Editor's Note Huntington Memorial Hospital, Pasadena, California, alerted health authorities on August 19 to a suspected outbreak of bacterial infections associated with contaminated duodenoscopes, the Los Angeles Times reports. Three patients with Pseudomonas bacterial infections had procedures with Olympus duodenoscopes. The bacteria are similar to the carbapenem-resistant Enterobacteriaceae superbug at…
Editor's Note The Food and Drug Administration (FDA) sent warning letters August 12 to three manufacturers of duodenoscopes involved in transmitting deadly bacteria earlier this year, the Boston Globe reports. The FDA says the companies (Olympus, Pentax, and Fujifilm) failed to: report problems with the scopes as required by law…
The Association for the Advancement of Medical Instrumentation (AAMI) has published its first standard on flexible endoscope reprocessing. ANSI/AAMI ST91: 2015 Flexible and Semi-rigid Endoscope Processing in Health Care Facilities was developed from research and input from manufacturers of flexible endoscopes, users, consultants, and regulatory bodies. The new standard, which…
Editor's Note Despite reprocessing in accordance with US guidelines, viable microbes and residual contamination persisted on gastrointestinal endoscopes after each reprocessing step, in this study, suggesting current guidelines are not sufficient to ensure successful decontamination. Investigators observed all reprocessing activities, using a checklist to ensure that protocols were performed in…
Editor's Note The Food and Drug Administration on August 4 released a Safety Communication that contains supplemental measures to enhance duodenoscope reprocessing. The measures emerged from an expert panel meeting earlier this year. In addition to following manufacturer reprocessing instructions, the FDA says facilities can use one or more of…
At least half the battle in making and sustaining process improvements is getting the entire team on board with a new workflow. One key to getting buy-in from staff is to clarify why changes are needed and what the consequences may be if the new processes aren’t followed. In a…
Perhaps no other departments in a hospital work as closely together as the OR and the sterile processing department, yet friction isn’t uncommon as both areas strive to meet service demands. Although the relationship between the two is unlikely to ever be free of tension, leaders of both departments increasingly…
Relations between the OR and the sterile processing department (SPD) are not always smooth. OR staff need timely, accurate instrument trays that meet the highest standards of safety. Anything short of 100% performance leads to complaints about the SPD. But many OR staff members do not appreciate the challenges faced…
Instruments that are still damp or wet after being sterilized cannot be placed in storage. The moisture that remains on or inside of a package can create a pathway for microorganisms to travel from the outside to the inside of the package. Moisture may be in the form of visible…
The Food and Drug Administration (FDA) on March 17 published a final guidance on reprocessing reusable medical devices. This guidance, which provides manufacturers with recommendations to validate their reprocessing instructions, comes on the heels of a host of “superbug” bacteria outbreaks related to reprocessing of endoscopic retrograde cholangiopancreatography (ERCP) duodenoscopes.…