**SUMMARY MINUTES**

**OF THE**

NATIONAL MAMMOGRAPHY QUALITY ASSURANCE

ADVISORY COMMITTEE MEETING

**Open Session**

**August 26, 2002**

**Gaithersburg Holiday Inn**

Gaithersburg, MD

NATIONAL MAMMOGRAPHY QUALITY ASSURANCE

ADVISORY COMMITTEE MEETING

**AUGUST 26, 2002**

## COMMITTEE PARTICIPANTS

Maryanne Harvey, MS Chairperson

James F. Camburn, B.S.  

Nancy J. Ellingson, RT (R)(M)  

Alisa M. Gilbert Consumer Representative

Miles G. Harrison, Jr., M.D.  

Jessica W. Henderson, Ph.D. Consumer Representative

Debra M. Ikeda, M.D.  

Andrew Karellas, Ph.D.  

Amy F. Lee, M.D.  

Melissa C. Martin, M.S.  

Etta D. Pisano, M.D.  

Linda S. Pura, RN, MPA Consumer Representative

Catalina R. Ramos-Hernandez, M.D. Consumer Representative

Amy R. Rigsby, R.T. (M)  

Donald C. Young, M.D.

## 

# FDA PARTICIPANTS

Charles Finder, M.D. Committee Executive Secretary

Associate Director

Division of Mammography Quality and Radiation Programs

Roger Burkhart, Ph.D. Accreditation and Certification Branch

Division of Mammography Quality and Radiation Programs

Michael Divine, M.S. Inspection and Compliance Branch

Division of Mammography Quality and Radiation Programs

Charles Gunzburg, M.S. Inspection and Compliance Branch

Division of Mammography Quality and Radiation Programs

Kish Chakrabarti, Ph.D. Accreditation and Certification Branch

Division of Mammography Quality and Radiation Programs

**CALL TO ORDER**

**Committee Chair Marianne Harvey, M.S.,** called meeting to order at
9:00 a.m. **Committee Executive Secretary Charles Finder, M.D.,** read
the conflict of interest statement, announcing full waivers to all
committee members and to **Daniel Kopans, M.D.,** for their professional
affiliations or their financial involvement with accrediting bodies,
manufacturers of mammography equipment, or mammography facilities. In
addition, several members reported that they received or will receive
compensation for lectures, but they affirmed that were asked to speak
for their expertise and not because of their membership on the
committee. Ms. Harvey then asked the committee members to introduce
themselves.

# ALTERNATIVE STANDARDS

Dr. Finder provided brief background information on the alternative
standard requirement and stated that since the last committee meeting,
the Division has approved several requests for alternative standards.

**Roger Burkhart, Ph.D., Accreditation and Certification Branch,
Division of Mammography Quality and Radiation Programs,** described the
alternative standards that had been approved since the last committee
meeting. First, an alternative standard for manufacturer's software
modification of the AEC was approved on September 24, 2001. Second, an
alternative standard for conducting mammography equipment evaluations
after a software upgrade under medical physicist oversight was approved
on May 31, 2002; the standard refers to testing conditions after a
modification takes place and involves a request related to specific
software upgrades. A third alternative standard was approved on June 27,
2002; the standard addresses the time period for corrective actions
following failure of quality control tests for full field digital
mammography (FFDM) units. Dr. Burkhart noted that the standard only
applies to those General Electric (GE) units mentioned in the requested
alternative standard.

# OPEN PUBLIC HEARING

**Kenneth Crocker, director of marketing, product planning, Fischer
Imaging Corporation,** stated that digital mammography is becoming more
widely used and that that the delays in providing oversight for FFDM and
lack of uniformity in standards are problems. Moreover, manufacturers
have no incentive for standardization. FDA and accrediting bodies should
develop uniform standards, seeking guidance from industry in the
process, and FDA should allow accrediting bodies to accept
manufacturers' manuals for accreditation on an interim basis.
Accrediting bodies should simplify accreditation requirements and make
them more uniform. In addition, Mr. Crocker suggested eliminating the
requirement to maintain a film/screen system because it imposes an undue
burden. FDA should synchronize tests that allow 30 days for corrective
action and develop a uniform standard rather than wait for manufacturers
to do it.

