Seattle, WAA new study suggests endoscope disinfection remains difficult for hospitals, meaning even with rigorous cleaning some endoscopes are still not fully clean. The study, conducted at a variety of hospitals and medical centers, highlights the difficulty of ensuring the medical devices are bacteria free. In 2015, the FDA issued a warning about the improper cleaning of endoscopes, while lawsuits have been filed against the makers of some of the medical devices.
A study published in the journal Gastrointestinal Endoscopy (4/16) examined medical scopes at 21 Providence Health and Services hospitals across four states to determine how clean the devices were after following manufacturer’s directions for cleaning. Unclean medical scopes have been linked to life-threatening and fatal medical events across the United States in recent years, prompting the US Food and Drug Administration (FDA) to issue a warning about the devices.
“Recent high profile MDRO (multidrug-resistant organisms) outbreaks associated with DLE have presented endoscopists with an inconvenient truth: despite strict adherence to published guidelines bacteria may on occasion survive within our instruments,” researchers wrote.
To complete the study, staff at participating medical centers cleaned duodenoscopes and linear echoendoscopes according to manufacturers’ guidelines and then cultured the devices to see if they still contained bacteria. No humans were exposed to the devices under examination.
Researchers found that around five percent of the devices showed some form of microbial contamination, despite following manufacturer’s cleaning guidelines. The good news is that most of the organisms found on the devices were of low-concern, and there were no multidrug-resistant organisms found. But approximately 0.6 percent of the microbial contaminants were bacteria that can cause health problems in humans. Further, those patients who undergo procedures using the scopes do so believing they are not at risk of potentially serious health problems linked to contaminants on the scopes used.
Despite that, outbreaks and deaths have been linked to improperly disinfected scopes, although how closely they are linked is still under question. Between 2012 and 2015, 18 patients died and another 20 suffered health problems linked to scopes, although whether the deaths were directly linked to the infections is not known.
Lawsuits have been filed against the makers of some of the medical scopes, alleging patients were put at risk of serious, potentially fatal health problems as a result of endoscopes that could not be properly cleaned as directed.
First Published Heidi Turner on www.LawyersandSettlements.com