The Food and Drug Administration is advising health care providers to stop using two models of a machine used to wash and disinfect flexible endoscopes, if the providers have an alternative method of disinfection.
The machines are the System 83 Plus Washer/Disinfector and the System Plus 83 Mini-flex Washer/Disinfector, which are manufactured by Custom Ultrasonics Inc. A statement issued by the FDA on Feb. 7 says that the agency and company signed a consent decree of permanent injunction, in which the company agreed to stop manufacturing and distributing the machines until it brings its methods and controls used to manufacture the machines into compliance with FDA's good manufacturing requirements. The company also agreed to develop and implement adequate written medical device reporting procedures, according to the statement.
The FDA is not aware of any adverse events resulting from this problem, the statement says, but adds that a potential health hazard exists because improperly cleaned and disinfected endoscopes “can be a source of transmission of pathogens between patients, causing life-threatening infections.”
The agency advised health care providers who use the machines to stop using them if they have other options, including using another device or “following appropriate protocols to manually wash and disinfect the device.” If they have no alternative, they “should carefully weigh the risks and benefits of using these products,” the FDA said.
In a letter to customers dated Feb. 8 and posted on the company's Web site, Custom Ultrasonics said that it was cooperating with the FDA and expected to be in compliance with the FDA's regulations and have the matter resolved “very shortly.”
The letter stressed that the company was not aware of any reports of an infection or disease transmission associated with the proper use of the System 83 Plus, and that it was safe and effective for cleaning and high-level disinfection of flexible endoscopes “when used in accordance with its labeling.” The System 83 Plus machines have been used to reprocess several million flexible endoscopes over the past 20 years, according to the letter.