Spaulding Classification Services
Earle H. Spaulding recognised a disinfection framework was required since all reusable medical devices cannot be sterilized. The Spaulding Classification met a key unmet need that today still forms the basis of international medical device disinfection guidelines.
Details
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).
Sterilization
- Sterilization destroys all microorganisms.
- Critical devices must be sterile when used.
High Level Disinfection (HLD)
HLD destroys all microorganisms however a small number of bacterial endospores are permitted to remain. A high level disinfectant is therefore bactericidal, virucidal (both lipid and non-lipid viruses), fungicidal and mycobactericidal.
Semi-critical ultrasound probes must undergo HLD and be used with a sheath.
Critical ultrasound probes that cannot be sterilized can also undergo HLD. They must also be used with a sterile sheath.
Sterilization and HLD processes are regulated by the FDA.
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