William Hyman: Food for Thought in an FDA Warning Letter on Reprocessing

August 29, 2013

Regulations, Sterilization

The reuse of single-use devices (SUDs) has been a controversial topic for some time. The process is distinct from reusing devices that were intended to be reused by the manufacturer, and following the manufacturer’s instructions while doing so—or at least being guided by them. The original device manufacturers of SUDs are opposed to reuse for several reasons. Lost sales is an obvious one, but so is fact that such devices are not designed for reuse and therefore no reuse instructions are provided. Manufacturers also believe that reprocessors are not held to the same standard that they would be if they proposed reuse. They fear being blamed for a post-reuse issue, believing there is inadequate distinction between a new device and reprocessed one.

On the other side are those who claim that many SUDs can be reprocessed safely and reused, thereby saving money—although one wonders if that price difference is properly reflected in patient charges. Some reprocessing is handled by hospitals. There is also a reprocessing industry. Reprocessors may take possession of used devices and resell them, or they may position themselves to reprocess your devices and return them to you. In either case, the U.S. Food and Drug Administration, after a period of avoiding the issue, established a regulatory framework for SUD reprocessors, be they hospitals or outside entities.

Against this backdrop, I came across an interesting warning letter issued this summer to one reprocessor. Such letters are a matter of public record, posted on the FDA website. In the letter, the FDA lists 11 alleged violations cited during an inspection, and to which the firm initially responded. The letter says that the firm’s responses to two of the 11 points were adequate. The agency concluded the company’s answers to the remaining nine points were inadequate, thus leading to the warning letter.

The nine alleged violations cited in the letter involved a variety of issues, including cleaning processes, complaint handling, corrective and protective action (CAPA) processes, and internal audit procedures. Separately, there were other two points—not numbered as the others—alleging that the reprocessed devices were not cleared or approved (as required by the SUD regulations), and that they were not properly labeled with respect to adding required reprocessor information.

In reading the letter, I found it interesting that the FDA says the reprocessor adds an O-ring to the manifolds supplied by the original manufacturer. To my eye, this seems to be more than just reprocessing. In addition, the FDA says a degreaser is used that is not labeled for medical applications and a high-level disinfectant is used manually although it is labeled as not appropriate for manual use.

Also of interest is that there does not seem to be a stop work order associated with the warning letter, although this could come later. For now, customers may be getting a product that was reprocessed and labeled under a system that has now been challenged. It seems to me that, at a minimum, a healthcare facility would want to know about the FDA’s correspondence with a vendor. Maybe facilities should have a clause in their contracts with vendors, requiring notification of significant regulatory action?

William Hyman, ScD, is professor emeritus of biomedical engineering at Texas A&M University. He now lives in New York where he is adjunct professor of biomedical engineering at The Cooper Union. Hyman may be contacted at w-hyman@tamu.edu

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One Comment on “William Hyman: Food for Thought in an FDA Warning Letter on Reprocessing”

  1. John Abbott Says:

    I get very worried when I hear an otherwise reputable hospital or healthcare provider buying and using re-processed single-use devices. And I sure would like to know if a reprocessed device is being used on me. I think maybe I would find another service provider.

    But in some respects I think it is (at least partially) the responsibility of the original manufacturer to ensure that devices labeled as “single-use” CANNOT be re-used or re-manufactured without essentially making a new device. It is not inconceivable to design single-use devices such that some critical piece of the device breaks or otherwise changes such that a second use is impossible. Perhaps the FDA should require such a feature if a manufacturer uses the term single-use. That is, perhaps the manufacturer in its 510(k) or PMA should be required to describe how their single-use device changes after use such that it cannot be used again. In such a scenario, any so-called “reprocessor” would actually be just another medical device manufacturer requiring their own regulatory clearance. Of course, that might open them up to intellectual property violations.

    Reply

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