A Shared Purpose

Disinfection and sterilization have a shared purpose to reduce the number of microorganisms on medical devices to reduce the possibility of transmitting infections to patients.

Understanding the Difference¹

Disinfection

A process that eliminates many or all pathogenic or all pathogenic microorganisms, except bacterial spores

Sterilization

A process that destroys or eliminates all forms of microbial life

Most Difficult to Kill

Less Difficult to Kill

Reprocessing Modality


Organism Sterilization High-Level
Disinfection (HLD)
Bacterial Spores   X
Mycobacteria    
Fungi    
Vegetative Bacteria    
Enveloped Viruses    

Reprocessing Modality


Organism Sterilization

Most Difficult to Kill

Bacterial Spores  
Mycobacteria  
Fungi  
Vegetative Bacteria  
Enveloped Viruses  

Less Difficult to Kill


Organism High-Level
Disinfection (HLD)

Most Difficult to Kill

Bacterial Spores X
Mycobacteria  
Fungi  
Vegetative Bacteria  
Enveloped Viruses  

Less Difficult to Kill

Classification and Examples of Medical Devices and/or Equipment²

For over thirty years, many infection control professionals have relied on the Spaulding Classification of critical and semi-critical instruments to determine the reprocessing modality.

Critical Items

Surgical instruments and ultrasound probes

Medical devices involved with a break in the skin or mucous membrane or entering a sterile body cavity

Semi-Critical

Laryngoscopes and some endoscopes used in GI Procedures

Medical devices that are intended to come in contact with mucous membranes or nonintact skin

Shift to Sterilization

Key organizations such as AAMI and AORN are calling for a shift to sterilization.

AAMI Logo

AAMI TIR68: 2018 3.43

“Semi-critical devices are devices that contact intact mucous membranes or non-intact skin. Users should be instructed to thoroughly clean these devices and then reprocess them by sterilization. If the device design does not permit sterilization (e.g., device materials cannot withstand sterilization), then high-level disinfection should be used.”

AORN Logo

AORN Recommendation4

“Items that are classified as semi-critical, such as endoscopes, should be sterilized whenever possible and undergo HLD at a minimum if sterilization is not possible.”

Evaluating the Appropriate Reprocessing Modality

STERRAD® Systems can sterilize a wide-range of instruments

For a list of model numbers that can be sterilized in STERRAD® Systems, please visit the STERRAD® Sterility Guide at www.sterradsterilityguide.com.

Request a consultation today with one of our sterilization experts.

References

  1. Centers for Disease Control and Prevention (CDC). Introduction, Methods, Definition of Terms -Guideline for Disinfection and Sterilization in Healthcare Facilities (2008) https://www.cdc.gov/infectioncontrol/guidelines/disinfection/introduction.html.

  2. Centers for Disease Control and Prevention (CDC). A Rational Approach to Disinfection and Sterilization - Guideline for Disinfection and Sterilization in Healthcare Facilities (2008). https://www.cdc.gov/infectioncontrol/guidelines/disinfection/rational-approach.html.

  3. American National Standard/Association for the Advancement of Medical Instrumentation. ANSI/AAMI TIR68:2018 Low and intermediate-level disinfection in healthcare settings for medical devices and patient care equipment and sterile processing environmental surfaces.

  4. Association of periOperative Registered Nurses (AORN). 6 Dos and Don’ts for Sterile Processing in ASCs. September 25, 2019. https://www.aorn.org/about-aorn/aornnewsroom/periop-today-newsletter/2019/2019-articles/sterile-processing-in-ascs

*ASP AEROFLEX™ AER and EVOTECH® ECR have been cleared by United States Food and Drug Administration (FDA) to high-level disinfect flexible, semi-critical endoscopes.

**Does not eliminate bedside cleaning and may not eliminate manual cleaning; Health Care facilities should follow their own policies and procedures related to the reprocessing of endoscopes to ensure they are complying with all steps recommended by the device manufacturers and are consistent with current standards and guidelines. Not all endoscopes can be automatically cleaned but may be high-level disinfected. It is recommended that endoscopes with open/closed elevator wire channels be manually cleaned as per manufacturer's instructions in addition to using the cleaning cycle of the EVOTECH® System. Please refer to the EVOTECH® ECR User Guide and specific connection diagrams for more detailed information regarding cycle capabilities.

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