VA, FDA, CDC Release Joint Endoscope-Processing Notice

Today the Food and Drug Administration issued a safety communication about the risks to patients if flexible endoscopes and their accessories are not processed properly, and recommends steps to reduce these risks. It is being issued jointly by the FDA, the Centers for Disease Control and Prevention, and the Department of Veterans Affairs. The communication also reminds manufacturers of endoscopes and endoscope processing equipment of their responsibilities in helping assure proper endoscope processing in healthcare facilities.

The document is as follows:

The Public Health Problem

If flexible endoscopes or endoscopic accessories are not properly processed, patients can be exposed to body fluids and tissue contaminants from prior patients, which can result in the transmission of pathogens and affect large numbers of people. Recent reports to FDA of processing errors with flexible endoscopes have highlighted the continuing importance of this issue. Reported errors included the use of improper accessories for endoscopy irrigation set-ups, improper reprocessing intervals for reusable endoscopy accessories, failure to discard single use accessories, and failure to follow the manufacturer's instructions for endoscope reprocessing.

Flexible endoscopes are fundamentally difficult to clean and disinfect or sterilize. Because of this, it is essential that facilities establish a quality system program that covers all aspects of endoscopy procedure management. Adequate patient protection can only be achieved by vigorous compliance with such a program.