Device Makers Will Now Have to Prove Duodenoscopes Can Be Cleaned before Approval, FDA Says

Makers Will Now Have to Prove Duodenoscopes Can Be Cleaned
Makers Will Now Have to Prove Duodenoscopes Can Be Cleaned

Makers Will Now Have to Prove Duodenoscopes Can Be Cleaned
Makers Will Now Have to Prove Duodenoscopes Can Be Cleaned

The U.S. Food and Drug Administration (FDA) will require manufactures to prove that new reusable devices can be sterilized effectively before gaining approval, LA Times reports. The agency is finalizing its draft guidelines for cleaning duodenoscopes and other reusable instruments after being criticized for their slow response to contaminated scopes infecting patients with antibiotic-resistant bacteria. Prior to this, device makers only had to attest that their cleaning instructions were adequate.

Duodenoscopes are used in a procedure called ERCP. The devices are inserted down the throat to diagnose and treat disorders of the digestive tract, such as gallstones, cancers, and bile duct blockages. These tools were linked to two recent superbug outbreaks, one at UCLA’s Ronald Reagan Medical Center and the other at Cedars-Sinai hospital. In both hospitals, a total of 11 patients were infected and 246 more were potentially exposed to carbapenem-resistant Enterobacteriaceae, or CRE, which is highly resistant to antibiotics.

In light of the outbreaks, the FDA has faced criticism for failing to respond to the situation sooner. Critics say the agency should have been quicker to take action over red flags about how hard it is to clean the scopes of superbugs. According to LA Times, the FDA is finalizing draft guidelines for cleaning the scopes, which were first published in 2011. The recent outbreaks “accelerated” the FDA’s work on the guidelines, said the agency’s chief scientist Dr. Stephen Ostroff. Ten House members sent a letter to the FDA inquiring about what the agency knew of prior to the infection and for how long.

Manufacturers will now have to prove that their devices can be cleaned before gaining approval. Additionally, the FDA is recommending that hospitals and medical providers regularly test the scopes for bacterial growth after they have been cleaned. However, the FDA did not recall the scopes. The agency also stated that it did not have the power to require manufacturers to re-design the devices.
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 warned health care providers last month that the design of duodenoscopes can impede effective sterilization, and that harmful bacteria can be spread even if manufacturers’ instructions are followed.

There has also been criticism over the fact that one of the device makers has been able to sell a duodenoscope without agency approval since 2010. Olympus, the largest manufacturer of the devices, has been selling its re-designed TJF-Q180V without approval; 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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