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 ...
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 ...
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 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 Emergency Care Research Institute (ECRI Institute) has released its annual "Top 10 Patient Safety Concerns for Healthcare Organizations," naming some repeat offenders—like device reprocessing—to ...
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 ...
Duodenoscope-associated infections remain a safety concern, and single-use duodenoscopes have been introduced to mitigate ...
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 ...
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 ...
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