Committee members noted that facilities use FFDM and film/screen
equipment differently; larger than average patients may need multiple
exposures, making them more appropriate for film/screen equipment.
However, from a public health viewpoint, it makes sense to not require
film mammography because it limits access in rural areas; with
film/screen equipment, one cannot electronically transmit images for
interpretation.

Dr. Finder then read a statement from **Pamela Gormley, R.T. (R) (M),
mammography supervisor, EPIC Imaging,** into the record. Ms. Gormley
wrote that the requirement to maintain a film/screen system is outdated
technology and a waste of resources; digital units provide better
resolution with less radiation than film/screen systems.

# OPEN COMMITTEE DISCUSSION

# Overview of MQSA Inspection Findings and Current Inspection Follow-up Actions

**Michael Divine, M.S., Inspection and Compliance Branch, Division of
Mammography Quality and Radiation Programs,** summarized FDA inspection
and compliance data. He noted that problems have been declining over
time. He listed FDA's options for inspection follow up and summarized
the specific types of regulatory actions FDA has taken, which are
primarily additional mammography reviews (35 actions) and patient and
physician notification (11 actions).

Good Guidance Practices and Directions for Discussion of the MQSA
Guidance Under the Final Regulations

Dr. Finder provided background information on FDA procedures for
developing new guidance documents and gave information about the policy
guidance help system.

### MQSA GUIDANCE: COMMITTEE DISCUSSION

#### **Automatic Exposure Control (AEC) Testing**

Committee members discussed whether all AEC modes should be tested at
the annual survey, or whether the medical physicist should perform a
test onsite only if the facility is using a specific mode clinically. It
seems unnecessary to test every available mode of a complex AEC system
if a facility does not intend to use those modes; however, what should
be done if a facility decides that it needs to begin using a particular
mode that hasn't been previously tested. In that case, Committee members
suggested that the medical physicist should be called in to evaluate the
AEC only when the new mode is a substantial departure from the initial
test. In addition, the longer testing takes, the longer a machine is out
of service for a facility and the more the testing costs.

Dr. Finder noted that the regulations are slightly different for testing
at the initial evaluation and at the annual survey and asked the
committee whether full testing at the initial evaluation and lesser
tests at the annual survey should be acceptable.

Committee members who are medical physicists indicated that they follow
ACR guidelines and test in mag mode. Some members said that if a
facility does not use a mode, they do not test it; others said that each
mode should be tested on some thickness to verify tracking between
modes. For units with individual detectors, the full set of tests should
be conducted on one of the detectors, then the results should be
cross-checked with the other detectors for 4 cm. Several committee
members suggested that only modes that are clinically used should be
tested routinely, but all modes should be tested at installation. Some
committee members suggested that it is to the medical physicist's and
the facility's benefit to test all the AEC modes while some suggested
that AEC problems are not a major clinical issue---problems become
evident quickly, and technologists are vigilant about image quality.
Some believed that this is more of a regulatory problem, than a
practical clinical problem.

Committee members pointed out that technologists may inadvertently use
the wrong submode, especially when many technologists use the same
machine; in addition, technologists have to make judgments for patients
who fall between sizes. For that reason, a range of AEC testing would be
appropriate. Each submode needs to be tested at some thickness to show
that it tracks. It was also brought up that when testing at 8 cm, the
density control on some units may have to be adjusted to obtain optimum
film density.

The committee discussed whether the manual mode could be used in the
event of AEC failure. Several committee members said that if the AEC
fails, their recommendation is that the unit be taken out of service;
their facilities do not allow manual exposure. The problem is not common
because AECs tend to drift a bit rather than totally fail.

**Priscilla Butler, director, Breast Imaging Accreditation Program,
American College of Radiology (ACR),** asked for clarification on FDA's
interpretation of AEC failure and the definition of manual mode. Dr.
Finder responded that AEC failure can refer to both testing failure and
when someone suspects that there are problems with the clinical images.
Regarding the manual mode, the FDA is trying to deal with the fact that
units have multiple AEC modes. If only 1 or 2 modes are affected, a
facility could continue to use the unaffected AEC modes. In cases of
complete AEC failure, the regulations allow use of the manual mode for
up to 30 days.

