At least 250 people, mostly in the U.S., have contracted potentially deadly infections spread by contaminated medical scopes in the past three years, according to a new report commissioned by Sen. Patty Murray.
The toll of potentially deadly infections tied to contaminated medical scopes — like those that sickened dozens at Seattle’s Virginia Mason Medical Center — is far higher than federal investigators previously estimated, according to a U.S. Senate committee report being released early Wednesday.
In less than three years, between 2012 and spring 2015, at least 25 incidents of antibiotic-resistant infections linked to specialized duodenoscopes sickened at least 250 people worldwide, most at U.S. hospitals.
That’s nearly double the 142 infections identified since 2010 by the federal Food and Drug Administration (FDA).
Read the report:
The new figures include the outbreak at Virginia Mason, where at least 39 people were sickened and 18 died between 2012 and 2014 after being infected with multidrug-resistant infections spread by scopes that could not be properly cleaned, even after following manufacturers’ directions.
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The numbers are the biggest surprise to follow a seven-month investigation launched by Sen. Patty Murray, D-Wash., who demanded in June that three medical-device makers tied to reports of “superbug” infections hand over internal documents about the problem.
And because most hospitals don’t look for the infections, the counts are probably low, according to the report from the Senate Health, Education, Labor and Pensions (HELP) committee.
“Patients should be able to trust that the devices they need for treatment are safe and effective,” Murray said 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.”
The report underscores previously recognized lapses that allowed the continued spread of infections, months or years after hospitals, the leading device manufacturer and federal regulators knew of the problem.
U.S. hospitals, including Virginia Mason, were slow to sound the alarm, the report notes. Although the hospital conducted what the HELP Committee described as an “exemplary” public-health investigation into the source of the infections, officials failed to notify authorities quickly enough.
“By December 2013, Virginia Mason knew that duodenoscopes were contaminated and spreading antibiotic-resistant infections between patients but did not alert the manufacturer to the issue until July 2014,” the report finds.
The hospital filed a required report with the FDA in May 2014 — five months after linking the patient infections to the tainted scopes.
Gale Robinette, a Virginia Mason spokesman, said Tuesday hospital officials were eager to read the report. “We will evaluate any guidance the report offers as an opportunity to further improve our processes. Patient safety and quality care are the highest priorities at Virginia Mason,” he said in an email.
The report confirms that Olympus, the manufacturer controlling 85 percent of the specialty endoscope market in the U.S., knew as early as 2012 that the scopes could harbor dangerous bacteria. The company didn’t warn U.S. hospitals for three years.
Mark Miller, an Olympus spokesman, said in a statement Wednesday that the firm cooperated fully with Murray’s office in compiling the report and recognized the need for regulators, hospitals and manufacturers to work together to address infection risk.
“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,” Miller said.
Murray sought records from Olympus, Pentax Medical and Fujifilm Medical Systems to understand ongoing concerns about the scopes used in about 700,000 procedures a year in the U.S., often to avoid invasive surgery.
On Wednesday, a Pentax spokeswoman said the firm appreciated Murray’s attention to patient safety.
“Pentax Medical has established a Patient First initiative with the goal of promoting safe and effective ERCP procedures through commitment to training and education around device reprocessing,” spokeswoman Shannon Coughlin said in a statement.
The devices are snaked down the throat and into the gut, where they’re used to diagnose and treat problems, including cancers and blockages in bile and pancreatic ducts. Tests by Virginia Mason and others found the closed channel at the end of the scopes retains bacteria, even after rigorous cleaning, and can spread germs among patients.
The report urges Congress to adopt unique device identifiers to better track device performance through insurance claims, and funding for a National Medical Device Evaluation System to ensure the FDA can better monitor device safety.
It calls on the FDA to quickly evaluate scope design and implement a recall to fix or modify the tools. It urges the agency to clarify rules about modifying the devices or denying changes. It also calls for quicker notification to health-care providers when patient safety appears to be endangered, a move the FDA announced last week.
Finally, Murray seeks to force hospitals to report problems more quickly by tying adverse-event reporting to Medicare participation.
An FDA spokeswoman, Deborah Kotz, said the agency appreciated the report and already had taken steps to address the scope-related infections, including some actions Murray recommended.
“We agree with the Senator that a broader approach to understanding how well duodenoscope devices work in real-time is critical to public health,” Kotz wrote in an email. “Mitigating the risks of bacterial infection associated with duodenoscopes is a top priority for the agency.”
The investigation was cheered by Lawrence Muscarella, a Pennsylvania hospital-safety consultant and advocate for uncovering scope infections, and by Theresa Bigler, of Woodway, whose husband, Richard Bigler, died in 2013 after an infection at Virginia Mason.
“I am very appreciative of the efforts Sen. Murray has made to find out the truth behind these life-threatening infections caused by these scopes and to improve the process so that what happened to my husband doesn’t happen to other families,” Bigler said.