The Food and Drug Administration is being accused of not reviewing the procedures of cleaning duodenoscopes and is now asking the manufactures for evidence of disinfecting the instruments.
According to The New York Times, the FDA never reviewed the information about the cleaning methods from the manufacturers and now wants evidence of that process.
“Institutions appear to have been doing the recommended procedures, and doing them extremely well,” said Dr. Stephen Ostroff, the agency’s chief scientist.
He added that because of the recent outbreaks though, more steps and precautions may need to be exercised.
As previously reported, deaths that occurred in both California’s UCLA and Charlotte’s Carolinas HealthCare hospitals have been linked to an infection patients got after undergoing endoscopic procedures. Officials said that the devices may not have been sterilized properly leading to carbapenem-resistant Enterobacteriaceae, or CRE.
Many more patients that could have also been infected have since been notified by their healthcare facilities. Also, The Times noted that since UCLA announced the outbreak, the hospital has begun sterilizing the devices with a gas called ethylene oxide. So far, after implanting this method, there have not been any new cases of CRE.