Developing Capacity to Conduct Proactive Post Marketing Safety Surveillance of Craniomaxillofacial Distractors Using Electronic Health Record Data

This Test-Case assesses the feasibility of using Real-World Data (RWD) captured through the NESTcc Data Network to conduct proactive post-market surveillance for safety with devices used in pediatric populations.

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 will therefore 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.

The use of implantable devices is generally rare in pediatrics, and therefore the study of devices such as craniomaxillofacial (CMF) distractors requires multi-site collaboration. The low patient density, combined with significant per-site start-up costs, have made pediatric device studies difficult to execute.

This Test-Case seeks to determine the feasibility of using RWD captured through PEDSnet, a NESTcc Data Network Collaborator, to conduct proactive post-market surveillance for safety and effectiveness for CMF distractors.