FDA Vision for Innovative Surveillance of Orthopedic Implants Danica Marinac-Dabic, MD, PhD Director, CDRH Division of Epidemiology Head, FDA ICOR Initiative
Total and Resurfacing Hip Systems: Post-Approval Studies as Condition of Approval Number of Orders and Requirements MoM Resurfacing CoM CoC 2 1 1 4 Number of Orders (n=14) 11 13 0 10 20 Count Number of Original Required Studies (n=18) Type of Requirement, N=18 MoM Resurfacing CoM CoC Risk/Benefit Gap* 1 2 2 2 5 6 0 5 10 Count Broader Patient Groups and Physicians Extended Follow-up of Premarket Cohort * Licensing PMAs
PAS Progress Status for Original Requirements, by Type of Implant, N=18 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 1 2 3 CoM MoM CoC PMA Withdrawn: Study Terminated Revised/Replaced Study Completed Adequate Study Pending Inadequate
FDA Making PAS Data Available to Public 1 completed PAS, results on the public webpage 1 ongoing PAS with label update 3 completed PAS, results on label and public webpage 4 PAS labeling updates 14 PAS orders, 18 requirements
Prior Attempt to Shift Pre-Postmarket Balance for Ceramic-on-Ceramic Licensing PMAs Premarket: 2004-2007 Licensing PMAs approved No premarket data PAS as Condition of Approval Postmarket: 2006-2009 Low device distribution Poor or no enrollment in PAS PAS redesigned Postmarket: 2009-Forward 1-PMA Withdrawn 1-Ceased market distribution Collecting Data: small cohort studies, enhanced surveillance systems, registries Challenges Poor follow-up Availability of Imaging, PRO and HHS data International Registry data for device components approved in US
Key Findings: US Based Registries Fifteen registries data on joint replacement surgery (11 with available data) Data includes: Diagnosis, age, BMI, comorbidities, and gender, implant hospital, uni- or bilateral, operative date, and primary or revision surgery Some have begun collecting data on quality of life after surgery California Joint Replacement Registry Harris Joint Registry HealthEast Joint Replacement Registry Hospital for Special Surgery Hip and Knee Joint Replacement Registry Kaiser Permanente Total Joint Kaiser Permanente Total Joint Replacement Registry Mayo Clinic Total Joint Registry New England Baptist Hospital Orthopedic Registry Ortho Carolina Outcomes Registry Rush University Medical Center Joint Replacement Registry Virginia Joint Registry American Joint Replacement Registry FORCE-TJR Registry
Prior Attempt to Shift Pre/Postmarket Balance ICOR New Initiative for Postmarket Surveillance MDEpiNet Update to Postmarket Surveillance Initiative Licensing PMAs Approved PAS enrollment problems Some PAS Progress made, but challanges remain UDI Final Rule American Academy of Orthopedic Surgeons and ICOR- USA 2005 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2014 7/20/2009 FDA Allowed Studies to be Redesigned Today
National and International Initiatives CDRH Strategic Priorities No. 2: Appropriate Pre/Postmarket Balance MDEpiNet ICOR National Medical Device Postmarket Surveillance (NMDPS) Plan Updated Report NMDPS Plan Final UDI Rule Proposed BO-PIE Model for ICOR USA 2010 2011 2012 2013 2014 2015 Today
Proposed BO-PIE Model within ICOR-USA General System Principles Capacity to employ layers of Infrastructure and Methodologies Flexibility for utilization of all or a subset of registries Linkages Short- or long- term Clinical and/or Patient Reported Outcomes General Registry Requirements Completeness Quality Adjudication Linkages Transparency Monitoring Access Minimum Registry Data Requirements B-Baseline 1-Device + Demographics 2-Device +Demographics + Risk Adjustment BO Surveillance Platform O-Clinical Outcomes 1-Revision 2-Revision + Reason for Revision 3- Revision + reason for Revision + Mortality P-PRO 1-Any Recognized PROM Instrument PIE Studies Platform I- Imaging 1-X-Ray 2-MRI or CT 3-X-Ray and (MRI or CT) E-Explants 1-Access to Explants
Impact: Added Value for Stakeholders Less burdensome postmarket surveillance Seamless TPLC data accrual Proposed BO-PIE Model within ICOR-USA Capacity to employ layers of Infrastructure and Methodologies General System Principles Flexibility for utilization of all or a subset of registries Linkages Clinical and/or Patient Reported Outcomes Short- or longterm Building harmonized national and global surveillance infrastructure General Registry Requirements Completeness Quality Adjudication Linkages Transparency Monitoring Access Creating platform for randomization-premarket clinical trials Potential for international regulatory convergence Advancing patient-centeredness Advancing standards in methodology Minimum Registry Data Requirements B-Baseline 1-Device + Demographics 2-Device +Demographics + Risk Adjustment P-PRO 1-Any Recognized PROM Instrument BO Surveillance Platform PIE Studies Platform I- Imaging 1-X-Ray 2-MRI or CT 3-X-Ray and (MRI or CT) O-Clinical Outcomes 1-Revision 2-Revision + Reason for Revision 3- Revision + reason for Revision + Mortality E-Explants 1-Access to Explants
Proposed Timeline Convene MDEpiNet Working Group, including ICOR, Registry Task Force and Planning Board liaisons Established ICOR-USA Registry Network Characterize capabilities of registries for national surveillance Meeting with ICOR-USA and MDEpiNet Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2014 Engaged stakeholders via MDEpiNet and other Mechanisms