William Hyman: Can the FDA Solve the Service Manual Problem?

The latest addition to the long-running battle over adequate access to service manuals for medical devices is The Joint Commission’s (TJC) announcement, via George Mills, at the recent AAMI Annual Conference that starting in January there will be a new element of performance, EC.01.01.01, EP 3, which states: “The organization has a library of information regarding inspection, testing, and maintenance of its equipment and systems. Note: This library includes manuals, procedures provided by manufacturers, technical bulletins, and other information.”

It is said that this EP will give the hospital owners of the devices new ammunition in insisting that manufacturers provide these documents. A simple interpretation of this is that if you are performing service functions you should have appropriate documentation on what those functions are and how they are to be done. But this doesn’t preclude the narrow interpretation that you only need such documentation for that which you are servicing, so that if the manufacturer is blocking you from servicing its equipment you don’t need documentation, and we are then back where we started. In this regard, the word choice in TJC standards is interesting in that EC 02.04.03 reads: “The hospital inspects, tests, and maintains medical equipment.” Is this the same as “The hospital has all medical equipment inspected, tested and maintained”?

Another third party that could be helpful here, but has not been, is the FDA. There exists a potentially powerful labeling requirement for prescription devices (21CFR801.109) for manufacturers to provide “information for use including, indications, effects, routes, methods, and frequency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions under which the device can safely be used.” Here, prescription devices include almost all hospital-based devices, i.e., those which cannot safely used be used by a layman.

The interpretation of this phrase has been that it is limited to the direct clinical use of a device on or for a patient. But a different interpretation for non-single use devices easily could be that “precautions under which a device can be safely used” must include maintenance and service. If service affects safety (which is a different discussion), then the device cannot even be ready to be used safely if it has not been adequately serviced. And if it must be adequately serviced to be used safely, then the labeling should be expected to provide the information for performing the necessary service functions. Thus, the FDA could reasonably decide that adequate labeling includes at least routine service and that, therefore, the manufacturer’s labeling (which includes both labels and other written material) must include how to service the device, preferably in a form other than “call us.”

A model for this interpretation exists in the regulations for diagnostic X-ray equipment which includes the provision (21CFR1020.30) that manufacturers must provide “instructions for assembly, installation, adjustment, and testing of such components adequate to assure that the products will comply with applicable provisions of this section … when assembled, installed, adjusted, and tested as directed.” Note in particular the words “adjusted and tested,” which sound like routine maintenance. This provision used to be cited often for the proposition that service manuals must be provided, even though as written it is expressly for imaging equipment and not medical devices generally. Whether this is the appropriate language for other medical devices is open to discussion, but the precedent, I believe, is clear.

However valuable any third party might be in this arena, hospitals already have the ultimate power to obtain necessary manuals—that power being their purchasing decisions and checkbooks. But this power has been poorly exercised, in part because of disconnections between selection, HTM, purchasing, and accounts payable. Yet it remains the case that if you buy new equipment for which you want and need the service manuals, and your purchase order includes these manuals, and you get the equipment without the manuals, and you pay for it anyway, the problem of no manuals might be your own fault.

William Hyman, ScD, is an adjunct professor of biomedical engineering at The Cooper Union and a consultant in New York. He is also a professor emeritus of biomedical engineering at Texas A&M University.


10 thoughts on “William Hyman: Can the FDA Solve the Service Manual Problem?

  1. Although this does not solve all the issues, our service, used in Australia and the UK (for over 9 years) goes some way to addressing some of these issues. The more people on board, the closer we get to solving the problem. It was created because I was tired of waiting. For details feel free to contact me. Thanks. George.



  2. The FDA created a requirement in 1967 that manufacturers of radiation producing equipment must provide assembly, installation, adjustment, and testing (AIAT) procedures and protocols for all who might service and install the equipment. It did not say these AIAT were provided free, but they had to be available. So, the FDA has already set precedence in being able to hold the manufacturer accountable. We as HTM would need to require the manufacturet to provide this on anything that requires a 2579 form.

    Now fast forward to having FDA adopt the NFPA (2018 version as properly revised) so the documents would need to be provided to the facility purchasing the equipment.

    Then, the HTM department would need to show evidence of the “library” and that meaningful efforts were being taken to hold service parties to the standards within the manuals.

    • Thanks for pushing this forward, Matt. I’m going to add that NFPA and FDA need to refer to the so-called AIAT procedures and protocols as a “service manual” in order to align with The Joint Commission EP.

