FDA Issues New Rules for Reusable Devices After Superbug Outbreak

FDA on Thursday released final guidance that will require reusable medical device makers to provide proof that their devices can reliably be cleaned before being approved by the agency, the Los Angeles Times reports.

Background

The final guidance comes after a superbug outbreak linked to a reusable medical device (Terhune/Petersen, Los Angeles Times, 3/12).

As many as 179 patients could have been exposed to Carbapenem-Resistant Enterobacteriaceae after having an endoscopic retrograde cholangiopancreatography at the UC-Los Angeles' Ronald Reagan Medical Center between October 2014 and January 2015. So far, seven patients have been confirmed to have CRE infections, and two of those patients died.

Meanwhile, Cedars-Sinai Medical Center in Los Angeles this month reported that four patients had been infected with CRE and up to 67 more might have been exposed after being treated with the same type of scope. FDA has received at least 75 reports, involving at least 135 patients, about ERCP endoscopes -- also called duodenoscopes -- over the last two years (California Healthline, 3/6).

FDA released draft guidelines for reusable medical device makers in 2011. FDA Chief Scientist Stephen Ostroff said that the agency had "accelerated" its work on finalizing the rules in response to the recent outbreaks.

Guidance Details

Under the new guidance, device makers will have to submit pre-approval data to FDA demonstrating that their devices can be effectively disinfected (Los Angeles Times, 3/12). The agency's previous guidelines, issued in 1996, did not include such a requirement (Perrone, AP/U-T San Diego, 3/12).

Specifically, device makers will need to thoroughly contaminate their devices and then demonstrate that the devices can be sterilized or disinfected by following their own cleaning instructions (Tavernise, New York Times, 3/12).

In addition, FDA stated that device makers will be expected to submit testing data that indicate their instructions on reprocessing their devices effectively help reduce bacterial contamination (Ross Johnson, Modern Healthcare, 3/12).

According to the New York Times, the requirements only apply to new devices. FDA officials said they only had the authority to recommend that makers of products currently on the market carry out more rigorous tests of existing devices (New York Times, 3/12).

FDA: Recalling Duodenoscopes Would Not Be Beneficial

Meanwhile, FDA officials reiterated the agency's position that duodenoscopes serve an important purpose in treating patients and should not be recalled, according to the Los Angeles Times (Los Angeles Times, 3/12).

FDA in an updated safety alert released earlier this month said that providers who use endoscopes -- including Olympus Corporation's ERCP endoscope, which has been linked to the UCLA outbreak -- should not cancel ERCP procedures. The agency said it "believe[s] that that removal of the device from the market could lead to an insufficient number of available duodenoscopes to meet the clinical demand in the U.S. of approximately 500,000 procedures per year" (California Healthline, 3/6).

Ostroff on Thursday said that using duodenoscopes "is by far the lowest-risk way to diagnose and treat these very serious medical problems," such as addressing blockages in patients' digestive tracts or combatting cancers (Los Angeles Times, 3/12).

Meanwhile, William Maisel, chief scientist at FDA's Center for Devices and Radiological Health, said, "Despite the recent concerns about multidrug-resistant bacteria infections associated with duodenoscopes, patients and health care providers should know that the risk of acquiring an infection from a reprocessed medical device is low" (Modern Healthcare, 3/12).

Reaction

Sen. Patty Murray (D-Wash.) said that she hoped the new guidance would help prevent the spread of superbug bacteria (Wheeler, The Hill, 3/12). However, she added, "I continue to be concerned about why these infections occurred in the first place and whether there is more we can do to prevent them from happening again" (Los Angeles Times, 3/12).

Meanwhile, Rep. Ted Lieu (D-Calif.) on Thursday said that the final guidance was "an important first step" but that "further steps are needed." Lieu said he would "continue to push for mandatory reporting requirements, better resources for hospitals and a new medical device which lessens the risk of infection" (AP/U-T San Diego, 3/12).

CDC Releases Guidance for Providers

In related news, CDC on Thursday unveiled an interim protocol for providers on how to test duodenoscopes for contamination after they have been cleaned and disinfected to better ensure their safety.

FDA Schedules Stakeholder Meeting

In other related news, FDA on Thursday also announced plans to hold a two-day meeting to further evaluate the risk of infection posed by duodenoscopes and discuss potential solutions (Los Angeles Times, 3/12). The public meeting will be held May 14 and May 15 by one of FDA's advisory committees (Modern Healthcare, 3/12).