1st Duodenoscope with Disposable Elevator Approved by FDA

Over the past several years this blog has frequently addressed the many problems caused by contaminated duodenoscopes. According to a recent study, data from three major hospitals documented the fact that seventy-one percent (71%) of their reusable medical scopes deemed ready for use on patients after reprocessing tested positive for bacteria.1 This study was published in March, 2018 in the American Journal of Infection Control and it underscores the infection risk posed by a wide range of scopes. The study further documents a critical lack of progress by scope manufacturers and regulators in reducing patient risk caused by scopes that remain contaminated after reprocessing. Sadly, this is after major news reports of CRE superbug outbreaks and patient deaths from contaminated scopes going back to 2013. In an effort to reduce patient harm and death caused by contaminated scopes, the FDA in 2015 ordered several scope manufacturers to conduct postmarket surveillance studies. The FDA requested these studies after several scope-related outbreaks in Los Angeles, Seattle and Chicago made national headlines. The purpose of the studies was to determine if healthcare facilities were able to properly clean and disinfect the scopes using the manufacturers’ reprocessing instructions for use (IFUs). Specifically, as part of the FDA approved study plans, all three manufacturers were required to sample and culture reprocessed duodenoscopes that were in clinical use to learn more about the issues that contribute to contamination, as well as a human factors study to assess how well trained hospital staff are when it comes to following the manufacturers’ reprocessing instructions. On March 9, 2018 the FDA sent warning letters to all three duodenoscope manufacturers for failing to comply with requirements of federal law under which they were ordered to conduct postmarket surveillance studies to assess the effectiveness of reprocessing the devices.2 Since receiving those warning letters 18 months ago, the scope manufacturers have devoted a lot of time, money and additional resources into solving the problems associated with reprocessing their scopes. Some of that effort paid off last week in the form of this press release from the FDA: Press Release3  This is good news for patients and clinicians everywhere when it comes to reducing the risk of a contaminated scope causing patient harm or even death. This is also another great example as to why it is critical to only use reusable medical devices whose IFUs have been validated to prove that they actually work to ensure a clean, sterile, moisture-free device on every reprocessing cycle! 1 “Residual moisture and waterborne pathogens inside flexible endoscopes: Evidence from a multisite study of endoscope drying effectiveness” Cori L. Ofstead, MSPH, Otis L. Heymann, BA, Mariah R. Quick, MPH, John E. Eiland, RN, MS, Harry P. Wetzler, MD, MSPH. American Journal of Infection Control, March, 2018. 2 FDA News Release March 9, 2018   3 https://www.fda.gov/news-events/press-announcements/fda-clears-first-duodenoscope-disposable-elevator-piece-reducing-number-parts-needing-disinfection