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High incidence of defective ultrasound transducers in use in routine clinical practice
KTH, Skolan för teknik och hälsa (STH), Medicinsk teknik, Medicinsk bildteknik.ORCID-id: 0000-0001-9419-910X
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2009 (Engelska)Ingår i: European Journal of Echocardiography, ISSN 1525-2167, E-ISSN 1532-2114, Vol. 10, nr 3, s. 389-394Artikel i tidskrift (Refereegranskat) Published
Abstract [en]

The objective was to evaluate the function of ultrasound transducers in use in routine clinical practice and thereby estimating the incidence of defective transducers. The study comprised a one-time test of 676 transducers from 7 manufacturers which were in daily use in clinical departments at 32 hospitals. They were tested with the Sonora FirstCall Test System; 39.8% exhibited a transducer error. Delamination was detected in 26.5% and break in the cable was detected in 8.4% of the tested transducers. Errors originating from the piezoelectrical elements were unusual. Delamination and short circuit occurred without significant differences between transducers from all tested manufacturers, but the errors break in the cable, weak and dead element showed a statistically significant higher frequency in transducers from certain manufacturers. The high error frequency and the risk for incorrect medical decisions when using a defective transducer indicate an urgent need for increased testing of the transducers in clinical departments.

Ort, förlag, år, upplaga, sidor
2009. Vol. 10, nr 3, s. 389-394
Nyckelord [en]
Ultrasound, Transducer, Probe, Test, Defect, Error
Nationell ämneskategori
Medicinsk apparatteknik
Identifikatorer
URN: urn:nbn:se:kth:diva-32380DOI: 10.1093/ejechocard/jen295ISI: 000264889300008Scopus ID: 2-s2.0-64749104230OAI: oai:DiVA.org:kth-32380DiVA, id: diva2:410367
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QC 20110413

Tillgänglig från: 2011-04-13 Skapad: 2011-04-13 Senast uppdaterad: 2017-12-11Bibliografiskt granskad
Ingår i avhandling
1. Evaluation of Errors and Limitations in Ultrasound Imaging Systems
Öppna denna publikation i ny flik eller fönster >>Evaluation of Errors and Limitations in Ultrasound Imaging Systems
2011 (Engelska)Doktorsavhandling, sammanläggning (Övrigt vetenskapligt)
Abstract [en]

There are binding regulations requiring safety and efficacy aspects of medical devices. The requirements ask for documentation that the devices are safe and effective for their intended use, i.e. if a device has a measuring function it must be correct. In addition to this there are demands for quality systems describing development, manufacturing, labelling, and manufacturing of a device. The requirements are established to guarantee that non-defective medical devices are used in the routine clinical practice. The fast rates in which the imaging modalities have evolved during the last decades have resulted in numerous new diagnostic tools, such as velocity and deformation imaging in ultrasound imaging. However, it seems as if the development of evaluation methods and test routines has not been able to keep up the same pace. Two of the studies in this thesis, Study I and IV, showed that computed tomography-based and ultrasound based volume measurements can yield very disparate measurements, and that tissue Doppler imaging-based ultrasound measurements can be unreliable.

Furthermore, the new ultrasound modalities impose higher demands on the ultrasound transducers. Transducers are known to be fragile, but defective transducers were less of a problem earlier when the ultrasound systems to a lesser extent were used for measurements. The two other studies, Study II and III, showed that serious transducer errors are very common, and that annual testing of the transducers is not sufficient to guarantee an error free function.

The studies in the thesis indicate that the system with Notified Bodies, in accordance with the EU’s Medical Device Directive, checking the function and manufacturing of medical devices does not work entirely satisfactory. They also show that the evaluation of new methods have led to the undesirable situation, where new measuring tools, such as volume rendering from imaging systems, and tissue Doppler-based velocity and deformation imaging in echocardiography are available for clinicians without proven knowledge about their accuracy.

Ort, förlag, år, upplaga, sidor
Stockholm: KTH Royal Institute of Technology, 2011. s. x, 74
Serie
Trita-STH : report, ISSN 1653-3836 ; 2011:3
Nationell ämneskategori
Medicinsk laboratorie- och mätteknik
Identifikatorer
urn:nbn:se:kth:diva-34177 (URN)978-91-7501-026-7 (ISBN)
Disputation
2011-06-10, Sal 3-221, Alfred Nobels Allé 10, Flemingsberg, 13:00 (Svenska)
Opponent
Handledare
Anmärkning
QC 20110527Tillgänglig från: 2011-05-27 Skapad: 2011-05-27 Senast uppdaterad: 2011-05-30Bibliografiskt granskad

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Mårtensson, Mattias

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Mårtensson, MattiasWinter, ReidarBrodin, Lars-Åke
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European Journal of Echocardiography
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