The European Commission this week issued regulations establishing common specifications for the reprocessing of single-use medical devices under the Medical Device Regulation (MDR). Under MDR, ...

Duodenoscope-associated infections remain a safety concern, and single-use duodenoscopes have been introduced to mitigate ...

In 2000, when FDA led the U.S. to become the first country in the world to regulate the use of reprocessed single-use devices, the agency responded to concerns from manufacturers and physicians that ...

The lifespan of medical devices is growing longer as more and more hospitals are turning to device reprocessing to cut costs, reduce waste and maximize potential use of these items. Millions of single ...

In 2000, the FDA began to view and regulate all companies reprocessing single-use medical devices in the same way it viewed and regulated original equipment manufacturers (OEMs). Before returning ...

The Association for the Advancement of Medical Instrumentation and the FDA hosted the 2011 Medical Device Reprocessing Summit to discuss challenges of reprocessing reusable medical devices. 1. Define ...

The European Commission (EC) on Tuesday set forth the common specifications (CS) for the reprocessing of single-use medical devices under the EU’s medical device regulation (MDR). The EC is proposing ...

Of the literature cited by reprocessors to support SUD reuse, few documents, if any, provide indisputable evidence of the safety of reprocessing. David N. Cowan, Stephen O. Cunnion, and Tina M. Swift ...