Not too long ago, I had discussions with operating room nurses, infection preventionists, and sterile process personnel who say their management does not think their institutions needs to follow the recommended practice in ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 (consolidated text), Comprehensive guide to steam sterilization and sterility assurance in health care facilities, because they do not work in hospitals.
Quality control of the steam sterilization process is the same for a hospital, ambulatory surgery center, clinic, dentist office, or anywhere a steam sterilizer is located. The sterilizer needs to be routinely tested with physical monitors, chemical and biological indicators. The recommended practices for cleaning/decontamination; disinfection; packaging; preparation; loading, sterilization; installation, care, and maintenance of sterilizers; and sterile storage also need to be followed.
All of these activities need to be performed by experienced, knowledgeable people and should be certified by either the Certification Board (http://www.sterileprocessing.org) or IAHCSMM (www.IAHCSMM.org) to document competency and verify qualifications and workplace training as required by regulatory and accrediting agencies.
The Joint Commission (TJC) is using ANSI/AAMI ST79 recommended practices to survey facilities. Both TJC and the Centers for Medicare and Medicaid Services (CMS) are surveying cleaning, disinfection, and sterilization activities. Both organizations want to make sure you have the manufacturer’s instructions for use for all medical devices, cleaning and disinfection products, equipment, and implements and sterilization equipment, packaging and monitors (chemical and biological indicators), and competent personnel. In addition, policies and procedures should be based on evidence-based guidelines such as those from the Centers for Disease Control and Prevention (CDC) and/or professional organization guidelines such as AAMI and the Association of periOperative Registered Nurses (AORN).
Patients should receive the same quality product no matter where the steam sterilization process is located. So yes, every facility that has a steam sterilization process should be following the recommended practices published by AAMI, AORN, and CDC.
Martha L Young, LLC