of Physicists
in Medicine and then by the ACR/CDC Imaging System Focus Group as the
standard kVp to be used in association with their radiation output
specifications. These specifications were utilized by FDA in
establishing this radiation output requirement. If a different kVp were
selected, the radiation output would likely have to be modified;
however, professional consensus on what modifications would be
appropriate is presently lacking. The agency, therefore, does not
accept these comments.
    (Comment 364). One comment recommended that the proposed
requirements under Sec. 900.12(b)(14) should be made part of
Sec. 1020.31 so that uniform requirements would be ensured nationwide.
FDA reiterates its previous position that this would not achieve the
desired impact on the installed base of mammography equipment. FDA
believes that most modern mammography systems can meet this
requirement. However, the agency is considering parallel requirements
under Sec. 1020.31 to ensure that future production is compliant.
    (Comment 365). One comment supported the test procedure specified
in Sec. 900.12(b)(14)(iii) as being an

[[Page 55921]]

improvement over the current specification. Another comment suggested
that the requirement in Sec. 900.12(b)(14)(i), as written, should only
apply to a molybdenum/molybdenum Mo/Mo anode/filter combination because
other target-filter combinations may not need to meet the requirement
to deliver adequate imaging.
    NMQAAC supported the proposed requirements, but suggested that the
specifications should be limited to Mo/Mo target-filter units only.
They also recommended that all of Sec. 900.12(b)(14) be moved to the
quality assurance section.
    FDA has accepted NMQAAC recommendations to limit the requirements
to Mo/Mo target-filter units and to codify the requirement with the QC
requirements.
    (Comment 366). One comment noted that xeromammography equipment
might not meet these proposed requirements.
    FDA believes that xeromammography units should be able to meet the
requirement, as proposed, but with the acceptance of the Mo/Mo
limitation discussed above, the requirement would no longer be
applicable to xerox systems, which incorporate tungsten targets.
    (Comment 367). One comment suggested that the proposed requirements
of Sec. 900.12(b)(14)(i) and (iii) need to be linked in order to
explain where the output is to be measured.
    FDA does not agree with this comment although it has reworded the
proposed Sec. 900.12(b)(14) for clarification. The provision has been
codified as Sec. 900.12(e)(5)(x).
    p. Automatic exposure control (Sec. 900.12(b)(10) (proposed
Sec. 900.12(b)(15)))
    As proposed, this paragraph required that each mammography system
have an automatic exposure control (AEC) for mA's, established a
specification for the AEC reproducibility, and set requirements for the
indication of the AEC detector positions and selected location.
    (Comment 368). One comment suggested that the requirements proposed
in Sec. 900.12(b)(15) should be prefaced with a statement that they are
intended to apply only to film-screen modalities. A related comment
reported that xeromammography systems do not have AEC controls as
required in Sec. 900.12(b)(15) and that this would bar their use.
    FDA agrees with these comments and has rewritten this requirement
to limit it to screen-film mammography systems.
    Under Sec. 900.12(b)(15)(i), the proposal required all AEC devices
to be operable in each equipment configuration provided and gave
examples of common configurations.
    (Comment 369). Several comments sought to limit the applicability
of this requirement in different ways. One comment supported the
proposed requirements in Sec. 900.12(b)(15)(iv)(A) and (B) as a means
to ensure appropriate detector location and thereby avoid repeat
exposures and reduce patient dose. One respondent did not believe that
the automatic exposure control photo-timing proposed in
Sec. 900.12(b)(15)(i) is significant in obtaining satisfactory
diagnostic mammograms. Three comments recommended modifying
Sec. 900.12(b)(15)(i) by replacing ``of equipment configuration
provided'' with ``where applicable.'' The comments further suggested
that the examples of equipment configurations in Sec. 900.12(b)(15)(i)
be deleted. One comment agreed with the April 1996 NMQAAC
recommendation that the requirements proposed in Sec. 900.12(b)(15)(i)
should be limited to clinically used configurations.
    FDA remains convinced that the use of AEC devices on mammography
equipment is an aid to quality mammography and believes that requiring
it for ``all combinations of equipment configuration provided'' is
appropriate and necessary. The agency notes that the requirement
applies to the configuration of the individual unit. For example, if
the unit is not provided with magnification capability, then it would
not be required to have a functioning AEC in a nonexistent
magnification mode. The agency also notes that NMQAAC reversed its
April 1996 position during its January 1997 meeting and concurred with
the requirement as proposed.
    Under Sec. 900.12(b)(15)(ii), FDA proposed that the AEC be capable
of providing automatic mA's selection.
    (Comment 370). One comment recommended deleting this requirement,
stating ``that it is the purpose of AEC to provide automatic mA's
selection'' and, therefore, the requirement was redundant. One comment
requested clarification of the phrase ``automatic mA's selection.''
Another comment asked whether Sec. 900.12(b)(15)(ii) required automatic
termination of exposure or automatic display of mA's and questioned why
the AEC should be able to automatically select mA's.
    FDA defines an automatic exposure control as a device that
automatically controls one or more technique factors in order to obtain
a desired quantity of radiation at a preselected location. Such a
device would automatically terminate the exposure when the selected
quantity of radiation had been delivered. This definition does not
restrict the technique factor(s) that may be selected; the control of
target material, focal spot, filtration, time, mA, and/or kVp are all
viable options for such a device. Because the mA's is the product of
time (in seconds) and mA, the control of time and/or mA represents
control of the mA's; therefore, AEC's generally function by controlling
mA's and/or kVp. FDA was initially concerned that an AEC that
controlled kVp alone, without capability to control mA's, could not
adequately ensure the small incremental changes in radiation that are
often necessary in mammography. FDA has reconsidered this position
because it has concluded that any such device that reaches the
marketplace would provide the necessary ranges of adjustment in order
to have been approved under the FDCA's requirements for safety and
efficacy of new devices. Therefore, FDA is removing the requirement
proposed in Sec. 900.12(b)(15)(ii) that all AEC devices provide
automatic mA's selection.
    Under Sec. 900.12(b)(15)(iii), FDA proposed a limit on the
reproducibility of the AEC.
    (Comment 371). One comment suggested the wording be changed to
include ``for each target/filter combination.''
    FDA believes the change is not needed; because no target-filter
combinations were specified in the regulation, all combinations are
subject to the requirement.
    NMQAAC recommended that this requirement be moved to the quality
assurance section. FDA has accepted this recommendation and the
specification for the evaluation of the AEC reproducibility is codified
in Sec. 900.12(e)(5)(i).
    Under Sec. 900.12(b)(15)(iv), FDA proposed requirements regarding
the positioning flexibility of the AEC detector, visual location of the
available detector positions, and indication of which AEC detector
location was selected.
    (Comment 372). Two comments recommended that the proposal be
expanded to require increased flexibility in placement of the AEC
detector. One comment commended the proposed requirement for AEC
positions to be indicated at the input surface of the breast
compression paddle. The comment believed that this requirement would
improve the quality of imaging and prevent repeat images. Two

[[Page 55922]]

comments suggested that FDA add a requirement specifying the necessary
accuracy of the indication of both the size and available position of
the AEC detectors. The respondents' suggested the indication might
depend on magnification of the indication resulting from various breast
thicknesses.
    FDA interprets these comments to mean that a projected indication
on the input surface of the breast might vary in size and location
depending on the magnification induced by the displacement of the input
surface caused by various breast thicknesses. FDA agrees that this
might occur and notes that such a system would be a design that might
not be able to meet the requirements.
    FDA intends the indications of the size and location represented on
the compression paddle to be representative of the actual size and
location of the detectors as they would appear if marked on the breast
support device. The agency anticipates no confusion will be caused by
varying displacement of the paddle from the patient support since the
indication of size and position will remain constant.
    (Comment 373). One comment suggested that the indicators should not
``give rise to artifacts in the image.''
    FDA believes that any such artifacts will be detected and corrected
during the normal QC process and, therefore, modification of this
requirement is unnecessary.
    (Comment 374). One comment stated that this requirement leaves too
much room for interpretation and would be very difficult to inspect
against. The comment suggested one could argue that merely knowing the
position via the handle that moves the detector would be adequate for
proper detector positioning. The comment further stated that all
current units do provide clear indication of detector position, which
is visible from both sides of the patient, and that the requirement
should be removed.
    FDA does not agree that the requirement is subject to conflicting
interpretation or would be difficult to inspect, but does agree that
the location of the position selector would be an adequate indication
of which detector position had been selected (although it would not
indicate the detector position itself). FDA also does not agree that
the installed base of systems all provide such flexibility or
indications and remains persuaded that the requirement will provide
useful tools for the technologist.
    NMQAAC recommended that FDA delete the proposal that the selected
detector position be visible from both sides of the patient because
they did not consider it of sufficient importance to require in the
regulations. FDA has adopted this recommendation and the requirement
has been amended accordingly.
    Under Sec. 900.12(b)(15)(v), FDA proposed that the operator be able
to vary the optical density from the normal density setting. No
specific comments were received on this proposal and FDA codified this
requirement without change.
    Under Sec. 900.12(b)(15)(vi), FDA proposed that, 10 years after the
publication of the final regulations, each unit would be required to
provide four steps above and four steps below the normal optical
density setting and proposed limits for the acceptable variability
between adjacent settings on this control.
     (Comment 375). FDA received a large number of comments on this
section. The overwhelming majority were opposed to the requirement
because of concerns regarding the wording of the provision, the
perceived cost to facilities, the range of control to be provided, the
incremental difference between adjacent settings, and the necessity for
the requirement. In response to these comments and because of agency
concerns regarding costs, FDA concluded that the proposal should be
deleted from the final regulations and that further study should be
undertaken to determine if future requirements in this area are
warranted. If regulations or guidelines are proposed later, the
individual comments will be reconsidered at that time.
    Under Sec. 900.12(b)(15)(vii), FDA proposed requirements for the
optical density variation permitted with a screen-film mammography
system under AEC.
    (Comment 376). Three comments supported the proposed requirement in
paragraph (b)(15)(vii) because it evaluates the equipment performance
when used on breasts of various size and density. Two comments
indicated that Sec. 900.12(b)(15)(vii) was not stringent enough and one
of these recommended that an initial value of 0.15 OD should be
specified.
    FDA disagrees with this comment because it believes that the
initial value should remain the same as that used in the interim
regulations. NMQAAC recommended that these requirements be moved to the
quality assurance section and FDA agreed. The requirements have been
codified under Sec. 900.12(e)(5)(i).
    In the proposal, FDA had specified that the system meet the
requirements for AEC reproducibility at each available detector
position.
    (Comment 377). Three comments suggested that the test under
Sec. 900.12(b)(15)(vii) is necessary for only one detector position
because the detector and associated electronics do not change.
    FDA disagrees with these comments because some AEC detectors
utilize individual detectors that are permanently fixed in position.
The switching of position is actually a change in contact points or
system logic to read the selected position. In such cases, the testing
of one position provides no indication of the function at other
locations.
    (Comment 378). One comment suggested that the testing of photo-
timer tracking with dosimeter positioning is usually not necessary
unless multiple detectors are used.
    The agency believes that when the process is accomplished by the
relocation of the same detector to different positions, the functioning
of the detector at each detector location is not guaranteed by testing
at only one position. This could be influenced by broken wires, poor
connections, or dirty contacts in the system.
    (Comment 379). One comment stated that testing of the AEC at all
detector positions will be dependent on the dimensions of the phantom.
The respondent stated that the commonly used 10 cm x 10 cm phantom may
not be large enough for all positions and that this will drastically
increase the time required to perform this test.
    FDA does not agree with this comment. The phantom could be placed
near the focal spot and thereby cover all available detector positions
without being repositioned.
    (Comment 380). One comment suggested that with multiple detectors
it is not necessary to test the tracking over the entire range of
phantom thicknesses.
    FDA interprets this comment to mean that, once the detector
reproducibility at each position has been established, the testing of
reproducibility for additional thickness need be performed at only one
position. FDA does not agree with this comment; it does agree, however,
that when one detector is used and moved from position to position,
once it is established that the detector is reproducible over the
entire range of thicknesses at one position, it is only necessary to
establish the correct functioning for one thickness at each other
position. In response to these comments and in recognition of the costs
associated with testing reproducibility at multiple positions, FDA has
deleted the specification for

[[Page 55923]]

testing at each detector position. Because the agency remains convinced
that the best way to ensure that the detector(s) functions properly at
each position is to test it/them at each position. FDA encourages
facilities and the medical physicists to include such testing as a
routine part of the annual survey. The remaining provisions of proposed
Sec. 900.12(b)(15) are codified as Sec. 900.12(b)(10).
    q. Disabled examinees (proposed Sec. 900.12(b)(16))
    In this paragraph, FDA proposed that each facility choosing to
schedule disabled patients have equipment and protocols in place to
ensure that the facility could adequately accommodate such disabled
patients. This proposal did not require each facility to accept
disabled patients, but did require those doing so to be capable of
performing the service.
    (Comment 381-382). Many comments expressed the mistaken belief that
FDA was seeking enforcement powers under the American with Disabilities
Act (ADA) or to duplicate the ADA.
    Other comments on this section ranged from calling the requirement
too lenient to calling it unnecessarily intrusive. The majority of the
comments, although not opposed to accommodating disabled patients, were
concerned that the screening of patients prior to their examination
would be difficult or impossible because many appointments are not made
by the patient. Comments also expressed concern that accepting disabled
patients under this requirement would obligate facilities to be able to
accommodate all disabled patients. Some comments also questioned
whether there was equipment available that could offer this range of
use.
    Another area of concern was related to mobile units and facilities
which, because of their size and stand-alone nature, would be difficult
to adapt to accommodate the range of disabilities the facilities might
encounter. NMQAAC consumer representatives supported this section and
urged FDA to require facilities to either serve disabled patients or
refer them to a facility that can. Other comments questioned the value
of referrals, citing lack of knowledge regarding other facilities'
equipment, staff, and ability to deliver the services necessary.
    Because of the lack of consensus on the need for this requirement
and the concerns raised in the comments, FDA has decided to delete the
proposed requirement and revisit it at a future date if a problem is
perceived. FDA strongly urges facilities to voluntarily institute
procedures that will direct patients with disabilities to facilities
that are capable of serving this population. The agency believes that
local consumer groups and all accreditation bodies can pool information
and educate the public and the mammography community about the
availability and locations of such services.
    r. X-ray film (Sec. 900.12(b)(11) (proposed Sec. 900.12(b)(17)))
    In this paragraph, FDA proposed a requirement that X-ray film used
for mammography must be designated for such use by the film
manufacturer.
    (Comment 383). One comment supported the proposed requirement.
Three comments suggested that it was too vague, one comment questioned
how one would know if a manufacturer's designated mammography film is
adequate for doing quality mammography under the requirements, and
another suggested the adoption of the storage recommendations from
ACR's Recommended Specifications for New Mammography Equipment. NMQAAC
supported this requirement as proposed.
    FDA has not proposed regulations governing film storage because it
believes that each facility should follow the manufacturer's
instructions for the particular film being used. The goal of this
requirement is to ensure that the film used by the facility is
considered, at least by the manufacturer, as being suitable for
mammographic use. The regulation is not intended to establish standards
for film; the only requirement placed on the facility is to check that
the film it uses has been designated by the manufacturer for
mammography. The requirement is not vague once its limited scope is
understood. FDA codified this requirement, without change, in
Sec. 900.12(b)(11).
    s. Intensifying screens (Sec. 900.12(b)(12) (proposed
Sec. 900.12(b)(18)))
    FDA proposed in this paragraph that only intensifying screens that
have been specified by the manufacturer as appropriate for mammography
may be used for mammography.
    (Comment 384). One comment supported the proposed requirement.
Again, one comment questioned how a facility would know if a
manufacturer's designated mammography screens are adequate for doing
quality mammography under the proposal. Another comment stated that
xeromammography systems do not use intensifying screens and that
Sec. 900.12(b)(18) would serve to ban their use.
    FDA does not intend a specification about screen requirements to
apply to any modality that does not use screens in the production of
its images. Therefore, the agency sees no impact of this requirement on
xeromammography. Although NMQAAC supported the requirement, one member
expressed concern that the wording of the proposal implied that the
facility was responsible for matching the spectral sensitivity of the
film and the screen. As explained in connection with the mammography
film specification above, the intent of the requirement is not to
address the quality of the product, but rather to ensure that it is one
intended by the manufacturer to apply to mammography. In general, the
facility is responsible for matching the spectral sensitivities of the
screen with the film. However, the facility is expected to use the
information provided by the manufacturers and not to derive the
information independently. FDA has reworded the requirement to clarify
this point and codified it as Sec. 900.12(b)(12).
    t. Film processing solutions (Sec. 900.12(b)(13) (proposed
Sec. 900.12(b)(19)))
    In this paragraph, FDA proposed that facilities use film processing
solutions capable of developing films in a manner equivalent to the
film manufacturer's minimum specifications.
    (Comment 385). Three comments supported this proposed requirement
and requested that guidance documents be established for this area. Six
comments suggested that the word ``minimum'' be deleted because, in the
respondents' opinions, most facilities generally comply with the
regulatory requirement and the regulation should encourage them to meet
more than the minimum. FDA appreciates these comments and notes that
facilities are free to exceed this minimum; the requirement, however,
is intended only to establish that facilities comply with the
manufacturers' minimum standards.
    (Comment 386). Three comments questioned how a facility could
demonstrate equivalence under Sec. 900.12(b)(19) because some
manufacturers of film processing chemicals refuse to acknowledge that
other vendors' chemicals produce ``equivalent'' results. The comments
requested that the wording be changed to clarify compliance.
    FDA believes these comments are similar to the ones regarding
quality of the film and screens used in mammography. It is not the
intent of the requirement that the facility experimentally determine
the compatibility of various solutions with the film, but only that the
facility obtain documentation from the suppliers showing that their
products are intended to be used for processing the

[[Page 55924]]

particular film used by the facility and that they provide results
consistent with the film manufacturer's specifications. The facility
would only be required to establish the equivalence independently if no
documentation, in the form of labeling or specifications, were
available from the chemical or film supplier.
    (Comment 387). One comment questioned how the requirement can be
met when the film manufacturer does not manufacture chemicals for film
processing.
    FDA notes that, in such cases, it would likely be easier to
establish equivalence because the film manufacturer would specify the
requirements for the processing as opposed to a manufacturer that
supplies both film and chemicals and is likely to specify solutions
only by name rather than characteristics.
    (Comment 388). One comment recommended that FDA allow accreditation
bodies to review and monitor the use of chemicals for film processing
and eliminate the requirement from the regulations.
    Although the agency is continually working with the accreditation
bodies to divide responsibilities when such division is useful and
possible, FDA did not adopt the recommendation. The MQSA requirements,
even when administered by the accreditation bodies, are implemented
through Federal standards. FDA may consider requiring accreditation
bodies to collect and monitor information about chemicals used for film
processing in the future. NMQAAC agreed with the requirement as
proposed. FDA has codified the requirement in the final regulations
under Sec. 900.12(b)(13).
    u. Lighting (Sec. 900.12(b)(14) (proposed Sec. 900.12(b)(20)))
    In this paragraph, FDA proposed a requirement that facilities
provide special lights for use during interpretation with variable
luminance capable of producing light levels greater than that provided
by the viewbox.
    (Comment 389). Four comments supported the proposal. One stated
that ``it might reduce the number of retakes, and provide better detail
to the interpreting physician.'' Two comments noted that the light
should be required wherever the interpreting physician is reading
films, but that it may not be necessary at all locations where images
are taken. One comment noted that the proposed requirement in
Sec. 900.12(b)(20) was for a ``bright light'' or ``hot lamp'' for
viewing dense areas of films. The comment suggested that the purpose of
the lamp should be included and that it should only be required for
facilities that use the screen-film modality.
    FDA agrees that the light is only required where mammograms are
interpreted but recommends that it may be useful to the technologist in
evaluating the quality of the films. FDA also agrees that facilities
not interpreting screen-film mammograms, or not reviewing previous
screen-film mammograms for reference, do not need these special lights.
    (Comment 390). Two comments stated that a fixed output lamp may
give the same information as the variable output ``hot lamp'' proposed.
NMQAAC supported the requirement, but recommended that the word
``variable'' be removed because it is the increased intensity and
masking provided by the light rather than any variability in output
that actually enhance the reading of the image.
    FDA has accepted these suggestion and has reworded the final
requirement accordingly.
    (Comment 391). One comment expressed difficulty imagining the
benefits of this requirement to the patient.
    FDA believes the usefulness of this device is well established,
especially in view of the trend toward denser films in mammography; by
optimizing interpreting conditions for physicians, the regulation
increases the likelihood that the patient's mammogram will be
accurately interpreted.
    (Comment 392). One comment recommended that FDA allow accreditation
bodies to review and govern the proposed requirement in
Sec. 900.12(b)(20), and eliminate it from the regulations. As indicated
above in response to a similar comment by the same individual.
    FDA has not adopted the recommendation, although it may consider
requiring such action by the accreditation bodies in the future.
    (Comment 393). Four comments suggested that the proposed
requirement was too vague. One comment suggested that the requirement
be reworded to specify that a ``spot lighting'' device be provided.
    FDA agrees with these comments and amended the final requirement to
clarify this point.
    (Comment 394). A number of comments chose this section to offer
suggestions regarding requirements for the viewbox or the viewing
conditions. FDA has discussed those comments in the general equipment
section above.
     Because of the deletion or movement of other paragraphs in the
equipment portion of the proposed regulations, the reworded
Sec. 900.12(b)(20) was codified as Sec. 900.12(b)(14).
    v. Film masking devices (Sec. 900.12(b)(15) (proposed
Sec. 900.12(b)(21)))
    In this paragraph, FDA proposed that all facilities ensure the
presence of film masking devices that are capable of limiting the
illuminated area of the viewbox to the exposed or smaller area of the
film, that facilities using nonrectangular collimation ensure suitable
masking, and that such devices be available to the interpreting
physicians.
    (Comment 395). Six comments supported the requirement. Two of these
comments further suggested that the requirement be modified to clarify
that any effective means of masking, including ``black film or manual
or automatic masking devices,'' would be acceptable. One comment
questioned how effective the film masking devices must be because the
respondent believed that many presently in use do a poor job of
blocking the unnecessary light. FDA has not attempted to specify
particular mechanisms for masking, only that provisions for masking be
available. Any device that blocks viewbox light not required for
viewing and interpreting the image would meet the intent of this
requirement. The level of ``blocking'' was not addressed, but with the
light levels under consideration, the agency believes that the
elimination of any noticeable transmission through the masking is
easily achievable. The device need not be an expensive or elaborate
system, but it must be capable of eliminating extraneous viewbox light.
    (Comment 396). Two comments supported the proposed requirement to
provide appropriate masking for nonrectangular images as a means to
further promote the correct masking of all shape images, but another
comment stated that the nonrectangular collimation referenced should be
eliminated because ``there is no need for it and it causes significant
problems in the masking of the films for proper viewing conditions.''
NMQAAC suggested that the requirement regarding nonrectangular masking
was redundant and recommended that it be removed from the final
regulation.
    FDA does not intend to express a preference for rectangular or
nonrectangular collimation. This section was included in the proposal
to reinforce the point that, in all cases, the masking should be
appropriate to the image. FDA is accepting the NMQAAC recommendation
and deleting the provision relating to nonrectangular collimation from
the final regulations; FDA agrees with NMQAAC that the

