Aug 12, 2019
The quality of an ultrasound image is strongly dependent on the quality of the ultrasound transducer used to acquire it. Defective as well as poorly remanufactured transducers can lead to a wrong or missed diagnosis. Regular assessment of transducer operation and quality control of repaired transducers are critical for optimal patient care.1,2
The American Institute of Ultrasound in Medicine recommends the following:
That manufacturers should provide for a periodic automated self-test of transducers to confirm proper operation and that they will inform the operator in the event of failure, as is recommended by US Food and Drug Administration (FDA) Guidance2 in Section 188.8.131.52.
That manufacturers should include periodic preventive maintenance instructions for operators to evaluate proper operation of transducers and to identify when the devices are no longer operating properly.
That users should add these or similar requirements to all purchase, quality control, and service contracts.
That users should regularly check the performance of their transducers by monitoring for element dropout to help ensure that high-quality images are being obtained.1
That users should ensure that replacement, and remanufactured transducers are cleared by the FDA according to Appendix C in the referenced Guidance2 and should contact the original equipment manufacturer for a list of third-party organizations that are qualified to repair its transducers (see Section 184.108.40.206.8 of the Guidance2).
1. Bigelow TA, Moore GW, Zagzebski JA. Ensuring clinical efficacy and patient safety with repaired ultrasound probes. J Ultrasound Med 2018; 37:315–328.
2. US Food and Drug Administration. Marketing Clearance of Diagnostic Ultrasound Systems and Transducers: Guidance for Industry and Food and Drug Administration Staff. Rockville, MD: Department of Health and Human Services, Center for Devices and Radiological Health; 2019.