  3. Mike’s point about the library being up to date is well taken. I guess the FDA would also need to “compel” the OEM to also provide all technical updates throughout the entire life cycle of the products, e.g., with every software and hardware update, etc. Additionally the manuals without relevant training are relatively useless in many cases. And since service manuals coupled with training are still generally useless if there is no access to repair parts, shouldn’t we also want the FDA to “compel” the OEMs to make training and parts available? And isn’t it also reasonable that if the OEM makes all those things available to the HTM so they can fix the system themselves, that the hospital should, in consideration of the OEM making all those things available, indemnify the OEM against a possible lawsuit stemming from an improper repair that results in a patient injury or death?

  4. Funny, but I see the JC adding this as just another “unfunded mandate.” We as HTM professionals can cite the JC, but the JC has no regulatory power over the manufacturer. I have gotten the same from manufacturers when citing NFPA. They are not regulated by the NFPA: Go fish. Until the manufacture is regulated to provide this, we are pretty much never going to comply 100%.

  5. Nothing is simple any longer. As biomedical leaders, we have to wear many hats. We have to be lawyers, risk managers, medical directors, engineers, and diaper changers.

    We cannot just look at a singular agency to address this issue. I agree that the FDA is the only agency that can hold manufactures accountable. George Mills stated that HTM professionals should not do business with manufacturers that do not provide complete service documentation. This is a nice comment, but does not really allow us to provide the safest and highest quality of care for our patients. At least, I still think that is the business I am in.

    We have a hospital regulatory agency (TJC) implementing a standard that was handed down by CMS. This standard references the NFPA 99 2012 voluntary standard and make it a regulation we need to follow. We will have a difficult time leveraging the full service manuals from the manufacturers who have very restrictive policies. They want to protect their “proprietary” information. This is a ploy to hide behind since they want to make money from our operations.

    How can we as medical equipment support professionals say we are doing the right thing if we are not able to hold the OEMs accountable to perform their maintenance procedures to their standards, if we do not have a copy of their standards? This is when we sign service contract with the OEM, so they are getting money from us. Who is the customer here?

    There are copyright laws to protect the service manuals. There are patent laws to protect their intellectual property. So, to me, it is about getting all the money they can from the equipment owners.

    The leads to several court cases of violations of antitrust monopolistic laws (Sherman Antitrust and the Clayton Acts). The manufacturers are creating service monopolies from sales monopolies. See the recent $141 Million ruling against GE. (Just Google GE anesthesia lawsuit.)

    So we need a combination of regulatory (CMS/TJC), FDA standards, and legal precedents to work to a common solution of improved patient safety, patient quality, value of support to be in alignment. I am hopeful … but prepared to be disappointed.

    • Everything has to start somewhere and then progress by one step at a time. First, TJC must extend the requirement from just having a ‘library of service manuals’ to having a policy indicating that, where applicable, ‘service manuals, associated with all devices meeting the department’s inventory inclusion criteria, are maintained and tracked within the facility’ (evidence of compliance). Second, the committee working NFPA 99 2018, should be compelled to update the language in Section 10.5.3 to include the term ‘service manual.’ This clarity is badly needed by HTM and other third party entities. Third, the FDA would need to follow this lead by clearly including the term ‘service manual’ in the 21 CFR 820 regulation at the next opportunity for change.

  6. I would like to add a couple of points to your article, William. You mention CFR 21 as an option. However even with this (law, rule), several vendors such as Medtronic will not provide any parts or manuals for their O-arm.

    You also mention to use our purchasing power. Medtronic is the only provider of an O-arm device so we have no options except for them.

    The FDA is of no help at all in these matters and the new TJC info will not assist with this at all.

    The FDA needs to step in to require all manufacturers to provide service and maintenance documentation with all their equipment so the owners can make decisions as to who they want to service it. Then the manufacturers would have to become more competitive in the service market.

  7. Good points William. I must add to the narrow interpretation category: An HTM department may indeed maintain a library of information and manuals and for this reason qualify as being compliant. However, the burning question is does it obtain service manuals and information for the equipment the team services? Is the library up to date, covering all devices captured in the department’s inclusion criteria? Is there a policy that outlines all of the device types serviced by HTM and that a service manual for each of these exists in the library? My point is that simply stating that you have a “library of service manuals” (hardcopy or electronic) may do little to convince vendors or even your own hospital that having a manual is mandatory. I think TJC should go further and look for a department’s policy on requirements to house service manuals and to what degree. In this scenario, TJC would force HTM departments to address the issue. This would provide vendors and institutions with specific references — the requirement from TJC and a hospital policy that is in compliance with the requirement.

    Mike Capuano
    Hamilton Health Sciences

    • Great observation on the potential difference between having a good (e.g., useful and comprehensive) library and just having a library which may not be useful and comprehensive. But the issue remains that TJC cannot compel manufacturers to provide manuals; it can only try to force hospitals to be more insistent.

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