[[Page 55925]]

general masking specification covers all sizes and shapes of images.
    (Comment 397). One comment questioned how much limitation of the
exposed image the proposal intended the masking to provide and one
comment proposed that the masking requirement be expanded to require
limitation of ``the illuminated area to a region or regions
substantially smaller than the exposed portion of the film.''
    FDA has not accepted this recommendation because it may not be
desirable, in all cases, to limit the view to an area ``substantially
smaller than the exposed portion of the film.'' The intent of the
section is that masking be as close to the full darkened film area as
possible. The masking can certainly be variable, so that the darkened
area can be reduced to a specific area of interest. This is not
required, however. Discussions with interpreting physicians have led
FDA to conclude that it is often desirable to visualize the entire
image to establish a ``gestalt'' impression before further
interpretation of the film. A masking system that prevented such a
practice, therefore, may be undesirable and is not being required.
    (Comment 398). One comment questioned to what extent the film
masking devices were required to be available. The comment asked if all
mammograms were required to be read on viewboxes equipped with masking
devices or if the facility need only require adequate masking for one
viewbox, even if multiple reviewers were reading film at the same time
on different viewboxes.
    In response to this comment, FDA has modified the final regulation
to indicate that such devices should be available in sufficient numbers
to allow each physician requiring one to have access to one. NMQAAC
recommended that the requirement that the devices be available to
physicians should be deleted, stating that any physician who desired to
use masking could provide their own at little or no expense and that
the facility need not provide such devices for them. FDA partially
agrees with this assessment but has not accepted this recommendation
because it has concerns about facilities that require significant
numbers of films to be read daily and where the interpreting physician
simply does not have time to individually mask images. Placing
responsibility with the facility will ensure that masking devices are
provided in such cases.
    (Comment 399). Two comments recommended that the regulation mandate
the use of film masking devices by the physician, and one of these
suggested that masking should be used by the technologists in their
film critique area. While FDA certainly agrees that both interpreting
physicians and technologists should utilize masking, the agency
believes that, if the devices are available, most individuals will use
them and that requiring their use would be difficult to enforce.
    (Comment 400). One comment stated that film masking devices may be
expensive to obtain and cumbersome to use. This comment maintained
that, although film interpretation may be improved by using these
devices, requiring that facilities provide such devices appears to be
excessive regulation and this requirement should be deleted.
    FDA notes that the goal of the MQSA is to provide a consistent
baseline of quality mammography services to all patients. If an item
that is consistent with that goal is identified as having a positive
impact on the diagnostic process, FDA believes it is important to
assure women that facilities at least have these devices available for
use on their behalf. FDA also notes that masking devices do not
ordinarily entail significant expense. FDA has codified the requirement
for availability of masking in the final regulations under
Sec. 900.12(b)(15).
    w. Film processors (Sec. 900.12(b)(22) (proposed
Sec. 900.12(b)(22)))
    In this paragraph, FDA proposed a number of requirements for the
film processors used to develop mammograms. As proposed,
Sec. 900.12(b)(22)(i), covering processor setup and maintenance, would
go into effect 1 year after final publication; Sec. 900.12(b)(22)(ii)
and (iii), requiring display of the time cycle and maintenance of the
developer temperature, would be phased-in after 5 years; and
Sec. 900.12(b)(22)(iv) and (v), requiring the display of the developer
temperature and for variable cycle processors to be interlocked to
prevent new film being accepted by the processor until cycle parameters
are stabilized, would be phased-in after 10 years.
    Section 900.12(b)(22)(i) proposed that all such processors be set
up and maintained at the technical development specifications for the
film used for mammography at the facility.
    (Comment 401). One comment requested a definition of technical
development specifications, as used in the proposed regulations.
Another comment stated that, if it is going to be mandatory to meet
film manufacturers technical requirements, then manufacturers should be
required to make written guidelines available as to what factors are
needed to achieve the maximum result from the film.
    FDA coined the phrase ``technical development specifications'' to
represent a listing of the technical aspects of correct processing as
provided by the film manufacturer. This would be expected to include
such items as correct solutions, proper temperatures, applicable
immersion times, replenishment rates, and any other instructions the
manufacturer deemed appropriate and critical to the processing of its
film. FDA believes that many manufacturers do provide such information
and that the market advantage these manufacturers will enjoy will
encourage all manufacturers to do so. The NMQAAC recommended that this
section be moved to the quality assurance provisions and FDA has
followed that advice.
    The agency has reconsidered the proposed requirements in
Sec. 900.12(b)(22)(ii), (iii), (iv), and (v). FDA received a number of
comments both supporting and opposing these proposals. However, based
on the anticipated costs associated with these proposals compared with
the marginal benefits they would provide, FDA has decided to delete
them from the final regulations. If the agency proposes future
regulations for these areas, all related comments will be reconsidered.
3. Medical Records and Mammography Reports (Sec. 900.12(c))
    This section establishes quality standards for medical records and
mammography reports as required by the MQSA under 42 U.S.C.
263b(f)(1)(G). The regulation provides, in general, that facilities
prepare written reports of mammography examinations, that results be
communicated to the patient or provider, and that films be maintained
for a reasonable period of time or transferred to the patient.
    (Comment 402). Public comments were received on Sec. 900.12(c). The
most controversial areas were specific provisions in the proposal for
use of standardized assessment categories in the mammography report,
written notification of all mammography results, and for original
mammograms to be transferred to other facilities or entities upon
patient request. Each of these areas will be discussed below in
connection with those specific provisions.
    a. General comments
    As an initial matter, FDA disagrees with four comments that asked
FDA to delete the entire regulation on medical records and reports
because it was an intrusion of FDA into the practice of medicine and
abridged the rights of

[[Page 55926]]

radiologists. The agency's authority and responsibility to regulate
these medical records, mammography reports, and communication of
results was established by Congress through specific provisions of the
MQSA. The agency could not eliminate the entire regulation, even if it
believed such action was appropriate. Discussions with NMQAAC clearly
indicated the committee's support for regulations in this area as well.
    b. Contents and terminology (Sec. 900.12(c)(1))
    The proposal established standardized assessment categories for
interpreting physicians to use to evaluate mammograms, ranging from
``negative'' to ``highly suggestive of malignancy.'' In addition, the
regulation requires the interpreting physician to address clinical
questions, if possible, and include recommendations, if any, in the
report.
    (Comment 403). Comments in support of the proposed standardized
assessment categories stated that such categories: would ensure that a
definitive result for each mammogram is reached; would establish
consistency across facilities; are a valuable tool to assist consumers
and clinicians in understanding results; should also be used in the
written notification to patients; and permit efficient and uniform
analysis of outcomes in medical audits. One comment in support of this
section suggested that the title be changed to ``Contents, terminology
and timeframes.''
    Fourteen comments stated that it is inappropriate for the Federal
government to establish medical terms for classification of mammography
results through regulation. Other comments opposing the establishment
of standard assessment categories stated that: Such categories would
prevent any particular facility from continuing to use its customary
terminology and, thereby, cause confusion to its referring physicians;
the message, rather than the exact words, are important and resources
would be wasted in monitoring the correct use of particular phrases;
and that establishing standard classifications would reduce flexibility
for the reporting physicians.
    Some comments objected to the details of a particular
classification category, rather than to the idea of standard
classifications. One comment stated that a ``negative'' report may
mislead a referring physician about the existence of breast cancer
because mammography cannot detect all breast cancers, while another
comment concluded that the term ``suspicious'' inherently suggests that
the lesion is malignant, and proposed ``indeterminate'' as a substitute
category.
    After considering all these comments, FDA has decided to keep the
proposed categories in order to promote consistency and clarity in
mammography interpretations. In discussions with NMQAAC, the use of
final assessment categories was supported because they promote
consistency in communication of results among medical care providers
and standard categories are necessary in the medical audit of
mammography interpretation. These particular categories are based on
similar categories developed by ACR. The ACR Breast Imaging Reporting
and Data System categories are: Assessment Is Incomplete-Need
Additional Imaging Evaluation; 1-Negative; 2-Benign Finding; 3-Probably
Benign Finding--Short Interval FollowUp Suggested; 4-Suspicious
Abnormality--Biopsy Should Be Considered; and 5-Highly Suggestive of
Malignancy--Appropriate Action Should be Taken.
    FDA believes that the medical community is familiar with these
categories and the assessment classifications established under the
final regulations (``negative,'' ``benign,'' ``probably benign,''
``suspicious,'' ``highly suggestive of malignancy'') are equivalent to
the ACR system. The medical community has already affirmed their
usefulness and value through widespread use of the ACR system.
Accordingly, the agency concludes that requiring these classification
terms in mammography reports will not be burdensome, given their
current level of use and acceptance.
    FDA has made minor changes in particular assessment categories in
response to comments. Two comments requested FDA to delete the word
``imaging'' from the proposed assessment category of ``needs additional
imaging evaluation'' and substitute the ACR category of ``needs
additional evaluation'' because physical examination may be part of
further evaluation. In fact, the ACR category is ``Need Additional
Imaging Evaluation,'' with ``incomplete'' as its descriptor.
Accordingly, FDA is adding the word ``incomplete'' to the description
of this category, which will now read: ``Incomplete: needs additional
imaging evaluation.'' The mammographic result should be categorized
into this or one of the other assessment categories. The agency notes
that, if the result is ``negative'' or ``probably benign'' based on the
mammogram, but physical examination is recommended, the recommendation
for clinical followup, surgical consultation, biopsy, or other action
should be stated in the recommendations section of the report. The
agency also is aware that there are screening mammography practices
that do not issue a final assessment until followup diagnostic
mammography has been scheduled and performed. These facilities, and
others, can continue their policy of not issuing an assessment, and can
use this category of ``Incomplete: needs additional imaging
evaluation.''
    FDA's proposed language for the ``negative'' category stated that
if the interpreting physician is aware of clinical findings or
symptoms, these should be explained. One comment asked if this
explanation must be written into the report or could be attached as a
symptom in-take form. The agency believes that the recommendations
section of the report is the most effective way to direct referring
health care providers to further work-up based on physical findings or
symptoms, despite negative mammographic results.
    (Comment 404). One comment stated that it would be hard to
determine compliance with the proposed requirement that clinical
questions raised by the referring health care provider be addressed in
the recommendation section of the report.
    FDA responds that it can determine compliance with a regulation in
a variety of ways, including review during an inspection of a
facility's standard operating procedures. FDA inspectors can be trained
to verify that each facility has in place a system that requires its
interpreting physicians to address the concerns of referring health
care providers in the recommendations section of the mammography
report. FDA agrees with comments that suggested that the recommendation
section of the report remain separate and unstructured; the agency has
not proposed specific categories or language for this portion of the
report in order to provide maximum flexibility for clinical management
recommendations.
    (Comment 405). One comment stated that there should be a unique
patient identifier to distinguish between two patients with the same
first and last name. NMQAAC also agreed, stating that the medical
report and the mammography films should have a patient identifier in
addition to the name. FDA agrees that an additional patient identifier
in addition to the name will improve the accuracy and clarity of the
results and subsequent followup and the proposal has been amended to
require reports to have this additional identifier. However, the

[[Page 55927]]

choice of the additional identifier, such as the date of birth or
hospital number, is left up to the facility because each individual
practice has a better understanding of its particular needs in this
matter.
    (Comment 406). Two comments asked if a radiologist who did not read
the film or dictate the report can sign a report if the radiologist who
did perform the interpretation is unavailable and concurs with this
practice. Another comment stated that FDA should allow signatures that
are authenticated through computers, which are normally accepted in a
court of law. A third comment stated that signatures should be evident
on the report filed in the patient's permanent file.
    FDA interprets the MQSA's requirement that each mammography report
be ``signed'' by the interpreting physician to mean that each report
must identify who interpreted the mammogram and rendered the reading on
the written report. The final regulations state that the name of the
interpreting physician must be on the mammography medical report. This
name may be handwritten, typed, stamped, written electronically, or
recorded in any other manner. However, with respect to ``signatures''
that are used to proof-read reports or to ``sign'' them out for
purposes of authenticating such reports or releasing them to other
parties or institutions, FDA believes that each facility is in the best
position to devise its own procedures to ensure accuracy of reports and
integrity of the system without the MQSA regulations in this area.
    (Comment 407). One comment recommended that there be a requirement
for facilities to maintain records that include the signature of the
qualified radiologic technologist who performed or supervised the
examination and the signature of any individual who conducted all or
part of the examination under supervision of a qualified radiologic
technologist.
    FDA disagrees with this comment. The MQSA does not have a signature
requirement for the technologist. The final regulations require
``technologist identification'' on each film image
(Sec. 900.4(c)(viii)(E)) and the agency believes each facility can
adopt its own system to identify technologists without having the
agency mandate such procedures.
    (Comment 408). One comment suggested that the term ``health care
provider'' should be replaced with ``referring physician.'' FDA
disagrees because patients are referred for mammograms by
nonphysicians, such as physician's assistants, nurse practitioners, and
other health care workers.
    c. Communication of mammography results to patients
(Sec. 900.12(c)(2))
    This provision requires that: (1) Each facility establish a system
to ensure that results are communicated to patients; (2) patients
without health care providers receive medical reports and lay summaries
of their mammography results; (3) each facility establish a referral
system for patients without health care providers, if necessary; and
(4) results that are ``suspicious'' or ``highly suggestive of
malignancy'' be communicated as soon as possible.
    (Comment 409). FDA received hundreds of comments on the proposal
that all patients receive written results of their mammography
examination. Comments that objected to this proposal generally focused
on disruption of doctor-patient relationships, confusion for patients,
and additional expense to facilities without commensurate patient
benefit. Ninety comments stated that the referring health care provider
is responsible for communicating results to patients and is best able
to convey such results and answer patient questions. Other comments
that raised concerns about disrupting the referring doctor-patient
relationship stated that written notification from the facility would
allow patients to bypass a referring physician and never get a physical
breast examination. Many comments stated that written notification to
every patient would cause confusion for the patients. Twenty-three
comments said confusion would arise if patients were notified about
results before such results were reviewed by their referring
physicians; twenty-one comments stated that many patients would
misinterpret their reports; ten comments stated that the difference
between the information provided in a lay notification and the
information contained in a copy of the actual written report would
confuse patients who received both.
    Seventy-two comments stated that the additional cost associated
with written communication to every patient would cause financial
hardship for mammography facilities. In general, these comments and
others argued that the cost of providing or ensuring written
notification in every case outweighs any patient benefit that might
result. Ten comments stated that radiologists would have to police
referring physicians who agreed to provide patient notifications and
followup. Other comments stated that: (1) Small or rural facilities
would be burdened by patient notification requirements, especially
those without a computerized system; (2) producing patient notification
reports is time-consuming and hinders the accomplishment of daily
operations, and would not directly improve patient care; (3) developing
a notification document that could explain every possible scenario
involving diagnostic findings is virtually impossible; and (4)
radiologists and providers of mammography would become more frequent
targets of litigation because of this reporting requirement. Thirty-
seven comments stated that it is unrealistic to expect radiologists,
who may never see patients, to determine the literacy level, ethnic,
cultural, and social sensibilities of those patients in order to tailor
an appropriate written notification. Fifteen comments stated that the
requirement would create excessive waste paper for the environment.
Some comments found the proposal for written notification unnecessary
in light of other reporting and followup requirements, the individual
patient's responsibility to communicate with her physician, and the
belief that patients are always informed of results by their
physicians. Two comments asserted that written notification for all
patients was not authorized by the MQSA.
    FDA also received 66 comments that supported the proposal for all
patients to receive written notification of mammography results
including comments offering strong support from national breast cancer
patient groups. These comments generally focused on the fact that women
otherwise were not assured of timely and accurate information about
their mammography examinations and that such written notification could
save lives by encouraging initiation of necessary followup.
    It was also noted that the experience of facilities that instituted
such notification was positive. Comments in support of written patient
notification stated that such notification was appropriate because
patients are entitled to know the results of their exams, it is the
facility's responsibility to inform patients of results, and there is a
public health need for written notification because not all referring
physicians discuss results with their patients.
    (Comment 410). Comments described written notification as an
important addition to quality mammography practice, a crucial component
to ensuring reliable mammography and consistency across the country,
and a major step toward fostering better communication between doctors
and their patients. One comment supported the proposed system to ensure
that patients and referring physicians receive reports, and that all
patients receive a

[[Page 55928]]

report in lay terms, but also stated that the referring physician
should continue to be responsible for patient followup. Another comment
stated that FDA should not allow any party, other than the facility, to
distribute these written notifications.
    Many comments asserted that written notification for each patient
may ultimately reduce health care costs and extend lives because of
earlier treatment. Five comments stated that written notification
empowers the medical consumer and minimizes the possibility of tragic
error when abnormal results slip through the cracks of the referring
physician systems. Comments asserted that referring physicians do not
always communicate results to patients, even when the results are
abnormal. Several breast cancer survivors commented positively on this
proposed requirement and one author stated that such written
notification saved her life. Seven comments stated written notification
has reduced medical liability of facilities, but that costs should be
offset with increased reimbursement.
    Comments from State health officials and some facilities having
experience with written patient notification reported that the
experience had been positive. Facilities that have instituted written
notification stated that the practice is appreciated by patients and
does not cause the facility any particular hardship. Massachusetts has
required such written notification since 1994. The comment from a State
official stated that, although initially resisted, the procedure is now
accepted by physicians throughout the State; facilities in
Massachusetts receive positive feedback from patients and no facility
has closed in that State because of this additional requirement.
    Some comments recommended that the notification include additional
information. Twelve comments asked that the written notification also
include information about the location of the films, directions about
how a woman could obtain them, and the facility contact person for
questions concerning the result. Another comment said the notification
should include information about the importance of clinical breast
examinations by a qualified physician, monthly self-breast
examinations, and mammograms at appropriate times, especially for
patients without physicians. Some comments wanted facilities to be
required to provide written notification to referring physicians and
patients.
    Many comments suggested alternatives that were variations to the
proposed requirement for written patient notification. Ten comments
supported the current interim regulations, which require written
notification from the facility only to those patients who do not have a
health care provider or referring physician. Thirteen comments stated
that, for referred patients, the required notification should simply
state that the mammogram report has been mailed to the physician and
the examinee should contact that physician. Twelve comments stated that
only those patients who request a written report should be sent one.
    Other comments agreed that patient notification of results by the
facility was appropriate, but preferred to leave the method of
communication up to the facility, which could tailor notification
procedures to its practices and the circumstances of particular
patients. Comments observed that in some screening cases, where the
radiologist never speaks to the patient, written notification of
results makes sense; however, where there is extensive interaction and
verbal communication with the examinee onsite, written notification can
be redundant, expensive, and wasteful of paper. Five comments stated
that patients should be verbally told at the time of the examination to
contact her physician's office and not to assume that ``no news is good
news.'' Other alternatives suggested by comments included several that
were in direct contradiction to each other: (1) Require written
notification only to those patients who have not received the final
report verbally at the facility or, if findings are negative, by
telephone; (2) encourage notification of patients with abnormal
studies; (3) require patient notification in lay terms only if the
results are negative and notify referring physicians, including
followup notes, when there are abnormal results; (4) send referring
physicians lists of patients who had mammography at a facility with
positive studies highlighted; (5) require notification of patients who
request results after a specified time period has passed in order to
allow communication between the patient and the referring physician and
to prevent duplication and failure to inform; and (6) require that
every patient receive a copy of her mammography report, if desired, or
by default if her preference is not stated.
    After reviewing and considering the hundreds of comments FDA
received concerning patient notification, the agency concluded that
these many comments all share the common goal of providing an effective
mechanism for communicating mammography results to patients, but that
the comments clearly advocate different approaches to achieving this
goal. FDA agrees with consumer groups that written notification of
mammographic results represents ``best practices'' in ensuring that
each and every woman is clearly and effectively notified of the results
of her mammogram. These ``best practices'' are outlined clearly in a
series of recommendations published by AHCPR in Chapter 4 of the 1994
guidelines entitled, ``Quality Determinants of Mammography'' (Ref. 2).
In these guidelines AHCPR strongly recommends that mammography facility
personnel provide each patient with written notification of the results
of her mammography examination either onsite or by mail. Studies cited
by AHCPR have shown that direct communication with patients, which is
in addition to written communication to health care providers,
dramatically increases compliance with followup recommendations.
However, FDA also recognizes that many in the health care community
have strong reservations, for the many reasons cited above, about
making written notification to all patients a Federal requirement.
Finally, FDA notes that although the MQSA requires mammography
facilities to notify patients' referring physicians, in writing, of the
examination results, the statute requires those facilities to notify
patients directly in writing, only in those instances where the patient
has no referring physician. FDA believes that the best way to reconcile
the many different points of view on this subject--and achieve the goal
of effective patient notification consistent with the statute--is to
issue a general rule requiring patient notification, together with a
recommendation that facilities follow the AHCPR guidelines regarding
written notifications to patients. The relevant portions of the AHCPR
guidelines have been printed as an appendix to the preamble of this
document for ease of reference.
    Accordingly, the agency has revised the final rule to eliminate the
requirement for written notification to every patient and has
substituted a performance-based regulation that requires each facility
to ensure that the results of each mammographic examination are
communicated to the patient. Under the final rule, each facility will
be responsible for establishing a system of notification, through its
own efforts or in cooperation with third parties, that guarantees that
patients are informed of the results of their examinations in a timely
manner. The system must also ensure that women who do not have health
care

