New Cleaning Steps Released for Devices Linked to CRE Outbreak

On Thursday, Olympus America issued updated guidance on how to disinfect its medical endoscopes, which were linked to a superbug outbreak at two California hospitals this year, the AP/Sacramento Bee reports (Perrone, AP/Sacramento Bee, 3/26).

Background

As many as 179 patients could have been exposed to Carbapenem-Resistant Enterobacteriaceae after having an endoscopic retrograde cholangiopancreatography at UCLA's Ronald Reagan Medical Center between October 2014 and January 2015. So far, seven patients have been confirmed to have CRE infections, and two of those patients died.

Meanwhile, Cedars-Sinai Medical Center in Los Angeles this month reported that four patients had been infected with CRE and up to 67 more might have been exposed after being treated with the same type of scope, called a duodenoscope.

In response to the outbreaks, FDA has released final guidance requiring usable medical device makers to provide proof that their devices can reliably be cleaned before being approved by the agency (California Healthline, 3/13).

Details of Updated Instructions

According to the Los Angeles Times, Olympus for months maintained that its cleaning instructions were effective if followed properly by hospitals.

However, doctors at some of the hospitals with reported outbreaks said the infection spread even though they thoroughly followed the steps.

On Thursday, Olympus released revised cleaning instructions that include additional steps to ensure full disinfection of the scopes. The updated instructions call for:

• Additional flushing to remove debris from the devices' crevices; and
• Using a smaller cleaning brush.

Olympus plans to send the new brushes to hospitals by May 8, according to the Times.

The company urged hospitals to implement the updated cleaning process as quickly as possible.

Meanwhile, FDA on Thursday said that it reviewed the new instructions and data from Olympus' tests to prove they work. In a statement, FDA said the scopes can be adequately cleaned with "high-level disinfection" if hospitals follow the new instructions.

Calif. Lawmaker 'Pleased' by Action

On Thursday, Rep. Ted Lieu (D-Calif.), who has called for congressional hearings on the superbug outbreaks, said, "I'm pleased we are seeing some action from the manufacturer."

He added, "At least they are acknowledging there is an issue with the current cleaning protocol" (Petersen/Terhune, Los Angeles Times, 3/26).