Report Says FDA Fails in Ensuring Safety of Medical Devices

America’s system for ensuring that medical devices are safe failed at every turn when dirty endoscopes began spreading deadly superbugs, according to a Senate investigation released today.

The report, from Senator Patty Murray, a Washington Democrat, blames device manufacturers, hospitals, and the Food and Drug Administration for infections that sickened at least 250 people worldwide since 2012 and that may have contributed to dozens of deaths.

The series of outbreaks went on for years before safety problems with the endoscopes came to light in the media in 2015. The report says the events expose systemic weaknesses in the FDA’s approach to protecting the public from medical technology that may be harmful.

“This investigation clearly demonstrates the inability of FDA’s current device surveillance system to accurately identify the extent of device problems when they occur, which poses an unacceptable risk to patients,” Murray’s office wrote.

Among the findings:

• Safety warnings took too long. It took 17 months from when hospitals in Seattle and Illinois first detected that intestinal scopes known as duodenoscopes spread antibiotic-resistant bacteria in 2013 and when the FDA warned other hospitals and the public about the risk early last year. The devices, which are threaded through a patient’s mouth to diagnose and treat ailments of the pancreatic or biliary ducts, are used in 700,000 procedures a year in the U.S.
• The problem is bigger than we knew.The number of hospitals and patients affected worldwide—at least 25 outbreaks affecting 250 people—is greater than what had previously been made public.
• The FDA didn’t spot a pattern of problems. The agency relies on a “passive” monitoring system of reports from hospitals and companies that catalog a million potential safety problems a year. Although at least 11 hospital outbreaks were tied to the devices by September 2013, “the agency had no way to identify this trend until the issue was directly brought to their attention” by the Centers for Disease Control.Manufacturers kept U.S. hospitals in the dark. Olympus, which makes most of the duodenoscopes used in the U.S., warned customers in Europe that the design of the scopes could make them particularly challenging to clean, but the company “left American doctors and hospitals in the dark,” according to the report.
• When hospitals did find problems, they didn’t report them properly. The report notes that 16 U.S. hospitals found superbug infections linked to duodenoscopes, “but none actually followed all of the required steps to promptly notify manufacturers or, in cases of death, FDA.” They alerted the device makers and regulator late or not at all and sometimes didn’t tell patients affected.

The FDA was aware of problems related to duodenoscopes even before the 2012 cases identified in Murray’s investigation. Bloomberg reported last year that outbreaks in Florida in 2008 and 2009 were tied to the same devices and affected 70 patients, including 15 who died.

On April 22, 2009, a CDC official investigating the Florida outbreaks e-mailed several FDA officials noting that “there is a real chance that these issues might be more widespread,” according to documents obtained by Bloomberg through a public record request. The CDC investigator suggested “some type of educational alert” about the difficulty cleaning the scopes and suggested that the manufacturers should also educate hospitals about the problem.

Murray’s report notes that the FDA’s systems to monitor safety problems with pharmaceuticals are more sophisticated than its oversight of devices. She urged improvements that would allow regulators to understand safety risks more effectively as they emerge. For now, the FDA relies on manufacturers to “to self-monitor and self-report” when they have incentives to keep device problems quiet.

The FDA “is already taking steps to address” some of Murray’s recommendations, spokeswoman Deborah Kotz said in an e- mail. She called reducing the risk of infections from the devices “a top priority for the agency.” The agency recently indicated it will try to alert the public to potential device problems earlier.

Olympus spokesman Mark Miller said the company cooperated with the Senate staff.

“Although we do not agree with all of the report’s conclusions, we are closely reviewing the recommendations” as part of the company’s ongoing safety efforts, he said in a statement.

Diane Rainey, a spokeswoman for Fujifilm, said safety is a top priority and the company is working with patients, hospitals, and regulators “to ensure the long-term sustainable use of duodenoscopes.”Pentax spokeswoman Shannon Coughlin said the company is working “to reduce the risk of infection in flexible endoscopy” and has established an initiative to promote safety and training around how to clean the devices.