The following post by AMDR President Dan Vukelich can be found in its entirety on the Protect Our Savings blog:
For more than ten years, America’s hospitals have known that FDA-regulated, reprocessed medical devices are safe, lower-cost and environmentally-responsible. The reprocessing industry has welcomed FDA’s strong oversight because, for customers, it demonstrates every reprocessor’s commitment to providing safe and effective medical equipment. The result is that today, hospital outsourcing to FDA-regulated third-party reprocessors (TPRs) has become the standard of care in America – in fact, of U.S. News & World Report’s “Honor Roll” hospitals (i.e., the top 17 medical institutions in the nation), every single one utilizes reprocessing programs.
In the rest of the world, the reprocessing of so-called “single-use devices” (SUDs) is thought to be quite commonplace, but it is seldom regulated. Perhaps spurred by the current economic climate, the growth of the U.S. third-party reprocessing (TPR) industry, or both, other nations are now looking to regulate reprocessing as a way to safely and effectively reduce healthcare costs and waste.
For example, the European Union (EU) does not have a comprehensive regulatory framework regarding the reprocessing of medical devices. However, the EU is in the process of revising its Medical Device Directive. The European Parliament identified reprocessing of SUDs as an issue in need of additional clarification, and a European Commission report highlighting the risks of unregulated reprocessing was released in August, 2010…
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