[[Page 55929]]

providers receive written notification, along with the mammography
medical report, no later than 30 days following an examination and that
each facility communicate abnormal results as soon as possible.
    As noted above, FDA continues to believe that written notification
of mammographic results is the most reliable way to guarantee that each
patient is notified of results and that any necessary followup will
occur. Comments from consumer groups and breast cancer survivors about
the importance of early and accurate communication to patients supports
the public health need for systems that ensure patient notification.
Written notification to a patient of results can permit that patient to
make informed medical decisions at critical times. One cancer survivor
informed the agency that having the actual results of an abnormal study
in hand allowed her to pursue treatment options that saved her life.
Furthermore, the agency disagrees with comments that assume all
patients are notified of their mammographic results; many referring
health care providers do not communicate results of mammograms to
patients and the adage ``no news is good news'' still rings true for
many patients. During the MQSA inspections, FDA has uncovered a handful
of facilities that do not even issue written mammography reports to
referring physicians. Accordingly, the agency is continuing to require
each facility to establish systems that will ensure that patients are
notified of the results of their mammograms.
    FDA believes that high quality mammography extends from the
production of high quality mammographic images to the communication of
results to the patient. Ensuring that patients get their results is the
responsibility of all participants in the mammography imaging chain:
The patient, the facility, and the referring health care provider. The
final regulations fully charge facilities to meet their responsibility.
    At its January 1997 meeting, NMQAAC recommended that all facilities
should not be required to provide written notification. While some
concern was voiced about difficulties in directly notifying all
patients who underwent diagnostic mammography, many members advised FDA
to require some type of direct notification of all patients and that
this notification be documented. Although the agency continues to
support written notification to all patients as the optimum practice
under most circumstances, the final regulation does not prescribe any
particular form of notification. Comments from facilities and
physicians indicate that facilities have devised a variety of systems
of communication to notify patients of mammography results. These
include verbal conversations at the time of the examination, telephone
communication after the examination, cooperative arrangements with
referring physicians who convey the results verbally to their own
patients, and written communications that are either directly issued
from the facility and convey results or instruct the referring
physicians to issue these reports. The AHCPR guidelines recommending
direct written communication to all patients also provided examples and
suggestions about the other types of communication.
    Under the final regulation, in the case where a facility decides to
rely on a third party to communicate results (either written or
verbally), there should be a documented agreement between the facility
and the third party that establishes this cooperative responsibility.
This documentation may be in the form of attestation by the third party
or letters of agreement signed by the third party. In addition, the
agency reserves the right during inspections to confirm not only the
presence of such documentation, but also to ask for further
documentation from the facility to verify that patients were indeed
notified. Further documentation can include copies of referring
physician medical records documenting that results were discussed or
sent to the patient. These descriptions of systems and documentation
are intended to be examples; others may also be acceptable. However, if
third parties do not provide the mammography facility with further
documentation when requested during inspections, the mammography
facility is subject to regulatory enforcement action under the MQSA for
failing to document that results were provided to patients. Thus, for
facilities that choose to rely on third parties for communicating
results, whether they be referring physicians or communication
consultants or other parties, the facility still has ultimate
responsibility to meet the patient notification requirements of the
final regulations.
    The agency also believes that the approach taken in the final
regulation will address the concerns about communication and cost that
were raised by so many of the comments. The flexibility that has been
built into the final regulation will permit facilities to tailor
notification systems to the particular needs of the general patient
population and individual patients they serve. At the same time,
requiring each facility to establish and document the existence and
operation of such systems achieves the primary goal of ensuring that
patients receive the results of their mammograms.
    In addition, the agency notes that the requirement for reasonable
attempts at immediate communication when results of an examination are
``suspicious'' or ``highly suggestive of malignancy'' has been retained
in the final regulation. Potential delays in diagnosing and treating
breast cancer are reduced with this requirement that facilities
directly notify patients who have no health care provider of abnormal
results as soon as possible. (The same requirement for immediate
communication in the case of ``suspicious'' or ``highly suggestive of
malignancy'' findings applies to the facility's communication with the
referring physicians of those women who have identified health care
providers). The agency concludes, therefore, that the most significant
public health risk that may result from failure to communicate results
is addressed in the final regulation.
    The final regulation continues to require written notification by
facilities to patients who do not have referring physicians, as
specified in the MQSA. The statute also sets forth, and the regulation
incorporates, the requirement that such self-referred patients receive
a copy of the actual mammography report that would be prepared and sent
to the referring physician, if there were one. In response to comments
that questioned the agency's authority to require patient notification,
FDA notes that the language of the MQSA is very explicit with respect
to patient notification of test results and the form that notification
must take in these particular circumstances (see 42 U.S.C.
263b(f)(1)(G)).
    (Comment 411). Many comments urged FDA to require referring
physicians to be responsible for the communication and followup of
results of mammography examinations. FDA agrees that a physician with
knowledge of a particular patient's entire medical history is often the
best source of communication and followup of results. However, FDA's
primary jurisdiction under the MQSA is related to mammography
facilities and not individual practices of referring health care
providers.
    One comment suggested an arrangement whereby facilities and each
provider of care enter into a written agreement that the referring
physician assumes responsibility and liability for informing his or her
patients of mammography results, and the mammography facility would be

[[Page 55930]]

allowed to breach this contract at any time when a patient requests the
results in writing. FDA agrees that this arrangement would meet the
requirements of the final regulations. However, if referring physicians
fail to communicate results to patients despite their agreement to do
so, the mammography facility is responsible under the MQSA for failing
to ensure communication of results and is subject to regulatory action
by FDA.
    FDA intends to look for documentation during inspections to
establish that patient notification systems are in place and
operational. For example, if a verbal communication system is used to
tell patients of results, this communication should be documented in
the patient's medical record and should be capable of verification by
the MQSA inspectors. If a facility sends letters to patients, records
of that correspondence, or standard operating procedures describing
this correspondence, must be available for inspection. In circumstances
where a facility relies on referring physicians or other third parties
to communicate results to patients, the facility must provide
documentation of these arrangement and their implementation, as
described above. In those cases where the mammography facility is the
primary breast care provider for the patient, there must be
documentation of results being conveyed to the patients. By allowing a
variety of notification systems, the agency has attempted to ensure
that communication of results will be accomplished effectively, but
without undue burden on mammography practices or unnecessary increases
in the cost of mammography services. Finally, the agency notes that the
regulations being issued to require facilities to establish and
maintain systems that ensure patient notification of results does not
preclude any patient from requesting additional reports or records from
the facility. Nothing in the record and report section of the MQSA
should be construed to limit a patient's access to the patient's
medical records (42 U.S.C. 263b(f)(1)).
    (Comment 412). One comment stated that FDA's intention to inspect
and monitor systems established by facilities to verify that patients
receive notification of results in lay language is unrealistic and that
facilities should not be required to establish such systems.
    FDA disagrees. FDA has issued interim regulations, as required by
the MQSA, that required notices in lay language to be issued, along
with the actual report when patients do not have a referring health
care provider (42 U.S.C. 263b(f)(1)(G)(ii)(IV)). This is a current
requirement for all facilities and is already subject to inspection and
verification.
    (Comment 413). One comment stated that complex situations, such as
when a mammogram is assessed as negative, but the patient has clinical
findings, need careful explanation to patients so that the importance
of the situation and recommendation for followup will be understood.
This comment recommended that the mammography facility be responsible
for patient care if it is accepting women who have no physicians.
    FDA believes this practice standard is largely being adopted by the
mammography community and supports this. Under the final regulations,
each facility is required to maintain a system for referring patients
to health care providers when clinical followup is recommended and the
patient has no physician.
    (Comment 414). One comment stated that followup reminder letters
are critical and should be mandated.
    FDA disagrees that these should be mandated. Rather, each practice
should be allowed to determine if such letters or other forms of
reminders are needed.
    (Comment 415). One comment reflected confusion about the immediate
followup call to patients required under Sec. 900.12(c)(2), which is in
addition to the notification requirements. Although notification is
required for all patients under the system established by the facility
to ensure such communication, FDA believes that special efforts at
communication are required when there are abnormal results and the
patient does not have a referring physician. In these cases, the
facility is expected to contact the patient who has no health care
provider as soon as possible and the 30-day timeframe for sending
reports and long summaries is superseded. Under the final regulations,
this immediate communication is required only in situations where the
probability of cancer is high (mammograms assessed as ``suspicious'' or
``highly suggestive of malignancy''). In cases where such immediate
notification is required, the facility remains obligated to also
provide the necessary written notifications within 30 days as followup.
    (Comment 416). One comment supported the requirement that, when an
examination shows suspicious findings, a facility should directly
communicate with a nonreferred patient. This provides patents the
assurance that they will receive the care they need.
    FDA agrees and the final regulations contain this requirement.
    (Comment 417). One comment stated that, in cases where assessments
are ``suspicious'' or ``highly suggestive of malignancy'' and results
must be ``immediately'' communicated to the examinee or physician, FDA
should define what ``immediately'' means. Another comment suggested
``immediately'' be defined as 24 hours.
    FDA believes that the variety of circumstances that may arise when
followup is required make a rigid definition of ``immediate''
unreasonable. Because there are circumstances when immediate
communication is not possible, FDA has revised the requirement to
communicate abnormal results from ``immediately'' to ``as soon as
possible.'' Health care professionals understand the importance of
accomplishing such notification when there are suspicious or highly
suggestive findings. Although it is impossible to establish a precise
timeframe, FDA expects such communication ordinarily can be
accomplished within 48 to 72 hours and not later than a week following
the examination.
    (Comment 418). One comment stated that 30 days is an unreasonably
long window in which to notify patients of results. Three other
comments agreed with FDA that 30 days was reasonable. Another comment
stated that reports and notification should not be sent out for at
least 5 days in order to wait for outside comparison films; otherwise,
addenda lay notification and reports would confuse patients and
physicians. Another comment recommended that notification to patients
should wait until all mammography imaging work up has been completed.
    FDA believes that issuing medical reports to health care providers
(or to patients with no health care providers along with lay summaries)
within 30 days is a reasonable standard. This does not mean facilities
must wait 30 days, as the first comment suggests, but rather that 30
days is the outside limit. FDA disagrees that notification of results
should be delayed until the total imaging work-up is completed because
situations arise when imaging work-ups can extend over more than 1
month. Therefore, FDA is requiring a report of the medical finding for
each mammogram to be generated within 30 days. Under the final
regulations, facilities must also ensure that patients have their
results communicated to them within that time. Many facilities may
notify patients or have other parties notify patients after written
medical reports are provided to physicians; other facilities may choose
to communicate

[[Page 55931]]

results to patients prior to the issuance of the medical report to the
referring provider by means such as providing verbal results at the
time of the mammography examination. As discussed above, a variety of
systems will be acceptable as long as they ensure that results are
communicated to patients and that communication is timely.
    (Comment 419). Eight comments stated that patients without health
care providers should not get the actual medical report along with the
lay notification. These comments claimed that the terminology in the
medical reports would confuse patients and either generate more
inquiries or keep them from understanding that further studies are
needed. They recommended instead, that patients can request the report
be sent to a physician if further medical advice is desired. One
comment also stated that, while it is critical to include the patient
in the information loop for the results of her mammogram, it is poor
medicine to send the patient who is self-referred the copy of the
mammogram report that is intended for the physician.
    FDA disagrees. The MQSA expressly requires facilities to provide
patients without referring physicians both the medical report and the
lay summary (42 U.S.C. 263b(f)(1)(G)(ii)). This requirement allows the
patient to provide her mammography report immediately to a subsequent
health care provider, if needed.
    (Comment 420). Two comments asked what is meant by ``reasonable
attempts'' to communicate results of suspicious studies to patients
without referring physicians as soon as possible. The comments asked
whether a certain number of phone calls or a registered letter would be
acceptable.
    FDA does not intend to mandate procedures for communication with
patients in these circumstances because different methods are likely to
be more or less effective with different facilities and patient
populations. Telephone calls and registered mail are examples of
attempts at communication that may work. Verification that contact has
been made is the goal. Each facility can consult with its risk
management director to establish procedures to convey results and
document attempts at communication that are ``reasonable.'' FDA
recommends that mammography facilities utilize the AHCPR's guidelines
in ``Quality Determinants of Mammography'' that address the effective
communication of mammography results to patients and follow those
guidelines with respect to written notification to patients. That
document includes excellent sample lay notices that facilities could
adopt. As noted previously, information from Chapter 4 of these
guidelines has been reprinted as an appendix to the preamble of this
document for ease of reference.
    d. Communication of mammography results to health care providers
(Sec. 900.12(c)(3))
    The final regulation requires each facility to provide the
mammography report to a referring or named health provider within 30
days of the date of the examination. The regulation also requires a
facility to make reasonable attempts to communicate with the health
care provider or the provider's designee as soon as possible when an
examination reveals suspicious results. These requirements paralleled
those for communication of suspicious results to patients without
identified health care providers.
    (Comment 421). Five comments requested guidance in defining who is
a responsible designee of the health care provider.
    In response, the agency notes that when referring health care
providers are not available, they ordinarily have responsible
designees, such as medical coverage services or partners, to assume
medical responsibilities for the unavailable provider's patients. These
requirements parallel and complement those related to patient
notification.
    (Comment 422). Twenty-nine comments stated that 30 days is a
reasonable time period for getting reports out (unless there are delays
in obtaining comparison studies). Three comments asked FDA to define
the timeframe required for ``immediately'' communicating the results of
suspicious or highly suggestive mammograms to health care providers.
One comment expressed concern that the requirement to attempt to
communicate ``suspicious'' or ``highly suspicious of malignancy''
findings to health care providers immediately will impose an
unmanageable burden on understaffed facilities.
    FDA disagrees with this last comment but, as with the provision
relating to communication with patients, the agency has changed the
language from ``immediate'' to ``as soon as possible'' because
immediate communication may not be possible given the variety of
circumstances that may be associated with communication of suspicious
results to a particular provider. FDA believes health professionals
understand the urgency of the situation when a patient has a suspicious
or highly suggestive mammogram and they are mandated to communicate
this result to the referring health care provider in an attempt to
expedite diagnosis or treatment. Again, although it is not realistic to
mandate a rigid schedule, the agency expects that such communication
ordinarily can occur within 48-72 hours, and not later than a week
following the evaluation of the examination. NMQAAC discussed this
section and supported the regulations as revised.
    (Comment 423). One comment questioned the ability of physicians who
read only twice a week to comply with the requirement to communicate
with health care providers within the mandated timeframes. FDA believes
timeframes and procedures are sufficiently flexible to balance the need
to protect patient health with the realities of good mammography
practices. Reading twice a week does not preclude a physician or the
facility that employs that physician from complying with the
requirements.
    (Comment 424). Another comment recommended that radiological
reports transmitted to the referring physician be acknowledged by
electronic signature, which should be kept in the electronic file
indefinitely. As stated previously, with respect to proof-reading
reports and ``signing'' them out (for authentification or release), FDA
assumes that facilities are able to devise their own procedures to
ensure accuracy of reports and integrity of the system without the MQSA
regulations at this time.
    e. Recordkeeping (Sec. 900.12(c)(4))
    FDA's final regulation implementing recordkeeping standards for
facilities requires each facility to maintain films and reports at
least 5 years or until the patient requests them or requests their
transfer. If the film and report represent the only mammogram for that
patient, the facility must retain them for 10 years or for any longer
period of time that is required by State law or until the patient
requests them or requests their transfer.
    FDA received numerous comments supporting its proposal to require
transfer of the original mammogram upon the request of the patient.
    (Comment 425). Fourteen comments stated that original films should
be transferred because copies are frequently poor quality and
jeopardize successful followup. Four comments stated that the request
for transfer should be in writing and that the regulation should state
``temporary or permanent transfer.''
    FDA believes each facility should be free to establish its own
procedures for transfer of films and may wish to consult its risk
management director for

[[Page 55932]]

guidance. FDA agrees in part with the last comment and has modified the
final regulation to clarify that a patient may request that the
transfer of the original films be temporary or permanent. FDA will
leave it to the facility to decide whether the request for transfer
should be in writing or may take some other form. NMQAAC also supported
the addition of this language to the final regulation.
    The agency has also amended the language of the provision to
clarify that a request for a transfer supersedes a facility's
responsibility to maintain the films for a particular length of time
and that the request may be made by an individual on behalf of the
patient as, for example, might be necessary in cases where the patient
is incapacitated or has a legal guardian.
    (Comment 426). Two comments agreed that original mammograms should
be sent for comparison to other facilities. However, these comments
stated that FDA's suggestion in the preamble to the proposal that
facilities make a copy is very difficult and expensive. Another comment
stated that copying originals to retain in the record when transfer is
requested should not be required because this would increase costs,
would not be adequate for comparisons, and would delay sending films
out in the timely manner.
    In response to these comments, the agency notes that there are no
requirements for facilities to make copies of films they are requested
to transfer. If this suggestion to make and keep a copy of the
mammograms is not practical or useful to a facility, it need not be
followed.
    (Comment 427). Three comments supported the transfer of original
films, but would require their return within 30 days in cases of
temporary transfer.
    FDA does not intend to establish a time limit on transfer of films
at the request of patients. Even in cases where the transfer is
temporary, the originals may be used during clinical procedures that
may not be completed in 30 days. However, FDA does support the return
of films in a timely manner and expects facilities that transfer and
receive films under such circumstances to cooperate in the interest of
the patient's treatment.
    (Comment 428). FDA also received many comments expressing concerns
about original film transfers. Twenty-six comments stated that
transferring original films is problematic because the films may be
lost, their transfer may breach confidentiality, the originating
institution will not be able to make comparisons, and patient may be
denied access to films at a later date. One comment stated that FDA
should clarify if the transfer of original films conflicts with State
or locals laws and how facilities should proceed if that is the case.
Four comments urged FDA to delete the proposal because the films
themselves are historically the property of the physician or
institution which generated them and their absence would disadvantage
those physicians or institutions in defending against claims asserted
against them. Fourteen comments asked if FDA will indemnify the
radiologist for not having original films in the event of a malpractice
action. One comment stated that there is no enforcement provision
against those facilities who refuse to release original mammography
studies on the grounds of ownership or the potential for legal action.
    FDA understands that the transfer of original films has not been a
universal practice among facilities and that physicians may have
concerns about the consequences of loss or misplacement. Nevertheless,
the agency has concluded that the overwhelming benefit to patients from
access to original films by other facilities or physicians providing
followup for patients justifies the need for this provision in the
final rule.
    All expert comments FDA received on this matter, including advice
from NMQAAC, emphasized the value of having original films for
comparison to subsequent studies or followup clinical procedures. There
was general agreement that copies of mammograms could not adequately
substitute for originals when difficult diagnoses or additional
procedures were required, and that clinical decisions, such as whether
to do surgery, require review of original films. The agency notes that
even those practitioners who criticized the proposal agreed that the
transfer of films was likely to enhance patient care. Those who
objected did so on grounds that were unrelated to patient care, namely
potential for liability and difficulty in defending malpractice
actions.
    FDA has not been persuaded that these concerns are insurmountable
or that they are sufficient to override the public health benefits
associated with the provision.
    Many facilities do routinely transfer films upon the request of
patients and have established procedures and systems to implement that
process. Those procedures may include written requests from patients,
release forms that establish transfer of responsibility for the films,
and agreements with receiving institutions for subsequent return. In
some cases, facilities that transfer films do make and retain copies
for their own files; other facilities have determined that the expense
of copying is not warranted. Loss of films will not be indemnified by
FDA.
    With respect to facility concerns about defense of malpractice
claims, FDA notes that rules of evidence, including civil discovery,
establish judicial procedures that are designed to protect each party's
ability to develop its case. Judges have authority and discretion to
craft remedies in situations where a patient has lost, withheld, or is
resisting production or examination of a necessary original record.
    FDA is not aware of any State laws that conflict with the
requirement that original films be transferred upon the patient's
request. State laws governing the management and retention of medical
records appear to be silent about the transfer of original films.
Rather, they are likely to state that patients are entitled to copies
of their records or that doctors are required to maintain records. This
was the case with the Florida and New York laws that were brought to
the attention of the agency.
    Were a State to enact a law that conflicts with this regulation or
if, contrary to FDA's understanding, such laws currently do exist,
those State laws would be preempted. The agency disagrees with comments
that have inferred such laws would be permissible under the provision
of the MQSA that allows States to establish more stringent requirements
relating to mammography (42 U.S.C. 263b(m)). The public policy
considerations underlying any State laws that would restrict a
patient's access to original films and the quality data that may only
be available from these original studies would not be related to the
public health objectives of the MQSA. Accordingly, such State laws
could not be characterized as more stringent than the MQSA or this
regulation. The agency also notes that the records provision of the
MQSA that is being implemented by this regulation explicitly states
that nothing in that provision shall be construed to limit a patient's
access to that patient's medical records (42 U.S.C. 263b(f)(1)(G)).
    (Comment 429). One comment recommended that FDA add that, upon
receipt of authorization to release mammography film, the mammography
facility must forward the films to the requestor in a reasonable
timeframe to minimize reporting delays. Another comment suggested that
each facility be required to provide original films and copies of
reports within 10 working days of receipt of a written request.
    FDA does not believe it is necessary or useful to mandate the
details of such transfers. The agency believes that each

