1 / 24

Device Specific Surveillance: UDI Demonstration & Beyond

Device Specific Surveillance: UDI Demonstration & Beyond. Joseph P. Drozda, Jr., M.D. Advancement of Innovative Methodologies and Medical Device Specific Infrastructure for Evidence-Based Regulatory Science and Public Health Surveillance

fatima-little
Download Presentation

Device Specific Surveillance: UDI Demonstration & Beyond

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Device Specific Surveillance:UDI Demonstration & Beyond Joseph P. Drozda, Jr., M.D.

  2. Advancement of Innovative Methodologies and Medical Device Specific Infrastructure for Evidence-Based Regulatory Science and Public Health Surveillance Implementation of Unique Device Identification Demonstration Projects Final Report Summary of Deliverable due December 31, 2013: “Final report of UDI demonstration project in Subtask 2.1” Joseph P. Drozda, Jr., M.D., Principal Investigator for Subtask 2.1 Paul Helmering, B.A. Vance Moore, B.S.I.M Timothy R. Smith, M.D. Available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/BenefitsofaUDIsystem/UCM416128.pdf

  3. Perspectives • Primary driver: Value to Mercy supply chain and to Mercy patients • Much larger vision: First step in creation of a system for assessing safety and effectiveness of all implanted devices • Proof of concept: Useful information can be gleaned from EHR data capture

  4. UDI Demonstration Project Aims • Implement a coronary artery stent UDI-based surveillance system in the EHR in a multi-hospital system (Mercy) • Identify obstacles to implementation of UDI in clinical information & to characterize the effectiveness of interventions to overcome them; • Assess the validity and utility of data obtained from the EHR and incorporated UDIs for purposes of post-market surveillance

  5. The Expert Work Group* • The Expert Panel: Five interventional cardiologists appointed in conjunction with ACC and SCA&I • “Ex officio” members • FDA representatives • Coronary Stent manufacturer representatives • HTG system representatives • NCDR representatives *Tcheng JE, et al. Unique device identifiers (udis) for coronary stent post-market surveillance and research: A report from the FDA’s Medical Device Epidemiology Network (MDEpiNet) udi demonstration, American Heart Journal , 2014;168(4);405-13,e2.

  6. UDI Demonstration Project High Level Architecture

  7. Performance Solutions- What we did… Major Process Major Process Major Process • Automated charge capture • Lost charge reporting • Tracking of shelf level inventory • Shelf level tracking of lot / serial / exp date of product • Automated inventory replenishment • Scanning product barcode to patient • Capture of UDI including lot / serial / exp date of product • Capture cost per case Goal: Enable capture of the UDI to the patient… Apply automation to highly manual process

  8. Step 1b:Device attribute: DES CombinedPatient characteristics: AllOutcome: Mortality Drug eluting stent: 1361 patients with 35 deaths Bare metal: 184 patients with 18 deaths Mortality

  9. Coronary Stent Distributed Data Sharing Network

  10. Vision for UDI Phase 2 The UDI Alliance: • HTG Health Systems (Mercy, Mayo, Geisinger, Intermountain, and Kaiser) • National medical societies and registries (ACC, SCAI/NCDR) • Industry (Medtronic, Abbott, Boston Scientific) • Consumer groups/patient representatives)

  11. Thanks! Joseph P. Drozda, Jr., M.D., F.A.C.C. Director, Outcomes Research Mercy 14528 South Outer Forty Chesterfield, MO  63017 314-628-3864 Mobile:  314-308-1732 Joseph.Drozda@Mercy.net

  12. UDI Demonstration Timeline • Began work on system design: April, 2012 • Identify 1 device and a multi-stakeholder group: Sep, 2012 • Develop IT infrastructure : Oct, 2012 • Processes & systems for surveillance: Feb, 2013 • Demonstrate surveillance capabilities: May, 2013 • Complete demonstration of surveillance capabilities: Oct, 2013 • Final report: Dec, 2013

  13. Single EHR UDI Tracking System Data Flow

  14. Step 1a:Device attribute: DrugPatient characteristics: AllOutcome: Mortality Paclitaxel: 19 patients with 0 deaths Everolimus: 1166 patients with 28 deaths Zotarolimus: 176 patients with 7 deaths Bare metal: 184 patients with 18 deaths Mortality

  15. Step 3: Identify Selection Bias

  16. Step 4: Reduce Selection Bias

  17. Step 5: Examine Matched-pair Samples

  18. Vision for UDI Phase 2 Create a robust system of medical device surveillance and research to support FDA and physicians in keeping patients safe and to enhance research on innovative technologies.

  19. Plans to Expand • Formally include all HTG members in the UDI system • Formally link with NCDR (HIE) • Demonstrate utility of system for – • Surveillance • Communication with practitioners, e.g., recalls and AE reporting • Research • Add ICD Demonstration

  20. What do we need to do? • Create partnerships to establish a UDI system • Health Systems (HTG) • Professional Societies • National Registries • Industry • FDA • Establish appropriate governance of the UDI system for long term sustainablilty

  21. ASTER-D

More Related