The Value of Quality – Ultrasound Probe Repairs
Wayne Moore
3/8/2022
At Acertara we are sometimes asked; “why do you charge more for the same probe repair than Company X?” 
In this cost-containment focused environment I consider that a fair question. Acertara operates its probe repair business under an ISO13485:2016 certified quality management system. Further, Acertara voluntarily complies with the strict FDA requirements applied to the introduction of new probes on the market that device Original Equipment Manufacturers (OEMs) are subjected to – and we validate our probe repair essential materials in our ISO17025:2017 accredited acoustic power laboratory. In fact, at Acertara we spend more than 7% of our total annual revenue on research and development focused on ultrasound devices. Our highly skilled and experienced degreed physicists, electrical, software, and mechanical engineers focus on understanding the “processes and mechanisms of failure” of probes used in clinical settings, not simply on how to repair a probe. Our research and development efforts are focused on designing disruptive test devices such as ATLAS™ and AmpSafe 2.0 that can detect problems at a much earlier stage in the failure process. Our test devices are used by HTMs everyday in the hospital to manage their ultrasound assets and protect patients in a more effective manner. With Acertara’s expansive knowledge base, we can mitigate failures through prophylactic design and correction measures, and design repair processes that are repeatable, less intrusive, and over the course of the probe’s product life cycle, less expensive. These actions lead to repair processes that are more deterministic in outcome, result in repairs that last longer (e.g., longer mean-time-to-failure), have a faster turn-around
(mean-time-to-repair) and allow the probe to be repaired multiple times thus extending its useful life. Because multiple repairs of reusable medical device often occur many OEMs also specify “service life” to describe how long their respective products may last in use in properly cared for. For many mechanical assemblies found in ultrasound probes, the wear-out time will be less than the desired operational life of the whole probe, especially with very complex devices such as TEE probes and 3D/4D volumetric probes. But proper replacement of failed assemblies, electronics, materials, and parts, coupled with expert repair techniques, testing and tooling, are the keys to extending the operational life of the probe to the specified OEM service life. This results in the Hospital saving thousands of dollars over premature replacement costs. The outcome of the Acertara probe repair centric engineering efforts result in a probe repair that will cost less over the life of the probe, and extend that life, compared to the so-called inexpensive repair or replacement in lieu of repair, provided by Company X.
Until next month,
Wayne