Patient registries are contributing significant data on the safety and effectiveness of implanted devices, and with the advent of the U.S. FDA’s unique device identification system, it is now possible to link implant characteristics to the Global UDI Database, a recent study suggests.
The retrospective study, funded by the FDA, looked at the utility of registries in tracking postmarket safety data on patients with orthopedic implants based on research using data pooled by the International Consortium of Orthopaedic Registries. The were published online in the Journal of Bone and Joint Surgery.
Among the findings: patient outcomes did not worsen when a larger-headed hip implant or different plastics — polyethylene and HXPLE — were used; the risk of revisionary survey in patients with large metal-on-metal implants more than doubled compared with patients who had other types of implants; and patients with knee implants that used mobile bearings faced a 40 percent higher revision rate than patients whose implants used fixed bearings.
According to the authors, the ICOR database of clinical attributes and characteristics, which assigns a catalog number to each implant, serves as a useful adjunct to the FDA’s GUDID. Any modification in design of the implant prompts a new catalog number. However, the study notes, “there has been no worldwide consensus on the encoding of part numbers, and, in some instances, different devices have been identified with the same catalog number, and different numbers have been used for the same implant, depending on where it was being sold.”
Even so, 99 percent of implants are correctly identified using the ICOR system, the authors add. “As UDI is implemented, the registries will also link implant characteristic to the UDI database,” increasing its value for researchers and practitioners.
“The ability to create an international, distributed research network for medical devices is unprecedented and opens new opportunities for the development of investigations of comparative effectiveness and device safety,” the authors say. They believe the approach could be used to track the safety and performance of other types of implants and surgical devices.