**Full Field Digital Mammography (FFDM)**

Dr. Finder noted that the guidance document is available for public
comment and includes a long new section on FFDM. He asked committee
members whether they had any comments on the guidance. Dr. Pisano noted
that a clinical trial for which she is the principal investigator has
generated a fair amount of data. Once the data are made public, the FDA
should be able to reduce the various quality control requirements
currently applied to FFDM units. Dr. Finder noted that the regulations
governing FFDM were written before any units were approved.
Manufacturers were asked to establish an appropriate quality control
system. FDA will revise the regulations as data become available.
Because units are so different from each other, it will be hard to
standardize quality control.

Dr. Karellas noted that medical physicists find it easier to work with
modules from accrediting bodies, such as ACR, than manufacturers'
manuals. If manufacturers cooperate, a document could be developed that
parallels ACR guidelines.

Ms. Gilbert noted that the guidance document does not contain much
information on mammography for breasts that have implants or have
undergone reconstructive procedures. Dr. Finder noted that the
regulations were written with cosmetic implants in mind. Recommending
additional training for technologists who do mammography on patients who
have undergone surgery was suggested.

**Claude Goode, State of California,** described a case in which a
woman's implants ruptured during mammography and said that the FDA or
another entity needs to set some standards for mammography of patients
with breast implants. Dr. Finder stated that the regulations currently
do have standards for patients with breast implants.

**Daniel B. Kopans, M.D., F.A.C.R., Harvard Medical School and
Massachusetts General Hospital, Boston,** noted that the standard of
care is not to do routine mammographies of women with mastectomies.
Committee members concurred that the case reflects an isolated incident;
they noted that mammography is not recommended for screening of women
with breast reconstruction. Committee members observed that sufficient
guidance about imaging of breast implants is available from professional
societies for technologists and radiologists. The issue is medical,
rather than regulatory.

#### **Assessment Categories**

Dr. Finder said that concerns have been raised about the BIRADS
assessment categories when evaluating postoperative breasts, because the
categories do not cover all situations. In addition, the categories were
not designed with the male breast in mind. Other areas of concern
include appropriate categorization when waiting for comparison films and
the use of category 3 (probably benign). Another issue is the use of
multiple assessment categories and the FDA requirement that an overall
assessment category be assigned if multiple categories are used.

The committee concurred that the currently available categories were not
necessarily appropriate in all cases. Suggestions included adding BIRAD
6, "known cancer present," and clarification of category 0. Dr. Pisano
noted that category 0 is intended to be used when a patient is in the
process of being worked up; it is not a final category. In most
settings, 0 means more tests are needed.

Dr. Finder observed that the issue of assessment categories for each
breast has been raised before and asked whether the assessment
categories should be for each lesion, rather than overall. Dr. Kopans
said that physicians are supposed to read the full report and that such
categorization would be redundant. Dr. Pisano stated that she believes
that ACR's BIRADS committee would not object to the use of a two-breast
assessment system. Dr. Finder noted that the regulations say to provide
one overall assessment category for the study. Part of the reason for
this requirement was to prevent a facility from counting a two-breast
study as two separate exams for purposes of initial or continuing
experience. Dr. Ikeda expressed concern about adding an assessment for
the second breast because of the possibility of missing the most
suspicious finding; if one must read 20,000 reports, an overall
assessment is important.

Dr. Finder provided background information on the regulatory history of
FFDM. When the first FFDM unit was approved in early 2000, no
accreditation body existed. The MQSA requires that units and facilities
be accredited and certified. The only way to handle the situation was to
link digital units to otherwise accredited film/screen units. As a
result, facilities with FFDM are required to have a film/screen unit;
the units need not be in the same location.

# ACRIN TRIAL OF FFDM

Dr. Pisano described the American College of Radiology Imaging Network
(ACRIN) trial, an NCI-funded screening trial for asymptomatic women
comparing outcomes following digital and film/screen mammography. The
goal is to enroll 49,500 women at 29 centers; if a woman would normally
be screened at the participating site, she is eligible to participate.
Exclusion criteria include dominant lump on physical exam, nipple
discharge, implants, pregnancy, and inability to participate in follow
up. Dr. Pisano described criteria for image acquisition and
interpretation as well as the procedures for workup of lesions. Outcome
measures include biopsy as well as ratings on the standard BIRADS scale,
Probability of Malignancy scale, and Call Back scale. Dr. Pisano also
described the follow-up protocol. The study is keeping track of
downstream costs; one hypothesis is that digital mammography has a lower
rate of false positives and therefore is associated with lower
downstream costs. In addition, a quality-of-life assessment is being
conducted through a telephone survey. Reader studies will take place in
Year 3; soft- and hard-copy readings for each manufacturer will be
compared. The study is also looking at image quality for different
machines across sites and is examining variation over time.

