Dive Brief:
- Almost two years prior to the CRE outbreaks at UCLA, Cedars-Sinai and other hospitals around the U.S., the manufacturer of the associated endoscopes was warning hospitals in Europe about the issues with disinfecting the devices, the L.A. Times reports.
- However, the leading global manufacturer of the devices, Olympus Corp., did not issue such warnings to U.S. hospitals, raising questions as to why the issue only came to public light domestically after news broke about the UCLA outbreak in February.
- The FDA said it learned of the warnings in Europe last summer but did not take action then to warn hospitals because it was still working with multiple scope manufacturers to finalize cleaning guidelines. Its revised instructions were released March 26.
Dive Insight:
Olympus is taking serious heat over its troubling omission in the U.S., given that it recommended specific scope cleaning advice to European hospitals in two separate safety alerts. The company was so thorough in Europe that it asked the hospitals to return a form acknowledging that they had circulated the information among staff. The company only issued a warning in the U.S. after news broke of the CRE outbreak in L.A.
The most disturbing issue, however, may be the FDA's slow response. While regulatory agencies in numerous European countries had posted the warning on their websites, the FDA sat on the information until it was satisfied with its new guidance.
Rep. Ted Lieu (D-Los Angeles) suggested to the L.A. Times that this oversight underscores a need for congressional hearings on the issue.
"With every passing week, more information is coming out showing that the manufacturer and regulators had a lot of information about risks of superbug outbreaks from these scopes, and nothing much happened until press stories started coming out," he said.