Medical Device Link.

Originally Published MX July/August 2002

GOVERNMENTAL & LEGAL AFFAIRS

Medical Device Refurbishment and FDA

In 1994, FDA undertook to review the activities of medical device rebuilders, refurbishers, and remarketers, with an eye toward possibly revising its 1987 compliance policy guide. In 1995, it began a dialogue about this issue with a trade association constituted primarily of remarketers of used medical imaging devices. Then, in October 1996, the agency announced changes to its good manufacturing practices (GMP) regulation, which was renamed the quality system regulation (QSR) and included new sections dealing with repairs to medical devices.

While the principal reason for the revised 1996 QSR was the harmonization of U.S. manufacturing standards with the ISO 9001 quality systems standard compiled by the International Organization for Standardization (ISO), the new regulation made medical device remanufacturers subject to the same manufacturing practices as original equipment manufacturers. Owing to intense internal disagreement among members of FDA’s Medical Device GMP Advisory Committee, however, equipment refurbishers, independent repair services, and hospitals were exempted from the revision. FDA promised to address, in separate rule-making proceedings, the application of GMP requirements to medical device repairers and refurbishers not under the aegis of the original device manufacturer.

The agency published an advanced notice of rule making in the Federal Register on December 23, 1997. But at the conclusion of a conference of interested parties hosted by the Association for the Advancement of Medical Instrumentation (AAMI) in September 1998, FDA officials stated that new regulations for repairers, refurbishers, and remarketers were unlikely, except perhaps some limited labeling regulations. FDA expressed a preference for a system of voluntary self-regulation, reserving the right to promulgate its own regulations if a voluntary framework could not be developed.

A voluntary self-regulatory framework has been proposed under the auspices of AAMI. Meanwhile, in January 1999, FDA rescinded its compliance policy guide that had regulated third-party servicers of medical devices.

While all of this was happening, FDA began to focus regulatory attention upon the related topic of reuse of devices originally intended for single use. FDA regulation of the reuse of single-use devices now seems far more likely to appear than any regulation of repairers, refurbishers, and remarketers. This may be explained, in part, by the fact that repair and refurbishment of more-durable medical devices is a multibillion-dollar industry, and that medical-care providers have viewed their ability to repair and refurbish through independent vendors as a valuable means of containing rising medical costs.

Therefore, the traditional protections of trademark law and false-advertising law may be the best avenues for combating shoddy or abusive repair and remarketing practices.

Copyright ©2002 MX