The company that manufactures the medical devices responsible for the superbug outbreak at the Ronald Reagan UCLA Medical Center had issued safety advisories about their scopes in Europe two years ago, but failed to notify hospitals in the U.S. of these precautions until after the outbreak this year, according to an article by the Los Angeles Times.
According to the Los Angeles Times, Olympus Corp. of the Americas first notified European hospitals about the potential health risks its duodenoscopes posed in January 2013. Olympus had recommended the use of a specific small-bristle cleaning brush that would help prevent bacterial contamination of the TJF-Q180V duodenoscopes, the Los Angeles Times reported. Although the U.S. Food and Drug Administration knew about the health concerns raised in Europe, it did not alert U.S. hospitals.
The FDA did release a safety communication about the proper cleaning of the duodenoscopes in November 2009, said Jennifer Corbett Dooren, a spokeswoman for the FDA. The announcement, however, did not specifically mention Olympus.
Doctors use duodenoscopes for endoscopic retrograde cholangiopancreatography, or ERCP, procedures. These procedures treat various digestive diseases and regularly save thousands of lives. The device helps meet the demand for more than 500,000 ERCP procedures annually in the U.S., according to a statement issued by the FDA on March 4.
On Feb. 18, the UCLA Health system issued a statement saying more than 100 people may have been infected with the superbug, or carbapenem-resistant Enterobacteriaceae – commonly known as CRE – following medical procedures that used Olympus duodenoscopes at the Ronald Reagan UCLA Medical Center.
CRE has been linked to two UCLA patient deaths and UCLA has notified more than 170 patients that they may have been infected. At least six lawsuits have been filed against Olympus alleging wrongful death, negligence and fraud, among other charges.
Following its first alert to European facilities in 2013, Olympus issued a second alert about the scopes in August, once again in Europe. This time, it asked hospitals to fill out forms acknowledging the potential safety hazards and return them to Olympus.
The FDA had been aware of the notices Olympus was circulating in Europe, Dooren said in an email statement. In accordance with new reprocessing instructions, Olympus submitted cleaning validation reports to the FDA in October. The initial high-level disinfection reports did not demonstrate an adequate safety margin, she said.
Olympus submitted its second round of reports at the end of February, after the superbug outbreak at UCLA. Between November and February, the FDA did not issue any safety communications to the public.
After reviewing the second report, the FDA decided that the new reprocessing instructions for the Olympus TJF-Q180V duodenoscope demonstrated consistent and reliable cleaning and high-level disinfection, Dooren said. Last month, the FDA issued a safety communication asking facilities to train staff on proper cleaning procedures for the duodenoscopes.
The new cleaning procedures involve immersing the duodenoscope in disinfectant while simultaneously raising and lowering the elevator, a part at the device’s tip, in order to flush out small crevices that are difficult to reach. The new procedure also calls for additional cleaning of duodenoscopes with disinfectant and the use of a new smaller brush in addition to the brush already used.
Currently, the Ronald Reagan UCLA Medical Center is still using the duodenoscopes with updated cleaning procedures, said Dale Tate, a spokeswoman for UCLA Health.
The FDA continues to systematically investigate the association between reprocessed reusable medical devices and cases of bacterial infection in U.S. health care facilities, Dooren added.
In the meantime, the FDA advised hospitals to continue the use of the scopes, even though they have not been approved for sale since the 2010 redesign.
Olympus could not be reached for comment.