Reprocessing: Going Global

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.

At this time, regulation of reprocessing activities is left to the individual European Member States. Since 2001, Germany has had in place a regulatory framework that does not distinguish between the reprocessing of “reusable” and so-called “single-use” medical devices. The guidelines, therefore, allow for SUD reprocessing if conformance with certain standards is achieved. Similarly, AMDR is aware that other nations, like Denmark and Sweden, allow for SUD reprocessing under a high quality standard.

Other Member States, such as the United Kingdom, Spain and France, discourage or prohibit SUD reprocessing. However, AMDR is aware that, despite these prohibitions or discouragements, reprocessing at the hospital level still occurs – though there is no government oversight. The majority of Member States in Europe do not have any national regulations regarding reprocessing.

Should the EU revise its Medical Device Directive to address reprocessing, Member States would be obliged to revise their regulations on reprocessing to ensure conformance with the EU requirements. As in the U.S., AMDR has provided input and recommendations to European regulators in an effort to ensure a framework that allows for only safe and effective medical device reprocessing.

AMDR has drafted a summary that outlines, to the best of our knowledge, the legal and regulatory status of SUD reprocessing in a number of jurisdictions, including the European Union (EU), Australia, Canada, South Korea, Saudi Arabia, and Israel.

Read the Full Summary