FDA, CDC, and VA release recommendations for endoscope reprocessing

By: December 2nd, 2009 Email This Post Print This Post

Given recent incidents of  improper endoscope reprocessing procedures, the U.S. Food and Drug Administration (FDA), CDC, and the Department of Veterans Affairs (VA) have released a joint communication cautioning healthcare facilities about the risk of improper disinfection and sterilization procedures.

The recommendations have been reviewed by The Joint Commission, the accrediting agency that recently tweaked its IC standards. Because flexible endoscopes are difficult to clean, the release urges healthcare facilities, including hospitals, ambulatory care facilities, and private physician practices, to develop a quality system program that covers all aspects of endoscopy procedure management.Below are the general recommendations for healthcare facilities:

  • Establish an endoscope processing program along with written procedures for monitoring employee adherence to the program, and a chain of accountability.
  • Train employees to set-up, clean, disinfect or sterilize, and store endoscopy equipment properly. Retrain when needed.
  • Ensure staff members follow the manufacturers instructions. Anyone responsible for endoscope repossessing needs to have the instructions for both endoscopes and any accessories, since each piece may be sterilized differently.
  • Ensure staff members know that cleaning and disinfecting endoscopes is a two-step process. First thoroughly clean the endoscope to remove heavy contamination and debris. “Without this step, the endoscope cannot be effectively disinfected or sterilized,” the recommendation reads. “Cleaning should begin immediately after use by thoroughly flushing the channels and rinsing/wiping the outside of the endoscope. This must be followed by a very thorough cleaning with brushes, concentrating especially on the channels. Only then is the endoscope ready for high level disinfection, which can be done manually or in an automatic endoscope reprocessor (AER).”
  • The AER or sterilizer is compatible with the endoscope. Adhere to the AER or sterilizer instructions that specify which endoscope makes and models it can process.
  • Endoscopes or accessories that contact sterile tissue should be sterilized before each use.  Endoscopes that contact intact mucous membranes (e.g., the respiratory and gastrointestinal tracts) should undergo at least high-level disinfection before each use.

The release also includes a bulleted list of responsibilities for the manufacturers, including instructions that are easily accessible and easy to understand, specify which AER is compatible with certain makes and models of endoscopes, and investigate clusters of infections associated with your device.

Specific FDA endoscopy processing procedures are included at the end of the document. You can also refer to the CDC/HICPAC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008.

You can also download the endoscopy excerpt from the CDC guidelines on the Tools page, along with a number of other sterilization checklists.


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