Development of transfer standard devices for ensuring the accurate calibration of ultrasonic therapy machines in clinical use

Project Description

Therapeutic ultrasound equipment is widely used upon patients. It can be estimated from a number of surveys that unfortunately 70% of the devices used do not comply with the relevant standard for accuracy in output which states: actual output shall be within ±20% of that indicated on the device. Extreme cases have often been reported where machines in use are delivering effectively no ultrasound or up to many factors greater than the amount indicated. This creates patient injury problems as well as mistreatment.

To address this problem the project plans to:

• Develop an ultrasound power standard, presently being exclusively developed for European national standards laboratories, into a robust and portable form. The power standard would include a Cavitation Detector to determine the onset of adverse measuring conditions. The power standard would be suitable for conducting in-the-field proficiency testing of small companies, hospitals and manufacturers undertaking routine ultrasound therapy machine testing.

• Produce a number of advisory publications and international standards for physiotherapists and those testing ultrasound therapy machines.

Final Report 2006-10-20

The project resulted in the following deliverables

• Four sets of transducers to be used in connection with the Portable Power Standard and Cavitation Detector
• Four prototype Portable Power Standards suitable for the proficiency testing of commercial testers of ultrasound therapy machines "in-the-field"
• Four prototypes Cavitation Detectors to determine the onset of cavitation during the use of the Portable Power Standard or for use as a general tool for establishing the onset of cavitation during power measurements
• Advisory publications in conjunction with the professional associations of interested parties and IEC standards which notify clinical users and commercial testers of the mechanism for obtaining traceability and the key documentation to seek
   

Publications:

• This project has was funded by the 5th Framework programme. (EC-Contract no. G6RD-CT-2001-00600)
• EC report: Development of transfer standard devices for ensuring the accurate calibration of ultrasonic therapy machines in clinical use; EU contract G6RD-CT-2001-00600.
• Rob T. Hekkenberg, Adrian Richards, Klaus Beissner, Bajram Zeqiri, Robert A. Bezemer, Mark Hodnett, Glen Prout and Chris Cantrall, “Transfer standard device to improve the traceable calibration of physiotherapy ultrasound machines”, UMB, Volume 32, Issue 9, September 2006, Pages 1423-1429.
• R. T. Hekkenberg et al.: Development of transfer standard devices for ensuring ... J. Physics. Conf. Series 1 (2004), 99-104.
• R. T. Hekkenberg et al.: Development of transfer standard devices for ensuring ... J. Physics. Conf. Series 1 (2004), 99-104.
• M. Hodnett, B. Zeqiri: A detector for monitoring the on-set of cavitation... J. Physics. Conf. Series 1 (2004), 112-117
• K. Beissner,  “Tragbares Leistungsnormal für die Ultraschall-Physiotherapie”, Development of transfer standard devices for ensuring the accurate calibration of ultrasonic therapy machines in clinical use.
• Final Newsletter on EC project Transfer standard device for ensuring the accurate calibration of ultrasonic therapy machines in clinical use., 14 June 2005 (included)