Senator Patty Murray (D-Wa) is going after duodenoscope makers again over continued concerns about high rates of contamination in the devices, even after sterilization and cleaning, according to letters the official sent to makers Olympus (TYO:7733), Fujifilm Holdings (TSE:4901) and Hoya’s (TYO:7741) Pentax subsidiary.
The letter comes only a month after the FDA released an analysis of medical device reports indicating three new deaths, 45 infections and 159 reports of device contamination among higher-than-expected rates of device contamination with “high-concern organisms.”
“These data raise serious questions about your company’s ability to ensure the health and safety of patients who undergo procedures using [Olympus/Fujifilm/Pentax]-manufactured closed-channel duodenoscopes. I am writing today to understand how your company plans to respond to these troubling findings and what changes may be necessary going forward to ensure patient safety. While important steps have been taken to reduce outbreaks, it is unacceptable that one in twenty patients who undergo a procedure using a duodenoscope may acquire an infection as a result of that procedure – even when hospitals have followed cleaning instructions correctly,” Murray wrote in matching letters to each company.
Sen. Murray went on to present each company with seven requests related to the company’s handling of duodenoscope contamination issues, asking that they submit the information requested by May 23.
In their first request, Sen. Murray asked the companies to submit a copy of each Medical Device Report submitted to the FDA since January 2017 “related to contamination of a closed-channel duodenoscopes.”
Sen. Murray’s second request was for data on the rate of contamination for both high concern organisms and low-to-moderate concern organisms from FDA-ordered sampling studies.
In her following requests, Sen. Murray asked for completion dates for FDA-ordered post-market studies, information on whether the companies have analyzed interim findings, how the scope makers plan to address findings in the studies and whether they believe closed-channel duodenoscopes remain safety use.
Sen. Murray also sought feedback the companies’ received from users on reprocessing the devices, and information on whether the companies had redesigned or modified them to address cleaning concerns.
Back in 2015 the federal safety watchdog warned Olympus, Fujifilm Holdings and Pentax subsidiary following a string of deadly “superbug” infections attributed to their duodenoscopes. The FDA ordered the companies to run post-market surveillance studies to assess the effectiveness of reprocessing the scopes; last year it sent the trio another set of warning letters over their failure to comply with that order.