New Senate Report Critical of Device Makers Hospitals and FDA in Superbug OutbreaksJan 15, 2016
An investigative report released on January 13, 2016 by Senator Patty Murray criticizes medical device makers, hospitals and the Food and Drug Administration (FDA) for their roles in superbug outbreaks linked to inadequately cleaned medical devices.
Sen. Murray, of Washington, launched the investigation of duodenoscopes after a cluster of infections in Seattle, the New York Times reports. Duodenoscopes, which can be difficult to clean and sterilize between uses, were linked to at least 250 cases of antibiotic-resistant infections worldwide from 2012 to early 2015. A number of deaths appear linked to the infections.
Manufacturers are required to report to the FDA within 30 days of learning that a device might have contributed to a death or serious injury, according to the Times. But from January 2013 through December 2014, the FDA received just 75 reports relating to possible infection from duodenoscopes, involving roughly 135 American patients. By early 2013, according to the report, Olympus already knew of two investigations in the Netherlands that found Olympus duodenoscopes scopes could transmit bacteria even after thorough cleaning. The company did not inform American hospitals or the FDA until February 2015.
The duodenoscope, a long, flexible tube with a camera at the tip, is used to examine the intestinal tract to diagnose and treat conditions including gallstones. The report says that at least a dozen hospitals around the country had traced antibiotic-resistant infections to duodenoscopes, but that "hospitals generally did not raise alarms about these infections with federal regulators," according to the Times.
More than 500,000 duodenoscope procedures are performed annually. For most patients, the FDA says, the benefits of the procedure outweigh the infection risk because the procedure often treats conditions that can lead to serious health consequences if not treated. But the FDA advises that any patient who experiences fever or chills, chest pain, severe abdominal pain, trouble swallowing or breathing, nausea and vomiting, or black or tarry stools after a duodenoscope procedure should seek medical attention.
Sen. Murray said the manufacturers' response to the infection risk was inadequate. "It is their responsibility when the device that they have manufactured has safety defects to notify the patients, the doctors, the hospitals," the Times reports. The report found that scope makers Olympus, Pentax Medical, and Fujifilm and Custom Ultrasonics, the maker of automated cleaning machines for duodenoscopes, failed to meet regulatory reporting obligations, according to Law360.
The report contains a variety of recommended remedies, including quick action by the to evaluate duodenoscope design and implement a recall to modify the devices, if necessary. The report also called for legislation to require "unique device identifiers" for insurance claims to make it easier to link devices to patient outcomes, the Times reports. The report urged Congress to fund a national medical device evaluation system, so the FDA can "effectively monitor the safety of medical devices on the market rather than relying on adverse event reporting."