The Association for the Advancement of Medical Instrumentation (AAMI) has released updated healthcare sterilization guidelines (ST79:2017).
Summary of changes
On November 1, 2017, the Association for the Advancement of Medical Instrumentation (AAMI) released a new edition of the Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities (ST79:2017) with numerous new guidelines issued.
The updated guidelines include:
New guidance on setting temperature and humidity parameters
New text on following manufacturers' instructions
Additional material about the types of cleaning equipment that may be used in a sterile processing department
Guidance on the use of ultrasonic cleaners
All healthcare organizations that perform sterilization, including ambulatory surgery centers, physician offices, cardiac catherization laboratories, endoscopy suites, radiology departments, and dentist offices.
Key changes for AAMI ST79:2017
- A major change in AAMI ST79:2017 is a new recommendation for daily testing of the equipment and the results documented (Section 13.2, Monitoring of mechanical cleaning equipment)
- This will require organizations to review their policy and procedures related to testing, look at the financial impact of this new recommendation and possibly look at other options for meeting this recommendation
- The reference tables on the Sterilization Parameters (Section 10.2) have been removed and organizations are now instructed to follow the manufacturer’s instructions. The revised guideline now states:
- “The sterilizer manufacturer’s written IFU should be followed for operation of the sterilizer and indications for use” (Section 10.2.2)
- “The sterilization cycles used by the health care facility should be FDA cleared and should incorporate sterilization monitoring accessories (e.g., CIs, BIs, process challenge devices [PCDs]) and sterilization packaging labeled and cleared for that sterilization cycle” (Section 10.2.2.1)
- A new definition and clearer guidance on immediate-use steam sterilization has also been added (Section 10.2.3)
- AAMI ST79:2017 still recommends that implant loads be monitored with a PCD containing a biological indicator and a Type 5 integrating indicator
- Biological indicators are intended to validate whether the sterilization conditions were adequate to kill a large number of highly resistant bacterial spores and are the only sterilization process monitoring instrument that measures the lethality of the sterilization process
- The section on Chemical indicators (CI) (Section 13.5) did not change in ST79:2017, but
- The ‘type’ definition, rather than ‘class’ of CI, now lines up with the labeling on the CIs you should be seeing on your prep and pack stations
- Internal chemical indicators (Section 188.8.131.52.2) has been slightly modified to read, “One or more internal chemical indicators should be placed within each package, tray, or rigid container. These indicators can be any type (Type 3, 4, 5, or 6) but preferably a Type 5 or Type 6 indicator as these types of CIs provide the user with more information on the critical steam sterilization parameters. All indicators should be used for the cycle(s) for which they are labeled and used in accordance with the manufacturer’s written IFU.”
- The guidelines go on to state: “Internal CIs should be placed so that:
- one CI is visible to the person opening the package;
- CIs are in the area or areas considered least accessible to steam penetration; and
- all applicable written IFU are followed.”
Why are these sterilization guidelines changing?
According to the CDC, approximately 46.5 million surgical procedures are performed each year, each involving contact by a medical device or surgical instrument with a patient’s sterile tissue or mucous membranes. The CDC states that disinfection and sterilization are essential for helping to ensure that medical and surgical instruments do not transmit infectious pathogens to patients.1
The AAMI ST79 guideline is designed to help ensure the steam sterilization of products in healthcare facilities and the maintenance of the sterility of processed items until the point of use. In addition to new or revised guidelines, AAMI ST79:2017 has also been reorganized for easy navigation and readability to further help you stay in compliance with accrediting bodies.
How should you prepare for AAMI ST79:2017?
If your organization performs sterilization, you should have a copy of ST79:2017 on hand and easily accessible to all staff. Whenever there is a revision to rules, regulations, and standards, review your organization’s relative policies and procedures for compliance with the revisions and update them as necessary.
Access these helpful resources to help your facility better prepare:
Additional resources for healthcare providers
The CDC guideline for disinfection and sterilization in healthcare facilities presents recommendations on the preferred methods for cleaning, disinfection and sterilization of patient-care medical devices and for cleaning and disinfecting the healthcare environment.
The International Association of Healthcare Central Service Material Management (IAHCSMM) offers education and certification for healthcare professionals in the cleaning, decontaminating, and sterilizing of medical and surgical instrumentation.
1: Centers for Disease Control and Prevention. 2008 Guideline for Disinfection and Sterilization in Healthcare Facilities: Introduction. 2008: 8, 8-9, 10-12, 84, 98-99. Retrieved from http://www.cdc.gov/hicpac/Disinfection_Sterilization/1_sumIntroMethTerms.html