AN INDECIPHERABLE DEBATE? AN OVERVIEW OF OPPOSING PERSPECTIVES AND THE SEARCH FOR A COHERENT REGULATORY SCHEME FOR THE REPROCESSING AND REUSE OF SINGLE-USE MEDICAL DEVICES

Abstract

Caught in the middle of this controversy, the FDA has struggled for only the past few years to devise a conclusive regulatory strategy for medical device reuse. Many critics claim, however, that this action by the FDA comes too little and too late. Indeed, one angry journalist has said of the FDA: "Acting more like a lookout than a law enforcer, the Food and Drug Administration has spent the past 22 years standing aside as hundreds - perhaps thousands - of hospitals have begun reusing disposable medical devices, even though such devices have been bathed in blood, and even though the instruments carry warnings against the practice." Not wishing to rush to judgment like these and other impassioned consumer groups, though, the FDA has chosen to proceed cautiously thus far, seeking first to discern and articulate the many discordant views in this debate before formulating a final guidance rule. This paper will explore, in turn, the many different perspectives inherent in the dispute over medical device reuse: the patient and consumer perspective; the health care provider perspective; the device manufacturer perspective; and also, the perspective of a new industry player, the third-party medical device reprocessor. It will then proceed to review the brief history of FDA regulation of medical device reuse from its outset to the current day. Finally, it will conclude with recommendations for additional measures the FDA ought to consider in arriving at an ultimate regulatory scheme.