New Standard for Access to Medical Equipment Service Manuals
In January of 2018 the Joint Commission, an accrediting agency for healthcare organizations, announced a new element of performance: EC .01.01.01, EP3. It intends to address the issue of adequate access to service manuals for medical devices. The new element of performance states “the organization has a library of information regarding inspection, testing and maintenance of its equipment and systems.” This library includes manuals, procedures provided by manufacturers, technical bulletins and other information.
This EP may give the hospitals that own these devices new power to insist manufacturers provide these documents, something they don’t necessarily do now, claiming protection of trade secrets. Also, EC 02.04.03 reads: “The hospital inspects, tests, and maintains medical equipment.” There is some question as to whether this is to be interpreted to mean: “The hospital has all medical equipment inspected, tested and maintained.”
The FDA could be helpful here, but has not been. They could require labeling on prescription devices for manufacturers to provide information for safe use. Labeling might also be expected to provide information for performing necessary service, instead of just “Call us.”
Best to be prepared! Hospitals may start to demand these manuals when purchasing equipment, knowing it is their right. So manufacturers may soon have to deal with this new requirement sooner rather than later.
If you are a manufacturer, please contact me to discuss this new reality, and whether you can benefit from my services. I have over 20 years’ experience in the development of service manuals for medical equipment, and write procedures for the testing and maintenance of manufacturers’ medical devices and systems. Manuals I create include information on precautions under which the device can be safely used, including maintenance and service schedules. I would be glad to assist you in meeting these requirements for this new standard.
Technical Writer & Editor