[[Page 55933]]

facility will develop standard operating procedures to implement this
standard and that those procedures will reflect the controls required
by risk management and acceptable practice standards.
    (Comment 430). Six comments suggested that the facility that took
the most recent mammogram should maintain ownership of all the
originals because this practice would make it easier to keep the films
available for future comparisons. FDA's final regulations do not
preclude this arrangement if the patient requests transfer of previous
films to the current facility.
    (Comment 431). Twenty-four comments asked who should bear the cost
of copying films when the original is released. One comment stated that
facilities should only be able to charge a nominal fee for transfer of
films and reports. Another comment believed that the fees must be
closely monitored; the comment noted that reports have been received in
the past from facilities charging unreasonably high fees for sending
reports and copies of mammography films. A third comment stated that
FDA should develop fee guidelines for charges for copying film and
postage to prevent some institutions from charging high fees.
    FDA generally agrees with these comments and its final regulations
limit charges to the documented cost of the transfer, so as to not
deter patients from requesting transfers when necessary. The agency
notes that nothing in the regulations requires facilities to charge
fees for transfer of records. If copies are made as part of the
facility's standard transfer process, then the cost of copies may be
documented and included in the transfer fee charged by the facility.
    (Comment 432). One comment asked if the fee can include a storage
charge or is it for medical records transfer only.
    The regulations clearly state that any fee is for services provided
under Sec. 900.12(c)(4)(ii), which is the transfer of films and
reports.
    (Comment 433). Twelve comments stated that the proposal that fees
charged for transfer of films and records not exceed costs appears to
be price controls, if not price fixing.
    The agency does not agree that it has taken any action to establish
prices. FDA is responding to complaints that fees charged for transfers
of records have been unreasonable. This practice prevents consumers
from making such transfers and obtaining medical care with the best
quality medical data. The regulation does intend to control such
charges in order to ensure access by patients to their films but the
final rule does not require facilities to absorb additional expenses.
Instead, each facility that decides to charge consumers for this
service must limit its charges to documented costs.
    (Comment 434). Nine comments stated that original mammograms should
be provided by other facilities for comparison purposes free of charge
as a courtesy among institutions.
    FDA supports this process; the final regulations do not mandate a
charge. However, if any fee is established, FDA's regulation requires
that it not exceed costs of transfers of such records.
    (Comment 435). Two comments suggested that FDA's regulations should
consider future technology, which may include the electronic transfer
of films.
    FDA regulations are for screen-film and xeromammography. As other
technology is approved for medical use, alternative standards under the
MQSA will be issued.
    (Comment 436). One comment asked if a facility must retain a series
of mammography records for 10 years and discard them as each record is
10 years old, or discard them when the oldest record is 10 years old.
FDA interprets the provision in the MQSA to mean that, if there is a
series of mammograms for a patient, the oldest mammogram of the series
can be 5 years old. If there is only one mammogram for a patient, it
must be kept 10 years unless a transfer is requested. One comment
stated that mammograms should be maintained for longer than 10 years if
mandated by State or local law. In fact, the MQSA mandates this and FDA
has written its regulations to conform to this provision.
    (Comment 437). Two comments recommended that mammograms be kept
indefinitely in order to spare a patient an unnecessary biopsy and
another comment recommended that FDA establish a standard retention
period of 5 to 7 years.
    The final regulations do not preclude facilities from keeping
mammograms longer than what is required by the statute as a minimum.
However, the agency rejects the 5 to 7 year standard because the
timeframes set forth in the regulation are prescribed by the statute.
    (Comment 438). One comment recommended that FDA reinstate a HCFA
requirement that previous mammograms be obtained for comparison with
present films.
    FDA believes that this is good medical practice, but it is not an
appropriate focus for FDA regulations under the MQSA.
    f. Mammographic image identification (Sec. 900.12(c)(5))
    This provision describes the elements that must be included on any
mammography film to identify the image. They are: patient identifier,
date of examination, view, laterality, facility identification,
technologist identification, cassette/screen identification, and unit
identification, if the facility has more than one unit.
    The NMQAAC advised FDA that these elements need to be present on
all mammogram films to ensure proper patient care. FDA agrees. These
are the same elements as those established by Sec. 900.4(c)(2)(viii) to
identify films submitted to accreditation bodies for clinical image
review. Comments received from the public relating to these elements
for film identification are addressed in that section of the preamble
that discusses Sec. 900.4(c)(2)(viii).
4. Quality Assurance--General (Sec. 900.12(d))
    This paragraph was intended to identify the individuals responsible
for the actions required by Sec. 900.12(e) and (f), including those
intended to ensure that safe radiation dose levels were used. With one
or two exceptions, the requirements of this paragraph were included in
the ACR quality assurance manuals that were made part of the interim
regulations by reference. The ACR manuals are not referenced in the
final regulations. However, certain significant aspects of those
manuals, such as the requirements in this section, were incorporated
into the proposal because there is broad agreement that these
principles are basic to a good quality assurance program.
    a. General comments on quality assurance
    (Comment 439). Two comments stated that all facilities should
follow the same set of universal guidelines to maintain the same
quality of results.
    FDA notes that the MQSA and the implementing regulations are
designed to require that facilities meet universal minimum standards.
Nothing in the statute or regulations is intended to prevent a facility
from applying additional, more stringent standards or procedures that
strengthen QC at that facility.
    (Comment 440). One comment stated that FDA should eliminate this
entire paragraph except for a single provision that would require each
facility to have a quality assurance manual and to verify, through the
signature of a responsible official, that the manual is followed.
    FDA does not believe that the general requirement suggested by the
comment would effectively establish minimum levels of quality assurance
at all facilities.

[[Page 55934]]

    b. Responsible individuals (Sec. 900.12(d)(1))
    This paragraph identified the responsibilities of the individuals
associated with the quality assurance program.
    (Comment 441). Two comments recommended that FDA be more specific
about what responsibilities should be listed and to whom they should be
assigned.
    FDA does not believe that additional detail will be useful in these
provisions. Greater specificity would limit the facility's flexibility
to design a quality assurance program that best meets its individual
needs and to quickly change its program in response to changes in
circumstances or technology.
    (Comment 442). One comment expressed the author's disappointment
that this section and the rest of the regulations failed to allot any
responsibility to administrators and Chief Executive Officers (CEO's),
who have the authority to make the decisions that control quality but
seem to be more motivated by financial concerns.
    FDA agrees that administrators, CEO's, owners, and operators of
facilities share responsibility for the quality of mammography at their
facilities. However, individuals working more directly in and with the
mammography facility on a daily basis often are better able to
determine when quality problems exist and how to correct them. The
agency recognizes that it is sometimes difficult for the staff to
obtain the administrator's support for necessary actions. Nevertheless,
if necessary actions are not taken to correct quality assurance
defects, the result could be sanctions against the facility by FDA.
Because such sanctions can affect the reputation and profitability of
any facility, FDA believes that administrators and CEO's will cooperate
to support actions to improve or maintain mammography quality.
    c. Lead interpreting physician (Sec. 900.12(d)(1)(i))
    This provision requires facilities to identify a lead interpreting
physician to have the general responsibility for ensuring that the
quality assurance requirements of Sec. 900.12(d) through (f) are met.
This is a change from the interim regulations, which assigned this
responsibility to a mammography medical physicist. This change drew a
number of almost evenly divided comments.
    (Comment 443). Eleven comments plus NMQAAC supported the change.
Various comments pointed out that the medical physicist often does not
have the authority to implement needed actions, especially if he or she
is a contract physicist who is rarely at the facility, and the medical
physicist usually does not have the expertise to deal with nonequipment
issues. One comment noted that Massachusetts' regulations have a
similar provision to the proposal and it had been found to improve the
quality assurance programs.
    Eleven other comments opposed the change. Some of these comments
stated the belief that interpreting physicians did not have sufficient
knowledge of or interest in quality assurance to properly handle this
responsibility. Others said that, in modern medicine, the physicians
also lack authority to implement necessary changes and pointed out that
interpreting physicians may also be contract employees and not actually
at the facility. A related comment warned that, if the interpreting
physician is to be given responsibility for oversight, he or she must
also have authority to institute necessary changes. One comment stated
that while it is important to have an interpreting physician in this
role, it is more important to assign this responsibility to someone at
the facility, even if it means involving a nonphysician. Another
comment questioned the basis for designating a lead interpreting
physician if he or she can assign their responsibilities to other
people. Two comments suggested that wording be changed to allow each
individual facility to decide who would be most appropriate for this
responsibility. Finally, one comment stated that the MQSA specifically
said that the medical physicist was to have responsibility for the
quality assurance program.
    After considering all these comments, FDA has decided to leave this
responsibility in the hands of an interpreting physician, as proposed.
Because the interpreting physician is the final arbiter of the quality
of a mammogram, it is logical that the responsibility for the quality
assurance program rest with an interpreting physician. The agency
recognizes that interpreting physicians in some facilities face the
same limitations on their authority as medical physicists. However, FDA
believes that an interpreting physician is more likely to have adequate
authority, or the ability to influence those that do, than a medical
physicist. The agency also recognizes that the interpreting physicians
may not be located at the facility itself. Even in those circumstances,
interpreting physicians have more regular interaction with the facility
through their mammography interpretations than do contract medical
physicists conducting annual surveys. Again, the agency realizes that
interpreting physicians may not have the knowledge to carry out all
aspects of the program themselves, but notes that this is likely to be
true of any other individual in this position. For this reason, the
final regulations do not require the lead interpreting physician to
perform all of the duties personally, but rather to see that they are
carried out in such a way as to meet the requirements. The basic
responsibility remains with the interpreting physician, even if some or
all individual duties are delegated to people with specific training to
carry them out. Contrary to the opinion expressed in one comment,
identifying a lead interpreting physician is valuable because it
assigns this basic responsibility and establishes accountability even
when tasks are delegated.
    Many important duties will be delegated to the medical physicist.
FDA is aware, as one comment noted, of the MQSA provision that requires
the medical physicist to ``survey mammography equipment and oversee
quality assurance practices at each facility'' (42 U.S.C.
263b(f)(1)(F)). As noted above, the interim regulations did assign to
the medical physicist the overall responsibility for quality assurance.
FDA's experience under the interim regulations, however, established
that the interpreting physician, who ordinarily has more interaction
with the facility and is more likely to be onsite, also has an
important role in the oversight of quality assurance. As discussed,
members of NMQAAC and public comments pointed out problems with the
medical physicist having the primary responsibility for all quality
assurance at the facility. After evaluating its experience and the
comments, the agency proposed, and now intends, to shift overall
responsibility for the quality assurance program to the lead
interpreting physician. The medical physicist will continue to do the
annual survey and oversee quality assurance practices, especially those
related to the equipment, as required by the MQSA and the agency
expects that the physicist's expertise will inform all final decisions
that are made on quality assurance issues. The final regulation,
however, requires additional oversight through the lead interpreting
physician. FDA believes this change from the interim regulations is in
accordance with its general authority to require the facility to
establish an effective quality assurance program (42 U.S.C.
263b(f)(1)(A)).

[[Page 55935]]

    Section 900.12(d)(1)(i) requires the lead interpreting physician to
determine whether individuals assigned to quality assurance
responsibilities are qualified to carry them out. FDA agrees with the
comment that urged that the lead interpreting physician also be given
authority to make needed changes because effective quality assurance
will require facilities to respond appropriately to situations that
need improvement or correction. Internal administrative and budgetary
decisions, however, are beyond FDA's authority and the agency cannot
control the business and management relationships that will affect any
lead interpreting physician's ability to institute change.
    d. Interpreting physicians (Sec. 900.12(d)(1)(ii))
    This paragraph was intended to emphasize the role that all
interpreting physicians should play in establishing and maintaining
quality mammography at a facility. As previously mentioned, the
interpreting physicians are the final arbiters of the quality of
mammography images. It is important that they communicate their
satisfaction or dissatisfaction with the quality of the images they are
provided to interpret to the technologists who produced them. Such
communication is the crucial first step in the identification of
problems and the initiation of corrective actions. FDA is aware that
this communication has not always occurred in the past, especially if
the interpreting physicians are not located at the facility. Media
investigations and many anecdotal accounts have illustrated this
failure in communication.
    None of the 17 comments on this provision disagreed with the basic
premise that interpreting physicians should provide feedback to
facility staff producing the mammograms. However, there were some
misunderstandings as to just what was required.
    (Comment 444). In particular, 13 comments mistakingly assumed that
each interpreting physician was required to contact every technologist
about the quality of each film taken. These comments requested that the
requirement be limited to reporting technically inadequate mammograms
to the QC technologist. Another comment pronounced the requirement as
excellent, but asked whether a report was required on the
technologist's performance for every film or if a summary of each
technologist's performance was sufficient. Another comment suggested
that feedback be given to the lead interpreting physician or, in his or
her absence, to the QC technologist. One comment requested that this
provision be more specific, and another recommended that all
interpreting physicians be required to have training in the technical
aspects of mammography, quality assurance, and QC.
    FDA drafted the proposed regulation to be general in order to give
each facility the flexibility to design a feedback system that best
fits its own situation. The agency believes this flexibility should be
retained in the final regulations. In response to the comments,
however, FDA has clarified that followup activities by interpreting
physicians are required only when the image is of poor quality. FDA
recommends, however, that positive feedback also be given when
warranted because such feedback is an effective incentive for
maintaining quality performance.
    e. Medical physicists (Sec. 900.12(d)(1)(iii))
    This paragraph summarizes the role of the medical physicist in
establishing and maintaining quality mammography.
    (Comment 445). Eleven of the comments received on this provision
suggested various wording changes. Seven of these supported changes
that would state that the physicist is to evaluate the equipment and to
survey it. An eighth comment wanted to amend the language to give the
medical physicist authority to take necessary steps to ensure quality
in his or her area of responsibility. Two comments suggested changes
that would limit the physicist's responsibilities to overseeing the
equipment-related quality assurance practices. These comments further
suggested limiting the physicist's review of the QC technologist's work
to verifying that it is performed and not to include providing advice
on tests or suggestions for corrective measures. Another comment,
however, clearly disagreed with this point of view and stated that the
medical physicists should be required to oversee the facility's entire
quality assurance program.
    FDA agrees that the physicist should be involved in equipment
evaluation and the annual survey and notes that changes made elsewhere,
in the survey definition and in Sec. 900.12(e), will achieve this goal.
FDA cannot require that the medical physicist be given authority to
initiate changes at the facility to improve quality for the same
reasons that it did not issue regulations giving the lead interpreting
physician similar administrative and budgeting authority. The agency
does agrees that the physicist's oversight responsibility should be
focused primarily on the equipment-related areas. The definition of the
position of lead interpreting physician in Sec. 900.12(d)(1)(i), as
discussed previously, should clarify that general overall
responsibility rests with that physician while responsibility for
equipment-related matters resides with the physicist. FDA does not
agree with the suggestion that would limit the medical physicist's role
in the oversight of the QC program to merely verifying that the
technologist's work was done. The agency believes that, as the
equipment and imaging physics expert, the physicist's role must be more
active and that ensuring an adequate QC program clearly should be part
of the medical physicist's duties. The medical physicist should not
stop with verifying that the QC tests were performed but should also
ensure that they were performed properly, that the results were
analyzed, and that any problems detected by the analysis were
corrected.
    (Comment 446). A final comment on this paragraph suggested that a
new intermediate position be created at a level between the QC
technologist and the physicist. The comment recommended that the person
in this position could do tests that do not require a physicist but are
beyond a technologist's training, and noted that such a position has
been quite useful in the respondent's facility.
    Provisions of Sec. 900.12(e) require that surveys and mammography
equipment evaluations be performed by medical physicists. Under the
interim or final regulations, a facility is free to create an
intermediate position for personnel to perform other testing during the
time periods between the surveys and evaluations, including performance
of the tests normally done during surveys. However, the agency does not
have sufficient evidence to demonstrate that it would be beneficial to
make this a general requirement and believes each facility is in the
best position to decide whether such a position would be of value in
its situation.
    f. QC technologist (Sec. 900.12(d)(1)(iv))
    This provision describes the QC technologist's responsibility to
perform all quality assurance duties not assigned to the lead
interpreting physician or the mammography medical physicist. The main
issue raised by the comments on this provision was about the
qualifications of the individual holding this position.
    (Comment 447). Eighteen comments expressed the opinion that the
person doing these tests should be a radiologic technologist who meets
all of the requirements necessary to perform mammography examinations.
Seven additional comments stated that the QC technologist should be a
technologist but, to increase flexibility for the

[[Page 55936]]

facility, should not necessarily have to be qualified to do mammography
examinations. One of these seven recommended that the QC technologist
should have some training in mammography. Ten comments argued that the
individual performing at least some of the tests did not even have to
be a technologist, as long as that person had training in the test
performance. Some of these pointed out that requiring a technologist to
do the tests would increase facility costs without an equivalent
increase in the quality of mammography.
    After considering the comments, FDA has revised the proposal to
permit nontechnologists to perform tasks for which they were trained,
as long as their work is supervised by a QC technologist who meets the
requirements to do mammography examinations. FDA believes this change
strikes the proper balance between the need for expert oversight and
the need to reduce unnecessary costs for facilities.
    NMQAAC discussed this issue at several meetings and, at different
times, expressed varying points of view. However, after its own review
of the public comments, NMQAAC supported the approach FDA has taken in
the final rule.
    (Comment 448). Twelve comments suggested changes, primarily to
allow or prohibit the facility from having more than one QC
technologist.
    FDA agrees that there are advantages to the consistency that can be
achieved if there is only one QC technologist. The agency also
recognizes that the facility may find it useful and necessary to have
more than one QC technologist, e.g., to ensure coverage when one QC
technologist is ill or on leave. The agency notes that facilities also
have the option of having the lead interpreting physician or medical
physicist fill in for the QC technologist, assuming they have the
necessary qualifications, by temporarily ``reassigning'' the
technologist's duties.
    (Comment 449). Another comment suggested that the QC technologist
should report directly to the lead interpreting physician rather than
to the medical physicist.
    FDA notes that the regulations permit the facility to decide for
itself what lines of communication to the lead interpreting physician
should be established. The agency believes that this flexibility should
be retained.
    (Comment 450). Another comment suggested that all mammographers
should be trained in all QC tests and procedures.
    From the context of the comment, it was clear that the author was
using the term ``mammographer'' to refer to technologists doing
mammography, and not, as is becoming increasingly common, to
interpreting physicians interpreting mammography. Section
900.12(a)(2)(ii)(A) does require such training as part of initial
training for technologists who will begin performing mammography after
the final regulations become effective. Training in these areas could
also be used to fulfill initial requirements under the interim
regulations, so many technologists presently doing mammography will
have had this training. Although FDA encourages all radiologic
technologists currently practicing to include such training as part of
their continuing education, the agency does not believe that the
benefits of retroactively requiring all present technologists to
receive this training would outweigh the costs.
    (Comment 451). A final comment suggested that adequate time should
be allotted for the quality assurance/QC duties.
    FDA fully agrees with this comment but does not believe that this
kind of commitment can be codified through a regulation. The agency
also notes that the amount of time needed will vary significantly, in
view of the different situations in different facilities and the
differing abilities of the individual QC technologists. As discussed in
connection with earlier sections, FDA believes that owners, operators,
and managers will have new incentives to ensure that quality assurance
programs are properly implemented and that these programs meet the
Federal standards with which all facilities must comply.
    g. Quality assurance records (Sec. 900.12(d)(2))
    The provisions of this paragraph have been significantly changed
from the proposal. The proposal required that the facility have a
quality assurance manual covering the procedures to be used in meeting
the requirements of Sec. 900.12(e) and (f). The manual was to be
readily available to all staff members and documentation that it was
read and approved by the lead interpreting physician and the medical
physicist was required. A list of individuals assigned quality
assurance responsibilities and details of their assignments was also to
be available to all staff members. Records were to be kept showing that
these individuals were qualified for their assigned duties. Records
were also to be kept showing the data obtained during monitoring of the
facility performance, the analysis of the monitoring data, the problems
detected and corrective actions carried out, and the effectiveness of
the corrective actions in resolving the problems. The records were to
be kept for each test for a minimum of 1 year or until the test had
been performed two additional times at the required frequency,
whichever was longer.
    In response to comments received, as summarized below, and in
keeping with the FDA's goal of less prescriptive and more flexible
regulations, this paragraph has been greatly simplified. The final
regulations do not require any description of the procedures to be
followed in performing the QC tests or a list of the individuals with
quality assurance responsibilities and their responsibilities. The
proposal requiring records documenting the qualifications of these
individuals to perform their duties is changed to simply require that
records be kept concerning employee qualifications. No review,
revision, or sign-off of the manual is required at any frequency but
there is a general requirement that the lead interpreting physician, a
QC technologist, and a medical physicist are to ensure that records are
maintained and updated. The time that the records of testing and
followup actions must be kept has been clarified but remains
essentially the same.
    The proposal divided the provisions of Sec. 900.12(d)(2) into four
paragraphs, (i) through (iv). As a result of these changes, paragraphs
are no longer needed but the comments received on the proposed four
paragraphs will be discussed, following the general comments.
    h. General comments on quality assurance records
    (Comment 452). One comment asserted that keeping quality assurance
records was an unnecessary burden but did not suggest an alternative
means by which a facility could demonstrate that it had carried out the
quality assurance tests and all necessary followup activities. A second
comment recommended that mammography facilities be required to retain
written specifications in a standardized format from the processor
manufacturer.
    FDA cannot accept the first of these comments without an adequate
alternative to keeping records. FDA agrees there would be value in
processor manufacturers providing specifications in a standardized
format but believes it would be premature to make this a requirement.
The agency's previous attempts to encourage the provision of processor
operating characteristics for different types of film showed that there
are significant problems to be solved, among them the very large number
of

