Deaths and infections are still occurring in patients treated with specialized endoscopes called duodenoscopes, even after the devices were reprocessed for reuse, the Food and Drug Administration (FDA) announced in a Safety Communication. The findings come from post-market surveillance studies of duodenoscopes required of manufacturers after the devices, used to diagnose and treat problems in the pancreas and bile ducts, were linked to outbreaks of superbug infections beginning in 2013.
The FDA said that three deaths reported in the U.S. last year were linked to contaminated duodenoscopes. “That’s three deaths too many,” said Jeff Shuren, MD, director of the Center for Devices and Radiological Health. The agency also received 45 additional reports of patient infection, one report of patient exposure, and 159 reports of device contamination from Oct. 15, 2018, to March 31, 2019.
In 2015, two years after the FDA became aware of patients becoming infected with drug-resistant bacteria after being treated with duodenoscopes, the agency ordered manufacturers of duodenoscopes sold in the U.S. – Fujifilm, Pentax, and Olympus – to conduct postmarket surveillance studies to better understand how the infections were being passed from patient-to-patient.
The specialized scopes have small crevasses that can harbor bacteria even after being cleaned and disinfected. The agency required manufacturers to redesign the devices and establish better reprocessing guidelines.
In December 2018, the FDA announced that it had observed a decline in the number of patient deaths and infections in patients treated with duodenoscopes after the safety measures were taken to improve reprocessing techniques beginning in 2015.
“However, late in 2018, we received additional medical device reports of patient infection and device contamination,” the FDA said. “These reports indicate that although the number of reports has declined, there continues to be a need for improvement of the safety of reprocessed duodenoscopes.”
The agency is reminding health care facilities and staff to strictly adhere to the manufacturer’s reprocessing and maintenance instructions.