Citing recent reports of infection control lapses, the FDA and Centers for Disease Control and Prevention are advising healthcare facilities to ensure they are complying with device manufacturers’ instructions for reprocessing reusable devices.
In a health advisory, the agencies recommend that healthcare facilities work with an expert to ensure correct device reprocessing procedures. Facilities also should train all personnel involved in reprocessing at the time they are hired or before they provide services at the facility. Personnel must show competency before performing procedures independently.
Further, employees should receive updated training at least once a year and when new devices or protocols are introduced.
The agencies also advise facilities to monitor and document adherence to cleaning, disinfection, sterilization and device storage procedures. Protocols should ensure employees can easily identify devices that have been properly reprocessed and are ready for patient use.
Earlier this year, the FDA said that between January 2013 and December 2014, it received reports involving about 135 patients infected with carbapenem-resistant Enterobacteriaceae after they were examined with a complex type of endoscope known as a duodenoscope. Antibiotic-resistant infections were reported in Chicago, Pittsburgh, Seattle and Los Angeles.
The FDA has sought to ensure adequate reprocessing, issuing final guidance strengthening controls on reprocessing in March (). It also provided new guidelines to help healthcare facilities in cleaning their duodenoscopes ().