[[Page 55937]]

possible combinations of film, chemistry, and processors.
    i. Records to be kept (proposed Sec. 900.12(d)(2)(i), (ii), and
(iii))
    (Comment 453). A few comments were received on the records to be
kept. Three comments opposed the change from requiring the use of the
ACR manual to allowing the use of whatever manual best fits the
facility's needs.
    FDA believes that the increased flexibility provided by allowing
the use of manuals other than the ACR manuals is desirable because it
permits facilities to more rapidly adjust their programs to incorporate
improvements in quality assurance procedures or new techniques for new
technology. When a manual is specified in regulations, the regulations
may have to be amended to facilitate use of even a new edition of that
manual, let alone an improved manual from another source. To increase
flexibility even further, in the final rule FDA has dropped the use of
the word ``manual'' altogether because it seemed to imply a certain
format. Facilities will now be able to keep the required records in any
suitable format.
    (Comment 454). A number of comments recommended addition of items
to the list of those required to be kept. Six comments suggested adding
technique charts to the required records, while a seventh suggested
adding documents related to the medical outcomes audit program. Another
comment stated that documentation for darkroom cleaning, screens, and
view boxes should not be eliminated.
    NMQAAC members pointed out that there was already a requirement in
the ACR manuals, which were incorporated into the interim regulations
by reference, that a technique chart be available. Although there was
some difference of opinion, NMQAAC seemed to support retaining a
requirement for keeping a technique chart with the equipment but not
necessarily in the manual. With respect to the quality assurance manual
in general, the view of NMQAAC seemed to be that elements required in
the final regulations were ``key'' or ``basic'' to the success of a
quality assurance program. At least one NMQAAC member expressed
reservations about the detail required and would have preferred to
limit the regulation to a general requirement that there be a quality
assurance manual. However, both this member and a second member
recognized that enforcement by inspectors would be difficult without
more detailed requirements.
    FDA notes that documentation of facility cleanliness activities is
required in Sec. 900.12(e)(11). The list of other records that must be
kept, although not necessarily in a ``manual,'' has been revised as
discussed previously.
    (Comment 455). Other issues that drew a number of comments were who
should sign off on the manual and how often should review, revision,
and sign-off take place. Nine comments supported having the QC
technologist sign-off in addition to the lead interpreting physician
and mammography medical physicist. A tenth comment would limit the
physicist sign-off to only those items related to his or her
responsibility. Three comments stated that the review, revision, and
sign-off should occur at least annually. NMQAAC supported both adding
the QC technologist to the sign-off list and the annual review,
revision, and sign-off.
    FDA has replaced the requirement for a formal sign-off with a
general statement that the lead interpreting physician, QC
technologist, and medical physician should ensure that the specified
records are kept.
    (Comment 456). Another comment stated that qualifications of the
individuals assigned responsibilities in the QC program should be kept
on record only if those individuals are not listed in the facility's
application (presumably for accreditation).
    FDA disagrees with this comment. The accreditation bodies do not
check the qualifications of personnel to perform quality assurance
tasks during the accreditation process.
    Proposed Sec. 900.12(d)(2)(ii), which required that a list be kept
of the individuals with quality assurance assignments and their
assignments, drew only one comment. The comment supported the list but
urged that the requirement be clarified so it was not construed to mean
that only the listed individuals could carry out the duties. As
discussed above, FDA has eliminated this proposed requirement.
    The only comment on the proposal for keeping records of
qualifications of quality assurance personnel, Sec. 900.12(d)(2)(iii),
suggested that those records should be kept indefinitely. As discussed
above, FDA has reworded the requirement slightly. Requirements for
record retention are discussed below.
    j. Monitoring performance (proposed Sec. 900.12(d)(2)(iv))
    As proposed, this provision would have required facilities to
maintain records related to monitoring of their facility's performance
for 1 year or until the tests has been performed two additional times
at the required frequency, whichever was longer.
    (Comment 457). One comment stated that the words ``for a minimum of
1 year'' should be replaced with ``from inspection-to-inspection''
because inspections may not occur precisely at annual intervals. FDA
has changed the wording to ``until the next annual inspection has been
completed and FDA has determined the facility is in compliance with the
quality assurance requirements.'' This change addresses concerns raised
by this comment and clarifies that an inspection includes the followup
and the actual visit to the facility.
    5. Quality Assurance--Equipment (Sec. 900.12(e))
    The primary purpose of the equipment aspects of the quality
assurance program is to prevent problems with equipment or detect and
correct problems before they can have a significant effect on clinical
image quality. In order to achieve this objective, the performance
parameters of the equipment must be tested at appropriate frequencies,
the test results must be analyzed promptly to determine if the
performance of the equipment is satisfactory, and any identified
problem must be corrected as soon as possible. Followup tests must also
be conducted to determine whether the corrective actions were effective
and adequate. Requirements for the types of equipment tests to be
performed and for the necessary followup actions were proposed in
Sec. 900.12(e). These requirements have generally been retained in the
final rule. However, on the basis of a number of valuable comments the
agency received in response to its proposals, some revisions to the
proposal have been made. Many of the revisions have been made after
discussions with NMQAAC. In addition, tests for radiation output and
decompression have been added to the annual QC tests as
Sec. 900.12(e)(5)(x) and (xi). The action limits for these tests were
proposed as equipment specifications in Sec. 900.12(b).
    a. General comments on equipment quality assurance
    In the preamble to the proposal (61 FR 14912), FDA specifically
requested comments on the value of a simple daily total system test
based upon the evaluation of the optical density and artifacts on an
image of a uniform phantom. The agency believed that the total system
test, when performed in conjunction with the processor performance test
set forth in Sec. 900.12(e)(1), would ensure the overall quality of X-
ray machine and processor performance and of the films produced. This
test would only takes a few minutes to perform and records of the test
would enable a medical physicist to

[[Page 55938]]

quickly detect the source of a problem when it occurs.
    (Comment 458). A large number of comments opposed the idea of such
a test. Several of these comments, however, confused this test with the
alternative phantom testing identified earlier as a possible basis for
performance-based standards (See 61 FR 14860). Some members of NMQAAC
also opposed this test. The agency also received a number of comments
supporting this test. Several comments agreed that more frequent
phantom testing in conjunction with daily processor testing is
important.
    In view of the mixed comments, FDA concluded that it should not
require the test until it gathers additional data on its usefulness.
However, FDA strongly encourages facilities to test their machines as
frequently as possible, either by a phantom evaluation or by the total
system test.
    A number of comments requested that FDA provide a detailed
description of all QC test procedures. Several comments wanted FDA to
reference ACR QC manual, while some comments considered the proposed
Quality Assurance-Equipment requirements to be appropriate.
    FDA notes that Sec. 900.12(e)(1) through (e)(5) lists the minimum
performance tests to be conducted on screen-film systems and their
required frequency. Action limits for the tests are also specified. The
agency has refrained from providing extensive detailed requirements or
prescriptive descriptions of test procedures, as some comments
recommended, in order to provide facilities with the flexibility to use
their own judgment as to what testing methods best enable them to meet
the required criteria. FDA has also decided not to base its QC
requirements on a single manual and, therefore, no such manual has been
referenced. In addition, NMQAAC has advised FDA that the ACR manuals
were intended to be used as guidelines, not in a prescriptive manner. A
facility may consult any appropriate manual on agency guidance to meet
the requirements in Sec. 900.12(e)(1) through (e)(5).
    (Comment 459). One comment stated that some of the tests should be
more rigorous. The comment further questioned why a monthly visual
checklist was not included.
    While conducting regular visual checks of the equipment is a
desirable practice, it is not an action that can be confirmed from test
data. Therefore, the agency has decided to encourage this and similar
desirable practices through educational means instead of making them
regulatory requirements.
    (Comment 460). Another comment stated that FDA should only issue
more stringent requirements if their benefits clearly exceed their
costs.
    FDA agrees with this comment and believes that the tests it has
required meet this criterion.
    (Comment 461). One comment stated that numerous paragraphs refer to
films, optical densities, and processors, without limiting the
requirements to any specific modality.
    FDA notes that the initial words in each paragraph from
Sec. 900.12(e)(1) to (e)(5) are ``Facilities with screen-films shall *
* *,'' making it clear what modality is referred to.
    (Comment 462). Another comment maintained that FDA should require
proper QC tests for stereotactic units. One comment stated that the
quality assurance standards should include a requirement to use a
digital mammography evaluation phantom developed by the author's
company that has been designed specifically for QC of digital machines
for stereotactic biopsy.
    Interventional mammography is presently exempt from the MQSA
requirements for reasons discussed in response to the comments on the
definition of mammography in Sec. 900.2(y). The agency is in the
process of developing quality standards for interventional mammography
and these will include QC tests. QC tests for other mammographic
modalities have been addressed in Sec. 900.12(e)(6).
    (Comment 463). Another comment stated that FDA should provide its
inspectors with more latitude to accept variations from regular
inspection procedures, if the physicist can adequately explain the
rationale for the deviations and demonstrate how the standard is met.
From the context, the agency assumes that the author of the comment is
actually referring to survey procedures rather than inspection
procedures.
    FDA has instructed inspectors to discuss variations with QC
personnel or medical physicists available in the facility during
inspection. In some cases, the inspectors, after receiving satisfactory
explanations for variances in test procedures, have refrained from
giving citations or withdrawn citations initially given to the facility
during inspection. However, because it is essential that the
evaluations of facility conformance with the quality standards be
consistent nationwide, the latitude provided to inspectors necessarily
has to be limited. Moreover, those wishing to use alternatives to the
requirements of the regulations who can demonstrate that their
alternative provides assurance of quality mammography equal to the
regulatory requirement, may do so in accordance with Sec. 900.18.
    (Comment 464). A few comments urged FDA to require testing with all
cassettes wherever that is appropriate.
    In the proposed regulations, the agency proposed that screen speed
uniformity of all cassettes in the facility be tested. In the final
regulations, FDA added that artifact evaluations should be performed
with all cassettes in the facility. The agency also considered
requiring performance of the phantom image quality test with all sizes
of image receptors. However, when FDA staff members carried out phantom
image evaluations using two different image receptor and cassette sizes
with five different mammography machines, no difference was seen in the
phantom image scores when results with larger image receptors were
compared to those with smaller. NMQAAC strongly advided FDA not to
require weekly phantom testing for all image receptor sizes because the
members do not believe that phantom image quality is affected by
receptor size. NMQAAC pointed out that the ACR manual did not recommend
phantom image evaluation with large image receptor sizes. Based on all
this information, the agency concluded that facilities should not be
required to conduct phantom image quality tests with all available
sizes of image receptors.
    b. Daily QC tests--screen-film system (Sec. 900.12(e)(1))
    The only daily tests required under the final regulations are those
that ensure adequate processor performance by assessing base plus fog
density, mid density, and density difference, using mammography films
used clinically at the facility.
    (Comment 465). Five comments stated that there should be a maximum
limit between time of exposure and time of processing. NMQAAC discussed
this issue in connection with requirements for mobile units, for which
image degradation due to delayed processing is a particular concern.
The committee concluded that, in general, this was not a significant
enough problem to require a regulatory requirement and FDA accepted
this position.
    (Comment 466). Ten comments suggested the word ``examinations''
should be replaced with ``films'' and the word ``performed'' with
``processed.'' The agency agrees with these comments and has made such
changes in the final regulations.
    One comment suggested adding the words ``and evaluate'' after
``shall perform.''

[[Page 55939]]

    FDA notes that Sec. 900.12(e)(8) generally defines tests for which
the evaluation of test results (and corrective actions) must be
performed before further examinations are conducted. The processor
tests are among them.
    (Comment 467). Several comments suggested that the last few words
in Sec. 900.12(e)(8)(ii), ``of no less * * * 1.2 OD, [optical
density]'' should be deleted. These comments stated that in some cases,
the step averages may turn out to be lower, for example 1.05, and that
should be acceptable if the next higher step shows a substantially
higher OD, such as 1.4. Another comment offered a similar argument,
noting that the proposed rules would not allow the use of modern high
gradient mammography films where the change in optical density between
adjacent steps in this density range can be as high as 0.7.
    FDA agrees with these comments and has deleted ``of no less * * *
1.2 OD'' in Sec. 900.12(e)(8)(ii).
    (Comment 468). One comment stated that QC measures should be in
place for densitometry and sensitometry equipment.
    FDA requires all sensitometers and densitometers its inspectors use
to be properly calibrated. If FDA inspectors detect problems in the
processor performance, the facility will have to identify the cause. If
the cause turns out to be related to inadequate performance of the
facility's sensitometry or densitometry equipment, the effort required
to determine the nature of the problem will give the facility
sufficient incentive to take actions to avoid a recurrence without the
need for a regulatory requirement.
    (Comment 469). Three comments asserted that the <plus-minus> 0.15
OD action limits for mid-density and density difference were too
restrictive as proposed and requested changing this limit to allow a
wider range.
    Under the interim regulations, facilities have been required to
comply with this limit and the inspection data reveal that most
facilities are able to do so. The agency does not find that there is
adequate reason for changing this limit in the final regulation.
    (Comment 470). One comment stated that a guidance document should
be published to provide a clear explanation of the scientific basis for
establishing an H&D curve and the importance of parameters taken from
this curve to monitor trends in processor QC.
    FDA believes that this is a widely accepted practice and the most
effective procedure that is currently available. Sufficient materials
providing the type of guidance requested already exist.
    c. Weekly QC tests--screen-film system (Sec. 900.12(e)(2))
    In the proposal, the image quality test using a phantom approved by
FDA, which was required monthly by the interim regulations, was made a
weekly test.
    (Comment 471). Twenty comments opposed changing the phantom testing
from monthly to weekly, arguing that the additional cost of performing
phantom image evaluation weekly would be burdensome to many facilities.
However, a larger number of comments supported this change, many
indicating that their facility already performs phantom tests weekly.
    FDA is convinced by the experience of the facilities that have been
performing phantom image evaluation at a higher frequency that the test
should be performed weekly. The agency believes that the benefit
outweighs a slight increase in costs. As noted in the preamble to the
proposal, if the daily total system test had been required, returning
the required frequency of the image quality test to monthly could have
been justified. However, because FDA is not mandating the total system
test at this time, it is essential that all facilities perform weekly
phantom image evaluation as an overall assessment of all aspects of the
imaging chain.
    (Comment 472). Some comments suggested changing ``image contrast''
to ``density difference'' and ``assess density difference'' to ``assess
image contrast'' in Sec. 900.12(e)(2)(iv).
    The agency agrees with these comments and has revised the wording.
    (Comment 473). One comment stated that the density difference
between the background and the test object needs to be defined. The
comment further stated that there is presently confusion over the ACR
recommendation for a density difference of 0.40 at 28 kVp.
    FDA notes that, with the changes made as suggested by the previous
comments, it is clear that the density difference is measured between
the background and a test object added to the phantom to assess the
image contrast. The agency has determined that the regulations should
not specify a number for the operating level for this density
difference, specify the test objects, or prescribe any technique
factors to achieve the desired operating level, because all these
variables may change with future changes in technology. However, FDA
considers it important that facilities make sure that the measured
density does not vary by more than <plus-minus> 0.05 from the
established operating level.
    (Comment 474). Several comments considered the requirement of a
minimum 1.20 optical density (OD) at the center of a phantom image to
be high and believed that many facilities will not be able to meet that
standard. One comment stated that higher OD is achieved at the expense
of patient dose. Some comments considered 1.20 OD too low. One comment
recommended that there be an upper limit of OD. Another comment stated
that OD within <plus-minus> 0.20 is reasonable if the film
manufacturer's tolerance is better than 0.3 OD from batch to batch.
    FDA believes that proper OD is vital to the early detection of
micro calcifications and, with the advent of new mammography screen-
film systems, an OD of 1.2 with a variation of no more than 15 percent
can be achieved if the processors and the units perform properly.
NMQAAC also advised FDA to require that the film OD at the center of
the phantom image be no less than 1.2 for the purposes of this test.
The agency, however, believes that a requirement for an upper limit on
OD may hinder any future development of mammography screen-film
systems. Therefore, the agency will retain Sec. 900.12(e)(2)(i) and
(ii) as proposed.
    (Comment 475). One comment stated that the point of the image
quality test is to determine constancy; therefore, it was unnecessary
to mandate the measuring position of optical density as the center of
the image, as long as the same location is measured each time.
    The intention of this requirement is that the OD be measured at the
same location of the phantom image each time, as the comment suggested.
The agency believes that the center of the phantom image is a
reasonable and easy place to locate such measurements. Further, it is
not advisable to measure OD too far away from the center towards the
anode side of the phantom image in order to avoid a decrease in density
due to the heel effect. This could lead to a failure to meet the
<gr-thn-eq> 1.2 OD requirement when it might have been met if measured
at the center of the same phantom image.
    (Comment 476). One comment recommended that Sec. 900.12(e)(2)(iv),
the phantom image contrast requirement, be deleted because daily film
sensitometry already measures this parameter.
    FDA disagrees. The daily sensitometry test only uses light that
simulates the screen phosphor luminescence. However, emitted light due
to X-ray induced fluorescence from the screen phosphors is different
both in spectral dependance and in intensity from the light output from
the currently available sensitometry equipment. It is

[[Page 55940]]

very important that contrast is evaluated when the film is exposed by
the emitted light from the actual screen phosphors, induced by the X-
ray beam. For this reason, the daily film sensitometry test cannot
replace this test of image contrast.
    (Comment 477). Several comments noted that the current phantoms are
not tissue equivalent and recommended that FDA specify only one type of
phantom and minimum acceptable performance criteria. A related comment
urged FDA to provide guidance to establish the adequacy of image
quality. Another comment requested specification of the test object and
measurement conditions for phantom evaluation.
    FDA has refrained from specifying phantom or test object type,
performance criteria, or scoring methodology in order not to inhibit
future advances in phantom technology. The agency continues to believe
that accreditation bodies should establish phantom specifications and
related performance criteria. However, as part of its responsibilities
for accreditation body approval and oversight, FDA will examine each
body's phantom specification and performance requirements, which will
have to be substantially the same among the different accreditation
bodies.
    d. Quarterly QC tests (Sec. 900.12(e)(3))
    Two QC tests were required to be performed quarterly in the
proposal. These were a test of the fixer retention in film and the
repeat analysis.
    e. Fixer retention in film (Sec. 900.12(e)(3)(i))
    This test determines the quantity of residual fixer in processed
film, which is an indicator of insufficient washing. Insufficient
washing may have a considerable adverse effect on image quality.
    (Comment 478). One comment believed that the fixer retention test
should be a semiannual test.
    FDA notes that quarterly performance was recommended by the ACR
manuals and required under the interim regulations. The agency believes
that it is generally accepted that facilities should perform this test
quarterly and has retained the frequency requirement of this test as
proposed.
    f. Repeat analysis (Sec. 900.12(e)(3)(ii))
    Facilities must perform this test quarterly with repeated and
rejected films. If the repeat or reject rate, calculated as a
percentage of the total films included in the analysis, changes by more
than 2 percentage points from the rate determined the previous quarter,
the cause of the change must be identified. (For example, if the repeat
rate the previous quarter was 4 percent and this quarter it is 7
percent, the cause of the change must be identified. If the repeat rate
this quarter is 6 percent, no further action is needed.)
    (Comment 479). A few comments suggested changing ``repeat'' to
``reject.'' One comment stated that it might be more appropriate to
simply refer to repeat rate change, rather than repeat or reject rate
change.
    FDA believes that while the repeat rate is perhaps the better
indicator of unnecessary radiation exposure in the facility, the reject
rate gives a better picture of the image quality situation. Both rates
give useful information and should be calculated.
    (Comment 480). Some comments recommended that FDA define repeat and
reject to ensure that all but nonclinical films are analyzed. Several
comments requested FDA to clarify that films repeated to correct
positioning should be included in the repeat analysis. FDA believes
that it is current practice that all repeated films are included in the
repeat analysis, regardless of the cause of such repeats, and so a
regulation mandating this practice is not needed.
    Other comments expressed opinions on the most desirable frequency
of the repeat analysis. One comment suggested that all repeats be
evaluated and corrective action be taken when possible. Several
comments recommended monthly repeat analysis and stated that this test
would be less useful if it were done quarterly. Another comment urged
monthly repeat analysis with 400 films. Another stated that the current
method of repeat analysis every 3 months was sufficient.
    FDA believes that low volume facilities would not have sufficient
numbers to conduct a meaningful analysis if the required frequency is
increased. Similarly, if the minimum number of films is set too high,
the time period required to collect them in a low volume facility will
be so great that problems could go undetected for a significant period
of time. FDA, therefore, has left the required frequency as quarterly
and has not specified a minimum number of films to be included in the
analysis. The agency notes that nothing in the regulations would
preclude a high volume facility from performing the analysis at an
increased frequency and with as many films as it wished.
    (Comment 481). Several comments urged FDA to include an acceptable
limit of repeat rate in the regulations, some suggesting that it be 2
to 5 percent. Two comments wanted FDA to require corrective action to
lower the observed repeat rate.
    FDA again notes that, while most of these comments referred to
``repeat'' analysis, an analysis of both the repeated and the rejected
films is required. In response to these comments, FDA observes that it
has long been recognized that the parameter with the greatest impact on
the repeat or reject rate is the subjective opinion of the physicians
doing the interpreting as to what is acceptable. As noted in the
preamble to the proposal (see 61 FR 14860), the repeat or reject rate
could be reduced by a facility through acceptance of lower quality
films. Any range or maximum value for repeat or reject rate that was
established as acceptable through a regulation thus could quickly be
rendered meaningless as an indicator of acceptable facility performance
by such action. Consequently, the agency believes that, while it is
important to keep the repeat or reject rate low, it is more important
and useful to assess the cause of any change (increase or decrease) in
the repeat or reject rate from the previously determined value.
Therefore, the agency has retained the proposed requirement that the
cause of a variance of more than 2 percent from the value previously
determined must be properly assessed and recorded.
    In looking for the cause of the change, the agency strongly advises
facilities to assess all the factors that can affect repeat or reject
rate. These can include personnel ability and preferences, changes in
personnel, or variance in machines, processors, films, or chemistry
performance.
    (Comment 482). Some comments asked why a decrease of 2 percent
requires action.
    FDA notes, that while it may appear that a decrease in repeat or
reject rate is a desired goal and should not require further
assessments of the results, this is not necessarily so. For example, if
a facility added a mobile unit to its operations, the interpreting
physician might feel a subtle pressure to interpret films taken with
that unit that he or she might normally reject because of the greater
difficulty in scheduling repeat examinations at mobile units. This
practice could lead to a reduction in the repeat or reject rate that
does not necessarily indicate an improvement in quality. Therefore, the
agency believes that the cause of either an increase or a decrease of
more than 2 percent from the value previously calculated must be
determined and any corrective actions should be recorded and assessed.
    (Comment 483). A few comments stated that repeat analysis for each
technologist should be evaluated and followup studies should be
standardized. One comment wanted

