Last week, the U.S. Food and Drug Administration (FDA) sent a warning to all three major duodenoscope manufacturers. The warnings were sent due to the failure of Olympus, Pentax and Fujifilm to comply with postmarket surveillance study requirements set with them by the FDA in 2015. During the FDA’s investigation of duodenoscope-related infections in 2015, […]
FDA Issues Warning To Duodenscope Manufacturers Read More »
Pentax Medical recently issued an urgent recall of one of its duodenoscope models. Pentax is informing customers of its voluntary recall of all ED-3490TK duodenoscopes. As part of the recall, Pentax aims to replace the forceps elevator mechanism, O-ring seal and distal end cap. There will also be an update issued to the Operation Manual
Pentax Issues Recall of Some of Its Duodenoscopes Read More »
Hang-time limits for flexible endoscopes have been a hot topic among GI, Infection Control and Sterile Processing professionals for the last several years. With no consensus emerging in hang-time limits (sometimes called an endoscope’s shelf life), hospitals are left to make this decision on their own. With different stakeholders within the hospital looking at different
How To Set And Track Hang-Time Limits For Flexible Endoscopes Read More »
Springfield, Massachusetts-based Baystate Medical Center is notifying nearly 50 patients that a recent colonoscope procedure may have exposed them to a life-threatening illness. The news was reported by Masslive.com, and continues the trend of endoscope-related safety issues across the US. Noble Hospital, which was acquired by Baystate Health in 2015, was found to have had
Massachusetts-Based Hospital The Latest To Reveal Endoscope-Related Infection Risk Read More »
The first trial accusing Olympus Corp. of wrongdoing associated with contaminated duodenoscopes in US hospitals will be re-tried due to the discovery of new evidence that may aid the plaintiff’s case. The case examines the death of Richard Bigler, a 57 year-old patient who underwent a scope procedure while battling pancreatic cancer in 2013. The
First Olympus Trial Gets A New Day In Court Read More »
Flexible endoscopes present a unique challenge for hospitals to track and manage – these expensive medical instruments must be quickly re-processed after usage in order to provide the required instrumentation for the next procedure, yet they must undergo rigorous, time-consuming reprocessing after every use to ensure the highest levels of patient safety. Due to different
How To Create An All-Electronic Audit Trail For Your Scopes Read More »
With the recent scrutiny placed on the Joint Commission (TJC) in publications like the Wall Street Journal, TJC has found itself on the defensive regarding its accreditations and how it holds hospitals accountable for safety violations. In response, TJC has been trying to open up a dialogue with the public about the importance of its
The Difference Between Passing a Joint Commission Survey and Continuous Improvement Read More »
The ECRI Institute, based in Philadelphia, has just released its annual list of health technology hazards for 2018. Unsurprisingly, endoscope reprocessing once again appears near the top of the list, coming in as the number 2 hazard for 2018. ECRI’s list is the result of extensive research by its own engineers, scientists and clinicians, as
ECRI Top Health Technology Hazards List Once Again Includes Endoscope Reprocessing Read More »
Many hospitals continue to underestimate the importance of a successful endoscope reprocessing practice. Several hospitals and medical facilities that we’ve visited invest too little in facilities and staff to prepare their endoscopes after usage in procedures. However, if a hospital is unable to successfully ensure the cleanliness of these vital reusable instruments, they could be
Is Your Endoscope Reprocessing Area Set Up For Success? Read More »
Visual inspection has emerged in recent years as an important quality assurance step during endoscope reprocessing. Updated guidelines from AAMI, AORN and SGNA have all included a visual inspection step during the disinfection process to ensure that scopes are being thoroughly prepared for the next patient. All three standards organizations have come out in support
The Importance of Visual Inspection for Endoscope Reprocessing Read More »