FDA Orders Medical Scope Makers To Study Cleaning Procedures
To help curb the spread of deadly bacterial infections, FDA on Monday ordered three manufacturers of duodenoscopes to complete post-market studies on how the devices are cleaned, the Washington Post's "To Your Health" reports (Dennis, "To Your Health," Washington Post, 10/5).
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 letter 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, 8/18).
FDA has 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 manufacturers must submit plans for the studies to FDA within 30 days (Ross Johnson, Modern Healthcare, 10/5).
William Maisel, deputy director for science and chief scientist at FDA's Center for Devices and Radiological Health, in a statement said the studies "will provide critical information about the effectiveness of current reprocessing instructions and practices that may provide additional information to inform the FDA's actions to protect the public health and help reduce the risk of infections."
According to "To Your Health," a spokesperson for Fujifilm, one of the scope manufacturers, said the company is reviewing FDA's order. Meanwhile, spokespersons for the remaining two companies, Olympus and Pentax Medical, said they will comply with FDA's request ("To Your Health," Washington Post, 10/5).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.