After the duodenoscope sterilization issues that plagued manufacturers and patients this year, the FDA is expanding its oversight on medical device disinfection. The regulatory body has ordered that the Pennsylvania-based device manufacturer, Custom Ultrasonics, issue a recall for all of the company’s Automated Endoscope Reprocessors.
According to a report produced by the FDA, the endoscope washers have violated the Federal Food, Drug, and Cosmetic Act. A safety alert issued by the agency advised healthcare facilities “to use alternative methods to reprocess flexible endoscopes as soon as possible.”
Insiders are saying this latest recall is not a standard voluntary recall; Custom Ultrasonics were given seven days from the date of issue – November 13 – to draft and submit a written recall to the FDA. According to the notice issued by the FDA, the most recent FDA inspection of the Custom Ultrasonics facility earlier this year noted continued violations originally identified by the agency in 2007.
“As part of the FDA’s ongoing investigation into infections associated with reprocessed medical devices and AER devices used for cleaning and disinfection, the FDA has been reviewing the validation test methods and performance data for all AER manufacturers,” said the notice. “To date, Custom Ultrasonics has not demonstrated that its AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection.”
The Automated Endoscope Preprocessors in question are washers used in healthcare facilities to disinfect endoscopes and other related parts, in preparation for future procedures using the medical device. The washers manufactured by Custom Ultrasonics are designed to clean scopes that are inserted into both the gastrointestinal and pulmonary tracts.
Custom Ultrasonics has responded to the FDA’s mandatory recall by posting a statement on the company’s website saying it, “has been performing testing at independent laboratories since July 2015 and will continue to perform the required testing until it is completed. Custom Ultrasonics will continue to submit data to the FDA as we receive it. Custom Ultrasonics continues to comply with any requests that we receive from the FDA and look forward to a positive resolution to this issue.”
According to the company, they “[have] no safety concerns regarding the safety and efficacy of the System 83 Plus Washer/Disinfector.” The action taken by the FDA however, raises questions about the sterilization techniques used to disinfect all types of endoscopes commonly used in exploratory procedures.
Earlier this year, the FDA faced criticism that they were slow to act on the issue of endoscope safety following hospitalization of patients infected with carbapenem-resistant Enterobacteriaceae (CRE), following procedures involving the scopes. Since 2010, there have been 142 reported cases of infections resulting from use of contaminated duodenoscopes.
- FDA orders recall of Custom Ultrasonics’ endoscope washer amid growing concerns over device sterilization – http://www.fiercemedicaldevices.com/story/fda-orders-recall-custom-ultrasonics-endoscope-washer-amid-growing-concerns/2015-11-16