Reprocessing single-use medical devices

AORN Journal,  March, 2002  by Barbara D. Cohoon

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POLICY OBJECTIVES

The intention of the FDA's new draft regulations was to increase regulation of medical devices by the FDA, provide assistance to OEMs by establishing the Division of Small Manufacturers Assistance, and create an extension for the FDA to issue its final regulations of the Federal Food, Drug, and Cosmetic Act. The explicit intentions of the draft regulations were to give advance notice of the FDA's proposed guidelines and provide an opportunity for feedback from the medical community and industry before implementing the regulations.

The FDA's draft regulations were meant to quiet concerns being voiced by lobbyists and reduce the mounting anxiety being heard on Capitol Hill. Congress' objective in its introduced legislation and round of hearings was to nudge the FDA to reevaluate, formulate, and implement regulatory changes in areas that Congressional members believed needed to be addressed. Legislation often is introduced to prompt regulatory bodies to make changes internally rather than have Congress pass proposed legislation.

The activity spurned by the passage of these amendments created increased regulations and forced the FDA to take responsibility for implementing and enforcing regulations on reprocessed SUDs. The establishment of the Division of Small Manufacturers Assistance and the extension gave the FDA the reprieve it needed to properly implement its new guidelines of the Federal Food, Drug, and Cosmetic Act. The introduction of HR 3148 and S 1542 was a written stance of Congress' overall concern about the reprocessing and reuse of SUDs. The FDA's draft regulations allowed the FDA and all parties affected to decide on the best course of action and solution to the problem.

PROS AND CONS OF THE POLICY

The proposed policies and finalization of the FDA guidelines will result in the reprocessing of SUDs being considered a legitimate practice and will open doors of opportunity. Consequences of the new regulations proposed by the FDA and Congress vary depending on the individual and organization affected.

Both OEMs and third-party reprocessors will benefit. Original equipment manufacturers will be able to continue to expand and grow as new medical devices are designed and marketed. Third-party reprocessors will be recognized for performing a safe job and for offering an alternative to disposable SUDs. Individual hospitals, however, may be unable to meet the new FDA requirements and may choose not to reprocess. (32)

Patient benefits still are in question. Numerous studies demonstrate the inability to adequately remove and properly resterilized SUDs. (33) Although the GAO failed to find any real evidence of harm, it did find evidence that not all SUDs can be reprocessed safely, and it strongly recommends oversight by the FDA. (34)

The savings from reprocessing have been touted by many. One researcher reports a savings of more than $9 million from reprocessing catheters during the past 20 years. (35) The Association of Medical Device Reprocessors (AMDR) says, "Simply put, medical device reprocessing allows us to provide more quality health care at an affordable price. (36) There are others, however, who are quick to disagree. One researcher discovered there are no published standards to demonstrate savings. (37) The ECRI formula demonstrates that the first time a device is reprocessed saves the greatest amount, and savings decrease significantly thereafter. (38) A cost comparison study found data necessary to determine actual savings were difficult to obtain and yielded too close of an outcome to warrant a decision to reprocess rather than dispose of SUDs. (39)