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 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, ...

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 ...

It might surprise you that Europe, and specifically the European Union (EU), is lagging far behind the United States when it comes to the re-use of single-use devices. After all, Europe is usually ...

With supply costs as one of the top two expenses for surgery centers (staffing is the other), more and more ASCs are purchasing reprocessed devices, which help to reduce costs, among other benefits.

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 ...

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 ...