Safety Concerns Over Reprocessed Duodenoscopes and Other Reusable Devices Do Not Apply to Third-Party SUD Reprocessing
FDA’s Feb. 19 safety communication pertaining to the effective cleaning of certain reusable Duodenoscopes, and ECRI’s Top 10 Patient Safety Concerns for 2015, both pertain to in-house (hospital) reprocessing of endoscopes and other reusable equipment. AMDR wishes to clarify that its member companies in the U.S. DO NOT reprocess the endoscopic devices that are the subject of FDA’s notice nor do AMDR member companies reprocess reusable devices. In-house hospital reprocessing of reusable devices is a distinctly different activity from FDA-regulated, third-party reprocessing and remanufacturing 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.
NewsSingle-use Device Reprocessors Urge EU Regulators to Settle Key Issue
As the European Council continues its deliberations over a proposed comprehensive new Medical Device Regulation, the requirements for the reprocessing of single-use devices remains one of the main issues to be settled, according to Dan Vukelich … Read More (with Subscription)