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 Minnesota Department of Health has issued a memo to healthcare facilities regarding proper reprocessing of endoscopes. According to the memo, several healthcare facilities have contacted the ...

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 ...

The US Food and Drug Administration (FDA) has issued new guidance requiring manufacturers of new reusable medical devices to more thoroughly test and label their devices to ensure patients are not ...

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 ...

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 ...

STEMart now offers Reprocessing Validations services in accordance with ISO, AAMI and ASTM standards to validate reprocessing instructions for reusable devices. The full range of medical device ...

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, ...

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 ...