# Committee Questions for Dr. Pisano

Committee members asked questions concerning the participation rate of
eligible women, the protocol if a suspected malignancy is found,
recruitment and minority representation, exclusion criteria, and cost.
Dr. Pisano replied that the capacity of the facility, not participant
willingness, poses the biggest limitation to participation. The study is
collecting age and ethnicity data. To recruit patients, the study is
publicized at centers that perform high daily rates of screening
mammographies, and it also has generated local publicity. Recruitment
has targeted minority populations; the goal is to reflect the proportion
in the general population. Minority participation is good so far. When a
suspected malignancy is found, it is handled by local clinicians. Each
site handles workup according to its own protocol. Everything is adapted
to accommodate both digital and analog images. Regarding exclusion
criteria, women who have had a mastectomy and would normally get a
screening mammography for the opposite breast are eligible, but women
who have had lumpectomy are not eligible because they are defined as
needing diagnostic, not screening, mammography. There is no specific age
cutoff. The facilities charge for the film/screen mammogram, but the
digital mammogram is free.

# POTENTIAL NEW APPLICATIONS OF FFDM

Dr. Kopans reviewed how digital mammography works and listed its
advantages. He then explained digital subtraction mammography, contrast
enhanced mammography, and digital tomosynthesis, saying that these
applications may turn out to be more useful than conventional digital
mammography alone. Because these technologies can create perfectly
registered images of the whole breast, direct correlation with
whole-breast ultrasound and other imaging modalities will be possible.
These will probably replace conventional digital mammography. Dr. Kopans
noted that by removing the structure noise of the breast (i.e.,
overlapping structures), digital tomosynthesis makes tumors easier to
see; he then showed many slides comparing tomosynthesis images with
conventional mammograms. Compared with film/screen mammograms, digital
tomosynthesis provides greater conspicuity of lesions, more clearly
defined borders of lesions, a reduced callback rate, an accurate
three-dimensional location, and better differentiation of benign from
malignant tumors. Some drawbacks are that the image-processing time is
currently too long (2 hours) and that the radiologist must read many
images, although they can be reviewed quickly at a workstation.

# Committee Questions for Dr. Kopans

Committee members asked questions concerning the angle from which the
images were taken and how the images are archived, whether the
researchers have been able to display left and right breasts side by
side, and the cost of the technology. Dr. Kopans responded that all
images are in oblique projection. The images are being archived on CD
and are viewed on a GE Advantage workstation. Breasts have been
displayed side by side, but readers tend to read one breast image at a
time. The process could add \$100,000 to a digital mammography system.
Dr. Kopans noted that 25 percent of recalls are for women with
superimposed tissues, so the technology may improve patient management.
Dr. Kopans suggested that it might take at least 2 years for digital
tomosynthesis to receive FDA approval as a diagnostic device.

# INSPECTION DEMONSTRATION PROJECT---UPDATE

**Charles Gunzburg, M.S., Inspection and Compliance Branch, Division of
Mammography Quality and Radiation Programs,** provided an update on the
Inspection Demonstration Project (IDP). When annual inspections began,
the facility compliance rate was initially low; as facilities learned
what was required, compliance increased dramatically. The 1998
reauthorization of the MQSA kept the annual inspection requirement but
added a provision for the IDP, a pilot program under which inspections
of selected facilities may be conducted less frequently than annually.
As required by the Act, the program could not be implemented before
April 2001. Mr. Gunzburg described the IDP plan and State participation
criteria, and presented the timeline for the study.

**FFDM ACCREDITATION AND CERTIFICATION---UPDATE**

**Kish Chakrabarti, Ph.D., Accreditation and Certification Branch,
Division of Mammography Quality and Radiation Programs,** updated the
committee on FFDM accreditation and certification. He summarized the
approval process and requirements for FFDM, noting that the rules and
application information are on the FDA Web site. Dr. Chakrabarti
observed that some problems with medical physicist testing of FFDM units
have been found. For example, with the GE Senographe 2000D, the
signal-to-noise (SNR) ratio should be ≥50. If a facility does not use
the raw image, the SNR will be artificially high. Some physicists are
using incorrect procedures when conducting equipment tests. Some tests
must be performed using the raw images, but that does not always happen.
In addition, physicists are deviating from manufacturers' requirements
with respect to viewing conditions, are not checking calibration
properly, or are using the wrong manual. Physicists are exhibiting
similar problems with Fisher units. These problems lead to delays in
certification approval.

