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Effective URL: https://www.nanosonics.us/infection-prevention/spaulding-classification
Submission: On December 02 via api from US — Scanned from US
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About Us Our Story Board of Directors Leadership Team Careers Investor Center Contact New Customer Setup Back Products Products View trophon®2 Nanosonics AuditPro™ trophon® EPR Global Standard of Care trophon Technology Probe Compatibility trophon® Companion Wipes Infection Prevention Infection Prevention View Healthcare-Associated Infections Clinical Use of Ultrasound Infection Risk from Ultrasound Spaulding Classification When to HLD Best Practice HLD Medical Device Reprocessing Guidelines Resources Resources View Customer Voices Clinical Resources Hub News Events Nanosonics Academy Customer Center Partner Center About Us About Us View Our Story Board of Directors Leadership Team Careers Investor Center Contact New Customer Setup Investor Center Partner Center Customer Center Nanosonics Academy Enquire now Search Home Infection Prevention Spaulding Classification SPAULDING CLASSIFICATION The internationally adopted framework for disinfection and sterilization of medical devices. Speak with a Clinical Specialist Speak with a Clinical Specialist +1 844 876 7466 infous@nanosonics.us Contact us Earle H. Spaulding recognised a disinfection framework was required since all reusable medical devices cannot be sterilized1 The Spaulding Classification met a key unmet need that today still forms the basis of international medical device disinfection guidelines. -------------------------------------------------------------------------------- THE SPAULDING CLASSIFICATION The Spaulding Classification stratifies the risk of infection transmission based on the patient tissue the device will contact during use. The device classification determines the level of disinfection/sterilization required (Table 1). Table 1: Overview of The Spaulding Classification.1-3 Spaulding Classification Medical Device Contacts Risk of Infection Transmission Disinfection Level Critical Sterile tissue or the bloodstream High Sterilization* Semi-critical Mucous membranes or non-intact skin Medium High Level Disinfection (HLD) Non-critical Intact skin only Low Intermediate level (ILD) or Low level disinfection (LLD) * Critical ultrasound probes can be high level disinfected and used with a sterile sheath if sterilization is not possible.2 -------------------------------------------------------------------------------- STERILIZATION Sterilization destroys all microorganisms.2,4 Critical devices must be sterile when used.1 -------------------------------------------------------------------------------- HIGH LEVEL DISINFECTION (HLD) HLD destroys all microorganisms however a small number of bacterial endospores are permitted to remain.2,4 A high level disinfectant is therefore bactericidal, virucidal (both lipid and non-lipid viruses), fungicidal and mycobactericidal. 2,4 Semi-critical ultrasound probes must undergo HLD and be used with a sheath.2,3 Critical ultrasound probes that cannot be sterilized can also undergo HLD.4,6 They must also be used with a sterile sheath.4,6 Sterilization and HLD processes are regulated by the FDA.4,5 Learn when to HLD ultrasound probes Learn about HLD with the trophon®2 device -------------------------------------------------------------------------------- LOW & INTERMEDIATE LEVEL DISINFECTION An intermediate level or low level instrument grade disinfectant may be used for disinfection of non-critical instruments.5 A low level disinfectant destroys all vegetative bacteria (except tubercle bacilli), lipid viruses, some non-lipid viruses, and some fungi, but not bacterial spores.2 An intermediate level disinfectant destroys all vegetative bacteria, including tubercle bacilli, lipid viruses, some non-lipid viruses, and fungi, but not bacterial spores.2 Low level disinfectants and intermediate level disinfectants are regulated by the US Environmental Protection Agency (EPA).4,5 -------------------------------------------------------------------------------- UNDERSTANDING DISINFECTION It is important to recognize there are differences between disinfection levels and sterilization. Correctly applying The Spaulding Classification to medical devices is a key part of keeping patients safe from HAIs. References References 1. Spaulding EH (1968). Chemical disinfection of medical and surgical materials. Disinfection, sterilization, and preservation. Lawrence C, Block SS. Philadelphia (PA), Lea & Febiger: 517-531. 2. CDC 2008. Guideline for Disinfection and Sterilization in Healthcare Facilities. 3. FDA 2019. Marketing Clearance of Diagnostic Ultrasound Systems and Transducers. 4. FDA 2000. Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants. 5. MOU 225-93-4005. Memorandum of Understanding Between The US FDA Public Health Service and The Department of Health and Human Services and The US EPA. 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