service and repair manuals for hospital equipment

The agency further reported that unregulated third-party servicers were associated with more than 4,300 negative incidents involving medical devices, including 40 deaths and 294 serious patient or device user injuries. The lack of regulation of third-party servicers has the potential to harm patients. FDA estimated in May 2018 that there were up to 21,000 companies servicing medical devices. Patient Harm from Unregulated Third-Party Servicers They are not even required to submit basic servicing information to FDA, which means the agency and OEMs are essentially flying blind and cannot ensure devices continue to meet their original standard of safety and effectiveness. They are not required to follow the same extensive FDA regulatory requirements as OEMs and their authorized servicers, putting patients and device users at risk. without proper training and sometimes without appropriate equipment and replacement parts. However, there are tens of thousands of unregulated third-party servicers working on complex medical devices - ventilators, imaging systems, infusion pumps, patient monitors, etc. Some OEMs also rely on contracted third-party servicers to meet their own servicing needs and hold these authorized servicers to the same servicing regulations the OEM is required to meet. In addition to servicing their own products, many OEMs also act as third-party servicers to other OEMs and comply with FDA regulations. This comprehensive set of post-market requirements helps ensure that all servicing done to a medical device is done by properly trained, properly equipped technicians that all work is thoroughly documented and adverse events are reported to the agency. In addition, OEMs and their authorized servicers are subject to numerous other FDA regulations covering reporting of adverse events, recalls, registration with the agency, and many others. OEM servicing programs must follow strict requirements set out in FDA’s Quality System Regulation, which include specific instructions for training, part and component replacement, documentation of servicing activities, and more.

Original equipment manufacturers (OEMs) dedicate extensive resources to establishing comprehensive servicing programs to ensure that their devices are properly maintained and continue to meet safety and effectiveness standards as determined by FDA.

Answers to frequently asked questions about OEMs and proper servicing of medical devices.

Service and repair manuals for hospital equipment