Old and TiredOld and Tired

Originally Published MDDI February 2004

EDITOR'S PAGE

The reprocessed single-use device debate is going in circles and needs an injection of scientific evidence. 

The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) stakeholders meeting, held December 3, 2003, was a productive, informative, cooperative event at which FDA and industry assessed which parts of the law have worked and which parts need further refining.

With one exception.

The panel discussion on the use of reprocessed single-use devices (SUDs) was filled with grandstanding, finger pointing, and the same anecdotes we've heard many times before. The rest of the meeting was a genuine exchange of ideas and conveyed the sense that the interested parties were talking to each other. (For more coverage of this meeting, see “NewsTrends,” p. 22, and “Washington Wrap-Up,” p. 40). During the SUD discussion, however, the interested parties were talking at each other, and seemed more interested in questioning the motives of those who disagreed with them rather than working together to resolve the issue.

Section 302 of MDUFMA requires submission of validated cleaning, sterilization, and functional-performance data for certain SUDs that FDA has identified. The provision also calls for FDA to identify which reprocessed SUDs require the submission of a 510(k) application proving substantial equivalence to their predicate devices before they can be marketed. 

At the meeting, however, there was not much discussion of how this section has worked in practice and whether it needs correcting or improving. Rather, the interested parties fell back on the same arguments that they have been making in public for years. 

Reprocessors and their allies among hospitals and healthcare systems argued that reprocessing SUDs is safe and effective and charged that some devices are designated SUDs only because of the financial interests of the medical device manufacturers. Pamela Furman, executive director of the Association of Medical Device Reprocessors (AMDR; Washington, DC), went so far as to call Section 302 a “product of OEMs' frustrations over the economic threat that reprocessing poses.”

Device companies and their trade associations countered that in many cases reprocessing SUDs is not safe and charged that in some cases the reprocessing of SUDs places costs savings ahead of patient safety. The presentation by Boston Scientific's Tony Blank, speaking on behalf of the Advanced Medical Technology Association (AdvaMed; Washington, DC), included photos of worst-case failed reprocessing jobs that seemed designed to shock rather than elucidate. 

What was missing was any demonstration of, and in most cases any references to, scientific evidence for either side. And ultimately, that's what should hold sway in this discussion. Rather than anecdotes, slide shows, and third-hand testimonials, the interested parties should be putting forth data showing which SUDs are substantially equivalent as a reprocessed device and which ones pose risks to patient safety. Which, by the way, is exactly what MDUFMA requires.

Of course, it's very likely that such evidence isn't going to show that all reprocessed SUDs are safe and effective, nor that all of them are potentially hazardous. As such, it might not make the best weapon to score political points. But it's the only way to turn the discussion from repetitive attacks on the other side's greed to a productive discourse on what makes sense for health, safety, and economics.

The Editors

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