In all recent cases of antibiotic-resistant bacteria infections tied to duodenoscopes, the hospitals used an automated endoscope reprocessor to disinfect the scopes, an investigation by USA TODAY found.
In the recent outbreaks of CRE infections, hospitals claim that their staff followed manufacturer instructions to a T, but infections still occurred. While the Food and Drug Administration has focused its investigation on scope design and instructions from scope manufacturers, it has recently widened its investigation to include AER manufacturers as well, according to the USA TODAY.
To be cleared for use by the FDA, AER makers need to validate their product on a representative sample of scopes currently on the market, not on every single scope design type.
Chris Lavanchy, engineering director with the ECRI Institute, questioned if generalized testing is "sufficient" for complex devices like duodenoscopes.
However, one AER manufacturer told USA TODAY that its product will work on the complex scopes. "Our validations with these particular [scopes] look very strong," Craig Smith, senior vice president of regulatory affairs and quality assurance at Medivators, an AER manufacturer, told the paper. "If you follow the instructions and do all the necessary pre-cleaning and put a scope in a Medivators AER, it's going to achieve high-level disinfection."
While the FDA has requested updated data from AER makers, the agency recommended that hospitals closely follow scope manufacturer's instructions, as "strict adherence to manufacturer's reprocessing instructions will minimize the risk of infection." Other industry organizations and experts urged hospitals to begin culturing their duodenoscopes for bacteria prior to releasing the instrument back into the pool for use on patients.