The Cedars-Sinai hospital in Los Angeles announced a possible “superbug” outbreak linked to gastrointestinal devices, the second hospital in a month to link the potentially deadly germs to devices called duodenoscopes.
The bug, called carbapenem-resistant enterobacteriaceae (CRE), is a bacteria resistant to some of medicine’s strongest antibiotics. The duodenoscope is a difficult-to-clean, complex flexible tube inserted through the throat of patients to check for issues in the upper intestines.
Cedars-Sinai hospital officials linked four transmissions of CRE to duodenoscopes. The hospital sent letters and home-testing kits to 71 more patients who may have been exposed between August 2014 and February 2015, “out of an abundance of caution”.
In late February, Ronald Reagan UCLA Medical Center sent letters to 179 patients informing them that two duodenoscopes used in medical procedures could have carried the CRE bacterium.
It’s far from the first CRE outbreak, and not the only ones linked to duodenoscopes. In Illinois, 38 patients were infected in 2013. And epidemiologists have warned that if the bacteria become common, it could have widespread healthcare implications.
In a strongly worded statement, Cedars-Sinai criticized the government’s lack of guidance on the medical devices, and called into question the manufacturer’s instructions.
“Given the potential insufficiencies of the manufacturer’s [Olympus Corporation] disinfection instructions, and the current absence of updated national guidelines, Cedars-Sinai is using additional measures to protect patients who need to undergo a procedure involving a duodenoscope,” Cedars-Sinai’s statement said.
The Food and Drug Administration, which regulates medical devices, has come under criticism since hospitals started discovering the duodenoscope-linked infections.
In the past 10 days, the FDA has asked manufacturers for more evidence that their scopes can be cleaned using the recommended procedures, and admitted that it never reviewed cleaning data from manufacturers, the New York Times reported.
The FDA allowed the Japanese manufacturer Olympus, which made Cedars-Sinai’s scopes, to market the devices without regulatory clearance. That approval normally required to sell such devices is known as a “510(k)”, a provision of the Food, Drug and Cosmetics Act. Olympus is probably best known in the US for manufacturing cameras.
The FDA defended the company in a letter to the healthcare industry on Wednesday, saying that infections were associated with “all three manufacturers” of duodenoscopes. It reiterated that hospitals should, “thoroughly clean and disinfect duodenoscopes, pursuant to the manufacturers’ instructions”.
Two patients infected in the outbreak at UCLA are suing Olympus, Reuters reported. Patients are alleging that the devices are unsafe because of the insufficient cleaning protocols. One of the patients is an 18-year-old high school student, who was hospitalized fighting the severe infection at the time the suit was filed.
“At the present time, the [CRE infection] numbers in the US are still very small, but the potential for it to spread and become bigger is huge,” Marion Kainer told the Guardian at the time of the UCLA outbreak. She is considered an expert on the topic, and is a member of Barack Obama’s advisory panel on antibiotic resistance as well as an epidemiologist in Tennessee. “It’s something that we want to get on top of very, very rapidly.”
