The BUILD Initiative: Next Steps in Supply Chain Innovation & Medical Device Evaluation
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1 The BUILD Initiative: Next Steps in Supply Chain Innovation & Medical Device Evaluation April 19, 2016 Slide 1
2 Overview Mercy MDEpiNet First round of MDEpiNet demonstrations MDEpiNet Public Private Partnership HTG PASSION SMART Informatics Think Tank Mercy UDI Demonstration BUILD Initiative Future Shock Slide 2
3 34 ACUTE CARE HOSPITALS 4,396 LICENSED BEDS 36,917 CO-WORKERS 185 PHYSICIAN PRACTICE LOCATIONS 4,659 MEDICAL STAFF MEMBERS 1,235 INTEGRATED PHYSICIANS $4.6 OPERATING REVENUE (Billions USD) Slide 3
4 The Mercy UDI Strategy Integration of UDI into EHR Creation of data sets containing clinical & device information Linkage to other health systems & national registries (Distributed Data Network) Slide 4
5 The Mercy Multidisciplinary UDI Team Research Clinicians (Cardiac Cath Labs) Health Information Technology Supply chain (ROi) Performance Solutions Slide 5
6 What was MDEpiNet? Part of the Epidemiology Research Program (ERP) at the FDA s Center for Devices and Radiological Health (CDRH) Collaborative program through which CDRH and external partners share information and resources to enhance our understanding of the safety and effectiveness of medical devices after they are marketed 6 Slide 6
7 7 Slide 7
8 MDEpiNet is now a Public Private Partnership Slide 8
9 MDEpiNet PPP: Predictable And SuStainable Implementation Of National Cardiovascular Registries (PASSION) Demonstrate the goals of MDEpiNet by using cardiovascular medical device registries to bridge evidence gaps across the medical device total product life cycle Registry Assessment of Peripheral Interventional Devices (RAPID) Infrastructure/feasibility Society for Vascular Surgery Patient Safety Organization Professional Societies (ACC, SIR, SVS) Governmental agencies (FDA, CMS) Manufacturers Slide 9
10 MDEpiNet PPP: SMART Informatics Think Tank February, Building UDI Into Longitudinal Data for Surveillance and Research (BUILD) Extension of UDI Implementation Pilot Electrophysiology structured reporting providing UDI for Leads and devices using industry Standards to Electronic Health Records and CVIS systems (EPulse) Medical Device Data Capture and Exchange: Leading Practices and Future Directions 2. An Internal Hospital Unique Device Identifier Registry: Workflow and Infrastructure Redesigns 3. EHR Minimum Data Set and Structured Data Capture for Registries 4. Venous Access: National Guidelines and Registry Development (VANGUARD) Slide 10
11 MDEpiNet Report to FDA: Coordinated Registry Networks Slide 11
12 The Healthcare Transformation Group (HTG) Alliance of 5 major health systems (Geisinger, Intermountain, Kaiser, Mayo, & Mercy) to accelerate Supply Chain Management (SCM) standards adoption and implementation Leadership team of supply chain management executives at each institution An Adoption and Implementation team made up of those driving these efforts at each institution HTG R&D team to make full use of supply chain data for device evaluation Members of HTG are individually participating in various aspects of MDEpiNet, FDA Sentinel Initiative, and the HMO Research Network. Slide 12
13 Key Components of UDI Demonstration Create prototype UDIs & associate with attributes in the FDA s Global UDI Database (GUDID) Create clinically meaningful supplemental attributes to be stored in a reference database Create UDI data flow through ERP to cath lab to EHR to UDI data set Create UDI fields in the CathPCI Registry Perform studies to demonstrate validity and reliability of data Identify obstacles to incorporating UDIs into EHR and explore solutions 13 Slide 13
14 What do we needed to do? Create partnerships to establish a UDI system Health Systems (HTG: Mayo, Geisinger, Intermountain, Kaiser-Permanente, Mercy) Professional Societies (American College of Cardiology and the Society for Cardiovascular Angiography & Interventions) National Registry (National Cardiovascular Data Registry s CathPCI Registry) Industry (Abbott, Boston Scientific, Medtronic) FDA Propose and appropriate governance of the UDI system for long term sustainablilty 14 Slide 14
15 - What we did Changes to Cath Lab Process The UDI project required us to make changes to how the Cath Lab process works The changes we made improved many aspects of the workflow in the Cath Lab 15 Slide 15
16 Mercy Device Data Flows Slide 16
17 The UDI Research Database (UDIR) Slide 17
18 Device attribute: DES Combined Patient characteristics: All Outcome: Mortality Drug eluting stents: 1361 patients/35 deaths Bare metal stents: 184 patients/18 deaths Slide 18
19 Building UDI Into Longitudinal Data for Medical Device Evaluation (BUILD) Lead Investigators: Joseph P. Drozda, Jr. (Mercy) & James E. Tcheng (Duke) Sub-project Principal Investigators: Jove Graham (Geisinger), J. Brent Muhlestein (Intermountain), Natalia Wilson (Arizona State), David Slotwiner (Weill Cornell) Slide 19
20 Components of BUILD Extension of UDI Implementation Pilot Electrophysiology structured reporting providing UDI for Leads and devices using industry Standards to Electronic Health Records and CVIS systems (epulse) Medical Device Data Capture and Exchange: Leading Practices and Future Directions (The BUILD Consortium) Slide 20
21 The BUILD Distributed Data Network Slide 21
22 Status of BUILD Funding from FDA (Grant # 1U01FD ) Work on 3-year initiative begun on 1/1/2016 Investigative team in place (lead investigators, IT & supply chain professionals, academics, industry representatives, FDA) Workgroups developing plans for UDIR & the distributed data network Coordinating with RAPID and VANGUARD Slide 22
23 What s Next? (Things we d like to do) Tap into other data streams Patient reported outcomes Claims Apply methodology to other devices Collaborate Sentinel PCORnet ICOR and other registries and registry networks Add hospital partners to the network HTG systems Others Slide 23
24 The National Medical Device Evaluation System Slide 24
25 Thanks! Joseph P. Drozda, Jr., M.D., F.A.C.C. Director, Outcomes Research Mercy South Outer Forty Chesterfield, MO Mobile: References: Drozda JP, Smith TR. Medical device research at a regional health system: the Mercy experience. Asian Hospital & Healthcare Management, 2014:30, Tcheng JE, Crowley J, Tomes M, Reed TL, Dudas JM, Thompson KP, Garratt KN, Drozda Jr. JP. 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., doi: /j.ahj Drozda JP Jr, Dudley C, Helmering P, Roach J, Hutchison L. The Mercy unique device identifier demonstration project; implementing point of use product identification in the cardiac catheterization laboratories of a regional health system. Healthcare(2015), 25 Slide 25
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