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 ...

Every healthcare facility faces the same challenge: to reduce costs without sacrificing the delivery of quality care. As a result of dwindling healthcare reimbursements, and increased awareness of ...

This article is written by Jason Wandersee, CEO of MEDISISS, a Medline-owned reprocessing company. MEDISISS is the leader in reprocessing to surgery centers throughout the United States since 1997.By ...

The Association for the Advancement of Medical Instrumentation published an infection control survey tool focused on reprocessing of medical devices. The survey covers reprocessing of semi-critical ...

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 established environmentalism mantra of “reduce, re-use, recycle” opened the door for medical device manufacturers to roll out recycling programs under the guise of sustainability efforts. But, in ...

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, ...

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 ...