Ultraschall Med 2012; 33(6): 544-549
DOI: 10.1055/s-0032-1325347
Guideline
© Georg Thieme Verlag KG Stuttgart · New York

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

EFSUMB Technical Quality Assurance Group – US-TQA/BLeitlinien für Technische Qualitätssicherung von Ultraschallgeräten (B-Mode) – Version 1.0 (Juli 2012) 
C. Kollmann
1   Center for Medical Physics & Biomedical Engineering, Medical University Vienna, Austria
,
C. deKorte
2   Clinical Physics Laboratory, UMC St Radboud Nijmegen, The Netherlands
,
N. J. Dudley
3   Medical Physics, United Lincolnshire Hospitals NHS Trust, U.K.
,
N. Gritzmann
4   Gruppenpraxis für Radiologie, Vienna, Austria
,
K. Martin
5   Department of Medical Physics, University Hospitals of Leicester, U.K.
,
D. H. Evans
6   Department of Cardiovascular Sciences, University of Leicester, U.K.
› Institutsangaben
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Publikationsverlauf

03. August 2012

16. August 2012

Publikationsdatum:
16. November 2012 (online)

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.

Supplementary Material

 
  • References

  • 1 King DM, Hangiandreou NJ, Tradup DJ et al. Evaluation of a low-cost liquid ultrasound test object for detection of transducer artefacts. Phys Med Biol 2010; 55: N557-N570
  • 2 Dudley NJ, Griffith K, Houldsworth G et al. A review of two alternative ultrasound quality assurance programmes. Eur J Ultrasound 2001; 12: 233-245
  • 3 Gibson NM, Dudley NJ, Griffith K. A Computerised Ultrasound Quality Control Testing System. Ultrasound Med Biol 2001; 27: 1697-1711
  • 4 Kollmann C, Dolezal L. Technical Quality Evaluation of diagnostic ultrasound systems – a comprehensive overview of regulations and developments. EFSUMB European Course Book Chapter 25; 2011 http://www.efsumb.org/ecb/ecb-01.asp (accessed 26.6.2012)
  • 5 Thijssen JM, Weijers G, deKorte CL. Objective performance testing and quality assurance of medical ultrasound equipment. Ultrasound Med Biol 2007; 33: 460-471
  • 6 Institute of Physics and Engineering in Medicine (IPEM). Quality Assurance of Ultrasound Imaging Systems, Report no. 102. York: 2009
  • 7 American College of Radiology (ACR). ACR Technical Standard for diagnostic medical physics performance monitoring of real time ultrasound equipment Res.3 -2011. www.acr.org/Quality-Safety/Standards-Guidelines/Technical-Standards-by-Modality/Medical-Physics (accessed 26.6.2012)
  • 8 American College of Radiology (ACR). Ultrasound Accreditation Program Requirements; revision 3/23/12. www.acr.org/Quality-Safety/Accreditation/Ultrasound (accessed 26.6.2012)
  • 9 International Electrotechnical Commission (IEC). IEC 60601-2-37, Ed. 2: Medical electrical equipment – Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment. Standard Geneva; 2007
  • 10 International Electrotechnical Commission (IEC). IEC/TR 60854 Edition 1.0. Methods of measuring the performance of ultrasonic pulse-echo diagnostic equipment. Geneva: 1986
  • 11 International Electrotechnical Commission (IEC). IEC 61157 Ed. 2.0 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment. Standard Geneva; 2007
  • 12 International Electrotechnical Commission (IEC). IEC 61161 Ed.3: Ultrasonics – Power measurement – Radiation force balances and performance requirements. Draft Geneva; 2012
  • 13 International Electrotechnical Commission (IEC). IEC 61391-1. Edition 1.0. Ultrasonics – Pulse-echo scanners – Part 1: Techniques for calibrating spatial measurement systems and measurement of system point-spread function response. Geneva: 2006
  • 14 International Electrotechnical Commission (IEC). IEC 61391-2. Edition 1.0. Ultrasonics – Pulse-echo scanners – Part 2: Measurement of maximum depth of penetration and local dynamic range. Geneva: 2010
  • 15 International Electrotechnical Commission (IEC). IEC 61685. Edition 1.0. Ultrasonics – Flow measurement systems – Flow test object. Geneva: 2001
