Title: Developing Capacity to Conduct Proactive Post Marketing Safety Surveillance of Intervertebral Body Fusion Devices Using Electronic Health Record Data
Technology of Interest: Intervertebral Body Fusion Devices
Disease Area: Orthopedics
Duration: 9 months
Network Collaborator(s): Lahey; PEDSnet
This test-case will assess the feasibility of using Real-World Data (RWD) captured through the NESTcc Data Network to conduct proactive post-market surveillance for safety for class II medical devices. Specifically, this test-case will conduct proactive post-market surveillance for safety and effectiveness of lumbar interbody systems captured within Lahey Hospital and Medical Center (Lahey), a NESTcc Data Network Collaborator. The project efforts will be completed in collaboration with PEDSnet Coordinating Center at the Children’s Hospital of Philadelphia.
Intervertebral body fusion devices are used in the treatment of a variety of spine pathologies such as degenerative disc disease or fractures at one or more levels to aid in spinal fusion and may be combined with autogenous and/or allogenic bone, and with supplemental fixation such as posterior pedicle systems. Post-market surveillance across various indications, populations, and hardware configurations becomes challenging. Test-case execution will provide information not only about performance of specific devices, but about ways to effectively support research in collaboration with manufacturers and regulators.
The European Union (EU) issued new Medical Device Regulations (MDR) in May 2017 that includes requirements for “proactive surveillance” for recertification of medical devices to remain on the market in the EU by May 2020. Companies that develop and manufacture medical devices therefore have a need to develop methodology and approaches for proactive surveillance of medical devices that meets the EU’s MDR standards in order to keep medical devices accessible to patients in the EU. This work will potentially develop methodology and approaches for proactive surveillance of medical devices that meets the EU’s MDR standards.