An extensive range of guidelines are available in the United States 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 |
|---|---|---|
|
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 |
|
Canada |
||
|
CSA Group |
CAN/CSA-Z314-18 Canadian medical device reprocessing |
2018 |
|
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 |
