Susan Klacik
By Susan Klacik, BS, CRCST, CIS, CHL, ACE, FCS
Everything done in sterile processing (SP) is done for a reason. Largely, the processes and practices embedded in sterile processing are based on regulations, standards and guidelines. Specific processes for a specific medical device or equipment are developed following the manufacturer’s instructions for use (IFU). IFU are developed using a validation method that is reviewed by the U.S. Food and Drug Administration (FDA). Before a medical device or equipment is permitted to be marketed in the U.S., it must be cleared by the FDA, and this includes the IFU.
Regulations come from the federal and state government, and they must be followed (they are requirements, not just recommendations). Three federal agencies administer regulations that significantly influence the SP department (SPD): the FDA, the Occupational Safety and Health Administration (OSHA) and the U.S. Environmental Protection Agency (EPA).
Best practices used in SP are based on either the Association for the Advancement of Medical Instrumentation (AAMI) standards or Association of periOperative Registered Nurses (AORN) guidelines. These are referenced by accreditation agencies such as The Joint Commission (TJC). The most current best-practice documents should be available in all SPDs for staff to review and reference as needed. While many of these standards and guidelines are similar, there are some notable differences, and any revisions to regulations, standards and guidelines should be communicated to all SP staff.
Essential AAMI standards
AAMI standards are consensus documents developed by technical committees and working groups [in addition to standards and recommended practices, they also develop technical information reports (TIR)]. Standards and recommended practices represent a consensus of users nationwide, and many have been approved as national standards by the American National Standards Institute (ANSI). AAMI documents are developed for medical device manufacturers for the development of instrumentation, sterilizers and quality monitoring products – and also for health care users, such as those in SP areas.
AAMI recommended practices are developed with health care professionals, including SP personnel, medical device and equipment manufacturers, regulators and independent experts. They are based on research and government regulations. The standards are updated every five years to incorporate information about new technology, research and process changes. Between those updates, however, AAMI groups may amendment standards as needed. For this reason, it is important to have the most recently published standards and TIRs ready available.
The following AAMI standards and TIRs should be included in the SPD library for all staff to access:
- ANSI/AAMI ST79 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
- ANSI/AAMI ST91 Flexible and semi-rigid endoscope processing in health care facilities
- ANSI/AAMI ST58 Chemical sterilization and high-level disinfection in health care facilities
- ANSI/AAMI ST90 Processing of health care products – Quality management systems for processing in health care facilities
- AAMI ST108 Water for the reprocessing of medical devices
- AAMI TIR63 Management of loaned critical and semicritical medical devices that require sterilization or high-level disinfection
- AAMI TIR68 Low and intermediate-level disinfection in healthcare settings for medical devices and patient care equipment and sterile processing environmental surfaces
- AAMI TIR67 Promoting safe practices pertaining to the use of sterilant and disinfectant chemicals in health care facilities
AAMI standards are available for purchase at my.aami.org/store.
Additionally, AAMI is currently developing the following new documents. SP leaders should be aware of these so they can obtain and review them and share with staff members:
- AAMI TIR99 Dilators, transesophageal and ultrasound probes in health care facilities
- AAMI TIR117 Guidance for processing tattoo machines and accessories in the healthcare setting
- AAMI TIR118 Guidance on ultraviolet (UV) disinfection for medical devices in health care facilities
- AAMI TIR119 Guidance on Healthcare Implementation and Use of ANSI/AAMI ST108 Water for the processing of medical devices
- AAMI/ADA ST113 Comprehensive guide for steam sterilization and sterility assurance for dental facilities
Key AORN guidelines
AORN Guidelines for Perioperative Practice are evidence-based. The research used is appraised and scored, and each recommendation is rated according to its strength and supporting evidence. Each AORN guideline includes recommendations that are meant to be achievable and represent what is considered best practice of perioperative patient care and workplace safety. Each guideline contains recommendations that are broad statements to guide the development of policies, procedures and criteria for measuring individual competency in a variety of practice settings where operative and other invasive procedures are performed.
Non-research may be included for items such as published literature, systematically developed standards and consensus documents. All are approved by the AORN Guidelines Advisory Board, an interdisciplinary collaboration with representation from allied clinical professional associations, including HSPA and the Association for Professionals in Infection Control (APIC). Each guideline is reviewed and updated on a five-year cycle.
The AORN guidelines that should be in the SPD library are:
- Guideline for Processing of Flexible endoscopes
- Guideline for Manual High-level disinfection
- Guideline for Environmental Cleaning
- Guideline for Care and Cleaning of Surgical Instruments
- Guideline for Sterilization Packaging Systems
- Guideline for Sterilization
- Guideline for Surgical Attire
AORN guidelines are available at www.aorn.org/guidelines.
