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

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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


Another important area of standardization concerns diagnostic data ports and communication protocols. Do we (HTM) own the data contained in our hospital's equipment? Anyone who has done any automotive work knows that they can jack an inexpensive code scanner into the OBDII jack under their steering wheel and read the common systems failure codes and their histories on a tablet or smart phone. The Department of Transportation mandated that the car industry implement OBDII on all cars sold in the U.S.

If I had a magic wand, I would ask for a similar thing for medical equipment from our FDA. Some equipment manufacturers have created ways for BMETs and ISOs to do the same thing while others have said only "their" service department may access this data. Timely access to this data is essential, and I think hospitals should "own" this data inside their equipment and manufacturers should be legally required to make it readily available in a "standard" format using commonly available methods. (PuTTY or Hyper terminal for example).

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I also have to mention that a lot of companies should be credited for already demonstrating industry best practices. Steris, Draeger and Spacelabs all come to mind and there are many others.

Rob Kerwin: I think Scot raised a lot of key points there. I’ll also mention that we certainly think there should be easier and more standardized opportunities for equipment owners and their designated servicers (in-house and ISOs) to obtain access from the manufacturers to service keys, passwords, A.I.A.T. information and spare parts of medical device equipment. If it’s truly about patient safety, and if the equipment has been purchased or leased, why shouldn’t the standards include a requirement that manufacturers should cooperate in providing this information? At a minimum, manufacturers should be complying with their longstanding regulatory requirements to provide A.I.A.T. information, as this is a regulatory obligation for radiation-emitting devices. It is not an accident that the Joint Commission imposed a new requirement on healthcare organizations and hospitals last year, that they are also required to possess a library of information regarding inspection, testing and maintenance of equipment and systems. This library includes manuals, procedures provided by manufacturers, technical bulletins and other information. Accordingly, there should be some public accountability and consequences when manufacturers simply decline to cooperate.

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