International

International

Since 2000, the United States Food and Drug Administration (FDA) has regulated reprocessors of so-called “single-use” medical devices (SUDs) as medical device manufacturers, subjecting all reprocessors (third-party, hospital, and original equipment manufacturers (OEMs)) to all of the agency’s medical device manufacturer requirements. Thus, FDA’s regulatory framework for reprocessing is perhaps the longest-standing, most comprehensive in the world.  However, the U.S. is not the only nation to address the reprocessing of SUDs.  This summary outlines, to the best of AMDR’s 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.

 

The reprocessing of SUDs is commonplace worldwide.  Even in developed nations, including those that have reprocessing prohibitions in place, hospitals routinely reuse SUDs.  Unless otherwise noted below, the available evidence indicates that the reuse of SUDs in most other nations is unregulated.  In many cases (particularly in Africa and Asia), uncontrolled reuse of such devices is relatively common, if not the norm.

 

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