Last week, an outbreak of a superbug known as CRE at UCLA’s Ronald Reagan Medical Center in Los Angeles prompted the FDA to alert hospitals and medical providers to the possibility that a medical device used for gastroenterological problems might be the culprit.
At this writing, two people have died and nearly 200 have been contacted if they recently had a specialized endoscope inserted into their throats to treat cancers, gallstones and other ailments of the digestive system.
CRE (carbapenem-resistant Enterobacteriaceae), as explained in the Los Angeles Times, are difficult to treat bacteria because they are resistant to most antibiotics. As many as half of all patients with CRE bloodstream infections die, according to the Centers for Disease Control and Prevention.
The FDA said that the design of the devices might make them more difficult to clean fully, and that even meticulous cleaning of the duodenoscopes might not eliminate the bug. The feds first warned about the problem of multidrug-resistant bacteria and duodenoscopes in 2013.
One hospital safety consultant interviewed by The Times said regulators and industry officials have been too slow to respond. “Hospitals and manufacturers often take months to assess what to do, with the infected patients being the last to know,” Lawrence Muscarella said.
“These outbreaks are raising questions about whether hospitals, medical-device companies and regulators are doing enough to protect patient safety,” according to The Times. “Some consumer advocates are also calling for greater disclosure to patients of the increased risks for infection before undergoing these procedures.”
Some hospitals using the duodenoscopes quarantine them for 48 hours after the initial cleaning to check for bacterial growth before reusing them on patients. If you are scheduled for such a procedure with an endoscope, make sure that it’s essential to your care, and that you clearly understand the risks as well as the benefits. Make sure that the facility has followed the cleaning and quarantine protocol.