The man slated to take over as head of the U.S. Food and Drug Administration has acknowledged the agency never reviewed the efficacy of manufacturers' instructions for cleaning and reprocessing medical endoscopes associated with the spread of drug-resistant bacteria.
The New York Times reported on Wednesday that FDA Chief Scientist Dr. Stephen Ostroff, who will serve as acting agency commissioner at the end of March when Commissioner Dr. Margaret Hamburg steps down, told the paper that the agency has now asked the companies that make duodenoscopes to provide proof their recommended disinfecting procedures are effective at reducing risk of contamination.
“Institutions appear to have been doing the recommended procedures, and doing them extremely well,” Ostroff reportedly said. But the agency has acknowledged even following recommended reprocessing procedures accurately may not be enough to avoid a risk of infection.
Hospital leaders at Ronald Reagan UCLA Medical Center in Los Angeles, where as many as 179 people were exposed to drug-resistant bacteria while undergoing endoscopic procedures, say they fully followed manufacturer-recommended protocols on cleaning and disinfecting duodenoscopes. Despite such measures, they reported between Oct. 3 and Jan. 28 two patients died and as many as seven others were infected with carbapenem-resistant enterobacteriaceae, or CRE, which is resistant to most antibiotics.
In a safety communication issued Feb. 19, the FDA acknowledged the complex design of duodenoscopes could “impede the ability to effectively clean, disinfect and sterilize reusable devices,” even when health providers strictly adhered to manufacturers' instructions.
The FDA has since updated its advisory, saying it was conducting “reviews of reprocessing validation data from each of the three manufacturers marketing duodenoscopes in the United States—FUJIFILM, Olympus and Pentax.”
The agency also noted that it was working with the Centers for Disease Control and Prevention on exploring other measures that can be implemented to reduce the risk of infection.
UCLA began treating duodenoscopes with ethylene gas to further sterilize their devices after Jan. 28 and have had no subsequent cases of infection.
In January 2014, Virginia Mason Medical Center in Seattle started instituting a reprocessing procedure that includes quarantining use duodenoscopes for 48 hours while culture samples are taken and analyzed for signs of bacteria. The step was added after the facility experienced a CRE outbreak of its own involving duodenoscopes that infected 32 patients between November 2012 and Jan. 2014.
“Since we implemented this process, we have not had another patient have an infection transmitted,” Dr. Andrew Ross, section chief for gastroenterology at Virginia Mason said in a recent interview with Modern Healthcare. “With a year's worth of data in our rearview mirror, we're fairly confident we have contained the problem.”
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