Transducer Testing and Repair

The diagnostic quality of an ultrasound image is strongly dependent on the performance level of the ultrasound transducer used to acquire it. Defective as well as poorly remanufactured or repaired 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:

1. That manufacturers should provide for a periodic automated self-test of transducers that confirms proper operation and informs the operator in the event of failure, as is recommended by US Food and Drug Administration (FDA) Guidance² in Section 5.2.5.6.
2. The manufacturer should also articulate what defines proper operation in terms of the range of 3D image resolution and image contrast that may result from a probe that passes the self-test but is perhaps no longer performing at its original quality.
3. That manufacturers should include periodic preventative maintenance instructions for operators to evaluate proper 3D operation of transducers so that operators can identify when the devices are no longer operating properly. These instructions should follow the recommendations for AIUM Quality Assurance Manual for Gray Scale Ultrasound Scanners and AIUM Routine Quality Assurance of Clinical Ultrasound Equipment 2.0.
4. That users should add these or similar requirements to all purchase, quality control, and service contracts. 
5. 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
6. 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 5.2.6.1.8 of the Guidance²).

References

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; 2023.