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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A good medical equipment management plan is a thing of beauty. The bad ones are often confusing, disorganized, out of date, incomplete, and downright painful to read. To make life easier for your Joint Commission surveyor, your superiors, and yourself, keep these tips in mind as you write, edit, and polish your MEMP.
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Rather than starting from scratch, you can use the HITRUST risk management framework to provide guidance for what you might need to change to ensure your common security framework provides adequate cybersecurity.
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The history of healthcare technology management has two sides: “before the introduction of complex information technology to the point of care” and “after,” says Rick Schrenker. But no matter how the field evolves, at least one thing hasn’t changed, or shouldn’t. Only CE/HTM is equipped with the perspective and experience to ensure the safe application of technology at the point of care.
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