Over 90 Total Lots Up For Auction at One Location - WA 04/08

Olympus unveils new FDA-endorsed reprocessing instructions for duodenoscopes

by Gus Iversen, Editor in Chief | March 27, 2015
Endoscopy
An outbreak of antibiotic resistant "superbug" bacterial infections in patients undergoing procedures with duodenoscopes and other endoscopes has recently stirred some controversy. The complex design of these minimally invasive surgical tools means residual body fluids and organic debris can sometimes remain in microscopic crevices after cleaning.

Duodenoscopes are used to treat diseases of the liver, bile duct, and pancreas. For Olympus, evidence indicated that even when following the reprocessing — or sterilization — guidelines they provided for a duodenoscope, infections could happen.

Higher level disinfection data was submitted by Olympus in February and the FDA has endorsed new cleaning protocols as consistent, robust, and reliable. Yesterday, Olympus sent letters to customers using the TJF-Q180V duodenoscopes which outline the new instructions. An update to user manuals is forthcoming.

The new validated protocol divides the cleaning process into three steps: pre-cleaning, manual cleaning, and manual high-level disinfection. The manual cleaning step requires a new brush, (called MAJ-1888) that will be shipped to users of the duodenoscope by May 8th, but changes to pre-cleaning and manual high-level disinfection can be implemented right away.

The FDA classifies high-level disinfection as a six-log — or million-fold (99.9999%) — reduction in the number of microbes at each of several locations along the scope. The agency recommends that facilities train staff to use the new instructions and implement them as soon as possible.

The duodenoscope in question is still not 510(k) approved, but has an application under FDA review. The FDA states that removing the device from the market could result in a shortage of duodenoscopes in the U.S., where the tools are needed for roughly 500,000 procedures annually.

As part of its ongoing effort to understand and minimize the risk of infections, the FDA will convene a public Advisory Committee Meeting on May 14th and 15th to seek additional expert scientific and clinical opinion related to the reprocessing of duodenoscopes and other endoscopes.

You Must Be Logged In To Post A Comment