service and repair manuals for hospital equipment

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. 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. The interpretation of this phrase has been that it is limited to the direct clinical use of a device on or for a patient. 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. 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”?Īnother third party that could be helpful here, but has not been, is the FDA. 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. 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.

It is said that this EP will give the hospital owners of the devices new ammunition in insisting that manufacturers provide these documents.

Note: This library includes manuals, procedures provided by manufacturers, technical bulletins, and other information.” 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.

Service and repair manuals for hospital equipment