ガイドライン

スポルディング分類に基づいたガイドラインは、患者の安全を守るための超音波プローブの最低限の消毒方法を決定するのに役立ちます。

超音波ユーザーが超音波プローブに必要とされる適切な消毒レベルを判断する際に役立つ幅広いガイドラインが世界中で利用可能です。


粘膜や非接触の皮膚に接触するすべての超音波プローブについて、ガイドラインでは、殺菌、殺ウイルス、殺真菌、殺マイコバクテリアの効果が実証された高水準消毒(HLD)を推奨しています。

表1.超音波プローブの再処理に関する
米国連邦政府のガイドライン、国家規格、専門学会のガイドライン。また、HLDと超音波プローブの再処理を扱った国際的なガイドラインも掲載しています。

発行機関

ガイドライン/規格の名称

米国

Centre for Disease Control and Prevention (CDC)

 

Guideline for Disinfection and Sterilization in Healthcare Facilities

2019

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

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

世界

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

欧州

欧州放射線学会

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(スウェーデン)

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(ベルギー)

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

2019

Ministère des Solidarités et de la Santé(フランス)

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

2019

Werkgroep Infectie Preventie(オランダ)

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

2017

Stuurgroep Flexibele Endoscopen Reiniging en Desinfectie(オランダ)

Kwaliteitshandboek Reiniging en Desinfectie Flexibele Endoscopen: 118

2016

Kommission für Krankenhaushygiene und Infektionsprävention(ドイツ)

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

2012

Direzione Sanitaria AUSL Pescara(イタリア)

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

2009

英国およびアイルランド

British Medical Ultrasound Society & Society & College of Radiographers

Guidelines For Professional Ultrasound Practice

2017

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

オーストラリアおよびニュージーランド

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).

2019

National Health and Medical Research Council (NHMRC)

Australian Guidelines for the Prevention and Control of Infection in Healthcare. Canberra, Australia: NHMRC; 2019

2019

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

AS/NZS 4187:2014 Cleaning, disinfecting and sterilising reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities 2015

2015

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

AS/NZS 4815:2006 Office-based health care facilities - Reprocessing of reusable medical and surgical instruments and equipment, and maintenance of the associated environment. 2006

2006

カナダ

CSA Group

CAN/CSA-Z314-18 Canadian medical device reprocessing

2018

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