When to HLD

Learn when to perform High Level Disinfection (HLD) of ultrasound probes.

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.1-3

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.6,7


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.

"Critical devices should be sterilized, and the use of a sterile sheath is recommended for each use."


"If [sterilization] is not possible, at a minimum the probe should be high-level disinfected and
covered with a sterile probe cover."


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.

"Probes used in semi-critical applications should undergo sterilization between uses whenever feasible, but high level disinfection is minimally acceptable."

"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

"Probes used in semi-critical applications should undergo sterilization between uses whenever feasible, but high level disinfection is minimally acceptable."

"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 trophon®2. trophon2 can integrate with the range of clinical workflows to help keep your patients safe from cross-infection.


Following these guidelines and standards are essential in the fight against HAIs.

Read about U.S. Federal guidelines

Read about Federal guidelines on reprocessing semi-critical and critical ultrasound probes

Download
trophon2 HLD solution

Read about the recommended guidelines and standards in ANZ

Download

Watch the ACIPC 2018 Symposium

Do you work in Emergency? Download our Clinical Bulletin on the importance of high level disinfection of ultrasound probes in ED' Link to gated download of: MM01447-US-CB V03 Oct-20 The importance of HLD of ultrasound probes in ED (A601249)

Download our Clinical Bulletin on Federal guidelines to help guide decision making on reprocessing external ultrasound probes used to guide invasive procedures.' Link to: MM01599-US-CB V05 Oct-20 Reprocessing external ultrasound probes to guide invasive procedures (A516437)

Watch the webinar here

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.

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