  • 16 International Electrotechnical Commission (IEC). IEC 62127-1. Edition 1.0. Ultrasonics – Hydrophones – Part 1: Measurement and characterization of medical ultrasonic fields up to 40 MHz. Geneva: 2007
  • 17 International Electrotechnical Commission (IEC). IEC 62127-2. Edition 1.0. Ultrasonics – Hydrophones – Ultrasonics – Hydrophones – Part 2: Calibration for ultrasonic fields up to 40 MHz. Geneva: 2007
  • 18 International Electrotechnical Commission (IEC). IEC 62127-3. Edition 1.0. Ultrasonics – Hydrophones – Part 3: Properties of hydrophones for ultrasonic fields up to 40 MHz. Geneva: 2007
  • 19 International Electrotechnical Commission (IEC). IEC 62306 Edition 1.0 Ultrasonics – Field characterisation – Test objects for determining temperature elevation in diagnostic ultrasound fields. Geneva: 2006
  • 20 International Electrotechnical Commission (IEC). IEC 62359. Edition 2.0. Ultrasonics – Field characterization – Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields. Geneva: 2010
  • 21 International Electrotechnical Commission (IEC). IEC 62558. Edition 1.0. Ultrasonics – Real-time pulse-echo scanners – Phantom with cylindrical, artificial cysts in tissue-mimicking material and method for evaluation and periodic testing of 3D-distributions of void-detectability ratio (VDR). Geneva: 2011
  • 22 International Electrotechnical Commission (IEC). IEC 62563-1 Ed.1: Medical Electrical Equipment – Medical image display systems – Part 1: Evaluation methods. Geneva: 2009
  • 23 International Electrotechnical Commission (IEC). IEC 62736 Ed. 1.0 Quality Control of Diagnostic Medical Ultrasound Systems. Draft Geneva; 2011
  • 24 Deutsche Industrie Norm (DIN): Sicherung der Bildqualität in röntgendiagnostischen Betrieben – Teil 57: Abnahmeprüfung an Bildwiedergabegeräten; DIN V 6868-57 (2001-02).
  • 25 American Association of Physicists in Medicne (AAPM). Real-time B-mode ultrasound quality control test procedures. 1998 www.aapm.org/pubs/reports/rpt_65.pdf (accessed 26.6.2012)
  • 26 Shaw A, Hekkenberg R. NPL Report: Standards to Support Performance Evaluation for Diagnostic Ultrasound Imaging Equipment. October 2007 ed. Teddington: National Physical Laboratory; 2007
  • 27 National Health Service (NHS). Guidance Notes for the Acquisition and Testing of Ultrasound Scanners for use in the NHS Breast Screening Programme. NHSBSP Publ. #70 (April 2011). http://www.cancerscreening.nhs.uk/breastscreen/publications/nhsbsp70.html (accessed 26.6.2012)
  • 28 American Institute of Ultrasound in Medicine (AIUM). Routine Quality Assurance for Diagnostic Ultrasound Equipment. Report 2008. USA: Laurel MD.
  • 29 Österr. Gesellschaft für Ultraschall in der Medizin (ÖGUM). Richtlinie über technische Basiserfordernisse für Ultraschall-Diagnostikgeräte (Sonographiegeräte) 2006. http://www.oegum.at/content/blogcategory/142/159/ (accessed 26.6.2012)
  • 30 Mammo–Screening Referenzzentrums für technische Qualitätssicherung (RefZQS). Richtlinie zur Anwendung von apparativen Prüfverfahren für Ultraschall-Diagnostikgeräte in der Mamma-Sonographie B-Bild, Task force Sono, Vers.1.0 (April 2011). Austria: http://www.zmpbmt.meduniwien.ac.at/index.php?id=77&L=0 (accessed 26.6.2012)
  • 31 Hangiandreou NJ, Stekel SF, Tradup DJ et al. Four-year experience with a clinical ultrasound Quality Control program. Ultrasound Med Biol 2011; 37: 1350-1357
  • 32 Martensson M, Olsson M, Segall B et al. High incidence of defective ultrasound transducers in use in routine clinical practice. Eur J Echocardiogr 2009; 10: 389-394
  • 33 Moore GW, Gessert A, Schafer M. The need for evidence-based quality assurance in the modern ultrasound clinical laboratory. Ultrasound 2005; 13: 158-162
  • 34 Martensson M, Olsson M, Brodin LA. Ultrasound transducer function: Annual testing is not sufficient. Eur J Echocardiogr 2010; 11: 801-805