Testing 1, 2, 3: The Importance of Authenticating Refurbished Ultrasound Parts and Probes
Due to its safe, non-invasive method to obtain images and expanded imaging capabilities, the reliance on ultrasound technology continues to escalate in the healthcare industry. As such, the biomedical engineers responsible for maintaining a hospital’s ultrasound equipment are constantly striving to minimize costly machine downtime — which prevents caregivers from conducting critical procedures for patients — while also controlling expensive equipment service costs.
An excellent way for healthcare facilities to control costs and ensure that ultrasound equipment is functioning properly is to partner with a credible ultrasound support organization that can repair transducers and systems with high-quality refurbished and tested replacement parts. This cost-effective approach can maximize the useful life of equipment and save operators as much as 97 percent relative to OEM solutions.
Ensuring the credibility of third-party support vendors and authenticating refurbished parts is vital to ensuring the reliability of the parts and the quality of ultrasound images and patient diagnosis, so if a part is not repaired correctly there may be serious consequences. Fortunately, there are steps that biomedical engineers can take to authenticate parts and catch any flaws prior to installing an inferior part.
All ultrasound repair companies are required by the FDA to meet original equipment manufacturer (OEM) specifications, but every company documents these specifications differently, and every vendor interprets them differently. Therefore, some ultrasound repair companies may inadvertently make mistakes during the refurbishing process. Even more concerning, some repair companies have been found to intentionally distribute bootlegged parts or parts with inferior or fraudulent repairs in order to increase their profits. For example, some companies remanufacture probe cables offshore and the result is often brittle, sub-quality wires that fail prematurely. There have even been instances of metal transducer connectors being replaced with plastic connectors spray-painted to give them the appearance of metal. This is particularly concerning because it compromises the grounding of the entire system and could put patients in danger.
When parts are not repaired correctly, whether inadvertently or otherwise, there can be serious repercussions. The biggest concern is the safety of the patients who are being examined with the machines. If a probe isn’t performing reliably due to poor repairs or inferior parts it will affect the monitors performing the scans, and diminish a physician’s ability to accurately identify abnormalities and provide a proper diagnosis to guide patient care and ensure the patient’s safety.
In order to avoid the repercussions of an incorrectly repaired part, it is important for clinical engineers to authenticate every refurbished part so they can catch flaws prior to installation. To make this process easier, biomedical engineers should start by identifying vendors that consistently provide high-quality parts. One good indicator of how reliable a company’s parts will be is the length of its warranty. Companies that offer longer warranties deliver higher quality parts that last longer. Another good indicator of a company’s service quality is its reputation within the clinical engineering community.
Upon receiving a refurbished part, healthcare technology managers should ask if the equipment was repaired using OEM specified parts. Although there is no guarantee that the vendor will answer honestly, it is important for clinical engineers to state that they expect OEM specified parts in order to ensure the highest level of quality. Ideally, a refurbished part will exactly match what an OEM would provide and perform to OEM specifications. If a part does not match the OEM, it could indicate a non-OEM specified part or repair.
The FDA requires technicians to meet OEM specifications for parts repairs, but this can be difficult to achieve because manufacturers often do not provide a thorough description of their specifications. This is because the OEMs offer their own repair services to healthcare organizations, so it behooves them to protect this information. As a result, third-party technicians must try to emulate the specs by breaking down and analyzing the quality characteristics of a probe, which is not always an accurate process. In addition, when the FDA is testing for compliancy they do not take into account important repair objectives such as image quality, resolution and how the repair was conducted. All of these elements are incredibly important to the long-term functionality of the part.
The best way for a clinical engineer to determine a refurbished part’s quality is to test it over and over again. When doing so, they should pay particularly close attention when testing arrays, the group of piezoelectric crystals within the transducer housing, because these are replicated with inferior pieces more frequently than other parts. If an engineer is concerned about the quality of a part they should also ask for the part’s repair history. Companies must keep on file the repair and testing logs for every part they refurbish for 10 years. This information provides insight into the repairs that have been performed in the past and confirms that they were completed. When reviewing the repair log clinical engineers should look for specific details about the type of repair to ensure these actions have actually been taken. For example, notations that specify at what point a chip was replaced or when a joint was soldered, can help confirm whether a repair was completed accurately.
Although testing and authenticating parts can be a tedious process, it is paramount to ensuring that ultrasound equipment functions properly. Every individual component contributes to the overall performance of an ultrasound machine. If one part is sub-par the entire machine and the images it produces will be affected and the quality of patient care may be adversely impacted.
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