Guidelines

Guidelines based on the Spaulding Classification help you determine the minimum disinfection for ultrasound probes to help keep patients safe.

Guidelines

Guidelines based on the Spaulding Classification help you determine the minimum disinfection for ultrasound probes to help keep patients safe.

An extensive range of guidelines are available in the Canada and internationally to help ultrasound users determine the appropriate disinfection level required for ultrasound probes.


For all ultrasound probes that contact mucous membranes or non-intact skin, guidelines recommend high level disinfection (HLD) with demonstrated bactericidal, virucidal, fungicidal and mycobactericidal efficacy.

Table 1. US Federal guidelines, National standards and guidelines from professional societies on ultrasound probe reprocessing. International guidelines are also listed that address HLD and ultrasound probe reprocessing.

Issuing Organization

Name of Guideline/Standard

Year

Canada

CSA Group

CAN/CSA-Z314-18 Canadian medical device reprocessing

2018

Health Canada

Safety and Effectiveness Requirements for High-Level Disinfectants and Sterilants for use on Reusable Semi-Critical and Critical Medical Devices

2018

Health Canada

Information to Be Provided by Manufacturers for the
Reprocessing and Sterilization of Reusable Medical Devices

2011

Sonography Canada

Professional Practice Guidelines and Member Policies

2018

United States

Centers for Disease Control and Prevention (CDC) 

Guideline for Disinfection and Sterilization in Healthcare Facilities

2008

Food and Drug Administration (FDA) 

Marketing Clearance of Diagnostic Ultrasound Systems and Transducers

2019

American National Standards Institute (ANSI), Association for the Advancement of Medical Instrumentation (AAMI)

ST58:2013 Chemical sterilization and high-level disinfection in health care facilities

2013

ECRI Institute

Cleaning and Disinfecting Diagnostic Ultrasound Transducers: Our Recommendations

2018

Society of Diagnostic Medical Sonography (SDMS)

Guidelines for infection prevention and control in sonography: reprocessing the ultrasound transducer

2020

American Institute of Ultrasound in Medicine (AIUM)

Guidelines for Cleaning and Preparing External- and Internal-Use Ultrasound Transducers and Equipment Between Patients as well as Safe Handling and Use of Ultrasound Coupling Gel

2020

United Kingdom and Ireland

British Medical Ultrasound Society & Society & College of Radiographers

Guidelines For Professional Ultrasound Practice

2018

Health Facilities Scotland/Health Protection Scotland

NHSScotland Guidance for Decontamination of Semi-Critical Ultrasound Probes; Semi-invasive and Non-invasive Ultrasound Probes

2017

Health Service Executive Ireland

HSE Guidance for Decontamination of Semi-critical Ultrasound Probes; Semi‐invasive and Non‐invasive Ultrasound Probes

2016

Australia & New Zealand

Australasian College for Infection Prevention and Control/Australasian Society for Ultrasound in Medicine

Guidelines for Reprocessing Ultrasound Transducers

2017

College of Intensive Care Medicine of Australia and New Zealand (CICM)

Prevention of pathogen transmission during ultrasound use in the Intensive Care Unit: Recommendations from the College of Intensive Care Medicine Ultrasound Special Interest Group (USIG).

2020

National Health and Medical Research Council (NHMRC)

Australian Guidelines for the Prevention and Control of Infection in Healthcare. 

2019

Standards Australia (AS), Standards New Zealand (NZS)

AS 5369:2023 Reprocessing of reusable medical devices and other devices in health and non-health related facilities

2023

Europe

European Society of Radiology

Infection prevention and control in ultrasound - best practice recommendations from the European Society of Radiology Ultrasound Working Group

2017

European Committee for Medical Ultrasound Safety

Best Practice recommendations for cleaning and disinfection of ultrasound transducers whilst maintaining transducer integrity

2017

Svensk Förening för Obstetrik och Gynekologi (Sweden)

SFOG råd angående transducerskydd och desinfektion av ultraljudsprober vid all gynekologisk och obstetrisk ultraljudsundersökning inom öppen och slutenvård

2019

Hoge Gezondheidsraad / Conseil Supérieur de la Santé (Belgium)

Aanbevelingen inzake de infectiepreventie en het beheer van warmtegevoelige endocavitaire endoscpen en medische hulpmiddelen

2019

Ministère des Solidarités et de la Santé (France)

Proposition technique du groupe de travail national. Prevention du risque infectieux associe aux actes d'echographie endocavitaire: 28

2019

Werkgroep Infectie Preventie (Netherlands)

Reiniging, desinfectie en sterilisatie van medische hulpmiddelen voor hergebruik niet-kritisch, semi-kritisch of kritisch gebruik: 56

2017

Stuurgroep Flexibele Endoscopen Reiniging en Desinfectie (Netherlands)

Kwaliteitshandboek Reiniging en Desinfectie Flexibele Endoscopen: 118

2016

Kommission für Krankenhaushygiene und Infektionsprävention (Germany)

Anforderungen an die Hygiene bei der Aufbereitung von Medizinprodukten. Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz: 66

2012

Direzione Sanitaria AUSL Pescara (Italy)

Linee Guida per la “Corretta gestione di Procedure Assistenziali e Igienico-Sanitarie in Setting di Cura Ospedalieri e Territoriali”: 88

2009

World

World Federation for Hospital Sterilisation Sciences

Guideline for Reusable Medical Devices

2019

World Federation for Ultrasound in Medicine and Biology

Guidelines for Cleaning Transvaginal Ultrasound Transducers Between Patients

2017

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