ANSI/AAMI ST79, The comprehensive guide to steam sterilization and sterility assurance in healthcare facilities is known in the sterile processing profession as the bible for reprocessing guidelines. There have been no updates or amendments since 2003, until now.
This comprehensive update to ST79 has major revisions, that includes a user-friendly reorganization of content, ST79 is more relevant and valuable to reprocessing personnel than ever before. I’m proud to have been a member of the standards committee that worked on this revision.
So, what’s new with the third edition of ST79:2017? The significant changes include new guidance on HVAC systems in relation to the well-being of sterile processing personnel and revised guidance on the placement of instruments.
On the first point, it helps to know about another standard: ANSI/ASHE/ASHRAE Standard170, Ventilation of Health Care Facilities. This document offers guidance, regulations, and mandates for facility designers, and it defines sterile processing as a critical area. In order to harmonize with the ASHRAE document, the new version of ST79 includes language in section 220.127.116.11 that explains that facilities should identify which version of ASHRAE 170 will be used, based on when the HVAC system was initially installed or last upgraded.
In the 2017 version of ST79, there is a new Annex Q that describes alternatives for keeping cool in the sterile processing environment. The guidance will help organizations to establish and implement systematic processes for monitoring HVAC performance parameters. If a variance in the HVAC parameters occurs, sterile processing personnel—in combination with a multidisciplinary team that includes, for example, the facility engineer, infection prevention controller, risk manager, sterile processing manager or designated personnel—should conduct a risk assessment. The effect of the HVAC system parameters falling out of range is variable. A small variance for a short period of time may not be of clinical concern, whereas a large variance for a longer period may have clinical significance. A risk assessment provides necessary information to guide appropriate response measures.
Annex Q explains that personnel wearing personal protective equipment, or PPE, in the decontamination may overheat and perspire. Unfortunately, just lowering the room temperature may not be an effective way to reduce body temperature because not enough skin is exposed to the air for perspiration to evaporate and cool the body. However, there are steps that can be taken to heat or cool the body as needed. The new annex discusses alternative cooling methods for personnel working in the decontamination room.
ST79 now offers clearer guidance on placement of instruments. Previous editions stated that instruments should be held open and unlocked. This guidance resulted in confusion because some surveyors thought it meant the instruments must be held wide open. In the new version of ST79, we eliminated the word “open” to alleviate the potential for confusion. It now states that “ratcheted instruments should be unlatched. Racks, pins, stringers, or other specifically designed devices can be used to hold the instruments in the unlatched position.”
Additionally, information on Immediate-use steam sterilization (IUSS) has been included in section 10, instead of just being mentioned in the introduction. As we know, the only difference between IUSS and terminal sterilization is IUSS has little or no dry time.
Lastly, as noted in the introduction, ST79 applies to a variety of facilities which includes hospitals, ambulatory surgery facilities, physicians’ offices, cardiac catheterization laboratories, endoscopy suites, radiology departments, dental offices, and other areas where sterile products are reprocessed, stored, and used.
ST79 is the go-to reference for steam sterilization in all healthcare facilities, regardless of sterilizer or facility size. Developed by sterilization and manufacturing professionals ST79:2017 helps you to:
- Ensure safety at every step for processing medical devices
- Assure continuous maintenance and proper sterilization practices of processed items across multiple facility departments (i.e., OR, ER)
- Understand the complete lifecycle of sterilization processing—from managing temperature and humidity to processes for the decontamination area
- Validate the need for equipment upgrades to meet federal guidelines that reduce potential citations
- Stay in compliance with the latest industry standards and regulatory bodies like The Joint Commission
- Support the delivery of properly processed medical devices critical to optimizing patients’ health
- Guide personnel toward desirable performance objectives