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Evidence-Based Guidelines and Standards: Following IFUs Results in Best Patient Outcomes

The Centers for Medicare and Medicaid Services (CMS) and The Joint Commission (TJC) emphasize the need for healthcare facilites to implement evidence-based practices relating to high-level disinfection (HLD) and sterilization. This means following the most current published guidelines and standards.

The Joint Commission’s National Patient Safety Goals (NPSG) 07.05.01 states facilities should: “Implement evidence-based practices for preventing surgical site infections.”1 Element of performance #3 under that NPSG states facilities should implement policies and procedures aimed at reducing the risk of surgical site infections: These policies and procedures meet regulatory requirements and are aligned with evidence-based guidelines (for example, The Centers for Disease Control and Prevention and/or other professional organizational guidelines).

The Joint Commission’s High-Level Disinfection and Sterilization BoosterPak was developed to helpensure work practices are carried out following regulatory standards and evidence-based guidelines for HLD and sterilization to minimize the potential risk of infection transmission to patients.1 

Professional organizations that publicize nationally recognized guidelines or recommendations on HLD and sterilization include, but are not limited to:

  • Association of periOperative Registered Nurses (AORN)
  • Association for the Advancement of Medical Instrumentation (AAMI)
  • CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008
  • Association for Professionals in Infection Control and Epidemiology (APIC)
  • Society of Gastroenterology Nurses and Associates, Inc. (SGNA)

AORNhas used an evidence-based practice model since 2012 when developing guidelines. The appropriate research and other evidence is critically appraised according to the strength and quality of the evidence. The AORN guidelines for reprocessing reusable medical devices include:

  • Cleaning and processing flexible endoscopes
  • High-level disinfection
  • Cleaning and care of surgical instruments
  • Selection and use of packaging systems for sterilization
  • Sterilization

AAMI standards development is a lengthy and meticulous process that requires a consensus review process by stakeholders who represent:

  • Manufacturers
  • Testing laboratories
  • Regulatory agencies
  • Professional associations: APIC, AORN, SGNA, and International Association of Healthcare Central Service Materiel Management (IAHCSMM)
  • Clinical users
  • Interested parties

AAMI standards for HLD and sterilization include:

  • ANSI/AAMI ST58, Chemical Sterilization and High-Level Disinfection in Health Care Facilities
  • 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 ST90, Processing of Health Care Products—Quality Management Systems for Processing in Health Care Facilities

Each AAMI standard is assigned to a working group who reviews the draft and then submits comments that have clinical implications or reflect process changes due to current evidence-based research. The review process includes face-to-face meetings, conference calls, consensus for a draft document, and substantial agreement among all stakeholders. The working group develops a draft document which actively seeks input from all stakeholders and then sends it out for public review and comment. These standards then go to the American National Standards Institute (ANSI) for approval as our American National Standards.

Following evidence-based guidelines and standards will improve processes that result in decreased risks to patients. That, of course, means following all device, equipment, and chemical manufacturers’ instructions for use (IFU). Frontline staff who are responsible for performing HLD and sterilization should follow all IFU steps thoroughly and accurately according to both the manufacturers’ IFUs and evidence-based guidelines.

However, we still see many questions on sterile processing social media sites asking how to process this or that device. I blame leadership. Why? Those who work in the healthcare organizations should continuously focus on improving safety and quality. High-level disinfection andsterilization are complex multistep processes. Leadership should ensure only competent individuals are performing these associated duties. Therefore, leaders should ensure staff have not only initial, but also ongoing and documented competency and training which must include the need to continuously adhere to manufacturers’ IFUs, as well as evidence-based guidelines and standards.1

Guidelines and standards are consistently being updated to reflect current evidence-based science. Healthcare facilities’ policies and procedures should be standardized and be written according to the most current evidence-based guidelines and standards to minimize the potential risk of infection transmission to patients.Failure to monitor the practices has the potential to compromise patient safety. Conducting and documenting ongoing competencies can help to ensure current guidelines, standards, and IFUs are consistently followed, which can improve patient outcomes and avoid condition level finding from accrediting organizations like CMS and TJC.  


  1. The Joint Commission, High-Level Disinfection and Sterilization BoosterPak. Available at https://customer.jointcommission.org/contentPublishing/Pages/Guest-Access-Page.aspx, Accessed June 23, 2019.

Rose Seavey, MBA, BS, RN, CNOR, CRCST, CSPDT, is president/CEO of Seavey Healthcare Consulting and formerly the director of the SPD at The Children’s Hospital of Denver. Rose served on the AORN board of directors and is a past president ASHCSP. She received numerous awards and was named as one of the Who’s Who in Infection Prevention by Infection Control Today. Ms. Seavey is the author of Sterile Processing In Healthcare Facilities: Preparing for Accreditation Surveys, published by AAMI. She serves on several AAMI committees helping to write national standards.

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