AAMI ST91, “Flexible and semi-rigid endoscope processing in health care facilities,” has just been released. This new standard was developed to help organizations reduce the risk of cross-contamination between patients who undergo endoscopic procedures. The use of endoscopes is extensive (there are more than 11 million gastrointestinal endoscopies performed each year). However, more health care acquired infections have been linked to endoscopes than to any other medical device. So while infection is rare as a percentage of outcomes, the numbers are still significant. If your facility uses endoscopes, you will want to get a copy of this new publication.
The new standard provides guidelines for the following processes: pre-cleaning, leak-testing, cleaning, packaging (where indicated), storage, high-level disinfecting, and/or sterilizing. The types of endoscopes covered by this standard include flexible gastrointestinal (GI) endoscopes, flexible bronchoscopes, surgical flexible endoscopes like flexible ureteroscopes, and semi-rigid operative endoscopes like choledochoscopes. Guidelines are intended to be used in health care facilities. The document provides comprehensive information and direction for personnel who handle the processing of these devices and accessories.
The committee actually started out writing a Technical Report, intending to create a document that would gather together all existing guidance in the area. However, during development it became clear that more guidance was required than existed at the time. So the publication has expanded to become an American National Standard.
AAMI ST91 starts with the usual scope and definitions sections. Clause 3 reviews the design of the endoscope processing area, including work flow considerations, etc. Clause 4 discusses personnel issues, like training, hygiene, clothing, policies, and immunizations. Clauses 5 to 9 cover various topics in sterilization and processing itself, including automated endoscope reprocessors, sterile endoscope sheaths, and processing accessories. Clauses 10 and 11 are focused on storage and transport. Finally a lengthy Clause 12 discusses the many facets of quality control required in this setting. A 5-page bibliography completes the document.
You’ll want to get a copy and you can order online at Document Center’s webstore, www.document-center.com. AAMI standards are available in both paper and pdf format, as well as part of our Standards Online multi-user subscription service. As an authorized AAMI distributor, Document Center can offer you not only the publication, but affiliated services to assure the proper use of compliance information in your organization. Make us your Standards Experts!
