Infections From Duodenoscopes Higher Than Previously Estimated

The number of potentially deadly infections linked to contaminated duodenoscopes in California and other states is greater than federal investigators had previously estimated, according to a report released Wednesday by the Senate Health, Education, Labor and Pensions Committee, the Seattle Times/Los Angeles Times reports (Aleccia, Seattle Times/Los Angeles Times, 1/12).

Background

More than 150 patients could have been exposed to Carbapenem-Resistant Enterobacteriaceae after undergoing a procedure with a duodenoscope -- also called an endoscopic retrograde cholangiopancreatography -- at UCLA's Ronald Reagan Medical Center between October 2014 and January 2015. Seven patients were confirmed to have CRE infections, and two of those patients died.

Meanwhile, Cedars-Sinai Medical Center in Los Angeles in March 2015 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 (California Healthline, 5/8/15).

Details of Investigation

Senate HELP Committee Ranking Member Patty Murray (D-Wash.) launched the panel's investigation seven months ago. For the investigation, Murray called on three manufacturers of duodenoscopes connected to superbug infections to share internal documents about the issue:

• Fujifilm Medical Systems;
• Olympus; and
• Pentax Medical.

The investigation found that there were at least 25 incidents of antibiotic-resistant infections linked to specialized duodenoscopes from 2012 to spring of 2015, which sickened at least 250 individuals worldwide. Most of the cases occurred at U.S. hospitals, according to the report (Seattle Times/Los Angeles Times, 1/12).

Those numbers contrast with what FDA found. The agency in May 2015 said it had received 142 adverse event reports between 2010 and Feb. 17, 2015, on patient harm from duodenoscopes (California Healthline, 5/8/15).

Further, the Senate report noted that its tally likely underestimates the number of infection incidents tied to the scopes because most hospitals do not monitor patients for the infections.

In addition, the report noted that hospitals did not notify federal officials of the infections promptly enough. The report emphasized that previously recognized reporting lapses that allowed infections to continue to spread for months or years after federal regulators, hospitals and the device manufacturers were made aware of the incidents.  

The report also confirmed that Olympus, which controls 85% of the U.S. specialty endoscope market, was aware as early as 2012 that its duodenoscopes could harbor dangerous bacteria if not adequately cleaned. The company did not alert U.S. hospitals of the issue for three years.

Report Recommendations

The report recommended that:

• Congress adopt unique device identifiers to improve tracking of device performance through health insurance claims;
• FDA clarify rules about modifying devices or denying changes;
• FDA quickly evaluate scope designs and implement a recall to fix or modify the tools;
• Funding for a National Medical Device Evaluation System be allocated to boost FDA monitoring of device safety; and
• Health care providers be notified faster of instances when patient safety appears to be endangered.

In addition, Murray is working to tie adverse event reporting to Medicare participation in an effort to prompt hospitals to report issues more quickly (Seattle Times/Los Angeles Times, 1/12).