Preventing Cross Contamination in Endoscope Processing (February 2010)

The FDA, the CDC and the Department of Veterans Affairs have issued a joint safety communication cautioning healthcare facilities about the risks to patients if endoscopes and their accessories are not processed properly between patients. The communication points out that if flexible endoscopes are not cleaned and then disinfected or sterilized adequately, patients can be exposed to body fluids and tissue contaminants from prior patients.

The three agencies are concerned about this problem because of continuing reports to FDA of processing errors. These include the use of improper accessories for endoscopy irrigation setups, improper reprocessing intervals for reusable endoscopy accessories, failure to discard single-use accessories, and failure to follow the manufacturer's instructions for endoscope processing.

The safety communication stresses that the only way facilities can assure that their patients are adequately protected against cross contamination is to set up a quality system program covering all aspects of endoscopy processing, and then to rigorously comply with it. The communication provides several general recommendations for a quality system program, plus a more detailed set of recommended policies and procedures.

Here's a summary of the general recommendations:

•Establish an institutional program with written procedures for endoscope processing, and ensure that those responsible for processing understand the importance of this job.

•Train and re-train employees to process endoscopy equipment properly, periodically assess their competence, and be sure they follow the endoscope manufacturer's processing instructions.

•Be sure staff members understand that endoscopes cannot be properly disinfected or sterilized without first cleaning them thoroughly in order to remove gross contamination and debris.

•Be sure your automatic endoscope reprocessor or sterilizer is compatible with the endoscope, and that the connecting parts of these devices fit properly.

•Finally, be sure that endoscopes or accessories that will come in contact with sterile tissue are sterilized before each use, and that endoscopes that will come in contact with intact mucous membranes -- in the respiratory and GI tracts, for example -- undergo at least high level disinfection before each use.

The safety communication also lists the responsibilities of manufacturers in helping to assure that endoscopes and their accessories are properly processed.

Category:

Science & Technology

Tags:

• Cross Contamination
• Endoscope Processing
• FDA
• Department of Veterans Affairs
• Patient Safety
• CDC
• Sterilization