Cedars-Sinai Medical Center in Los Angeles has confirmed several cases of infections linked to the same type of medical endoscopes implicated in a superbug outbreak last month, Reuters reports (Gorman, Reuters, 3/4).
Background
In February, UCLA’s Ronald Reagan Medical Center began notifying 179 patients who may have been exposed to Carbapenem-resistant Enterobacteriaceae, or CRE, from contaminated medical endoscopes.
Following the announcement of the superbug, FDA issued a warning about medical endoscopes, stating that the device’s design might make it difficult to “clean, disinfect and sterilize reusable devices.” However, the agency said it is not safe for hospitals to stop using the devices because there are no viable alternatives (California Healthline, 2/24).
Details of Cedars-Sinai Outbreak
Cedars-Sinai has confirmed four cases of CRE infections linked to contaminated endoscopes.
One affected patient has died, but hospital officials said it was due to an underlying medical issue unrelated to the superbug infection (Chang, AP/San Francisco Chronicle, 3/4).
As many as 67 additional patients might have been exposed to the bacteria (Gorman, Reuters, 3/4).The hospital said there is no evidence the other patients are at risk, but it is sending home-test kits to potentially affected individuals as a precaution.
Cedars-Sinai has stopped using the endoscopes and will continue endoscopic procedures after it has consulted with other hospitals and government agencies (AP/San Francisco Chronicle, 3/4).
FDA Updates Safety Warning
In related news, FDA on Wednesday updated its safety warning for the scopes that were linked to the superbug infections, Reuters reports.
Specifically, FDA recommended that providers:
- Continue procedures using duodenoscopes for patients who require them;
- Inform their patients of the risks associated with the devices and the benefits of the procedure; and
- Report to manufacturers and FDA if they suspect problems with the devices might have led to an infection (Chiacu, Reuters, 3/4).
FDA Criticized for Medical Scope Oversight
Meanwhile, FDA on Monday said that it has failed on several occasions to have medical scope manufacturers prove that the devices can be fully decontaminated, the Los Angeles Times reports.
According to the Times, FDA did not request information on how medical scopes can be fully cleaned until spring 2014, despite earlier warnings about the devices. Further, FDA said it has given manufacturers three opportunities to prove their cleaning protocols work.
FDA spokesperson Karen Riley said FDA determined prior submissions by the company to be insufficient and is waiting for updated information from manufacturers Olympus, Pentax Medical and Fujifilm.
Reaction
Rep. Ted Lieu (D-Torrance) said, “I think it’s unacceptable that FDA didn’t ask for this data much earlier when it’s clear they were aware of these outbreaks for years,” adding, “If … FDA had acted earlier there would be fewer unnecessary deaths.”
Lisa McGiffert, director of Consumers Union’s Safe Patient Project, said it is “outrageous” that FDA is giving medical scope manufacturers “a third try to prove these devices can be cleaned properly and the public didn’t know about it [until] today.”
Meanwhile, Fujifilm spokesperson Diane Rainey said, “Fujifilm, along with other industry members, has been working in cooperation with … FDA to evaluate and respond to concerns regarding the possible association of certain reprocessed endoscopes … with disease transmission” (Terhune, Los Angeles Times, 3/3).