What is the future of reprocessed, single-use devices?

In Unique Device Identifier, Vigilance Reporting on November 5, 2012 at 2:39 pm

In 1999 the FDA conducted a meeting to discuss reprocessing of single-use devices (SUDs). In August 2000, a guidance document was published to communicate the FDA’s enforcement policy for 3rd parties and hospitals that reprocess SUDs. Many reports have been published on this topic in the USA, Europe and Canada since that time.

I couldn’t think of an ideal song title to match up with reprocessing, but I was listening to my Amy Winehouse station on Pandora at 2am…it just seemed to fit.

In an article published earlier this year, Daniel J. Vukelich, Esq. (President of the Association of Medical Device Reprocessors), explained that 95% of the reprocessing is performed in the USA, and “AMDR is confident that reprocessed SUDs will continue to play an increasingly important role in our healthcare system”.

OEMs are deeply concerned about reprocessing of SUDs—and it’s not just about the money. Jon Speer recently wrote a blog that voiced some of the industry’s concerns. Specifically, the post addressed the issue of complaint investigation.

The FDA published a guidance document that outlines the process for adverse event reporting of reprocessed SUDs .

The problem is that even with electronic medical records, not all the necessary information regarding traceability is included in those records. This situation is about to change dramatically in the next few years as new global regulatory requirements force companies to implement Unique Device Identification (UDI) and as Europe implements the proposed regulations (Article 15).

How do you anticipate these changes will impact the prevalence of reprocessed SUDs globally?

Will these changes result in changes to your company’s product labeling of risks associated with re-use of SUDs?

If you would like to see the comments others have, please join the following LinkedIn Group: Medical Device: QA/RA. If you are not already a member of the parent group (Medical Device Group), you should join.


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