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, ...
Medical device reprocessing is the backbone of the medical industry, and global standards continue to shift in this highly volatile field. Some of the key changes to watch for in the medical device ...
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 ...
Medline recently doubled the square footage of its facility in Redmond, Ore., that reprocesses medical devices slated for landfills. The site increased by nearly 52,000 square feet, Medline said Nov.
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 ...
Asia-Pacific is projected to be the fastest-growing region. The global medical device reprocessing market is projected to ...
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 ...
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 ...