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

AdvaMed Rearranges FDA’s Priority List

The medical device trade group tells FDA which guidance topics should be tackled first. The Advanced Medical Technology Association (AdvaMed) has voiced its opinion on which topics the medtech industry believes should be FDA’s highest priorities. In early January, FDA’s Centers for Device and Radiological Health (CDRH) released its Fiscal Year 2015 Proposed Guidance Development. […]

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