In Light of Superbug Outbreak, FDA Requires Manufacturers to Show Duodenoscopes Can be Sterilized

FDA Requires Makers Show Duodenoscopes Can be Sterilized

FDA Requires Makers Show Duodenoscopes Can be Sterilized

Following a superbug outbreak linked to contaminated duodenoscopes, the U.S. Food and Drug Administration (FDA) is requiring device makers to submit data showing that new usable devices can be cleaned effectively. Up until now, manufacturers did not have to provide any evidence that their cleaning instructions were sufficient, LA Times reports.

Duodenoscopes are long, flexible instruments that are inserted through the throat in order to diagnose and treat disorders of the digestive tract, including gallstones, cancers, and bile duct blockages; they are used in a procedure called ERCP. The two recent outbreaks linked to the tainted scopes took place at UCLA’s Ronald Reagan Medical Center and Cedars-Sinai hospital. A total of 11 patients were infected with carbapenem-resistant Enterobacteriaceae, or CRE at the two hospitals and 246 more were potentially exposed. CRE is a so-called “superbug” because it is highly resistant to antibiotics and can kill up to 50 percent of infected patients.
The FDA has been criticized for failing to respond sooner to red flags about how difficult it is to truly eliminate antibiotic-resistant bacteria from the scopes. Now, the agency is finalizing its draft guidelines for cleaning the instruments along with other reusable medical devices, which were first published in 2011. In addition to requiring that device makers prove that their cleaning methods work prior to approval, the agency is advising that hospitals and medical providers regularly test the scopes for bacterial growth after they have been cleaned. The FDA did not, however, recall the scopes. Additionally, the agency said it did not have the authority to mandate that the devices be re-designed.

Dr. William Maisel, chief scientist at the FDA’s Center for Devices and Radiological Health, said “This guidance is an important step toward further enhancing the safety margin by outlining for manufacturers the steps they should undertake to make their reprocessing instructions effective,”
The FDA received a recent letter from Ten House members inquiring about what the agency knew of prior to the infection and for how long.

Last month, the FDA warned health care providers that duodenoscopes can spread harmful bacteria even if manufacturers’ instructions are followed. The tiny crevices near the tip of the device can still harbor pathogens.

The FDA has also been criticized for allowing one of the device makers to sell a duodenoscope without agency approval. Olympus, the largest manufacturer of the devices, has been selling its re-designed TJF-Q180V since 2010. The company claims it did not realize it needed regulatory approved for the revised product, and has since filed for approval, which is pending.

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