A new Senate report faults the Food and Drug Administration’s oversight of medical devices, saying agency was slow to respond effectively to a recent “superbug” outbreak linked to a device.
When the FDA began investigating the spread of the infection in September 2013, the report says, the agency took no action to alert hospitals and the public about the danger from the devices for 17 months. At least 68 more patients were infected during that time, according to the report.
The report also faults the FDA’s larger system for ensuring medical device safety. It says the agency largely relies “almost exclusively on the self-reporting and self-regulation of manufacturers and hospitals.”
Murray recommends an oversight system more similar to the one used for drugs, which relies on electronic health records and insurance claims to look for problems with a drug.
“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 investigation comes at a time when the HELP Committee is working on a medical innovation bill that is meant to speed up the FDA’s approval of drugs and devices. The House version of the bill, 21st Century Cures, was criticized by some consumer groups and experts for putting patients at risk, though backers said they made sure to maintain high safety standards.
“We appreciate the report from Senator Murray and will carefully consider its recommendations, many of which FDA is already taking steps to address,” FDA spokeswoman Deborah Kotz said in response to the report. “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 report also faults 16 separate U.S. hospitals for failing to raise alarms about the infections with federal regulators.
In addition, the report says, Olympus, the manufacturer of many of the devices in question, knew of lab reports saying the devices could spread bacteria even after cleaning, but did not alert hospitals or the FDA.
Olympus said in a statement that it cooperated with the investigation. “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,” spokesman Mark Miller said.