Assessment of Repaired Diagnostic Ultrasound Probes

Abstract

A growing number of repaired and refurbished diagnostic ultrasound probes are supplied by a small number of original equipment manufacturers (OEMs) and many third-party vendors. OEMs ensure that their devices meet regulatory requirements; any repairs using non-OEM materials carry the risk of non-compliance. The aim of this study was to test examples of probe repairs using methods selected to illustrate their possible impact on function. Of 3212 used probes assessed, 21 were found to have undergone repair involving functional parts: 9 incorrectly wired, 11 non-OEM arrays and 1 relensed probe. For repairs not involving functional parts, before and after electronic probe testing may be sufficient to determine that no damage has occurred. For repairs involving functional parts, a more comprehensive suite of tests is necessary to determine that the materials, parts and final product match the performance of the OEM probe and meet regulatory requirements.