After issuing draft guidance in 2011 and considering hundreds of comments, FDA released its finalized guidance on medical device reprocessing on Thursday. This guide is meant for cleaning, disinfecting, and sterilizing reusable devices that are reprocessed in the health care setting, not single-use devices that are reprocessed by a third party.
The issue is particularly timely since duodenoscopes, a type of endoscope used to diagnose and treat diseases of the liver, bile duct, and pancreas, have been associated with numerous cases of carbapenem-resistant enterobacteriaceae (CRE) infections. FDA said last week that one duodenoscope model, made by Olympus Corp. of the Americas and blamed for some of the infections, never received FDA approval because the maker initially did not think agency review was required. The issue of these superbug scopes was even raised at a Senate hearing earlier this week.
In the final guidance, manufacturers are asked to tackle six criteria to make sure that customers understand how to reprocess the devices. Device labeling should define its intended use and reprocessing instructions should allow for thorough cleaning, choose an appropriate microbicidal process, be technically feasible with available tools, and finally, be comprehensive and understandable.
The guidance goes on to explain that companies should conduct validation testing to show that the reprocessing instructions repeatedly result in decontamination, and the devices should be designed to avoid cleaning difficulties.
Makers looking to introduce some reusable devices like duodenoscopes and other types of endoscopes to the market are being asked to give FDA data showing that their reprocessing methods and instructions work. Currently, duodenoscopes are difficult to sterilize completely because an ‘elevator’ mechanism on the devices features miniscule spaces that can be hard to brush or clean perfectly.
Dr. William Maisel, deputy director for science and chief scientist at FDA’s Center of Devices and Radiological Health, said in an FDA press release, “Despite the recent concerns about multi-drug resistant bacteria infection associated with duodenoscopes, patients and health care providers should know that the risk of acquiring an infection from a reprocessed medical device is low.”
In tandem with the issuance of final guidance, FDA announced a public advisory panel slated for May 14 and 15 to discuss the duodenoscope-linked CRE infections.
Marie Thibault is the associate editor at MD+DI. Reach her at [email protected] and on Twitter @medtechmarie.
[Image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]