FDA Orders Recall of Some Medical Scope Cleaning Machines
On Friday, FDA ordered Custom Ultrasonics, a medical device maker, to recall 2,800 machines used to disinfect certain medical scopes that have been linked with recent superbug outbreaks, AP/Modern Healthcare reports (AP/Modern Healthcare, 11/13).
FDA said Custom Ultrasonics could not show that the cleaning machine -- called the System 83 Plus, which is an automated endoscope reprocessor -- adequately disinfected the scopes. Further, the company failed to report adverse events to federal officials in a timely manner, according to FDA (Terhune, Los Angeles Times, 11/13).
FDA in August sent warning letters to three companies that manufactured duodenoscopes linked to a recent superbug outbreak, saying the companies failed to properly report issues with the devices and ensure they could be cleaned appropriately. The letters were sent to:
- Olympus; and
- Pentax (California Healthline, 8/18).
In October, FDA ordered the manufacturers to determine:
- Whether cleaning instructions provided with the device are sufficient to ensure users will adhere to them;
- The percentage of devices that remain contaminated after they are cleaned in accordance with the manufacturers' directions; and
- What factors contribute to contamination after disinfection procedures are completed.
The letters came after as many as 179 patients could have been exposed to Carbapenem-resistant Enterobacteriaceae, or CRE, after undergoing a procedure with the duodenoscope -- also called an endoscopic retrograde cholangiopancreatography -- at UCLA's Ronald Reagan Medical Center between October 2014 and January 2015. Seven patients were confirmed to have CRE infections, and two of those patients died.
Meanwhile, Cedars-Sinai Medical Center in Los Angeles in March reported that four patients had been infected with CRE and that up to 67 more might have been exposed after being treated with the same type of scope (California Healthline, 10/7).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.