[[Page 55941]]

such analysis performed for each machine used in the facility.
    The agency supports the idea that analysis of the repeat rate for
each technologist, radiologist, and/or machine can be valuable.
However, many facilities with a sufficient volume for a meaningful
analysis of their total operation would not have a sufficient volume
for meaningful analysis of each technologist, interpreting physician,
or machine. For this reason, FDA does not believe that a separate
analysis for each technologist, interpreting physician, and machine
should be a regulatory requirement. However, the agency recommends that
each facility consider whether such analysis would be useful in its
particular situation.
    (Comment 484). One comment urged FDA to provide more guidance,
either in a guidance document or by reference to the ACR QC Manuals, as
to criteria for repeat and reject rate evaluation and corrective
action. Another comment stated that this section needs to be elaborated
to specify the frequency at which this test needs to be performed both
for large and small volume facilities, guidelines about whether the
analysis should be site- or technologist-specific, and acceptable
repeat or reject rates. FDA notes that it has provided guidance for
establishing an effective repeat and reject analysis program in the
past and may provide additional information in the future. However, the
agency believes that, as repeat or retake analysis has been an
established procedure in radiology for 20 years or more, abundant
guidance is also available from other sources. As stated previously,
the agency in the final regulation will not reference any manual in
order to provide the QC technologists and the medical physicists with
flexibility to design their own analysis, recording, and corrective
action procedures.
    g. Semi-annual QC tests (Sec. 900.12(e)(4))
    The proposal included requirements for semiannual tests of darkroom
fog, screen-film contact, and compression.
    The test of darkroom fog in Sec. 900.12(e)(4)(i) is intended to be
performed to identify light sources in the darkroom that can cause
significant mammographic film fogging.
    (Comment 485). One comment supported Sec. 900.12(e)(4)(i) as
written. The comment further stated that retaining the paragraph as
proposed would eliminate variables for inspectors when performing this
test. Several comments urged that certain test conditions be required,
such as: ``Carry out the test under clinical conditions, with or
without the safelight;'' ``use previously sensitized film;'' or ``place
the test film on the counter top or on the processor feed tray (if not
covered), whichever is closer to a safe light that remains on when the
film enters the processor.'' Several other comments recommended adding
words such as ``emulsion side up'' or ``where the mammography film is
usually handled'' at specified points in the requirement.
    After discussions with NMQAAC, FDA concluded that the comments did
not provide a basis for amending the provision. The agency has retained
Sec. 900.12(e)(4)(i) as proposed, except that the words ``emulsion side
up'' have been added for clarification. The agency will provide
information on test procedures, as some comments requested, separately.
Each facility can design its own procedures to meet the generally
accepted features of an adequate darkroom fog test.
    (Comment 486). A number of comments suggested requiring the
darkroom fog test after any change in the darkroom that could result in
an increase in the amount of fog.
    FDA agrees that many changes in the darkroom could produce darkroom
fog but it also believes that it is difficult to specify which changes
will lead to increased film fogging. The agency has left it to the
judgment of the facility as to which changes may lead to increased film
fogging and thus warrant an additional darkroom fog test.
    (Comment 487). One comment recommended that the acceptable value of
darkroom fog be raised to 0.10 OD and believed that 60 percent of
facilities will not be able to pass the test as written.
    FDA does not agree that the majority of facilities will not be able
to meet the required acceptable level of dark room fogging within 0.05
OD. This requirement is currently in effect under the interim
regulations and the agency's inspection data indicate that most
facilities are in compliance with this requirement.
    (Comment 488). One comment urged FDA to require a clearly written
procedure that ensures that the darkroom tests are performed using
mammography films.
    The agency considers this a good practice and recommends that
facilities adopt such procedures. However, FDA does not believe that
this requires a regulation.
    The screen-film contact test in Sec. 900.12(e)(4)(ii) is intended
to ensure that proper contact is maintained between the screen and film
in each cassette used in the facility for mammography.
    (Comment 489). Several comments noted that the material of the 40
mesh screen used for the test was not specified and suggested that it
be copper or a material with an atomic number similar to copper.
    FDA agrees with these comments and has specified the requirement of
40 mesh copper screen in the final regulation. It has also clarified
that all cassettes used in the facility for mammography must be tested.
    (Comment 490). Two comments asserted that a minimum background
density needs to be specified for the screen-film contact test, with
one of these stating that it should be 0.60 to 0.85 so that the films
are not underexposed leading to false readings. One comment wanted
acceptance levels to be prescribed in some detail, while another
comment stated that additional information was needed as to what
constitutes an adequate screen-film contact test result. Two comments
suggested the following criterion: ``Areas greater than 1 cm are not
acceptable, five or more areas less than 1 cm are acceptable.''
    FDA considers this test very important. A 40 mesh copper screen
provides adequate resolution and contrast with a mammography film when
exposed to a proper density. However, evaluations of these test results
can be subjective and cannot be verified against a quantified
acceptance level. Therefore, the agency cannot prescribe a numerical
value of acceptance level in the regulation, as some comments
suggested, because it would not be readily enforceable. FDA notes,
however, that it does not agree with the comment that stated that five
or more areas of poor contact with a size smaller than 1 cm are
acceptable. The agency intends to provide further information on this
test. The agency also notes that advice is also available in most QC
manuals.
    Compression testing is required to ensure that a mammographic
system provides adequate compression and, at the same time that the
equipment does not allow dangerous levels of compression to be applied.
In the proposal, FDA required the compression device to meet
specifications described in Sec. 900.12(b)(12)(i) and, in accordance
with Sec. 900.12(e)(4)(iii), to be tested semi-annually to see if the
specifications continue to be met. After further consideration, the
agency determined that in the final rule it would be more appropriate
to treat the compression forces as performance outcomes rather than
equipment specifications. As a result, the standards for the amount of
the compression force

[[Page 55942]]

have been transferred from Sec. 900.12(b) to Sec. 900.12(e)(4)(iii).
The comments received on this aspect of proposed Sec. 900.12(b)(12)(i)
are discussed at this point with the related comments received on
Sec. 900.12(e)(4)(iii).
    (Comment 491). A number of comments stated that some of the
characteristics of the compression system described in
Sec. 900.12(b)(12)(i) did not need semiannual QC testing.
    FDA agrees with these comments and, in the final regulation under
Sec. 900.12(e)(4)(iii), has required that only the compression force be
tested.
    Under Sec. 900.12(b)(12)(i)(c) FDA proposed that, 5 years after
publication, the compression device shall provide a maximum compression
from the power drive between 111 newtons (25 pounds) and 200 newtons
(45 pounds).
    (Comment 492). Several comments urged FDA to make the compression
force requirement in the power drive mode effective immediately, not 5
years from publication as proposed. On the other hand, one comment
disagreed with the April 1996, recommendation of NMQAAC that the
proposed requirements be implemented 1 year after the publication of
the final rules. One manufacturer stated that this requirement would
affect approximately 2,000 of their units in the field and noted that
it would be impossible to upgrade many of these units to the full 25
pounds. Additionally, the retrofit kit is likely to be very expensive
and not welcomed by users who find a precompression force of 17 pounds
adequate when accompanied with appropriate manual compression.
    Although NMQAAC did recommend making the requirement effective 1
year after publication at its April 1996 meeting, they reversed that
position in January 1997 after considering the possible cost of the
action. The agency has thus retained in the final rule at
Sec. 900.12(e)(4)(iii), the requirement of compression force in power
drive mode 5 years from the date of publication, as proposed in
Sec. 900.12(b)(12)(i)(c).
    FDA, however, also considers it important that all mammography
machines used currently provide adequate compression force. Under the
interim regulations, facilities are required to use equipment that
provides a minimum compression of 111 newtons. The agency is continuing
to require this minimum compression force. In case of machines where
such force is not available in power drive mode, the facilities may use
the manual compression to attain this minimum compression requirement.
However, 5 years after the publication of the final rule, all machines
must provide a maximum compression force in power drive mode of between
111 newtons (25 pounds) and 200 newtons (45 pounds).
    h. Annual QC tests (Sec. 900.12(e)(5))
    Section 900.12(e)(5)(i) through (xi) lists a number of tests a
facility must perform annually. Action limits for the test results are
specified, except for the system artifacts (Sec. 900.12(e)(5)(ix)) and
decompression (Sec. 900.12(e)(5)(xi)) tests; the nature of these do not
allow the agency to provide any quantified acceptance level. The tests
described in Sec. 900.12(e)(5)(i) through (ix) were proposed as QC
tests. The tests in Sec. 900.12(e)(5)(i)(x) and (xi) have been moved
from Sec. 900.12(b) of the proposal after FDA concluded that they are
more performance than specification oriented and, therefore, are more
appropriately located in Sec. 900.12(e) in the equipment quality
assurance section of the final regulation.
    (Comment 493). One comment stated that the regulation should
require these tests to be done by a qualified medical physicist. FDA
notes that this requirement already appears at Sec. 900.12(e)(9), which
requires that these tests be done as part of the facility survey and
further requires that the survey be performed by a qualified medical
physicist.
    Two comments questioned why the proposed requirements under
Sec. 900.12(e)(5) established testing limits different from those used
by the accreditation body. The comments claimed that these
``discrepancies'' will hinder compliance. FDA believes that the authors
of these comments are mistaken. The agency assumes that by ``testing
limits,'' the comments are referring to action limits. FDA notes that
the action limits of Sec. 900.12(e)(5) are the same as those in the ACR
manuals, and thus, the same as those the facilities and the
accreditation bodies are using under the interim regulations.
    The automatic exposure control (AEC) test in Sec. 900.12(e)(5)(i)
measures several parameters of the AEC system.
    The first action limit specified for the AEC is that it shall be
capable of maintaining the film optical density within <plus-minus>
0.30 of the mean optical density as the phantom thickness and kVp are
varied in Sec. 900.12(e)(5)(i)(A).
    (Comment 494). Some comments wanted a definition of ``Mean Optical
Density.''
    FDA notes that such a definition was provided in Sec. 900.2(w) of
the proposal, now Sec. 900.2(ee) in the final regulation.
    (Comment 495). Other comments asked FDA to specify the type of
phantom needed for this test or asked if the same phantom used for the
image quality test is required. A related comment stated that the test
blocks used by the physicists should be specified to be 15 x 15 mm
homogeneous material, in order to ensure an even scatter pattern or
distribution that would not be affected by the position of the AEC and
inhomogeneous scatter. The comment suggested that phantoms made up of
either acrylic or BR12 can be used. Another comment wanted the test
details and acceptance levels to be prescribed.
    The agency requires the thickness of the phantom to be varied from
2 to 6 cm. These thicknesses are currently required under the interim
regulation and the facilities may use any homogeneous material of
appropriate thicknesses that will provide a film OD of no less than 1.2
at the center of the image. The agency has previously discussed its
rationale for not providing detailed test procedures.
    (Comment 496). One comment requested FDA to clarify whether testing
is required with all available thicknesses and kVp's. FDA has changed
the wording in the final regulation to clarify that AEC tracking is
required only for phantom thickness varied over a range of 2 to 6 cm
and for kVp's varied appropriately for such thicknesses over the kVp
range used clinically.
    Proposed Sec. 900.12(e)(5)(i)(C) established an alternative to
proposed Sec. 900.12(e)(5)(i)(A) by allowing the development of a
technique chart of kVp and density control settings to ensure that the
film optical density requirements of Sec. 900.12(e)(5)(i)(A) would be
met in cases where it could not be done directly by AEC.
    (Comment 497). Two comments stated that a technique chart should be
required for all machines under all situations. Two others stated that
the proposal created a loophole for the AEC equipment specification
requirements proposed in Sec. 900.12(b)(15)(vii)(A). One comment asked
if a technique chart would be acceptable in the year 2000 when all
machines are expected to meet the <plus-minus> 0.3 OD variance
requirement. One comment suggested eliminating the option of using a
technique chart.
    The agency has combined the provision permitting the use of a
technique chart with Sec. 900.12(e)(5)(i)(A) in the final rule. After
consideration of the comments, FDA has decided to permit the use of a
technique chart to meet the <plus-minus> 0.3 OD variance requirement
only for 5 years after the publication of the final regulation. After 5
years, the AEC equipment must meet the <plus-minus> 0.30 OD variance
requirement directly.
    FDA has moved a provision proposed as an equipment requirement in

[[Page 55943]]

Sec. 900.12(b)(15)(vii)(B) to the quality assurance paragraph as
Sec. 900.12(e)(5)(i)(B). As explained earlier, the move was made
because this provision was more appropriately located with the QC
performance tests than with the equipment specifications. This
provision requires, effective 5 years from the publication of this
regulation, that the film optical density be maintained within
<plus-minus> 0.15 of the mean optical density at the appropriate kVp-
thickness combination. Use of the technique chart to compensate for
inadequacies in the AEC will no longer be permitted after that date.
    (Comment 498). In response to the original proposal in
Sec. 900.12(b)(15)(vii)(B), one comment requested that FDA clarify
whether compensation steps using a technique chart will be allowed. The
comment also stated that <plus-minus> 0.15 OD criteria can not be met
if the film manufacturers allow 0.3 OD variation from one film batch no
another.
    As noted in the previous paragraph, FDA will permit the use of a
technique chart to compensate for inadequacies in the AEC for 5 years
after the publication of the final rule; after that time the technique
chart can no longer be used as an aid in maintaining the film optical
density within <plus-minus> 0.15 of the mean optical density at the
appropriate kVp-thickness combination. The agency also advises
facilities to use films from the same batch so that film variability,
if any, is not introduced while testing AEC performance. Because film
variability can be eliminated as a source of bias in the AEC
performance test, there is no justification for increasing the AEC
actions limit to <plus-minus> 0.30 OD because that would simply mean
that the facility would have to contend with variability of
<plus-minus> 0.30 from the film and another <plus-minus> 0.30 from the
AEC.
    (Comment 499). Two comments stated that the proposed requirement
was too lenient, while two others believed that it was too restrictive.
Three comments supported the proposed requirement.
    FDA believes, after discussion with NMQAAC, that it is reasonable
to require that the <plus-minus> 0.15 OD limit be met by all units 5
years after publication of the final rule. The agency believes that the
cost to meet this requirement will be minimized by the fact that, by
the end of this period, many of the units unable to meet the
<plus-minus> 0.15 OD requirement will have been replaced by facilities
on their normal replacement schedules. The agency does not believe it
has any basis to require a tighter limit than <plus-minus> 0.15 OD.
    Section 900.12(e)(5)(i)(C) (proposed Sec. 900.12(e)(5)(i)(B))
proposed that the operating OD be no less than 1.20.
    (Comment 500). Several comments suggested deleting the word
``operating.'' One comment requested the definition of ``Operating
OD.''
    FDA agrees that the word operating should be deleted. This
requirement is now moved to Sec. 900.12(e)(5)(i)(C) in the final rule.
    One comment urged FDA to require a mean optical density of at least
1.3 OD. FDA notes that the regulation allows facilities to use a higher
film OD if they believe that will make the test a better indicator of
the ability to detect micro-calcifications and will aid in improving
image quality. However, the agency does not consider it necessary at
this time to require any higher OD. The agency also notes that NMQAAC
advised FDA to retain the 1.2 OD requirement as proposed.
    The annual test in Sec. 900.12(e)(5)(ii) tracks the kilovoltage
accuracy and reproducibility.
    (Comment 501). A large number of comments stated that kVp accuracy
should be within 5 percent instead of the proposed <plus-minus> 10
percent.
    The agency is persuaded by these comments and has made the change
in the final regulation.
    (Comment 502). One comment questioned the justification of a very
tight coefficient of variation for the kVp reproducibility.
    FDA believes that the coefficient of variation of a given set of
kilovoltage measurements should be less than 0.02, as was proposed.
This is the standard presently required under the interim regulations
and most facilities are currently in compliance with it; there is no
justification for relaxing the standard, either from the point of view
of public health or a cost consideration.
    (Comment 503). Several public comments and a member of NMQAAC
expressed concern that one widely used kVp testing instrument does not
read below 23 kV, while kilovoltage settings as low as 21 or 22 kVp are
sometime used. A few comments suggested requiring kVp testing at two
clinical setting values. One comment stated that
Sec. 900.12(e)(5)(ii)(B), as written, could be interpreted to mean kVp
reproducibility should be measured from 25 to 30 kVp in 0.5 kVp
increments. Another comment stated that it should be acceptable to test
kVp reproducibility in just one setting within the clinical range.
    In response to these comments, FDA has revised the final regulation
to require that the lowest kVp at which accuracy be tested is the
lowest clinical used kVp that can be measured by a kVp test device. The
agency, however, disagrees with the comments that recommend testing kVp
at one or two clinical settings only. FDA considers it important to
test kVp accuracy at least at the highest and lowest measurable
clinically used values, and at the facility's most commonly used
clinical kVp. The agency, however, has modified the regulation to
require that the coefficient of variation of reproducibility be
determined at the most commonly used kVp only.
    One comment claimed that the kVp accuracy requirement should be
checked with all focal spots. The agency has no reason to believe this
is necessary.
    The focal spot condition (proposed as system resolution) test in
Sec. 900.12(e)(5)(iii) was proposed to evaluate the performance of the
mammography unit by assessing the resolution capability of the system.
    (Comment 504-505). A few comments stated that some mammography
machines could not meet the proposed resolution requirement even though
the focal spot size was adequate. One comment maintained that the line
pair resolution requirement was too restrictive. A member of NMQAAC
stated that, in magnification mammography, the resolution requirement
would be difficult to meet. These comments suggested that the focal
spot size measurement be added as an alternative requirement, as is the
current practice under the interim regulation. Two other comments also
urged FDA to continue to permit focal spot dimension measurements as
part of acceptance tests for mammography equipment evaluation. One
comment supported replacing focal spot measurement with performance
related specifications of system resolution.
    FDA considered the immediate economic impact on facilities of
meeting the resolution requirement as proposed and decided to permit
continued use of the focal spot size measurement as an alternative to
the measurement of system resolution for a period of 5 years from the
publication of the final regulation. During this period, facilities may
evaluate the condition of the mammography unit by determining either
the system resolution, proposed as Sec. 900.12(e)(5)(iii) (new
Sec. 900.12(e)(iii)(5)(A)), or the focal spot dimensions as described
in Sec. 900.12(e)(5)(iii)(B). The agency believes that by the end of
this period, when the regulation will require the evaluation of system
resolution only, many of the units unable to pass the system resolution
test will have been replaced by the facility on its normal replacement
schedule.

