The spread of ultrasound technology into point-of-care devices has brought cost-effective, high-quality imaging and color flow to virtually all points of the globe. But with this major technological change comes rethinking how to properly care for and test the performance of smartphone-based ultrasound devices.
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The FDA has issued a call for comments concerning medical device repair and refurbishment conducted by original equipment manufacturers and third parties, including healthcare organizations. Seize the opportunity to make your voice heard.
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Since William Hyman published his report on the Food and Drug Administration’s call for comments regarding repair and refurbishment of medical equipment by OEMs and third parties, 24×7 readers have had a lot to say.
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In the past, the FDA has occasionally waded into the territory of medical device service, refurbishment, repair, reconditioning, and modification. The FDA’s new foray into this arena comes in the form of an open-ended request for comments titled “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-party Entities and Original Equipment Manufacturers.”
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Clinical engineering plays a central role in planning for the replacement and acquisition of new capital equipment. The data you provide will directly impact the day-to-day operations and financial well-being of your organization for years to come. So what information do you need to provide, where do you get it, and who needs to receive it?
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