# Committee Questions for Dr. Chakrabarti

Dr. Karellas asked whether FFDM facilities are required to have a
printer; Dr. Chakrabarti said that FDA requires the facility to have the
capability to provide the original mammogram on hard copy. The printer
does not have to be onsite. The printer must be compatible with
manufacturer specifications and included in the facility FFDM
application.

**Ms. Butler** updated the committee on ACR's FFDM accreditation module.
In November 2001, ACR was asked to submit a formal application for FDA
approval of the module. In July 2002, ACR submitted a complete
application to FDA. At the end of July, FDA advised ACR that the
information provided with the alternative standard request was
insufficient. In early August, ACR's digital subcommittee collected
additional data to supplement the alternative standard request.
Currently, the material is under internal ACR review.

Ms. Butler reviewed the proposed accreditation process for FFDM,
including the evaluation process and requirements for phantom exposure
and dosimetry. She noted that the requirements apply only to GE
machines. After final FDA approval of the GE module, ACR will complete
modules for other FDA-approved units. She added that ACR supports
efforts to harmonize quality control tests among different
manufacturers.

**Joel Gray, Lo Rad/Hologic Corporation,** asked whether the phantom
image requirements for fibers, specks, and masses remain the same as for
screen-film. He also asked if each accrediting body will have to
individually apply to become an accreditor of FFDM units? Ms. Butler
noted that for GE, the standard was 4 fibers, 3speck groups, and 3
masses. Dr. Finder stated that each accreditation body will have to
individually apply to be an FFDM accreditation body. Committee members
discussed the basis for the standards; Ms. Butler noted that they flow
from the GE quality control manual. Committee members noted that a new
phantom is being developed for digital mammography that is much more
challenging. Committee members concurred on the need for a new phantom.

**Jerry Thomas, Uniformed Services University of the Health Sciences,**
suggested that 8 hours of training with digital mammography systems
might not be enough for technologists and physicists but should be
sufficient for physicians. Dr. Pisano stated that in her experience, the
8 hours of training was adequate for technologists. Ms Martin stated
that 8 hours of general training for the physicist was not sufficient
and recommended that training be done in conjunction with the
manufacturer's service engineer.

Dr. Crocker stated that the need for a uniform accreditation process is
urgent. The process seems sequential, rather than parallel.

**Stephen Vastagh, industry manager, National Electrical Manufacturers
Association (NEMA),** said that NEMA plans to work with manufacturers to
harmonize quality control requirements and that NEMA is pleased the
accreditation bodies are supportive.

# STATES AS CERTIFICATION AGENCIES

Dr. Burkhart reviewed the history of the States as Certification
Agencies (SAC) Demonstration Project. The project provided FDA with a
great deal of information that was subsequently used to develop
regulations and to establish procedures and criteria for FDA's future
oversight activities. The final SAC regulations became effective in May
2002. States interested in becoming SAC States should talk to FDA about
their plans. One of the first steps a State will have to take will be to
develop regulations equivalent to MQSA regulations. FDA currently has no
active SAC applications.

# REVIEW OF SUMMARY MINUTES

The Summary Minutes of the August 2001 meeting were reviewed; no changes
were made.

# FUTURE MEETINGS

Dr. Finder noted that Dr. Lee's term is expiring and thanked her for her
efforts. The next committee meeting is planned for spring 2003; the
agenda will depend on what happens with MQSA reauthorization.

### ADJOURNMENT

Ms. Harvey thanked the participants and the committee and adjourned the
meeting at 4:11 p.m.

> **I certify that I attended this session of the National Mammography
> Quality Assurance Advisory Committee on August 26, 2002, and that
> these minutes accurately reflect what transpired.**
>
> **\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**
>
> **Charles Finder, M.D.**
>
> **Executive Secretary**

**I approve the minutes of the August 26, 2002,**

**meeting as recorded in this summary.**

Maryanne Harvey, MS

Chairperson

Summary prepared by

Caroline G. Polk

Polk Editorial Services

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