On May 15, 2018, FDA released FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices. This report was written to address concerns that have been raised about the quality of service provided by third-party organizations—that is, organizations other than original equipment manufacturers (OEMs). These third parties include hospitals and independent service organizations (ISOs). In developing the report, FDA held hearings and allowed for public comment about the issues. The main findings are:

1. FDA will not issue additional regulatory requirements regarding the servicing of medical equipment, as there is insufficient evidence to justify additional regulations.

2. The evidence that is available shows that many organizations other than the OEM who service medical equipment are providing "high quality, safe, and effective servicing of medical devices."

3. Most of the events that have been attributed to service issues were actually associated with the "remanufacturing" of medical equipment (defined by FDA as any "act to a finished device that significantly changes the finished device's performance or safety specifications, or intended use") and not with its servicing.

4. Third-party service providers are essential to ensure the safe operation of the U.S. healthcare system. 

This is an important announcement. If FDA were to conclude that only OEMs could service medical equipment, it would potentially more than double the cost of equipment service (which, during the life of the equipment, may already equal the acquisition cost). Moreover, equipment would be unavailable for longer times than is currently the case, as the hospital would have to wait for the OEM to send repair staff. (Most hospitals have staff on-site to maintain and repair equipment.) Some hospitals would therefore need to purchase additional equipment to use while their current equipment is out of service, further increasing the cost of healthcare without improving service delivery.

In explaining its findings, the FDA report includes a summary of an analysis performed by ECRI (section 5.3). ECRI searched over two million records, including the publicly available FDA Manufacturer and User Facility Device Experience (MAUDE) database; in addition, we analyzed our private databases of hazards and recalls and our investigations of hospital-based incidents. We concluded that there is no safety problem that is associated with the servicing, maintenance, and repair of medical devices either by the OEM or by third-party maintenance organizations.

For 50 years, in its focus on patient safety, ECRI has covered a broad array of inspection, service, and maintenance issues. These issues arise in our Evaluations of medical devices, our annual Top 10 Health Technology Hazards list, our annual Health Technology Excellence Award competition, our User Experience surveys, and much more. We are pleased that FDA has investigated this issue, has solicited input from responsible parties, and has come to the same conclusion as we have: The servicing of medical devices is safe, and there is no need for additional regulation.