August 8, 2002

Lester Crawford, D.V.M., PhD

Acting Principal Deputy Commissioner

Food and Drug Administration (FDA)

5630 Fishers Lane, Rm. 1061

Rockville, MD 20852

Dear Dr. Crawford,

On behalf of over 18,000 members, the American Academy of Orthopaedic
Surgeons (AAOS or Academy) welcomes the opportunity to comment on the
development of a Food and Drug Administration (FDA) regulation requiring
bar code labeling for human drugs and biologics \[Docket No. 02N-0204\].
The AAOS has continually supported initiatives to reduce medical errors
and increase patient safety.

As advocates for our patients, the AAOS demands the highest standards
for patient care. However, the Academy realizes that medical errors
inadvertently occur and are part of a system wide problem. The Academy
provides the following recommendations on bar code labeling of
pharmaceuticals, biologics, and devices:

-   FDA should consider using the alternative term "automatic
    identification" rather than bar code labeling;

-   The FDA should proceed with a proposed and final rule on automatic
    identification for pharmaceuticals;

-   The FDA should implement the national drug code as the first phase
    of automatic identification;

-   If FDA intends to provide a regulation on device identification, it
    should be addressed in a separate document.

**[[FDA should consider using the alternative term "automatic
identification" rather than bar code
labeling]{.underline}]{.smallcaps}**

The FDA should assess the use of nomenclature for the proposed
regulation on bar code labeling. As technology rapidly proceeds, it
would not be prudent for the federal government to recognize an
identification technology, such as bar code labeling, which may become
obsolete due to the use of newer technologies. The Academy is aware that
radio frequency technology, in addition to bar code labeling, is used to
identify products. Therefore, the use of the term "automatic
identification" would circumvent the use of out dated technologies in
FDA guidances and regulations.

The FDA should proceed with a proposed and final rule on automatic
identification for pharmaceuticals

Since the publication of the Institute of Medicine (IOM) report, "To Err
is Human: Building a Safer Health System" in 1999, efforts to implement
patient safety measures have increased. As errors involving
pharmaceuticals comprise a significant percentage of all medical errors,
it is necessary to implement a strategy to identify pharmaceuticals in
healthcare systems. The AAOS recommends that the FDA issue a proposed
and final rule immediately, requiring the use of automatic
identification on all pharmaceuticals. All pharmaceutical companies
acknowledge the current use of automatic identification therefore, the
proposed and final rule would have an insignificant effect on drug
companies. The implementation of automatic identification on
pharmaceuticals however, will have a significant effect on reducing
medical errors. Pilot programs, including the Veteran's Administration,
report a decrease in medication errors of at least 70% when automatic
identification systems are utilized. Additionally, the Academy supports
national efforts to automatically identify blood and blood components.

As noted in the IOM report, a few medications pose a risk of death or
serious patient injury, especially when an excessive dose is
administered. Examples of these medications include electrolytes such as
potassium chloride, potassium phosphate, and sodium chloride in
strengths greater than .9%. Additionally, heparin, warfarin, insulin,
lidocaine, magnesium, muscle relaxants, chemotherapeutic agents,
dextrose injections, narcotics, adrenergic agents, theophylline, and
immunoglobin are all considered high-risk medications. The AAOS urges
the FDA to ensure that the regulation on automatic identification
includes all high-risk medications.

The FDA should Implement the national drug code as the first phase of

automatic identification

Pharmaceutical manufacturers currently utilize automatic identification
for inventory control purposes. Therefore, these manufacturers currently
possess the ability to provide information about the drugs in a readable
form. The Academy recommends that the FDA include the national drug code
in the first phase of implementation of the regulatory efforts on
automatic identification of pharmaceuticals. The AAOS suggests that the
FDA include the lot number and drug expiration date as part of the
second phase of implementation. Furthermore, the Academy recommends that
all pharmaceutical drugs should be manufactured in unit dose packaging.
By packaging per unit dose, medical errors will be substantively
reduced.

If FDA intends to provide a regulation on device identification, it
should be addressed in a separate document

The Academy believes that efforts to include medical devices in a
regulation on automatic identification on pharmaceuticals and biologics
are unwarranted at this time. The automatic identification of drugs is
an important patient safety initiative, in that many patients have died
or been harmed from the improper use of medications. However, this
rationale is not easily applied to devices. Devices range from simple
band-aids to capital equipment and pose varying degrees of risk to the
patient. As such, the Center for Devices and Radiological Health (CDRH)
classifies devices into three categories according to patient safety
risk.

The Academy believes that the practical utility of the automatic
identification of devices primarily lies in inventory control measures
and device recall efforts. The AAOS notes that surgeons visually
identify devices in operating rooms when automatic identification
labeling has been removed. To date, there does not seem to be a patient
safety risk for most devices absent the improper administration and
programming of infusion pumps that deliver an improper drug dosage.
Therefore, the Academy urges the FDA to prioritize automatic
identification efforts to those problematic areas outlined in the IOM
report.

Moreover, the identification of devices may be a more complex issue than
the automatic identification of pharmaceuticals. Many hip and knee
prostheses are comprised of several components. The Academy believes
that the automatic identification of devices presents a unique set of
concerns. In addition to the use of prostheses, orthopaedic surgeons
utilize an arsenal of devices to complete their surgical cases. Hence,
if the FDA intends to provide a regulation on device automatic
identification, it should be addressed in a separate proposed rule.

# Conclusion

In conclusion, the AAOS shares the concerns of the FDA in ensuring
patient safety. The Academy believes it is appropriate to accelerate
regulatory efforts on the automatic identification of pharmaceuticals.
The AAOS has been active for many years with initiatives to increase
patient safety. In 1997, the Academy launched the "Sign Your Site"
initiative to prevent wrong site surgery. The AAOS has been actively
working with the Sentinel Event Advisory Group of the Joint Commission
on Accreditation of Healthcare Organizations (JCAHO) to develop
initiatives to increase patient safety. In August 2002, JCAHO approved
six recommendations, including marking the operative site. The AAOS
looks forward to working with the FDA on future efforts to increase
patient safety.

Sincerely,

William W. Tipton, Jr., MD

Executive Vice President