Guideline for Technical Quality Assurance (TQA) of Ultrasound devices (B-Mode) – Version 1.0 (July 2012)

Abstract

The Technical Quality Assurance group was initiated by the EFSUMB Board in 2007 and met firstly in 2008 to discuss and evaluate methods and procedures published for performing technical quality assurance for diagnostic ultrasound devices. It is the aim of this group of experts to advise the EFSUMB Board of effective and efficacious methods for routine use and to make recommendations regarding the technical aspects of EFSUMB by-law 9, parts 11.6. & 11.7. The group´s work focused on new developments and related European projects to establish a common guideline. There is a great need of a well established protocol and dedicated processing software for the performance testing of medical ultrasound equipment. The measurements should be user independent as much as physically possible. Only if these goals are achieved in an international (firstly European) context, the optimal quality of ultrasound imaging can be offered and maintained to the medical community. This guideline aims to offer and summarize suitable procedures and evaluation processes to lend support for an optimal Technical Quality Assurance (TQA) scheme. The content of this guideline was presented to the EFSUMB Board of Directors (delegates) and approved by the EFSUMB Executive Board (ExB) at the regular meeting during EUROSON 2012 in Madrid April 2012.

Zusammenfassung

Die Technische Qualitätssicherungsgruppe wurde 2007 vom EFSUMB Board initiiert und trat 2008 das erste Mal zusammen, um bestehende Methoden und Prüfprozeduren zur technischen Qualitätssicherung von diagnostischen Ultraschallgeräten zu diskutieren und zu bewerten. Ein Anliegen dieser Gruppe von Experten ist es, das EFSUMB Board über effektive und wirksame Methoden für den alltäglichen Gebrauch zu beraten und Empfehlungen zu den technischen Aspekten im EFSUMB by-law 9, Teil 11.6. & 11.7 abzugeben. Dabei fokussierte die Gruppe ihre Arbeit auf neue Entwicklungen und vorhandene europäische Projekte, um eine Leitlinie mit breitem Konsens zu schaffen. Es besteht ein großer Bedarf an geeigneten Prüfabläufen und entsprechender Auswerte-Software für Performance-Tests von medizinischen Ultraschallgeräten. Außerdem sollten die Messungen dabei so Durchführer-unabhängig sein wie möglich. Erst durch Erreichen dieser Ziele in einem internationalen (vorerst europäischen) Kontext kann eine optimale Qualität der Ultraschallbildgebung für den medizinischen Bereich angeboten und gewährleistet werden. Diese Leitlinie hat daher zum Ziel, geeignete Prüfprozeduren und Evaluierungsprozesse zusammenzustellen und zur Verfügung zu stellen, um bei der Durchführung einer optimalen technischen Qualitätssicherung (TQA) Unterstützung zu bieten. Der Inhalt dieser Leitlinie wurde dem EFSUMB Board of Directors (Delegierte) präsentiert und vom EFSUMB Executive Board (ExB) in der regulären Sitzung auf der EUROSON 2012 in Madrid im April 2012 beschlossen.

Key words

ultrasound - QA/QC - safety - technical aspects - physics

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