A Senate committee is suggesting Congress require tweaks to health insurance claims as a way to improve tracking and monitoring of device safety and efficacy after a damning report found that the number of deadly infections associated with the use of contaminated medical scopes far exceeds previous estimates. The committee Wednesday said it found nearly twice as many cases as previously reported by regulators.
As many as 250 patients who had acquired antibiotic-resistant infections in 25 separate incidents between 2012 and 2015 were linked to the same type of contaminated duodenoscopes, according to a minority staff report (PDF) from the Senate Health, Labor, Education and Pensions Committee.
“Patients should be able to trust that the devices they need for treatment are safe and effective,” said Sen. Patty Murray (D-Wash.), the ranking Democratic member of the HELP Committee in a statement. “Unfortunately this investigation makes clear that current policies for monitoring medical device safety put patients at risk, and in this case, allowed tragedies to occur that could have, and should have, been prevented.”
Duodenoscopes were identified as causing outbreaks of carbapenem-resistant enterobacteriaceae, or CRE, that occurred at Ronald Reagan Medical Center at UCLA Health and Cedars-Sinai Medical Center, both in Los Angeles, between August 2014 and January 2015. The same devices were linked to a CRE outbreak at Virginia Mason Medical Center that infected 32 patients between November 2012 and January 2014.
The report culminates a yearlong investigation initiated by Murray in January 2015 to examine the cause of the outbreaks at Virginia Mason and other hospitals across the country.
A review (PDF) conducted by a U.S. Food and Drug Administration advisory committee identified 146 reports of infections from duodenoscopes dating back to 1997, with 142 of those incidents having occurred since 2010.
The report criticized the FDA's response to initial reports that there was a possible link between outbreaks of multidrug-resistant infections and contamination of the scopes even after product maker's cleaning and disinfecting instructions were correctly followed.
Particularly damning were assertions that regulators waited months after beginning their investigation on duodenoscopes in September 2013 before taking action to alert the public of a possible risk associated with their use. In February, the FDA issued its first safety communication warning providers that the complex design of the endoscopes “may impede effective reprocessing.”
Other problems included the agency's adverse-event reporting system, which the report described as being too slow to identify incidents related to the scopes and warned future issues would occur without improvements to regulators' post-marketing surveillance capabilities.
The report found 16 hospitals linked to infections caused by duodenoscopes that failed to notify regulators of the incidents; none of the providers that experienced scope-related infection outbreaks submitted adverse event reports to device manufacturers as required. Hospitals that did report problems with devices often had information that arrived late and was incomplete.
Device manufacturers Olympus Corp., Pentax and Fujifilm were cited by the report for failing to adequately test cleaning procedures. Also cited was Custom Ultrasonics, the maker of the automated cleaning machines used by many hospitals where infections occurred.
The report claims that by early 2013, Olympus, which makes 85% of duodenoscopes used in the U.S., knew of lab reports that found the devices were at risk of becoming contaminated even after cleaning instructions were followed. But the company failed to share the information with regulators or warn hospitals until February 2015, according to the report.
Olympus spokesman Mark Miller said the company was “closely reviewing the recommendations detailed in an ongoing effort to increase patient safety."
He added that Olympus has been cooperating with the Senate committee staff for months, providing documents and conducting a duodenoscope demonstration and briefing for the staff.
"We appreciate that the staff report noted Olympus' cooperation and that the report demonstrates the shared responsibilities of duodenoscope manufacturers, hospitals, manufacturers of automated endoscope reprocessors and the FDA, each of which can contribute to increasing patient safety," Miller said, "Although we do not agree with all of the report's conclusions, we are closely reviewing the recommendations in the report as part of Olympus' ongoing efforts to increase patient safety associated with use of Olympus duodenoscopes.”
One of the committee staff's key recommendations called for Congress to require health insurance claims to include the FDA's unique device identifier codes to improve tracking and monitoring of device safety and efficacy.
The UDI system was established under a provision of the 2012 Food and Drug Administration Safety and Innovation Act. The agency issued a final rule in 2013 requiring manufacturers to include a unique device identifier on device labels and packages.
Some critics say incorporating UDI into medical claims would create administrative burdens and IT challenges for hospitals that could dampen providers' willingness to participate.
Dr. Josh Rising, director of healthcare programs for the Pew Charitable Trusts, said any real improvements to post-market surveillance must include UDIs on medical claims.
“We really need a comprehensive system to assess performance of medical devices," Rising said, adding that information can then help improve product safety and drive innovation.
“You need to have better data on devices than we do now, and one of the key places that are missing information that needs it is the claims forms,” he said.
The FDA sent a statement saying it will consider the report's recommendations, and the agency is already taking steps to address some of those suggestions.
“We agree with the senator that a broader approach to understanding how well duodenoscope devices work in real-time use is critical to public health," the statement said, referring to Sen. Murray. "Mitigating the risks of bacterial infection associated with duodenoscopes is a top priority for the FDA. The agency has taken several actions to address the issue of duodeoscope-related infections and will continue to work to protect patients, while ensuring access to these important devices for those who may benefit from minimally invasive procedures."
Duodenoscopes are used in more than 500,000 endoscopic retrograde cholangiopancreatography procedures, or ERCPs, annually in the U.S., and provide minimally invasive ways to drain fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones or other conditions.
The FDA has maintained the benefits of ERCP outweigh the potential risk of contamination from the endoscopes.