Editor's Note An investigation by the Pasadena Public Health Department, Pasadena, California, into the outbreak of Pseudomonas aeruginosa bacterial infections from duodenoscopes found that 16 patients at Huntington Hospital were infected from January 2013 to August 2015, including 11 who have now died, the June 1 Los Angeles Times reports.…

Read More

Editor's Note In patients having endoscopic retrograde cholangiopancreatography (ERCP) with a contaminated duodenoscope, biliary stent placement, a diagnosis of bile duct cancer, and hospital inpatient status were independently associated with an increased risk of carbapenem-resistant Enterobacteriaceae (CRE) transmission, this study finds. The findings were based on data from a 2015…

Read More

Editor's Note In this study, a nonpunitive and collaborative peer methodology for assessing endoscope reprocessing at five Johns Hopkins GI endoscopy sites (three hospital based and two ASCs) was successful in capturing and sharing best practices for cleaning, disinfection, and sterilization of endoscopes. The assessments showed that 20 (42%) of…

Read More

Some complex medical devices cannot withstand high-temperature sterilization. An alternative is low-temperature sterilization, which works for heat- and moisture-sensitive devices. There are different types of low-temperature sterilizers, and this article will review them.   Spaulding classification A deciding factor in whether an instrument can undergo high-level disinfection is the Spaulding…

Read More

Editor's Note The Food and Drug Administration (FDA) has dropped its recall of approximately 2,800 Custom Ultrasonics’ System 83 Plus automated endoscope reprocessors. This action comes despite the FDA's finding last year that the recall was “necessary to protect public health,” the May 6 Kaiser Health News reports. The FDA…

Read More

Editor's Note A new congressional investigation shows that the number of infections from contaminated duodenoscopes is much higher than previously estimated, the April 15 Los Angeles Times reports. The Food and Drug Administration (FDA) told investigators that from 300 to 350 patients at 41 facilities in the US and abroad…

Read More

Editor's Note The Food and Drug Administration (FDA) on March 15 announced that Olympus (Center Valley, Pennsylvania) has issued updated, validated manual reprocessing instructions for the TJF-160F and TJF-160 VF duodenoscope models to replace those provided in the original device labeling. The FDA reviewed the updated reprocessing instructions and the…

Read More

Editor's Note The Food and Drug Administration (FDA) on February 19 announced that it had reviewed updated reprocessing instructions and validation data issued by Pentax Medical (Montvale, New Jersey) for its ED-3490 Video Duodenoscope. The FDA recommends that facilities train staff on the updated instructions and implement them as soon…

Read More

Sterilization packaging is considered a medical device and thus it must undergo validation testing before being used in healthcare facilities. To ensure proper packaging that will maintain the integrity of sterilization, consult the packaging manufacturers’ instructions for use (IFU) and follow the sterilization standards and guidelines from the Association for…

Read More

Editor's Note The Food and Drug Administration (FDA) on February 1 posted updated information on which manufacturers of automated endoscope reprocessors (AERs) for duodenoscopes have completed validation testing with adequate results. There are five companies in the US that manufacture AERs labeled to reprocess duodenoscopes. Companies that have completed their…

Read More