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Multi-Purpose Methods: Hernia repair is an epidemic and greater understanding and dissemination of interventions to treat hernia will advance public health. We believe that Hernia Care CRN would: • Reduce the overall burden of hernia in the U.S. • Improve the value in hernia care delivered to patients • Help address regulatory needs, • Improve our understanding of devices’ long-term effectiveness and safety with reduced large and costly randomized clinical trials. The eventual national medical device evaluation system could identify new indications for existing devices or real world outcomes/risks that spur additional development and advancement of specific devices and could improve the efficiency of device evaluation and development throughout the lifecycle of devices. BUILDING A REAL-WORLD DATA NETWORK TO ADDRESS QUESTIONS ON MEDICAL TECHNOLOGIES UNIQUE TO HERNIA CARE HERNIA CARE TECHNOLOGIES COORDINATED REGISTRY NETWORK (CRN) Conclusion: TIME COST Level of Information Non-Standardized Goals: Build a strategically coordinated registry network to improve the value in hernia care delivered to patients • To combine the needs of multiple stake holders and establish a CRN capable of monitoring patient, provider, device, and procedure characteristics and associated outcomes using standardized data elements • To create an interoperable platform that link existing registries and data networks to each other for longitudinal follow-up and assessment of patient care across devices used for hernia care. • To serve as a scalable data infrastructure to support TPLC decision making for 510k devices The poster was prepared by Division of Epidemiology on behalf of OSB
