The National Evaluation System for health Technology Coordinating Center (NESTcc) is tasked to be a catalyst for the timely, reliable, and cost-effective development of real-world evidence (RWE) to enhance regulatory and clinical decision-making for medical devices. Real world data (RWD) reflects information relating to patient health status and the delivery of health care routinely collected from a variety of sources, including information obtained at the point of care. This type of data complements data generated from traditional clinical trials which possess the inherent challenges of being extremely costly, time-consuming, and by design, highly limited in generalizability. The Federal Drug Administration (FDA) is committed to exploring new methodologies to enable the collection and use of data from routine medical care and developing valid scientific evidence that could be used for regulatory decision-making. In the current environment, the absence of unique device identifiers (UDI) in electronic databases, and the phased implementation and enforcement of unique device identification compliance by federal agencies has been a hurdle to conducting post-marketing epidemiology studies for medical devices.
Abroad, the European Union (EU) issued new Medical Device Regulations (MDR) in May of 2017 that include requirements for “proactive surveillance” for the 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 meet the EU’s MDR standards in order to keep medical devices accessible to patients in the EU.
The proposed test case seeks to determine the feasibility of using real-world data captured through PEDSnet, a participant of the NESTcc network of health systems (NESTcc Network), to conduct proactive post-market surveillance for safety and effectiveness for craniomaxillofacial (CMF) distractors. PEDSnet is a national consortium of leading children’s hospitals that has established an analysis-ready database of electronic health record (EHR) data for over 6 million children to be used to advance multi-institutional clinical research among children and youth.