Superbug outbreak spreads, but FDA won't take device off the market

Patients sickened by CRE exposure at Cedars-Sinai; some duodenoscopes sold without FDA approval
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The controversy surrounding medical devices blamed for spreading drug-resistant superbug Carbapenem-resistant Enterobacteriaceae (CRE) shows no sign of slowing down, as the outbreak now has spread to two more hospitals amid news that some of the devices were sold without federal approval.

The recent rash of CRE outbreaks, which began as early as 2012 in Pittsburgh, Seattle and Chicago hospitals, gained national attention in recent weeks when contaminated duodenoscopes were linked to two patient deaths in UCLA's Ronald Reagan Medical Center. CRE-contaminated scopes also sickened at least four patients at Cedars-Sinai Medical Center in California, and 67 others may have been exposed, the Los Angeles Times reported Wednesday. In response, the hospital took the tainted device out of service and adopted additional safety measures, according to the newspaper.

Hartford HealthCare in Connecticut also reports an uptick in cases of a different type of superbug--a drug resistant version of E. coli known as extended spectrum Beta-lactamase E. coli--associated with its duodenoscopes, according to NBC News. Though the hospital does not believe any patients were harmed by exposure to the bug, it is reaching out to all those who may have been affected, an official told NBC.

Following the UCLA outbreak, the Food and Drug Administration (FDA) issued a warning that the design of duodenoscopes, which are used for endoscopic retrograde cholangiopancreatograph (ERCP) procedures, makes them difficult to sterilize, even if the manufacturers' own protocols are followed, FierceHealthcare reported. The agency issued an additional statement Wednesday that indicated it will not take duodenoscopes off the market because it "could lead to an insufficient number of available duodenoscopes to meet the clinical demand in the United States of approximately 500,000 procedures per year."

Karen Riley, deputy director of strategy for the FDA's Office of External Affairs, told CNN Wednesday that Olympus, one of the companies that makes duodenoscopes, started selling a redesigned version of the device in 2010, but the FDA didn't notice until late 2013 or early 2014 that the company had never asked for clearance to put it on the market. The FDA ackowledged in its statement that Olympus' new application for the redesigned device was under review, and that it will not take action against the company during the review.

Riley said she doesn't know why the FDA didn't notice the change in the device's design, which concerned the part of the duodenoscopes linked to CRE contamination, according to CNN. Another FDA official also recently said that the cleaning protocol tests of Olympus and fellow manufacturers Fujifilm Holdings Corp and Pentax were flawed.

The FDA has received criticism for what some believe is a slow regulatory response to the contamination risk associated with duodenoscopes, FierceHealthcare has reported.

One of those critics is Lisa McGiffert, director of the Safe Patient Project at Consumers Union, who told the L.A. Times that the agency's current efforts to make the devices safer aren't good enough.

"It's just a little late--especially for those who got infections and maybe died as a consequence," she said.

To learn more:
- here's the FDA statement
- read the L.A. Times article
- here's the NBC News report
- check out the CNN article

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