|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.
|Bigelow TA, Moore GW, Zagzebski JA
|Journal of Ultrasound in Medicine 2018;37:315-328.
|Relevant for clinical/medical physics departments who have repaired ultrasound probes.
|The performance of probes which are not repaired by original equipment manufacturer are not FDA regulate.
|Physics and US equipment; Quality and Safety issues