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Meeting third-party stakeholders halfway: Service after the FDA report

by Gus Iversen, Editor in Chief | August 07, 2018
HTM Parts And Service
From the August 2018 issue of HealthCare Business News magazine

Scot Mackeil: Based on my years of experience, standardization is needed in many key areas. My colleagues in AAMI and the ACCE are doing a great job at addressing this on a larger scale, but I do have three personal favorites, which I’ll recap here.

The first is concerning Service Manual Standards. If a document is to be labeled as a "service manual" this should be legally defined and required. At minimum, a document labeled as a "service manual" should meet the NFPA-99 definition and should be required to specifically include sections on diagnostic data and log files, cybersecurity, and clinical network/software systems integration.

A service manual should also contain a parts source cross reference table so if the device goes out of support or is orphaned by a merger or takeover, the BMET has a chance to support the equipment so as to minimize the negative effects loss of support for a key device can have on the care environment. Such a cross reference would also help enhance the quality of later refurbishing and remanufacturing activities.

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Some manuals feature elaborate drawings and schematics and comprehensive repair and maintenance procedures, including the passwords to access diagnostic routines. Others have what are basically operators manuals with the words "and service" added into the title. Worse yet are what I call “fake” service manuals, these appear on the surface to be legitimate documents, but key information is just not there. Manufacturers concerned about patient safety should provide well-written comprehensive manuals that all HTM professionals could use to service equipment to the highest of standards.

The next area of concern is with regard to preventive maintenance (PM) standards. I have seen a lot of variability in OEM PM "procedures" in similar device types and classes. Some robust and comprehensive, others little more than the same pre-use check the users would perform. In comparison, a "standard" that could be held out as an example, is the ECRI health devices PM procedures document. For me, PM procedures published by an OEM should meet a minimum, professionally set standard for a given device-type for basic common core content, include a clear and comprehensive method to fully test and verify the output/function of the device, and ensure that all key safety features are intact and functional.

In an era when so many devices are driven by software, this is even more important. PM and performance verification procedures are among the key tools used by the BMET in their role in maintaining a safe environment of care for patients and caregivers.

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