Assessment of Repaired Diagnostic Ultrasound Probes

Area of Science:

• Medical Imaging
• Biomedical Engineering
• Ultrasound Technology

Background:

• A significant market exists for repaired and refurbished diagnostic ultrasound probes.
• Original Equipment Manufacturers (OEMs) guarantee regulatory compliance for their devices.
• Repairs using non-OEM materials pose a risk of non-compliance and functional impairment.

Purpose of the Study:

• To evaluate the impact of probe repairs on diagnostic ultrasound probe function.
• To assess the adequacy of testing methods for repaired ultrasound probes.
• To determine if repaired probes meet OEM performance and regulatory standards.

Main Methods:

• Assessment of 3212 used diagnostic ultrasound probes.
• Identification and categorization of probes that underwent repair involving functional parts (incorrect wiring, non-OEM arrays, relensed probes).
• Application of selected testing methods to illustrate the impact of repairs on probe function.

Main Results:

• Out of 3212 probes, 21 required repair involving functional parts.
• Specific issues identified included incorrect wiring (9 probes), non-OEM arrays (11 probes), and relensed probes (1 probe).
• Electronic testing may suffice for repairs not involving functional parts, but comprehensive testing is crucial for functional part repairs.

Conclusions:

• Repairs involving functional parts necessitate a comprehensive testing strategy.
• Ensuring repaired probes match OEM performance and meet regulatory requirements is critical.
• Standard electronic testing is insufficient for verifying the integrity of repairs involving functional components.