Clinicians Industry Info

Third-Party Medical Device Processing

AMDR Alert on Duodenoscopes Safety Communication

The FDA’s Feb. 19 safety communication pertaining to the effective cleaning of certain reusable Duodenoscopes applies to in-house hospital reprocessing of endoscopes. AMDR member companies in the U.S. DO NOT reprocess the endoscopic devices that are the subject of this notice. AMDR member companies DO NOT reprocess reusable devices. In-house hospital reprocessing of reusable devices is a distinctly different activity from third-party reprocessing of single-use devices (SUDs); the practices should not be confused. Any safety concerns associated with cleaning and sterilization activities by in-house central sterile departments have no bearing on the safety of third-party, FDA-regulated reprocessing of SUDs.

 

 

News

Keep Vendors and Their Surprises Out of Your ORs and Your Contracts

… The Story: You’re doing all you can to reduce your expenses, but then a vendor shows up in the operating room with a “surprise” implant. Or an expensive piece of technology breaks down, and you have to call in the vendor to repair it. Ambulatory surgery programs are getting creative in how to address these […]

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