Mike Powers: Where Have the Instructions Gone?

I remember a time when a service manual contained the value for a variable resistor that was needed to derive the expected operation of a piece of equipment. I also remember learning how to tweak those resistors, carrying a “tweaker” for just such instances, using an oscilloscope, and even soldering discrete components to a circuit board for an extremely cost effective repair. Those skills attracted me to healthcare technology management as a field because I would be able to put to use things I knew how to do, which were not commonplace in the market.

Then a slow and steady change occurred—that is, the ingress of disposable parts, field-replaceable units, and technicians that could network devices together or build a microprocessor but knew little of measuring the legs of a transistor. Moreover, those changes came amid a flurry of desire for cost savings on repairs, and it did not matter if those savings allowed for a greater margin in for profit service providers or allowed for a lower cost of service for a nonprofit.

I have to admit—I can only think of one person who regularly uses an oscilloscope or can still solder proficiently discrete components on a single or multilayer circuit board. For that matter, I can only think of one brick-and-mortar retailer of discrete components within a four-hour drive of where I sit writing this piece, and there used to be a RadioShack on nearly every corner where you could go test vacuum tubes for free!

With the transition first to depot level repairs, and then to software taking the place of circuitry altogether, I’ve noticed an unfortunate trend. Software is often called “intellectual property” and as such can be considered a trade secret, or at least proprietary to the organization publishing said software. Software can also be licensed instead of purchased in the more discrete way that hardware is, so that often provides a better business model for continuing revenue streams. That, I suspect, is why technical manuals have gotten thinner, and the amount of (AIAT) assembly, installation, adjustment, and testing instructions provided has diminished.

Perhaps as a result, today when you look at your NFPA-99 2012 10.5.3 required documents for servicing and maintenance of equipment, or The Joint Commission’s requirement in the Environment of Care section EP3 that each hospital has a library of information regarding inspection, testing, and maintenance of its equipment and systems, you run into a conflict because the manufacturer’s deem that software information to be intellectual property and trade secrets that they can keep close to their vest.

The service software of today has become the oscilloscope of days gone by, and as long as service software provides a competitive advantage, perhaps in the way that the TV repair person with an oscilloscope versus their competition once shared, then there may be a continued erosion of AIAT.

Mike Powers, MBA, CHTM, CDP, CBA, is a quality manager in Newark, DE.

One thought on “Mike Powers: Where Have the Instructions Gone?

  1. well for me, as I have written in the past, the issues of service manuals and right to repair are to our industry as climate change is to the human race. far too many Biomeds, CEs and Biomed shops must be giving OEMs a free pass thru incoming inspections for new equipment and DEMO device inspections. The only way HTM can win back the high ground is to have an ironclad policy of, if the OEM rep does not provide a fully NFPA compliant factory service manual at the time of inspection, the device fails and does not pass into the hospital.
    not stories, no exceptions. When a vendor accepts a vendor agreement or a vendor mate badge, one of the conditions they accept is that they agree to do business in compliance with federal, state and local laws regulation and codes. NFPA-99 has been accepted as a federally recognized code and thus the service manual clause in it is binding. So don’t just accept a document labeled as a service manual, inventory and check it and require the vendor to provide any missing sections before accepting the device past the inspection. all of the requirements defined for a service manual in NFPA-99 are a subset of the documents required in an FDA device master record so a vendor may not say they don’t have them. As the information is requisite under the national healthcare facilities code, such info made not be withheld as intellectual property. They can in fact share this with BMETs because under the same CBA the vendor signs with the hospital the hospital agrees to safeguard their documents. So if HTM wants to save its own future, it is important that we step up our practice of requiring the sales rep to provide complete factory service manuals.

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