The Spaulding Classification indicates when to perform high level disinfection (HLD). The Spaulding Classification is the universal framework used by Federal authorities and National standards to determine the minimum level of disinfection for reusable medical devices, including ultrasound probes (Table 1).
Table 1: Overview of The Spaulding Classification.1-4
|
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
HLD must be used for critical ultrasound probes if sterilization is not possible, a sterile sheath must also be applied to the probe.
Ultrasound probes are delicate, heat sensitive medical devices that cannot undergo steam sterilization. Low temperature sterilization methods require the probe to be out of circulation for extended periods of time, disrupting clinical workflow.
Critical probes can be high level disinfected if sterilization is not possible, however the probe must also be covered with a sterile sheath at use.
Probes that risk contact with sterile tissue or the bloodstream are critical, and include probes used in:
- Surgery
- Ultrasound guided percutaneous interventions where the probe may contact the sterile puncture site (e.g. drainages, injections, biopsies)
- Scans across open wounds (e.g. surgical wounds, skin avulsion, 2nd or 3rd degree wounds)
HLD is minimally required for semi-critical ultrasound probes, a sheath must also be applied to the probe.
"Ultrasound transducer probes that will come in contact with mucous membranes shall, at a minimum,
be cleaned and undergo high-level disinfection according to the MIFUs. A clean or sterile sheath shall be
applied to the probe before use as a semi-critical item."
"A vaginal probe and all endocavitary probes without a probe cover are semicritical devices because they have direct contact with mucous membranes (e.g., vagina, rectum, pharynx). While use of the probe cover could be considered as changing the category, this guideline proposes use of a new condom/probe cover for the probe for each patient, and because condoms/probe covers can fail, the probe also should be high-level disinfected."
Probes that risk contact with mucous membranes or non-intact skin are semi critical, and include probes used in:
- Transvaginal scans
- Transrectal scans
- Scans across rash, dermatitis or 1st degree burns
The use of a probe sheath does not change the Spaulding classification of the probe
"Ultrasound transducer probes that will come in contact with mucous membranes shall, at a minimum,
be cleaned and undergo high-level disinfection according to the MIFUs. A clean or sterile sheath shall be
applied to the probe before use as a semi-critical item."
"A vaginal probe and all endocavitary probes without a probe cover are semicritical devices because they have direct contact with mucous membranes (e.g., vagina, rectum, pharynx). While use of the probe cover could be considered as changing the category, this guideline proposes use of a new condom/probe cover for the probe for each patient, and because condoms/probe covers can fail, the probe also should be high-level disinfected."
HLD can optionally be used for non-critical probes, however low level disinfection is sufficient.
Non-critical probes will only contact healthy, intact skin. Low level disinfection is sufficient for these probes. However, optionally performing HLD ensures the probe is ready for any subsequent procedure.
Learn about high level disinfection with the trophon2 device. The trophon2 device can integrate with the range of clinical workflows to help keep your patients safe from cross-infection.
Over 1,000 probes from 25 manufacturers are tested, approved and endorsed for use with trophon devices. View the probe compatibility list.
Following these guidelines and standards are essential in the fight against HAIs.
Read about Federal guidelines on reprocessing semi-critical and critical ultrasound probes
Read about the recommended guidelines and standards in Canada and USA
The trophon® family includes trophon® EPR and trophon®2 which share the same core technology of 'sonically activated' hydrogen peroxide.
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. Canadian Standards Association (CSA). CAN/CSA-Z314-18 Canadian medical device reprocessing. 2018.
3. Health Canada. Guidance Document: Safety and Effectiveness Requirements for High-Level Disinfectants and Sterilants for use on Reusable Semi-Critical and Critical Medical Devices. 2018.
4. Health Canada. Guidance Document: Information to Be Provided by Manufacturers for the
Reprocessing and Sterilization of Reusable Medical Devices. 2011
5. US CDC 2008. Guideline for Disinfection and Sterilization in Healthcare Facilities.
