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Frontiers in Medical Device Reprocessing


Q4 Innovative Health Newsletter


Medical device industry increasing value while hospitals suffer

Recent analysis by Innovative Health paints the picture of American healthcare exploited by the medical device industry: The top medical device manufacturers in EP/Cardiology have – on average – more than doubled their stock value since the fall of 2014. During the same time period, the largest US hospital systems have seen their stock value decline by at least a third. Medical device manufacturers continue to increase their prices on new generation devices – while most hospitals are losing money on a Medicare/MediCaid A-Fib case.

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Don’t lose your reprocessing savings

Medical device manufacturers in the Cardiology industry have launched a systematic attempt to reduce hospital savings by installing built-in obsolescence features in their next-generation most expensive devices. Most hospitals save 80% of their device reprocessing dollars on 3-5 very expensive devices. When these devices are blocked from reprocessing, hospitals are at risk of losing most of their reprocessing savings – sometimes $1/2M to $1M per year. Click the image below to get Innovative Health’s recipe for How to Protect Your Reprocessing Savings:

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Record number of 510(k) clearances

Innovative Health received 11 510(k) clearances in 2016 and 7 clearances in 2017 (and counting) – all in the EP/Cardiology area. No reprocessor has ever come close to building this level of reprocessing capability over a two-year period. In fact, the last EP/Cardiology clearance from Stryker was granted in 2012. Keeping up the pace of 510(k) clearances is critical for the hospital because devices become obsolete all the time when manufacturers upgrade their technology. Before the end of the year, Innovative Health will publish an FDA data-based report on FDA clearance efficiency and performance.


Hospitals and reprocessors have forgotten what reprocessing should be all about

Since device manufacturers in 2009 and 2010 bought out the largest medical device reprocessors, hospitals have seen a decline in the results they have achieved through reprocessing. New 510(k) clearances have almost stopped, and reprocessing programs are all but stalled due to lack of support and program monitoring. Click the image below to read Innovative Health’s white paper on Five Things Healthcare Has Forgotten About Reprocessing and get your program back on track:

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Europe catching on!

Recent legislation in the EU has begun regulating medical device reprocessing. The Association of Medical Device Reprocessors (AMDR) – the trade association of medical device reprocessors backed by all substantial US and European reprocessors devoted to reducing hospital costs – has supported the development of legislation in Europe that removes unsafe reprocessing practices from the hospital and place them with controlled, third-party reprocessing. We’ll see adoption of US standards and practices in Europe.