U.S. Sen. Patty Murray has called on the federal Food and Drug Administration to finalize guidelines and step up tracking after a deadly superbug outbreak tied to contaminated medical devices at Virginia Mason.
In the wake of a deadly superbug outbreak tied to contaminated medical scopes at Virginia Mason Medical Center, U.S. Sen. Patty Murray is calling on the federal Food and Drug Administration (FDA) to take stronger action to make sure the specialized devices are properly cleaned.
Murray, D-Wash., sent a letter Tuesday to FDA Commissioner Margaret Hamburg urging the agency to finalize draft guidelines to provide health workers with updated best practices for sanitizing the duodenoscopes often used to treat pancreatic cancer and other gut problems.
She also asked the agency to step up tracking of infections and other problems potentially related to the devices, particularly after an outbreak that left 32 people with multidrug-resistant superbug infections at Virginia Mason between 2012 and 2014.
Eleven of those patients died, though hospital officials said it’s not clear the infections were the cause. None of the patients nor their families was notified that they were part of an outbreak, hospital and health officials said.
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“Due to their complicated and intricate design, duodenoscopes are harder to clean and to disinfect than many reusable medical devices,” Murray’s letter stated.
She noted that investigations by the state Department of Health and the Centers for Disease Control and Prevention (CDC), found the devices routinely harbored dangerous bacteria, even after they had been cleaned according to the manufacturer’s directions. In some cases, recommended cleaning procedures didn’t get rid of the debris and soil, forcing medical staff members to take more aggressive action.
“These findings indicate that even when providers carefully follow manufacturers’ labeling regarding cleaning and disinfections of duodenoscopes, contamination still poses grave risks to patients,” Murray added.
Leslie Wooldridge, an FDA spokeswoman, said the agency would respond to Murray directly. “The FDA has been actively working with federal partners, manufacturers and other stakeholders to better understand the issues that contribute to infections and what can be done to mitigate them,” she said in an email.
Investigations by the CDC, hospital officials and officials with Public Health — Seattle & King County found evidence of infections with CRE, or carbapenem-resistant E. coli bacteria, plus another type of multidrug-resistant bacteria known as Hyper-AmpC, or HAC, transmitted by the devices. The patients had undergone a procedure known as endoscopic retrograde cholangiopancreatography, or ERCP, which examines and treats diseases of the bile or pancreatic ducts. A long, flexible tube is inserted down a patient’s throat and into the gut to allow treatment.
Those infections echo outbreaks of virulent forms of CRE transmitted on dirty scopes documented in Chicago and Pittsburgh, among other sites, in recent years. CDC officials have dubbed CRE a “nightmare bacteria” with a mortality rate as high as 50 percent.
Dr. Andrew Ross, Virginia Mason’s section chief for gastroenterology, said he welcomed Murray’s action.
“We’re very happy to see that Sen. Murray is taking this up on the national level,” he said. “One of the things we really hope to do by disclosing and discussing our experience here has been to elevate this issue to a national level.”
Hospital officials would like manufacturers to change the design of the scopes to make them easier to sterilize, he added.
Infections were documented between November 2012 and March 2014, the investigation found. But it wasn’t until November 2013 that hospital officials confirmed an outbreak of the bacteria. The outbreak was reported in an abstract submitted to an infectious-disease society conference in October 2014.
Virginia Mason officials have overhauled their cleaning protocol for the devices, even though no breach of infection-control practices was detected. Since spring, the hospital has taken steps to culture and quarantine all duodenoscopes used in some 1,800 procedures performed there each year. Each device is tested and held for 48 hours to make sure it’s free of CRE and other dangerous bugs.
Since the new procedures were implemented, no infections have been detected, Ross said.
Swedish Medical Center, which performs about 1,000 of the procedures each year, has detected no cases of CRE infection associated with the scopes, said Dr. John H. Vassall, chief medical officer. The hospital uses high-level disinfection practices recommended by the CDC, the FDA and the manufacturer of the scopes, he added, and has not changed practices in response to the Virginia Mason outbreak.
Harborview Medical Center, which performs 200 of the procedures each year, has detected no cases of bacterial infection linked to the scopes, said spokeswoman Susan Gregg. The hospital has a robust program for cleaning the devices but has implemented additional steps to screen the endoscopes for contamination, she added.
Lawrence Muscarella, a patient-safety expert who has advocated for better tracking and disclosure of CRE infections tied to endoscopes, praised Murray’s effort.
“Fast action is warranted at this time to prevent further instances of patient morbidity and mortality linked to GI endoscopes contaminated with CRE,” he said.
Muscarella urged patients undergoing ERCP to ask their doctors whether the hospital performing the procedures has seen an outbreak of CRE. He also urged families who think they may have been harmed to seek medical records with evidence of multidrug-resistant infections and to hold hospitals accountable for the infections.