[[Page 55944]]

    The agency believes the benefits of assessing overall performance
of the system through use of the system resolution test justify their
transition. NMQAAC also advised FDA to require the system resolution
test.
    (Comment 506). One comment suggested that FDA should only require
that the resolution shall be sufficient so that the system can detect
micro-calcifications of 300 <greek-m>m and greater sizes.
    FDA notes that available scientific data indicate that 50
<greek-m>m resolution is necessary in mammography imaging for early and
proper detection of micro-calcifications. This is equivalent to about
10 cycles (lp)/mm resolution when the bar pattern is used. The agency
believes that all new equipment meets this requirement as proposed.
Under the interim regulation, this criterion is already being met by
the facilities which chose to evaluate focal spots by assessing system
resolution. Further, NMQAAC advised FDA to adopt such a requirement in
the final regulation. For these reasons, the agency did not accept the
comment.
    (Comment 507). A member of NMQAAC advised FDA that the units should
be specified in SI units and suggested using ``ycles/mm'' in place of
``ine pairs/mm.'' One comment stated that the height of the line-pair
test pattern above the image receptor must be specified in association
with the resolution limits and suggested that the height should be 4.5
cm. Other comments requested clarification of ``parallel'' and
``perpendicular'' to the axis in terms of the bars of a test pattern
whose orientation was being described. Three comments urged that test
specifications be included in the regulations.
    In response to these comments, FDA has added a new
Sec. 900.12(e)(5)(iii)(A) to specify that the high contrast resolution
bar patterns must be placed 4.5 cm above the breast support surface and
be oriented parallel and perpendicular to the anode-cathode axis. FDA
has also introduced cycles/mm as the primary unit.
    (Comment 508). One comment asked at what magnification the system
is required to resolve 11 and 13 lp/mm. Another comment suggested that
the tests should be performed at all magnifications used. Two comments
urged FDA to require focal spot assessment for all focal spot sizes.
One comment suggested that the system resolution should be tested with
the grid in use. One comment suggested that the grid should not be in
the imaging chain during magnification.
    FDA reiterates that 5 years from the date of publication of the
final rule, all facilities must perform the system resolution test
annually and must meet the requirements specified in
Sec. 900.12(e)(5)(iii)(A)(1), both in contact mode and in all
magnification mammography modes used in the facility. The agency
believes that if a machine can meet the requirements using the large
focal spot size used in contact mode, it will meet the requirements
using the small focal spot size also. The agency also believes that the
resolution test must be conducted under the normal operating condition,
that is, for contact mammography the resolution assessment must be
performed with the grid in place whereas for magnification mammography,
the grids should be removed. The agency intends to provide more
discussion about these procedures in educational documents.
    (Comment 509). Two comments stated that the line-pair minimum
should be increased.
    FDA believes that the present values are generally accepted as
representing the best cost/benefit compromise.
    (Comment 510). One comment recommended requiring a monthly phantom
test with indicators of what should be expected in resolution
capabilities at a given magnification to ensure adequate performance
between physicist surveys. The comment also recommended that the system
resolution in magnification mode be monitored to determine whether it
diminishes with time.
    Although it encourages facilities to carry out this type of
performance-based study, FDA does not believe there is adequate
evidence to show that these additional tests would produce benefits
that outweigh the costs facilities would incur in performing them.
Therefore, at this time, the agency is not including them in the
regulation.
    The beam quality and half-value layer (HVL) paragraph as proposed
in Sec. 900.12(e)(5)(iv), required the HVL to meet the specifications
provided in Sec. 900.12(b)(11). Two comments stated that the exact
specifications should be included under Sec. 900.12(e)(5)(iv), rather
than merely by reference. Two comments suggested that the upper HVL
limits described in the 1994 ACR QC Manual should also be included and
that HVL limits should be specified for other target filter
combinations.
    In the final rule, FDA has specified HVL requirements only in
Sec. 900.12(e)(5)(iv). The specifications for kVp's in the mammographic
range are provided in a tabulated form. Values not shown in the table
may be determined by linear interpolation or extrapolation. NMQAAC
members were unable to reach a consensus on the value of having an
upper limit of HVL or on what the upper limit should be. FDA views this
as an indication that there is a general lack of consensus on this
topic in the mammography community and, therefore, the agency has
decided not to include any upper limit in the regulation.
    The breast entrance exposure and AEC reproducibility paragraph, as
proposed in Sec. 900.12(e)(5)(v), established the action limit for the
coefficient of variation of these two variables at 0.05.
    (Comment 511). Three comments suggested deleting the breast
entrance exposure requirement, while another considered it to be an
equipment standard. This last comment further stated that lack of AEC
reproducibility will be identified by other QC tests and the phantom
image. Another comment inquired whether it was the intent of the
provision to require facilities to calculate exposure reproducibility
for data points consisting of mR divided by mAs, or to separately
measure the reproducibility of exposure and mAs.
    FDA believes that this test must be performed at least annually and
that the coefficient of variation must be calculated for both exposure
and mAs. If a unit does not indicate a post-exposure mAs value, then
mAs should be obtained by a secondary method. In accordance with the
movement towards the use of SI units discussed in connection with the
new definition of air kerma (Sec. 900.2(d)), the agency has also
introduced air kerma as the primary quantity to be measured in this
test. Breast entrance exposure remains as an alternative quantity.
    The dosimetry test in Sec. 900.12(e)(5)(vi) determines the mean
glandular dose delivered during a single cranio-caudal view using an
FDA approved phantom simulating a standard breast. When the mean
glandular dose exceeds 3.0 mGy, corrective action is required.
    (Comment 512). A number of comments were received on the
specifications for the phantom to be used in performing this test. Some
comments stated that most facilities are using phantoms simulating a
4.5 cm breast and it would not be cost effective to change to phantoms
simulating a 4.2 cm breast. One comment suggested that FDA should
recognize that most technique charts are set using whole number
thicknesses, arguing that 4.0 cm is probably the most reasonable. One
comment stated that ACR phantoms are not tissue equivalent phantoms.

[[Page 55945]]

 Another comment stated that, to date, most dose data had been set
using the RMI accreditation phantom. The comment questioned its actual
tissue equivalence and further stated that dose standards should be set
using a phantom that correlates as closely as possible to actual
thickness.
    In the preamble to the proposal (61 FR 14912), FDA solicited
comments about actual thickness that the existing phantoms simulate.
FDA did not receive enough evidence in response to this question to
convince the agency that the existing phantoms simulate a 4.0 cm
compressed breast more closely than they simulate a 4.2 cm compressed
breast, which is the figure currently used. The agency, therefore,
continues to require that the dose should be determined under the
assumption that the phantom simulates a 4.2 cm compressed breast and
that the technique factors should be chosen accordingly. FDA did not
propose, nor has it required in the final rules, any change in the
phantoms currently being used. As stated earlier, the agency believes
that accreditation bodies should establish phantom specifications and
related performance criteria. In the future, if better tissue
equivalent phantoms are available to simulate a different compressed
breast thickness that can change dose calculations significantly, the
agency will revise the thickness requirement for average dose
calculation. FDA also notes that a change from 4.2 cm to 4.0 in
thickness does not result in a significant change in the calculated
dose.
    (Comment 513). One comment stated that calculation of the entrance
dose to the phantom is not necessary if kVp, HVL, and mAs for the
exposure are within limits. Another comment stated that, because the
existing image quality phantom simulates a 4.2 cm compressed breast,
not 4.5 cm, the dose limit could be lowered. One comment stated that
the regulations should not allow any dose less than 0.8 mGy, while
another comment stated that there is no reason for accepting 300 mrad
as a maximum mean glandular dose because, even at 25 kVp, the typical
mean glandular dose is 120-150 mrad (1.2-1.5 mGy). This comment
recommended setting the dose limit at 250 mrad (2.5 mGy). Another
comment recommended that FDA consider lowering the patient dose
requirements to that of the State of California requirement.
    FDA strongly believes that a proper dose calculation at least once
a year for each unit is critical for public health and safety. FDA
further believes that the present dose limit of 3.0 mGy provides
adequate protection from unnecessary radiation and does not want to
change the dose limit to 2.5 mGy or establish a lower limit of 0.8 mGy,
in order to avoid the possibility of inhibiting future advances in
imaging technology, as discussed in the preamble to the proposal (61 FR
14912).
    (Comment 514). One comment suggested that the phantom kVp and mAs
must be compared to the average of 20 or more 4.2 cm clinical breast
mammograms to ensure that the measured glandular dose is consistent
with patient radiation doses.
    In response to this comment, the agency notes that the dose must be
determined with technique factors and conditions used clinically for a
standard breast. The agency understands that, for some facilities,
commonly used technique factors may be slightly different from what
would be technique factors for a standard size breast and therefore
different from what would be used for the available phantom, which
simulates a standard breast. However, the agency does not believe that
dose will vary so significantly that it will exceed the required limit
of 0.3 mGy in cases of patients with non standard breast size, as long
as the mammography unit is capable of meeting the dose requirement
using a phantom simulating a standard breast.
    (Comment 515). Two comments urged FDA to require that the time of
exposure be less than or equal to 2.5 seconds. FDA did not accept this
comment because the agency believes that it does not have enough
evidence to confirm that 2.5 seconds is the absolute maximum exposure
time needed to cover all patient sizes. The agency recommends that
facilities determine the proper exposure time for their needs through
consultation with the medical physicists and the equipment
manufacturers.
    The requirements for X-ray field/light field/image receptor/
compression paddle alignment in Sec. 900.12(e)(5)(vii) are intended to
ensure that: (1) All systems have beam limitation devices that prevent
the patients from receiving unnecessary radiation dose, permit imaging
of the critical breast tissue near the chest wall, and avoid white
borders on the film; (2) if a light field is provided, the congruence
of the light field with the X-ray field should be such that the sum of
misalignments on opposite sides between X-ray field and light field is
within 2 percent of the SID; and (3) the alignment of the edge of the
compression paddle with the chest wall edge of the image receptor is
sufficient to permit pulling the breast tissue away from the chest wall
for imaging and to keep the shadow of the vertical edge of the paddle
from being visible on the image. The test also ensures that the
extension of the edge of the paddle is within 1 percent of the SID so
that the patient's chest is not pushed away from the breast support
surface.
    (Comment 516). One comment stated that Sec. 900.12(e)(5)(vii)
should include exact specifications rather than just a reference to
those specifications in Sec. 900.12(b)(5). One comment argued that
confinement of the X-ray field within the image receptor cuts off
useful film area and misses some of the breast tissue. The comment
further suggested that this requirement should be changed so that the
X-ray field can extend slightly beyond the edges of the image receptor
in order to make full use of the film area and not potentially miss any
breast tissue that is overlying the image receptor, and to blacken what
would be an otherwise clear border.
    In the final regulation, FDA has moved the X-ray field/light field/
image receptor/compression paddle alignment specifications to
Sec. 900.12(e)(5)(vii). FDA notes that Sec. 1020.31(f)(3), which the
agency referenced in the proposal, allows extension beyond the chest
wall edge of the image receptor by as much as 2 percent of the SID so
as to properly image breast tissue on the chest wall side. In the final
rule, the agency allows extension of the X-ray field beyond all edges
of the image receptor but limits this extension to within 2 percent of
the SID.
    (Comment 517). Two comments suggested that the term ``image
receptor'' should be defined. In the agency's earlier discussion of the
definitions, the agency has referenced Sec. 1020.31 as providing a
definition of image receptor.
    (Comment 518). One comment stated that the requirement for a light
field in this section imposes an unwarranted expense.
    FDA notes that a light field is not required but if one is present,
it must meet the light field-X-ray field alignment requirement.
    (Comment 519). One comment urged FDA to consider relaxing the
requirement for the alignment of the compression paddle and the breast
support surface. One comment questioned whether limiting the extension
of the compression paddle beyond the image receptor to within 1 percent
of SID is achievable in all units. Another comment suggested that this
requirement be written to more accurately reflect the need to extend
past the edge of the image receptor, although by no more than 1 percent
of the SID. Three comments stated that it appeared from the proposed
regulation

[[Page 55946]]

that it was permissible for the compression paddle to be visualized on
the mammography film.
    FDA believes that the one percent extension limitation can be
achieved and notes that the current requirement under the interim
regulations is one percent. The agency has also clarified the final
rule to emphasize that the shadow of the compression paddle shall not
be visible on the image.
    (Comment 520). One comment requested clarification on whether the
reference was intended to be with respect to a vertical line or with
respect to a line connecting the focal spot and edge of the image
receptor when the requirement that the chest wall edge of the
compression paddle not extend beyond the chest wall edge of the image
receptor by more than one percent of SID is being met.
    (Comment 521). One comment suggested that FDA specify whether this
requirement is with respect to the interior surface of the paddle or
the exterior surface. The comment, however, acknowledged that this is
not an important issue with a 1 or 2 mm paddle thickness.
    FDA disagrees with comments that suggest including all these
details in the regulation. However, the agency wishes to clarify that
the reference is the vertical line and the requirement refers to the
interior surface of the paddle.
    One comment stated that this requirement should be met with all
image receptors. FDA notes that the regulation as written requires this
test to be performed for all full-field aperture sizes used for beam
limitation in the facility; this will ensure that all image receptors
meet the requirement.
    The screen speed uniformity test, as proposed in
Sec. 900.12(e)(5)(viii), requires that at least once a year, each
facility must ensure the consistency of the screen speed among all
cassettes used in the facility for mammography. The same test is
required currently at the same frequency under the interim regulation.
    (Comment 522). One comment stated that Sec. 900.12(e)(5)(viii) did
not allow for slow and fast screen variations due to large and small
screens having different relative speeds. Another comment suggested
that the maximum optical density difference should be reduced to 0.15.
    FDA believes that the difference between the screen speeds of all
cassettes, small or large, should be such that the OD variation is
within 0.3 OD. The agency, however, does not believe that tightening
the restriction on density difference to 0.15 is justified. Members of
NMQAAC supported this view.
    One comment requested FDA to describe the test procedure to be
used. As discussed earlier, FDA made a general decision to refrain from
describing specific test procedures for QC tests in the regulations.
The agency will include a more detailed description of some tests in
its guidance document.
    System artifacts in Sec. 900.12(e)(5)(ix) mean artifacts produced
by any part of the mammographic system, including the X-ray machine,
screen-film system, and/or processors. This subparagraph requires the
facility to determine the level and possible adverse effects of
artifacts produced by its systems. These artifacts should be
distinguished from the patient related artifacts.
    (Comment 523). One comment stated that the evaluation should be
done for all full-field image receptor sizes.
    FDA agrees and has added this requirement to the final regulation.
    (Comment 524). One comment recommended elimination of this test
because the physicists always watch for artifacts whenever a film is
taken.
    FDA strongly believes that a separate test solely meant for
artifact evaluation is necessary. Further, this test should also
evaluate the whole imaging chain for the source of any artifacts
detected.
    (Comment 525). One comment stated that the test can also be done
with a smaller phantom positioned closer to the collimator. As advised
by NMQAAC, FDA proposed that artifacts should be evaluated through the
use of a test object of high grade defect-free material that is large
enough to cover the mammography cassette.
    FDA notes the intent in requiring an object of this size is to
capture and identify artifacts that are caused anywhere in the cassette
and its screen-film combination. In this way, the quality of the entire
film can be better assured. FDA understands that there may be other
ways of accomplishing this goal, such as the method suggested in the
comment, but the agency lacks data to confirm that the suggested
procedure will produce equivalent results. The agency notes that the
alternative requirement mechanism of Sec. 900.18 provides a way by
which alternatives to the requirements can be evaluated, and possibly
accepted, by FDA.
    (Comment 526). One comment stated that more guidance should be
provided on evaluating artifacts. One comment wanted the test details
and acceptance levels prescribed.
    Again, FDA has decided that test details are subjects more
appropriately addressed separately from the regulations. The agency
also notes that the acceptance level for artifacts is at present a
subjective assessment and not amenable to the establishment of specific
numerical standards.
    (Comment 527). One respondent believed that testing X-ray systems
for artifacts does not require the use of a test object. Another
comment stated that use of a thick (4 cm) acrylic test object will
harden the beam to the point that it will mask grid and/or carbon fiber
cover artifacts and may even mask grid lines.
    FDA disagrees. The agency believes that an exposure time sufficient
to image appreciable artifacts may not be achieved if a test object is
not used, while these artifacts would be visible during a normal
patient exposure.
    FDA has moved the radiation output requirement from
Sec. 900.12(b)(15) to Sec. 900.12(e)(5)(x) because it concluded that it
was more appropriate to treat this test as an annual QC test rather
than an equipment specification. This test is intended to determine if
the mammographic system is capable of producing a minimum required
output. Five years from the publication of the final rule, the
requirement will change to require a higher output from each system.
    (Comment 528). Two members of NMQAAC opposed this requirement as an
annual test. One member stated that a 3-second field test of the unit
may cause damage to the tube. The same NMQAAC member further stated
that averaging the results over a 3-second exposure time would not
reveal whether the output rate dropped unacceptably low at any time
during the exposure.
    FDA does not have evidence indicating that any significant
fluctuation in exposure takes place within an exposure time of the
order of 3 seconds. However, the agency has revised this requirement in
Sec. 900.12(e)(5)(x)(B) from that originally proposed in
Sec. 900.12(b)(14) to clarify that no instantaneous radiation output
requirement is intended; instead, the requirement is the output
averaged over a 3-second period. Also, because the exposure times can
be lengthy for some patients, the agency does not consider 3-second
exposure time unreasonable. The agency also considers a yearly check of
radiation output important and reasonable.
    i. QC tests--other modalities (Sec. 900.12(e)(6))
    This provision requires facilities using image receptor modalities
other than screen-film to establish a quality assurance program that is
substantially the same as that recommended by the image receptor
manufacturer, except that the maximum allowable dose is not allowed to
exceed that established in

[[Page 55947]]

Sec. 900.12(e)(5)(vi) for screen-film systems.
    No public comments were received on this paragraph and it has been
codified as proposed.
    j. Mobile units (Sec. 900.12(e)(7))
    This provision requires mammography units used at more than one
location to meet all of the quality assurance requirements established
in Sec. 900.12(e)(1) through (e)(5). In addition, at each visit at each
examination location, before any additional examinations are conducted,
the facility is required to verify the performance of such units using
an adequate test method.
    (Comment 529). Three comments supported the additional testing of
mobile units. One of these noted that the many environments in which
the units operate made the testing necessary. Six comments opposed the
additional testing. The most common reasons given for the opposition
was concern about being able to process the test images before
mammography is performed and that the additional testing was
unnecessary because moving the unit did not create any problems.
    When the need for additional testing of mobile units was discussed
at the NMQAAC meeting of September 1994, it was noted that a recent ACR
survey of facilities operating mobile units had found that about one in
seven facilities reported quality problems with their mobile units at
least weekly. Largely based on this information, NMQAAC recommended
that postmove, preexamination testing of mobile units be included in
the final regulations. NMQAAC continued to support this proposed
requirement at its January 1997 meeting.
    FDA agrees that no change should be made to the proposal. The
agency further notes that several of the opposing comments based their
concern upon the difficulty of processing phantom images at the mobile
site. However, the final regulation does not require the use of any
specific test, only that the test method be able to verify that
adequate image quality is being produced by the unit. This gives the
facility the option of using other tests that do not require processing
of images before examinations are conducted, as long as the test can
demonstrate that adequate image quality is likely to be achieved. One
such test, based on the consistency of mAs readings, was described by a
speaker at the September 1994 NMQAAC meeting.
    (Comment 530). Five comments expressed concern about the fact that
acceptable testing methods were not specified in the regulations. Three
of these comments asked who a facility should consult to determine if
its test method would be considered adequate by FDA. Related comments
on this issue asked how inspectors would determine adequacy without
guidance and noted that the State of Massachusetts left it to the
medical physicist to determine what test method should be used. One
comment urged that a test based on the mAs reading be considered
acceptable, while another stated the performance test required by the
State of Illinois should be recognized by FDA.
    FDA plans to issue information describing test methods that it is
likely to consider acceptable for verification of performance of mobile
units after a move and before examinations are conducted. It is
expected that at least one of these methods will not require the
processing of images before the examinations begin. Because these
methods will not be regulatory requirements, FDA may accept other test
methods proposed by facilities, medical physicists, or other interested
parties. Facilities are always free to discuss any particular method
with FDA prior to establishing its use.
    (Comment 531). One comment opposed allowing central film processing
for mobile services out of concern for degradation of the latent image
during the time between exposure and development.
    This issue was discussed at some length at two NMQAAC meetings and
the conclusion was that this degradation would not be significant
during the typical times between exposure and development of mobile
facility images. FDA, therefore, has not prohibited central processing.
    (Comment 532). One comment stated that if diagnostic imaging is
done at a mobile facility, a radiologist should be present. Practice of
medicine issues have made it difficult to define the distinction
between screening and diagnostic mammography. Because of this
difficulty, FDA has issued the final regulations to apply to all
mammography, rather than addressing specific requirements to one area
or the other.
    k. Use of test results (Sec. 900.12(e)(8))
    The provisions of this proposed paragraph were intended to ensure
that the facility did not stop with the performance of the quality
assurance tests but analyzed the results of the tests to determine if
problems existed and took necessary actions to correct those problems.
Ongoing anecdotal evidence and the MQSA inspection data indicate that,
even 20 years after the introduction of the concepts of quality
assurance, some facilities are still neglecting to take the important
final steps in the process.
    Section 900.12(e)(8)(i), as proposed, requires facilities to
compare the results of their quality assurance tests with action limits
specified in Sec. 900.12(e)(1) through (e)(6) and, if their results
fall outside the action limits, to repeat the tests immediately to
verify that the testing process was not responsible for the result.
    (Comment 533). Thirteen comments opposed, at least in part, the
requirement to repeat the tests immediately. Some of these comments
urged that it be applied only to the processor QC, screen-film contact,
and average glandular dose tests. Two comments supported exempting
annual tests. Four of the comments stated that the decision about what
tests should be repeated should be left to the medical physicist.
NMQAAC recommended complete deletion of the proposed requirement that
the tests be repeated immediately. One comment took the opposite view,
stating that this requirement helps facilities identify trends.
    FDA notes that this requirement was originally added to ensure that
the facility confirmed whether the problem was due to the equipment
rather than an improperly performed test before it went to the trouble
and expense of taking corrective actions. However, the agency has been
persuaded that a facility that goes to unnecessary expense to correct
an equipment problem that was actually a testing problem is likely to
take steps on its own to avoid repetition of such a situation. In view
of that conclusion, and the public comments, the requirement to repeat
the test has been deleted from the final regulations.
    Section 900.12(e)(8)(ii), as proposed, stated that if the repeated
tests continue to produce unacceptable results, the problem shall be
identified and corrected before any further examinations are performed.
    (Comment 534). Seven comments stated that this provision, as
proposed, was too broad and that at least in some cases it would not be
necessary to shut down the entire facility until the problem was
solved. Other comments gave the views of their authors as to which
tests, if failed, indicated problems serious enough to require the
facility to stop doing mammography until the problem was solved. The
most frequently mentioned tests in this category were the processor QC
tests of Sec. 900.12(e)(1) and the average glandular dose test of
Sec. 900.12(e)(5)(vi), each of which was listed by 13 comments.

