An advisory panel to the U.S. Food & Drug Administration (FDA) warned today that patients who require routine medical procedures continue to face serious health risks from specialized medical scopes linked to multiple outbreaks of the deadly Carbapenem-Resistant Enterobacteriaceae, or CRE, superbug.
Update: FDA Validates Updated Olympus Duodenoscope Cleaning Instructions
March 15, 2016 – Olympus Corp. of the Americas announced today that it has issued updated reprocessing instructions for its TJF-160F and TJF-160VF model duodenoscopes. FDA has reviewed and validated the updated reprocessing instructions for the devices, and continues to evaluate the link between endoscopes and the transmission of infectious agents.
What’s the Problem?
May 14, 2015 – Testimony from doctors and researchers came as the FDA and Olympus Corp., manufacturer of the duodenoscope suspected of passing the CRE superbug in a number of recent outbreaks, took criticism for not taking control of the situation.
A day of technical presentations was contrasted by the testimony of a North Carolina woman whose husband recently died of a CRE infection. “His battle was more than I could bear to watch,” Carla Warner said, pointing the finger at Olympus and the FDA. “They have failed me, my family, and my husband paid the ultimate price with his life.”
Olympus Declines Participation in Hearing
Olympus has thus far refused to participate in the panel. The company was invited to speak at the hearing, but “for various reasons they’ve declined to participate,” the Los Angeles Times quoted Dr. Stephen Ostroff, the FDA’s acting commissioner, as saying. Two other duodenoscope manufacturers, Pentax Medical and Fujifilm, also declined to speak at the hearing.
UCLA Doctor Testifies about Superbug Outbreak
Dr. Zachary Rubin, director of clinical epidemiology and infection prevention at UCLA, testified about the recent superbug outbreak at the Ronald Reagan Medical Center. Rubin said 8 patients at the facility developed CRE infections from 2 contaminated duodenoscopes, and 3 of them — including one that was previously undisclosed — have died.
Rubin speculated that the problem with the scopes is bigger than what’s been reported in the news, describing the difficulty in detecting infections, even with an informed staff and considerable resources that many hospitals lack.
“If you don’t look for these infections,” Rubin said, “you won’t find them.”
Committee to Discuss Endoscope Cleaning Alternatives
The committee is expected to meet today to hear testimony from medical experts about cleaning alternatives for the duodenoscope, and to consider recommendations on how the FDA should respond to the problem. Mark Miller, a spokesman for Olympus who attended the hearing, said the device maker is continuing its dialogue with the FDA. Olympus “will evaluate whether to provide written input” to the advisory panel after the hearing.
FDA Orders Recall of 2,800 Endoscope Washers Over Sterilization Concerns
November 13 – In an effort to crackdown on infections caused by medical devices, the FDA has ordered Custom Ultrasonics to recall its endoscopes, citing violations of the Federal Food, Drug, and Cosmetic Act. In a separate safety alert, it told healthcare facilities “to use alternative methods to reprocess flexible endoscopes as soon as possible.”