FDA Finds Link Between Manufacturing Problems in Medical Equipment and Superbug Outbreaks at Hospitals
The Food and Drug Administration (FDA) has sent warning letters to medical manufacturers after finding a link between last year’s superbug outbreaks at some major hospitals, and problems in the design or manufacturing process of the medical devices.
Duodenoscopes have been linked to outbreaks, especially in 2014, of carbapenem-resistant Enterobacteriaceae, or CRE. Initially, safety regulators pointed fingers at hospitals for failing to properly clean the scopes, which examine patients’ digestive tracts. However, the hospitals noted that they followed all necessary and required cleaning procedures for the devices, along with all other medical equipment at the hospital. They suggested that something was amiss in the design of several of the duodenoscopes on the market, making them difficult to clean after procedures.
Superbug outbreaks of Escherichia coli (E. coli) and CRE have injured and even killed patients at Ronald Reagan UCLA Medical Center in Los Angeles, Cedar-Sinai Medical Center (also in Los Angeles), and a hospital in Connecticut, in the last year alone.
The FDA found several complaints in its investigation of several major manufacturers regarding infections contracted from the duodenoscopes that date back at least three years. In fact, Olympus Corp, which makes one of the problematic models of duodenoscope, was found to know about at least 16 patient infections involving its medical product, but failed to notify federal regulators for three years.
“The fact that it took the leading scope manufacturer three years to report patient infections is flat out unacceptable,” Rep. Ted Lieu (D-Los Angeles) said in a statement, calling the lapse “disturbing.” “If scope manufacturers had reported infections earlier, then lives might have been saved.”
“The FDA takes these violations very seriously and will continue to monitor these firms to ensure they take appropriate corrective action,” said agency spokeswoman Jennifer Dooren. The FDA gave the major companies 15 days to respond to their alleged violations.
FujiFilm and Pentax may have also failed to warn the FDA about infections or outbreaks associated with their duodenoscopes, which could be caused by a design or manufacturing flaw.
The FDA inspected all three manufacturers’ facilities and found lapses in quality control during the production process, especially around testing the scopes’ accuracy and safety.
Senator Patty Murray (D-Wash) noted that the FDA’s investigation and letters have raised more questions about the agency’s oversight, or lack of oversight, over medical device manufacturers.
“The patients and families who have been impacted deserve the facts,” Murray said. “That’s why I asked the FDA to conduct a full investigation into how this happened in the first place.”
The FDA did note that the manufacturers’ duodenoscopes used the maligned 510(k) approval process, which allows medical manufacturers to put new devices on a fast-track approval process if they significantly resemble a previously-approved device. The process has been heavily criticized in recent years for allowing dangerous, defective devices onto the market without enough testing or oversight.
In spite of the risks, the FDA did note that duodenoscopes are still one of the best ways to provide some life-saving treatments for severe gastrointestinal problems. The agency is not looking to recall the devices yet, and if they do, they will make the determination on an individual basis, rather than on the devices as a group.