[[Page 55948]]

    (Comment 535). Seven comments included the image quality test of
Sec. 900.12(e)(2) and six each, the screen-film contact test of
Sec. 900.12(e)(4)(ii), the compression test of Sec. 900.12(e)(4)(iii),
the tests for modalities that did not use screen-film of
Sec. 900.12(e)(6), and the additional test for mobile units of
Sec. 900.12(7) on their lists of tests important enough that their
failure required problem detection and correction before mammography
continued. The system resolution test of Sec. 900.12(e)(5)(iii) was
listed in five comments. One comment each also would include the
artifact test of Sec. 900.12(e)(5)(ix) (if there were ``serious''
artifacts), the kVp test of Sec. 900.12(e)(5)(ii), and tests of output
and the phototimer (if the errors were ``large'') on the list.
    NMQAAC as a group supported the requirement that the problem must
be corrected before mammography continues only in the cases of the
processor QC tests, the average glandular dose test, and the screen-
film contact test. However, the medical physicists serving as committee
members and consultants for NMQAAC, when discussing specific tests in
their individual comments, presented somewhat different and conflicting
views. They agreed that the processor QC and the average glandular dose
tests were of sufficient importance that, if they were failed, the
facility should cease doing mammography until the problem was
corrected. They also supported adding the image quality test to that
list. Opinions of these physicists were split on whether the screen-
film contact test, the automatic exposure control tests of
Sec. 900.12(e)(5)(i), the breast entrance exposure and AEC
reproducibility test of Sec. 900.12(e)(5)(v), the tests for modalities
other than screen-film, and the additional test for mobile units should
be considered important enough that their failure would require problem
correction before mammography continued.
    After consideration of the comments, FDA agrees that not all test
failures are serious enough to require the facility to cease doing
mammography until the source of the problem is corrected. The agency
also agrees with two additional comments that stated that, even if the
test failure does indicate a problem that requires immediate
correction, it may not be necessary to shut down the entire facility.
For example, if the processor QC tests are failed, it may be possible
to continue to perform mammography, but to delay processing the films
until the processor problem is corrected, as long as the anticipated
processing delay is not of such duration that image degradation becomes
a concern. Similarly, if the facility has more than one mammography
unit, the failure of one unit would not be a reason for stopping the
use of another unit that did pass the tests.
    In response to these considerations, FDA has revised
Sec. 900.12(e)(8)(ii) by dividing the tests into two groups. Those
tests listed in Sec. 900.12(e)(8)(ii)(A) are those whose failure
requires immediate problem evaluation and correction. However, the
wording has been changed to state that the corrective actions must be
taken ``before any further examinations are performed or any films are
processed using the component of the mammography system that failed the
test'' (emphasis added). If the failure is related to a component for
which there is no alternative, for example, a failure of the facility's
only mammography unit, then the facility will still have to cease doing
mammography until the problem is corrected. However, if there is
another unit or processor that has passed the tests, the facility will
be able to continue producing and processing mammograms with that
equipment while the problem with the first unit is corrected.
    Included in Sec. 900.12(e)(8)(ii)(A) are the processor QC tests
(Sec. 900.12(e)(1)) and the average glandular dose test
(Sec. 900.12(e)(5)(vi), both of which everyone who commented on this
paragraph agreed were important enough that their failure required
evaluation and correction of the problem before the piece of equipment
was used for further mammography. FDA has also included the image
quality test (Sec. 900.12(e)(2)) in this group, even though it was
mentioned in fewer comments. The importance of this test is underscored
by the fact that the primary goal of the MQSA is to ensure adequate
quality mammography for all women. The agency has also included the
additional test for mobile units (Sec. 900.12(e)(7)) because it is a
test that directly evaluates image quality.
    FDA has also included the tests for nonscreen-film modalities
(Sec. 900.12(e)(6)) on this list. This particular provision was
intended to facilitate the introduction of new modalities because it
ensures that facilities using the new modality will have an adequate
quality assurance program, while at the same time not requiring
amendment of the requirements of Sec. 900.12(e) before the new modality
can be used. Because it is not possible to predict in advance what new
modalities may appear and what QC tests may be required for them, FDA
believes they must be placed in Sec. 900.12(e)(8)(ii)(A) to adequately
protect the public. Should it prove to be the case that some or all of
the tests that are applicable to the new modality might more
appropriately be placed in Sec. 900.12(e)(8)(ii)(B), regulatory relief
can be provided through the alternative requirements mechanism of
Sec. 900.18 until Sec. 900.12(e)(8)(ii) can be amended.
    FDA has also agreed with comments urging that the screen-film
contact test (Sec. 900.12(e)(4)(ii)) and the compression test
(Sec. 900.12(e)(4)(iii)) be placed on the list of those tests whose
failure should require taking a piece of equipment out of service until
the problem is detected and corrected. The agency notes that the new
wording referred to above means that failure of the first of these
tests only requires taking the cassette in question out of service and,
as one comment pointed out, the corrective action most likely will
simply be replacement of the cassette. The compression test is included
out of concerns raised by both anecdotal accounts and reports to FDA's
Medical Device Reporting System of injuries resulting from excessive
compression and the knowledge that inadequate compression can lead to
poor quality images.
    Finally, FDA retained the darkroom fog test (Sec. 900.12(e)(4)(i))
on this list, even though it was not mentioned by any of the comments.
FDA has concluded from studies, such as the Nationwide Evaluation of X-
ray Trends program of the Conference of Radiation Control Program
Directors, that excessive darkroom fog is more pervasive and has a
greater impact on image quality than is commonly realized. The agency
also notes that the detection and correction of the problems
contributing to darkroom fog is a relatively uncomplicated process and
can be carried out relatively rapidly. Often the problem is associated
with the safelight and simply discontinuing use of the safelight until
it can be replaced or repaired may provide a temporary correction that
would permit returning the darkroom to service.
    FDA has placed all other tests under Sec. 900.12(e)(8)(ii)(B).
These are tests whose failure indicates that there are problems that
must be corrected, but, for various reasons are not considered to
present a health hazard serious enough to require taking a piece of
equipment out of use until the problem is corrected. Retake analysis is
included in this group (Sec. 900.12(e)(3)(ii)). In this case,
mammography must be allowed to continue to determine if the corrective
action has indeed had the desired effect on retake rate. Also in this
group are tests such as kVp accuracy (Sec. 900.12(e)(5)(ii)) and
alignment (Sec. 900.12(e)(5)(vii)), for which, as one of

[[Page 55949]]

the NMQAAC physicists argued, there are compensation methods that can
be used as temporary corrective actions until the problem can be given
a more permanent correction. Other tests included in this group, such
as the system resolution test (Sec. 900.12(e)(5)(iii)--called the focal
spot condition test in the final regulations) are early warning tests
that give an indication of possible approaching problems. In the case
of the system resolution test, FDA has accepted the argument of the
NMQAAC physicist who believed that, unless the system resolution was so
poor as to lead to failure also of the image quality test, some time
could be permitted for the correction of the resolution problem. Of
course, if the image quality test is failed, the piece of equipment
will be taken out of service until the problem is corrected. Finally,
this group includes the artifact test (Sec. 900.12(e)(xi)), for which
there are no objective action limits against which to compare the test
results.
    Although problems revealed by the tests in the second group are not
considered serious enough to take a piece of equipment out of service
until corrected, FDA believes that they must not be allowed to exist
indefinitely. Therefore, Sec. 900.12(e)(8)(ii)(B) requires that when
tests in this group are failed, the problems must be evaluated and
corrected within 30 days.
    l. Surveys (Sec. 900.12(e)(9))
    This paragraph required that a facility survey be performed by a
medical physicist no less often than once a year. The tests and reviews
that, at a minimum, were to be included in the survey were specified
along with requirements that the medical physicist provide a survey
report to the facility within 30 days of the survey. Identification of
those who performed the survey was to be provided in the report.
    (Comment 536). Two comments were received on Sec. 900.12(e)(9)(i),
which specified that the surveys should be conducted annually. One
comment indicated confusion about the requirement by stating that an
annual FDA inspection was not needed if a certified physicist conducted
biannual surveys. The other comment asked that the requirement be
modified to allow the annual surveys to take place in a year plus or
minus a reasonable period.
    FDA notes that an inspection is not a survey but rather is a check
by an independent authority on how well the facility is meeting the
requirements. An inspection and a survey serve different functions and
are both required under the MQSA. Furthermore, the inspection does not
duplicate the physicist's work. The inspection involves conducting only
the tests that provide the most general picture of the equipment
performance but also includes review of other aspects of the facilities
performance such as personnel qualifications and reporting and
recordkeeping practices, which are not considered by the physicist
during the survey. Recognizing the unique characteristics of both the
survey and the inspection, and the benefits of multiple oversight
mechanisms, Congress required that each be conducted annually.
Performance of more frequent surveys, semi-annually, e.g., does not
eliminate the need for inspections. FDA has retained the requirement
for an annual survey in accordance with 42 U.S.C. 263b(e)(1)(B)(iv).
This requirement does not prohibit the facility from having a survey
more frequently if it wishes. In response to the second comment, FDA
notes that it has exercised its enforcement discretion under the
interim regulations, and intends to continue to do so under the final
regulations, to permit short periods of additional time beyond 12
months for the facility to obtain a survey under certain circumstances.
The agency has done so in recognition of the difficulty that facilities
that rely on contract physicists have in scheduling surveys. However,
this exercise of enforcement discretion in a particular year is not
intended to set a pattern that will permit facilities to impemissibly
lengthen the timeframes between surveys to longer than annually.
    (Comment 537). Several comments were received on the survey report
required under Sec. 900.12(e)(9)(iii). One comment recommended that a
standard physicist report format should be required to facilitate
review. Another stated that there should be provision for
identification of units if the facility has more than one unit or has
installed a new unit in an old room. A third comment stated that the
report should include the calibration dates of the exposure measuring
instruments.
    FDA recognizes the advantages of a standardized report and in the
past has encouraged the use of the report format recommended in the ACR
quality assurance manuals. This format includes provision for
identification of the unit being evaluated; such information has been
and will continue to be implicitly required, because without it, the
facility is unable to prove that a particular unit was included in the
survey. FDA also believes that there has been a move towards
standardization under the interim regulations because reports that
inadequately provide the information needed during inspections have
created extra work for facilities and physicists who must provide the
information. This has led to improvements in later reports. However,
while there are advantages to a standardized report, FDA also
recognizes the need to allow flexibility in this respect to cover
special situations and to permit the use of individual initiative in
developing improved formats. The agency concludes, therefore, that it
is both unnecessary and needlessly restrictive to require a specific
report format by regulation.
    Because the calibration requirement for exposure measuring
instruments (Sec. 900.12(e)(12)) is a new requirement, this information
has not been checked during inspections under the interim regulations.
Because it is now a requirement under the final regulations, FDA
expects that, in most cases, this information will be included in the
survey report and that there is no need for a specific regulation
requiring it to be there. However, if the facility wishes to provide
the information in some other format, it will have the flexibility to
do so.
    (Comment 538). Four comments were related to the requirement of
Sec. 900.12(e)(9)(iv) that the report be provided to the facility
within 30 days of the survey. One comment suggested shortening the
interval to 2 weeks. Another stated that Massachusetts had found that a
requirement that the facility's lead interpreting physician sign the
report within 30 days had been effective in ensuring that the findings
of the medical physicist were implemented. A third comment proposed
that the deficiencies noted by the medical physicist be corrected
within 1 month. The fourth comment urged that if the report is not
received within 30 days, the facility be required to take the equipment
out of service. This, it was believed, would stimulate the physicist to
be timely.
    FDA believes that a shorter time period would be unreasonable in
situations where contract physicists might do several surveys in a
several day trip before returning to his or her office to complete the
reports. The agency also believes that it is common practice that
before leaving the facility, the physicist gives a preliminary report
to the facility staff, which would include identifying conditions that
require prompt action. The new provisions of Sec. 900.12(e)(8), which
require correction of certain serious test failures before the failed
equipment is used for further examinations, will further stimulate the
provision of

[[Page 55950]]

preliminary reports. The agency continues to believe, therefore, that
the 30-day timeframe is reasonable. With respect to the second and
third comments, the agency believes that the new Sec. 900.12(e)(8)
adequately ensures that the more serious failures are corrected before
the equipment is used again and that all identified problems are
corrected within 30 days. A separate requirement is not needed here.
With respect to the fourth comment, FDA believes that there is already
sufficient incentive for the facility to make sure it receives its
report within the 30 days without need for the drastic action
suggested.
    (Comment 539). The last comment on this paragraph endorsed the
requirement in Sec. 900.12(e)(v), that not only the physicist, but
anyone who is performing part of the survey under the physicist's
direct supervision be identified.
    FDA retained this requirement when the regulations were codified.
    m. Mammography equipment evaluations (Sec. 900.12(e)(10))
    FDA proposed this provision to resolve several somewhat conflicting
concerns. The basic goal was to ensure that newly installed equipment
or equipment that had undergone major changes is tested for adequate
performance by a qualified person before the equipment is used for
examinations. However, this goal had to be achieved within the
statutory limitations that provide for the issuance of provisional
certificates prior to the completion of the survey and that require
review of QC data as part of the survey. Such data cannot be generated
unless the unit is in clinical use (42 U.S.C. 263b(c)(2)). The agency
was also concerned about the costs that might be incurred by a facility
that required two visits by the physicist, one visit for the original
equipment check and the second for the full survey. There was also
concern about the possibility of reduced access attributable to delays
in putting the equipment into use due to inability to arrange for a
visit by a physicist for some period of time.
    Proposed Sec. 900.12(e)(10) was an attempt to balance these
conflicting concerns by requiring a mammography equipment evaluation of
units or processors that were either new or had undergone major changes
before those units were put to use in performing examinations. The
evaluations were to be done by a qualified person, who could be a
physicist or could be another individual, such as an installer or
manufacturer's representative, and any problems found were to be
corrected before the equipment was used clinically.
    (Comment 540). One comment supported this paragraph as written, but
27 comments opposed allowing anyone but a medical physicist who met the
requirements of Sec. 900.12(a)(3) to perform the mammography equipment
evaluation. NMQAAC also supported requiring that the physicist perform
this evaluation.
    In view of these comments, FDA has changed the wording to limit the
performance of the mammography equipment evaluation to a medical
physicist or someone under the direct supervision of a medical
physicist. As noted above, this may mean a delay of some weeks in the
use of the equipment at some facilities until a medical physicist can
be scheduled for the evaluation. However, the agency has been persuaded
by the unanimity of the public comments and the advice of NMQAAC that
the benefits of having a medical physicist perform the evaluation
outweighs the disadvantage of a possible delay. The agency also notes
that by planning ahead, the facility may be able to minimize this
delay.
    (Comment 541). Several comments addressed the issue of the content
of the mammography equipment evaluation. Two comments urged that this
be a complete survey but a third noted that the equipment would have to
be in use for a period of time before the complete evaluation could be
done. Four other comments suggested some specific tests to be included
in the evaluation, but two more comments recommended leaving the
decision about necessary testing to the person doing the testing.
    As noted above, the MQSA provisions relating to provisional
certificates and the physical impossibility of checking QC data before
the equipment is put into use preclude the possibility that the
mammography equipment evaluation can be the full survey required by the
statute. Although the agency agrees that it may be beneficial to do a
variety of tests at the time of the equipment evaluation, it does not
intend to designate particular tests in the regulations. The revised
provision simply requires that the evaluations determine if the new or
changed equipment meets the applicable requirements of Sec. 900.12(b)
and (e), thereby focusing on the primary public health concern, which
is to establish that units are not put into clinical use without proper
testing. This more general wording, the agency believes, also
eliminates the need to consider processors and mammography units
separately with respect to this evaluation, as suggested by six
comments.
    Related to the content of the mammography equipment evaluation is
FDA's concern, mentioned earlier, about the expense to the facility if
two physicist visits are required, one for a mammography equipment
evaluation and another, later, for the survey. The agency's original
efforts to reduce costs was its proposal to permit the mammography
equipment evaluation to be performed by qualified individuals other
than physicists. The revised final regulations eliminate this
possibility. In a different approach to limiting costs to the facility,
FDA plans to permit the initial survey of the new or changed equipment
to be done in two stages. The first stage, the mammography equipment
evaluation, will obviously require a facility visit by the physicist.
If the facility and physicist can cooperate to produce adequate
documents, FDA will permit the second stage, the review of the QC data
after it is available, to be done by mail. Presumably, this will cost
the facility less than two onsite visits to the facility by the
physicist. The agency stresses that this two-stage process is intended
to help contain costs associated with a facility's initial survey of
new or changed equipment and is entirely optional and within the
discretion of the facility and its physicist. The agency will require
subsequent annual surveys of that equipment to be done at one time
through an onsite visit.
    The proposal required a mammography equipment evaluation for new
equipment and also after major components of the equipment were
changed. FDA specifically asked for comments on what should be
considered to be ``major components'' but received relatively few
responses.
    (Comment 542). One comment suggested processor rollers in the case
of the processor. For the X-ray unit, two comments suggested the X-ray
tube and one of these went on to add the bucky, the screen-film system,
and the photo-timing system. Two comments also suggested changes in the
ventilation system because such changes can cause major artifact
problems. Another comment simply suggested that repairs by service
personnel should require testing.
    FDA found these suggestions useful and will take them into account
in determining what constitutes a major component. With respect to the
regulations themselves, in view of the limited number of comments, the
agency decided to continue to keep the wording general.

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    (Comment 543). One comment opposed the entire idea of a mammography
equipment evaluation before the equipment was put into use, stating
that it would only increase the cost of installation. Another comment,
however, strongly supported the correction of all problems before any
equipment was put into use. FDA agrees that there will be some cost
associated with mammography equipment evaluations, but believes that
the dangers inherit in permitting the use of untested equipment in
patient examinations more than justifies this requirement. Therefore,
the agency has retained the requirement in the final rules and
clarified that the evaluation is also required for new and reassembled
equipment, or whenever a major component is changed or repaired.
    n. Facility cleanliness (Sec. 900.12(e)(11))
    This proposed paragraph required the facility to establish and
implement protocols for maintaining darkroom, screen, and view box
cleanliness and to document that the protocols were followed.
    (Comment 544). Six comments stressed the importance of darkroom,
screen, and view box cleanliness, primarily because of the likelihood
that dirty conditions will lead to artifacts. Three comments took the
opposite position, stating that the section should be deleted due to
lack of evidence of a hazard. Seven comments urged FDA to go further
and establish protocols for cleaning in the regulations. On the other
hand, 13 identical comments questioned whether it would be possible for
FDA to establish regulations on cleanliness.
    FDA believes that proper standards of cleanliness contribute to
quality mammography; e.g., they do reduce undesirable effects
associated with artifacts. However, as the agency stated in the
preamble to the proposed regulations, there are a variety of cleaning
protocols and a variety of circumstances affecting the cleaning needs
of a facility. FDA continues to believe that facilities must be given
the flexibility to establish cleaning protocols that best fit their
needs. The presence and use of such protocols can easily be determined
during inspections and their effectiveness, or lack thereof, will be
demonstrated by the results of the QC tests, such as the artifact test.
    (Comment 545). Six comments stated that FDA was paying attention to
disinfecting the equipment but not to screen cleanliness, apparently a
reference to Sec. 900.12(e)(13), discussed below.
    FDA disagrees with these comments and believes that adequate
attention has been paid to both areas. The agency also notes that the
infection control requirements will also address the concerns raised by
the comment, which stated that cleanliness requirements for bucky and
compression paddle and examination room cleanliness should be added.
    o. Calibration of air kerma (exposure) measuring instruments
(Sec. 900.12(e)(12))
    This paragraph, as proposed, required calibration of the
instruments used by medical physicists in their annual surveys to
measure exposure, at least annually. Ten years after publication of the
regulation, additional requirements would have to be met by those doing
the calibration.
    (Comment 546). Numerous comments urged FDA to change the required
frequency of calibration to once every 2 years. A few comments opposed
the requirement entirely, while others suggested calibration more
frequently than annually. In response to these comments, FDA changed
the required frequency to once every 2 years as a normal practice, but
also retained the requirement for calibration after a repair of the
instrument.
    As discussed in connection with the definitions of kerma and air
kerma, the agency has also introduced the quantity of air kerma into
this rule in accordance with the move towards use of SI units. Also in
accordance with the agency cost concerns discussed earlier, the
requirements proposed in Sec. 900.12(e)(12)(ii) to be phased-in over 10
years have been eliminated.
    p. Infection control (Sec. 900.12(e)(13))
    This paragraph was proposed in recognition of the fact that, while
transfer of disease caused by blood borne pathogens during mammography
has never been reported, it is theoretically possible. Therefore, the
agency concluded that appropriate precautions should be taken. Because
FDA believes that this concern is not unique to mammography, it did not
propose specific requirements for mammography equipment but stated
instead that the facility should follow the general requirements for
infection control related to medical devices.
    (Comment 547). Seven comments opposed this requirement. Reasons
given included that it was redundant, unnecessary, and time-consuming;
would create needless paperwork; and did not deal with a radiation
control problem. Two comments, however, urged additional measures, such
as requiring informed consent and the use of protective covers. Another
comment warned that any material placed between the breast and the
image receptor would cause increased dose and degradation of image
quality.
    FDA believes that the comments do not provide convincing arguments
for a change in the agency's position in either direction. The agency
continues to believe that at least a theoretical concern about disease
transmission exists and that the best way to deal with this concern is
to address it as part of infection control procedures to be followed
during the use of medical devices in general.
6. Quality Assurance-Mammography Medical Outcomes Audit
(Sec. 900.12(f))
    This paragraph requires that every mammography facility establish
and maintain a mammography medical outcomes audit program for followup
on mammographic assessments and correlation of pathology results with
the interpreting physician's recommendations. This program should be
designed to ensure the reliability, validity, and accuracy of
interpretation of mammograms.
    a. General comments on medical outcomes audit
    (Comment 548). A single comment was received on the general
difficulty in conducting a medical outcomes audit faced by facilities
that rely on contract interpreting physicians. Specifically, the
comment noted that there would be a higher potential for bias in
medical outcomes audits conducted for small facilities that employed a
relatively greater number of interpreting physicians.
    FDA disagrees that the use of a number of contract interpreting
radiologists will necessarily result in biases in medical outcomes
data. Data should be calculated both for the aggregate facility data
base of patients and again for each interpreting physician. Because the
data are to be calculated for individual physicians, any particular set
of data that represents unusual or anomalous results will be readily
identified and additional calculations can be performed by the facility
to project average outcomes without that outlying data. The benefit of
tracking these results, therefore, includes the ability to identify
problems and find trends. The facility will be required to designate a
reviewing interpreting physician to review these data and to notify all
interpreting physicians, including contract interpreting radiologists,
of both aggregate and individual results. Such analyses may require
followup actions, which are to be documented by the reviewing
interpreting physician.
    b. Confidentiality
    The issue of maintaining confidentiality of medical outcomes audit
information collected by the

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