On average, the fastest-growing cardiology reprocessing company has received one FDA clearance every 10 weeks for the past 10 years. An FDA clearance to reprocess a single-use device requires ...

Late last month, FDA's Center for Devices and Radiological Health (CDRH; Rockville, MD) issued updated guidance on the reprocessing of single-use devices (SUDs). Under the new guidelines, reprocessors ...

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, 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 ...

Throughout the healthcare community, the reuse of medical products designated by original equipment manufacturers as single-use devices (SUDs) remains a controversial topic. In the reprocessing ...