FDA, CDC, VA Release Guidelines for Processing Flexible Endoscopes

The U.S. Food and Drug Administration, the Centers for Disease Control and Prevention and the Department for Veterans Affairs have issued a new set of guidelines for healthcare facilities, including hospitals, ASCs and private practices, for the cleaning and processing of flexible endoscopes and their accessories, according to an FDA news release.

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, according to the release. Flexible endoscopes are fundamentally difficult to clean and disinfect or sterilize, and as a result, it is essential that facilities establish a quality system program that covers all aspects of endoscopy procedure management.

The guidelines were reviewed by The Joint Commission, and the commission's general recommendations are as follows:

  • Establish an institutional program for endoscope processing, along with written procedures for monitoring adherence to the program and a chain of accountability. Ensure that those responsible for endoscope processing understand the importance of this job and that they maintain proficiency in performing it for each type of endoscope they handle.
  • Train employees to set-up, clean, disinfect or sterilize and store endoscopy equipment properly. Periodically retrain and assess competence. Endoscopy is a constantly evolving technology, so it is essential to stay up to date with the specifics of each device your institution uses.
  • Instruct staff to read and follow the endoscope manufacturer's instructions for use. People responsible for reprocessing endoscopes must have the manufacturer's instructions available for each endoscope and its accessories, because various endoscopes and their accessories often must be processed differently (e.g., most flexible endoscopic equipment cannot tolerate steam sterilization).
  • Be sure staff members understand that the cleaning and disinfecting of endoscopes are two separate processes. Thorough cleaning of the endoscope must be done first, in order to remove gross contamination and debris. Without this step, the endoscope cannot be effectively disinfected or sterilized. 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. During disinfection, the high-level disinfectant must contact every contaminated surface/channel for the time recommended by the disinfectant manufacturer.
  • Be sure that the AER or sterilizer is compatible with the endoscope. Before using an AER, confirm that it properly fits the endoscope. Adhere to the AER or sterilizer instructions that specify which endoscope makes and models it can process. And be sure that the instructions for endoscopes, AERs and germicides do not contradict one another. If you become aware that instructions are contradictory, inform the endoscope and AER manufacturers as well as FDA.
  • Be sure that endoscopes or accessories that contact sterile tissue are sterilized before each use, and that endoscopes that contact intact mucous membranes (e.g., the respiratory and gastrointestinal tracts) undergo at least high-level disinfection before each use.

The release also encourages facilities to report adverse events related to flexible endoscopes that do not fall under the requirement for mandatory reporting. This can be reported either directly to the manufacturer or to the FDA's MedWatch.

To view the complete FDA guidelines, click here.

Read the release about the FDA's new guidelines for flexible endoscope processing.

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