Update on the National Postmarket Surveillance System

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Presentation transcript:

Update on the National Postmarket Surveillance System Danica Marinac- Dabic MD, PhD Director, Division of Epidemiology 1 1 1

FDA’s Current Surveillance System Four Key Proposed Actions Outline Background Vision FDA’s Current Surveillance System Four Key Proposed Actions Public Engagement 2

Postmarket Surveillance: Background High-profile postmarket issues underscore weaknesses, challenges ICDs, metal-on-metal hip implants, etc. IOM Report recommended FDA develop comprehensive medical device postmarket strategy Devices pose unique challenges as compared to drugs/biologics 3

Postmarket Surveillance: Background Current system often seen as inefficient, costly, slow: Patients needlessly exposed to preventable adverse events Mandated manufacturer studies are inefficient and expensive Fails to leverage postmarket data to facilitate development of new devices and new uses of existing device 4

FDA’s Vision for National System Communicates timely, accurate, systematic, and prioritized assessments of device benefits and risks throughout their marketed life using high quality, standardized, structured, electronic health information (EHI) Identifies potential safety signals in near real- time from variety of privacy-protected data sources Reduces burdens and costs of medical device postmarket surveillance Facilitates clearance and approval of new devices or new uses of existing devices 5 5

Public Engagement Issued Strengthening Our National System for Medical Device Postmarket Surveillance September 7, 2012 Roll-Out Draft report posted on CDRH web site Received Comments Web site provided e-mail form Held Public Meetings Postmarket Plan (September 10) MDEpiNet Workshop (September 11) Registries Workshop (September 12 and 13)

Proposed Specific Actions to Strengthen Device Postmarket Surveillance Establish a UDI System and Promote the Incorporation of UDI into Electronic Health Information UDI critical for various surveillance efforts (including attributes) UDI critical to leveraging distributed data sources Promote the Development of National and International Device Registries for Selected Products Critical in development of proof-of-concept active surveillance efforts Need to be linked to other longitudinal data sources for effective ongoing and prospective surveillance

Proposed Specific Actions to Strengthen Device Postmarket Surveillance Modernize Adverse Event Reporting and Analysis Automated methods may enhance reporting and case ascertainment Bi-directional surveillance may amplify potential signals Develop and Use New Methods for Evidence Generation, Synthesis, and Appraisal Surveillance operating characteristics vary by study design, parameter specification, and data source Need to understand and account for learning curve effects

MDEpiNetMDEpiNet MDEpiNet MDEpiNetMDEpiNetMDEpinet PARTNERSHIP METHODOLOGY INFRASTRUCTURE TPLC GLOBAL

Next Step Release the Implementation Plan Work with partners/stakeholders to align, leverage and promote national and international infrastructure

Thank you! danica.marinac-dabic@fda.hhs.gov (301) 796-6689 ‏