Regulatory Compliance

The United States Food and Drug Administration (FDA) has begun its effort to move the US healthcare industry to use duodenoscopes with disposable components, such as end caps. The effort is being made to reduce the incidences of superbug transmissions through inadequately reprocessed duodenoscopes that have been reported in recent years. The FDA is urging […]

Hospitals continue to focus on duodenoscopes and their successful reprocessing in order to reduce the incidence of superbug breakouts related to endoscopes. The primary concern that hospitals have to address regarding duodenoscope reprocessing revolves around some of the manual components of disinfecting these devices. Bret T. Petersen, MD of the Mayo Clinic in Rochester, Minnesota

Over the last decade, incidences of outbreaks from infections that can be attributed to poorly disinfected endoscopes have been showing up in the news regularly. So much so that regulatory bodies from the US Congress to the FDA have been increasing their scrutiny of these extremely useful, yet sometimes problematic reusable medical instruments. Many different

The US Government is continuing its scrutiny of Olympus and the other major endoscope manufacturers following several reports of infections related to duodenoscopes in recent years. The latest chapter includes a letter written by a US Senator asking for additional information regarding duodenoscope investigations. Sen. Patty Murray (D-WA) wrote a letter to the three major

The United States Food and Drug Administration (FDA) has released another update regarding its research into the safety and contamination risks associated with the use of duodenoscopes. After receiving further research results, the FDA is reiterating its previous recommendations regarding the proper handling and reprocessing of duodenoscopes that it released in a Safety Communication in