A United States Senate investigation found the superbug outbreak at the Ronald Reagan UCLA Medical Center in January 2015 may have resulted from hospitals’ and manufacturers’ failure to report previous outbreaks of a drug-resistant bacteria.
Senator Patty Murray launched the investigation after multiple international and domestic outbreaks prompted officials to search for changes that can prevent the same events from occurring in the future.
According to the report, the Ronald Reagan Medical Center was one of 25 hospitals affected by the outbreak, which occurred from January 2012 to April 2015. The medical center reported two deaths and contacted 179 patients who were treated from October 2014 to January 2015 who may have been infected. According to the report, seven people from the center were infected by the bacteria.
In 2013, about two years before the outbreak at the Reagan, two hospitals in Seattle traced infections to duodenoscopes, tubes that can be inserted into patients’ throats and stomach in more than 500,000 procedures each year.
The hospitals found the devices remained contaminated even after proper cleaning, but it took 17 months since the 2013 incident for duodenoscope manufacturers and the Food and Drug Administration to alert hospitals, according to the investigation.
U.S. hospitals also did not report the infections to federal regulators even after tracing the infections to the duodenoscopes. When they reported them to manufacturers, they did so informally and did not include all information necessary for the manufacturers to submit a complete report to the FDA.
The investigation found that by the spring of 2012, Olympus Corp., which manufactured 85 percent of the contaminated duodenoscopes in the U.S., knew the device could spread bacteria but never informed hospitals or the FDA. The report also said the FDA’s device database was outdated and their system to find information about problematic medical devices is ineffective.
The report made several recommendations aimed at avoiding delays in reporting similar incidents in the future, including requiring device identifiers to allow the FDA to monitor medical devices more effectively. The report also recommended the FDA create a guide to disseminating information to health care centers when they find flaws in medical devices.
Compiled by Alejandra Reyes-Velarde, Bruin senior staff.