FDA, CDC and VA Issue Endoscope Processing Recommendations

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Agencies urge facilities to improve staff training and compliance with proper processing techniques.


Healthcare facilities should develop a comprehensive safety and quality assurance program for flexible endoscope processing to prevent cross-contamination, 3 government agencies announced this week.

The joint safety communication from the Food and Drug Administration, Centers for Disease Control and Prevention and the Department of Veterans Affairs comes in response to recent reports of errors in flexible endoscope processing, including "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."

The agencies outline several steps healthcare facilities and their staffs should take to prevent these errors and the infection risks they could pose to patients:

  • On the administrative side, facilities should establish an institutional quality assurance and safety program that covers all aspects of endoscopy procedures; provide extensive training and retraining for staff tasked with processing endoscopes; and "establish a chain of accountability for endoscope processing procedures."

  • Staff should immediately begin manual cleaning of flexible endoscopes after use and before they are disinfected and sterilized.

  • Procedures for high-level disinfection and sterilization must match the flexible endoscope's manufacturer's instructions. Make sure instructions for the endoscope, automatic endoscope reprocessor (if you use one) and germicides don't contradict each other.

  • Endoscopes or accessories that come into contact with sterile tissue or the vascular system must undergo sterilization and those that contact intact mucous membranes, such as the respiratory or GI tracts, must undergo at least high-level disinfection before each use.

    Read the full statement for more comprehensive recommendations from the FDA, CDC and VA.

    Irene Tsikitas

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