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.

BUILDINGAREAL-WORLDDATANETWORKTOADDRESSQUESTIONSONMEDICALTECHNOLOGIESUNIQUETOHERNIACARE

HERNIACARETECHNOLOGIESCOORDINATED REGISTRYNETWORK (CRN)

Conclusion:

TIME

COST

LevelofInformation

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