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What's the Harm? - December 2015 - Outpatient Surgery Magazine

Outpatient Surgery Magazine, providing current information on Surgical Services, Surgical Facility Administration, Outpatient Surgery News and Trends, OR Excellence and more.

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failed to ensure their scopes could be properly cleaned. • Last month the FDA recalled an estimated 2,800 automatic endo- scope reprocessors made by Ivyland, Pa.-based Custom Ultrasonics. • To top it off, the ECRI Institute, an independent healthcare research firm in suburban Philadelphia, has tabbed dirty endoscopes as the top technology hazard for 2016. Duodenoscope doubts Patients who have undergone endoscopic retrograde cholangiopan- creatography (ERCP) have become infected with carbapenem-resis- tant Enterobacteriaceae (CRE) that remained in improperly cleaned duodenoscopes. Highly publicized outbreaks have occurred at the UCLA Medical Center in Los Angeles, the University of Pittsburgh Medical Center, Advocate Lutheran General Hospital in Park Ridge, Ill., and Virginia Mason Medical Center in Seattle, Wash. Last month, the widow of a 55-year-old man who was allegedly exposed to CRE during an ERCP performed at Carolinas Medical Center in Charlotte, N.C., filed a wrongful death lawsuit against duodenoscope manufac- turer Olympus and Custom Ultrasonics. In August, the FDA sent warning letters to Olympus, Fujifilm and Pentax, informing the manufacturers that their duodenoscopes are misbranded. Then, in October, the FDA gave the companies a month to submit written plans for assessing how their scopes are being reprocessed and what steps can be taken to improve the process. Another bombshell hit last month when the FDA ordered the imme- diate recall of nearly 3,000 AERs manufactured by Custom Ultrasonics. According to the recall, Custom Ultrasonics must validate the ability of its AERs to effectively clean and disinfect specific duo- denoscopes. The company says in a statement that it is complying with the request, that its washer/disinfecter has not been linked to any 8 4 O U T P A T I E N T S U R G E R Y M A G A Z I N E O N L I N E | D E C E M B E R 2 0 1 5

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