Evidence-based practices critical to sterilization, HLD

Aug. 24, 2018

The Joint Commission (TJC), who has deeming authority by the Centers for Medicare and Medicaid Services (CMS), to survey healthcare facilites emphasizes the need to follow evidence-based guidelines and standards. TJC strongly recommends that healthcare facilites implement evidence-based practices relating to High-level disinfection (HLD) and sterilization.


TJC’s National Patient Safety Goals NPSG.07.05.01 states facilites should be: “Implementing evidence-based practices for preventing surgical site infections”.1,2 Element of performance #3 under that NPSG states facilites 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 (CDC) and/or other professional organizational guidelines.

The High-level Disinfection and Sterilization BoosterPak from TJC was developed to help ensure work practices are carried out following regulatory standards and evidence-based guidelines for HLD and sterilization in order to minimize the potential risk of infection transmission to patients.2

There have been some gastroenterology and ophthalmology physician societies that have published their own guidelines for reprocessing instruments and equipment. Their recommendations are somewhat concerning and confusing to reprocessing professionals who have expertise in these areas. These guidelines are somewhat disconcerting because:

  • Those specialty practice guidelines did not go out for public comments (to my knowledge), consequently, there was no chance of input from experts in the field of HLD and sterilization.
  • Many of the guidelines referenced old or outdated data, and which did not acknowledge the most current evidence based research, thus leading to somewhat misrepresentation of statistics.
  • These physician generated guidelines often contradict nationally recognized guidelines based on strong foundation of scientific evidence that is current.
  • Developments and technologic advancements cleared by the Food and Drug administration for HLD and/or sterilization also were not addressed.

Professional organizations that publicize nationally recognized guidelines, and/or recommendations according to TJC include the:

  • 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).1,2

TJC surveyors are instructed to evaluate compliance based on guidelines that the organization has based their policies and procedures on. The surveyors will look for practice to be consistent throughout the organization.1

TJC recommendations include that facilites conduct a proactive risk assessment as way of identifying gaps in compliance with evidence based guidelines and product manufacturer’s IFU.1, 2 The introductory section of the Leadership (LD) chapter in TJC standards provides an example of a pro-active risk assessment model that an organization may use.1


AORN has 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. 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, and
  • 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, Society of Gastroenterology Nurses and associates (SGNA), and International Association of Healthcare Central Service Materiel Management (IAHCSMM)
  • clinical users, and
  • 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.

Each 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.

Healthcare professions should decrease risks to patients and improve processes by using evidence based guidelines and standards. Staff who manage or perform reprocessing must be competent and follow validated instructions. According to TJC “Managerial staff have knowledge of and use evidence-based guidelines to develop education, training, and competency for high-level disinfection and sterilization”.2 “Front-line staff that are responsible for performing HLD and/or sterilization are initially and routinely monitored to assure that all steps are being conducted thoroughly and accurately (according to both the manufacturer’s instructions for use and evidence-based guidelines).”2

Leadership responsibilities

TJC Standard LD.03.06.01 states: Those who work in the hospital are focused on improving safety and quality.

Element of Performance (EP) 4: states: Those who work in the hospital are competent to complete their assigned responsibilities. Examples include:

“High-level disinfection and sterilization are both complex multi-step processes that rely on competent individuals to assure that safety and quality are continually recognized as driving factors. Initial and on-going competency, training, and adhering to manufacturer’s instructions for use and evidence-based guidelines are important to patient safety.”2


Guidelines and standards are consistently being updated to reflect current evidence-based science. Healthcare facilites’ policies and procedures should be standardized and be written according to current evidence-based guidelines and standards in order to minimize the potential risk of infection transmission to patients. Failure to monitor practice has the potential to compromise patient safety. Conducting a risk assessment routinely can help to ensure theses guidelines are consistently followed and can avoid a Condition Level Deficiency from surveyors. hpn


1. The Joint Commission — Standards FAQ Details. Accessed June 18, 2018.

2. The Joint Commission, High-Level Disinfection and Sterilization BoosterPak. Available @ https://customer.jointcommission.org/contentPublishing/Pages/Guest-Access-Page.aspx Accessed June 18, 2018

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