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Ensuring clinical efficacy and patient safety with repaired ultrasound probes

Overview This special communication highlights the potential electrical, heating and clinical risk caused by repairs carried out on ultrasound probes by manufacturers who are not the original equipment manufacturer (OEM). Such manufacturers are not regulated by the FDA and thus can result in ‘repaired’ probes with significant electrical, acoustic or heating defects. Three recommendations are made by the authors: (1) All ultrasound probe repair manufacturers should be held to the same regulatory and compliance standards as OEMs. (2) When selecting or replacing probes, clinics should select a quality vendor (ISO certified). (3) Clinics should track performance of probes by regular scanning of a tissue mimicking phantom target.


Authors Bigelow TA, Moore GW, Zagzebski JA


Journal Journal of Ultrasound in Medicine 2018;37:315-328.
Recommendation/Comment Relevant for clinical/medical physics departments who have repaired ultrasound probes.
Clinical implication The performance of probes which are not repaired by original equipment manufacturer are not FDA regulate.
Link (DOI) https://doi.org/10.1002/jum.14503
Ultrasound speciality Physics and US equipment; Quality and Safety issues