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.