Developing Capacity to Conduct Proactive Postmarket Safety Surveillance of Intervertebral Body Fusion Devices Using Electronic Health Record Data

This Test-Case assessed the feasibility of using Real-World Data (RWD) captured through the NESTcc Research Network to conduct proactive postmarket surveillance for safety for class II medical devices. Specifically, this Test-Case is conducting proactive postmarket surveillance for safety and effectiveness of lumbar interbody systems captured within Lahey Hospital and Medical Center (Lahey), a NESTcc Research Network Collaborator. The project efforts were 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. 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.