Center for Improvement in Healthcare Quality Newsletter
November 2021

CIHQ-ARS Article

High Level Disinfection: Training Requirements

By: Cara Nissen
Individuals performing and supervising high-level disinfection (HLD) in healthcare organizations must be knowledgeable and competent to protect patients and employees from the risk of exposure to potentially pathogenic microorganisms. Advances in healthcare technology along with the emergence of new diseases have brought an increased focus on the quality and safety of HLD reprocessing of semi-critical devices.
American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI) ST58 and Center for Disease Control’s (CDC) Guideline for Disinfection and Sterilization in Healthcare Facilities provide specific recommendations regarding the training of personnel which should guide the development of policies, procedures, and training for HLD. Hospitals accredited by CIHQ are required to follow both ANSI/AAMI standards and CDC guidelines. The Joint Commission (TJC) specifically requires hospitals to follow the CDC guidelines, although ANSI/AAMI standards are also frequently used by infection preventionists at these hospitals. This article will summarize requirements from both ANSI/AAMI and CDC to assist hospitals in creating a robust program inclusive of the latest guidelines available.

Competency Validation Requirements for HLD Processing Personnel

Initial training and competency validation is required prior to an individual performing HLD independently. In addition, staff competency is needed when there is a new device, processing equipment, product, or method. The elements that should be included are:
  • Decontamination
    • disassembly/reassembly
    • manual and mechanical cleaning methods
    • microbicidal processes
    • equipment operation
    • standard and transmission-based precautions
    • engineering and work-practice controls
  • Preparation including leak testing
  • High-level disinfection
  • Rinsing
  • Drying
  • Storage
  • Distribution of processed medical devices
  • Specific HLD system used in department
  • Principles of sterilization and infectious disease transmission
  • Infection prevention and control
  • Worker safety as it relates to medical device processing
  • Use of personal protective equipment (PPE) to preclude exposure to infectious agents or chemicals through the respiratory system, skin, or mucous membranes of the eyes, nose, or mouth.
  • Performance characteristics of solution test strips (if applicable) and quality control processes (for example, logs, air filter changes, cleaning of machines)

Training and Activities Recommended for Supervisory Personnel

All the tasks above should be supervised by competent, qualified personnel with a combination of education, training, and experience. Minimum recommended qualifications for supervisors of HLD include:
  • Specialized training (for example, a sterile processing management certification examination)
  • Current knowledge
  • Adequate relevant experience
  • Participation in continuing education programs and courses
  • Comprehensive knowledge of Occupational and Safety Health Administration (OSHA) regulations related to occupational exposure to bloodborne pathogens
  • Participation in facility and departmental in-service and training programs including hands-on training of staff
  • Supervision of all personnel work until competency is documented for each reprocessing task
  • Participation in organizational committees and quality improvement activities
  • Review of written reprocessing instructions regularly to ensure they comply with scientific literature and manufacturers’ instructions for use

Common HLD Challenges

Misconceptions regarding HLD staff training requirements can lead to increased risk for patients and staff and citations by accreditation agencies. Some common missteps include:
  • Staff competency assessment NOT completed:
    • Annually
    • With purchase of a new device requiring a change in HLD process
    • After implementation of new HLD equipment (for example, automatic endoscope reprocessor (AER)
    • With change in HLD soaking solution
  • Vendor in-service lists used instead of individual staff competency assessment forms. Vendors provide a valuable service by providing education to staff. However, staff competency must be validated individually for each employee performing HLD. A vendor in-service attendance list does not meet this requirement unless individual competency validation is completed by hospital personnel at the same time.
  • Lack of awareness that HLD is used or required for certain semi-critical devices (contact mucous membranes). Examples include dental equipment, reusable continuous positive air pressure (CPAP) masks in the sleep lab, laryngoscope blades (emergency department, intensive care unit), anorectal manometry catheters, nasopharyngoscopes in outpatient speech therapy departments, and pessary or diaphragm-fitting rings.
For more information on any of the topics discussed, please reference the ANSI/AAMI standards and CDC guidelines. Team up with your infection prevention, accreditation, and sterile processing departments to ensure HLD processing and supervisory staff are providing care and services that don’t put patients or staff at risk.

References

Chemical sterilization and high-level disinfection in health care facilities Developed by AAMI Approved 21 August 2013 and reaffirmed 9 September 2018 by American National Standards Institute Inc.
Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 Update: May 2019. William A. Rutala, Ph.D., M.P.H., David J. Weber, M.D., M.P.H., and the Healthcare Infection Control Practices Advisory Committee (HICPAC).