Key Components of UDI Demonstration

Transcription

1 Key Components of UDI Demonstration Create Draft UDIs & associate with base 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 121

2 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 122

3 Expert Work Group Outputs Constrained list (9) of supplemental coronary stent attributes Use cases for UDID in clinical data sets Recommendations re governance and operations of Supplemental UDI Database (SUDID) Recommendations re broader registry-centered data sharing network for device surveillance 123

4 Table 3: SUDID Clinical Attributes and Parameters Attribute Definition Parameter Data Type Length Nominal length per manufacture specification Fractional dimension in mm 4 significant digits, w/1 precision Diameter Nominal (inner) diameter per manufacturer 4 significant digits, w/2 Fractional dimension in mm specification precision Stent having nonconventional design, Covered stent Non-conventional variable or multiple length/diameter Bifurcation Stent Property parameters Tapered Stent Alphanumeric Structural Material Composition of principal structural element Constrained list e.g. L605 cobalt chromium -- Constrained list to be developed Alphanumeric Coating(s) Drug(s) Strut Thickness Surface to Artery Ratio* Expansion Method MRI Compatibility Non-Structural material covering surface of structural element Active agent released from stent Maximum nominal thickness of stent struts on a radius from the center of the stent Percentage of the surface area of the artery covered by the stent at nominal expansion of the stent Method used to achieve nominal stent deployment MRI compatibility category per testing Constrained list -- Constrained list to be developed --Need to handle multiples --name that would be mostly referenced --start with what is in the IFU --accommodate multiple coatings NDC directory (default) --Use name if no applicable NDC code do it uniformly Dimension in microns Balloon Self 4 categories per existing standard: --Safe --Conditional --Unsafe --Not tested *This attribute was originally selected by the Expert Panel but subsequently withdrawn SUDID = Supplemental Unique Device Identifier Database; IFU = Instructions for Use; NDC = National Drug Code; MRI = Magnetic Resonance Imaging Alphanumeric Alphanumeric 4 integer digits 3 significant digits, w/1 precision Alphanumeric 4 Categories

5 UDI Demonstration Project High Level Architecture

6 Single EHR UDI Tracking System Data Flow

7 - 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 127

8 - What we did Patient Level Product Scanning Major Process Inventory Mgmt. Major Process Automated Charging Major Process Scanning product barcode to patient Capture of UDI including lot / serial / exp date of product Capture cost per case Tracking of shelf level inventory Shelf level tracking of lot / serial / exp date of product Automated inventory replenishment Automated charge capture Lost charge reporting Goal: Enable capture of the UDI to the patient Apply automation to highly manual process 128

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10 Options for Device Comparisons in the UDIR Baseline patient characteristics Demographic Clinical (lab, diagnoses, etc.) Devices Product identifier +/- production identifier Attributes Outcomes (MACE) Individual Combined

11 Step 1a: Device attribute: Drug Patient characteristics: All Outcome: 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

12 Step 1b: Device attribute: DES Combined Patient characteristics: All Outcome: Mortality Drug eluting stent: 1361 patients with 35 deaths Bare metal: 184 patients with 18 deaths Mortality

13 Step 3: Identify Selection Bias Baseline Characteristics (N=1405) DES (n=1230) BMS (n=175) P-value Standardized Diff (DES-BMS) % Female 32.4% (398/1230) 32.6% (57/175) Age > % (653/1230) 53.1% (93/175) Caucasian 95.9% (1177/1227) 92.5% (161/174) Married 69.6% (854/1227) 59.2% (103/174) Alcohol used (Y) 37.4% (440/1178) 32.9% (53/161) Illicit drug used (Y) 6.0% (66/1106) 10.9% (16/147) Acute MI (Y) 35.0% (431/1230) 53.1% (93/175) < Cardiac arrest (Y) 0.3% (4/1230) 1.1% (2/175) Shock (Y) 1.9% (23/1230) 9.7% (17/175) < COPD (Y) 12.9% (158/1230) 18.9% (33/175) Diabetes mellitus (Y) 37.0% (455/1230) 27.4% (48/175) Dialysis (Y) 1.9% (23/1230) 0.6% (1/175) EF < 30% (Y) 2.0% (25/1230) 5.7% (10/175)

14 Step 4: Reduce Selection Bias Baseline Characteristics (N=290) DES (n=145) BMS (n=145) P-value Standardized Diff (DES-BMS) % Female 33.1% (48/145) 34.5% (50/145) Age > % (68/145) 42.8% (62/145) Caucasian 95.9% (139/145) 94.5% (137/145) Married 57.2% (83/145) 56.6% (82/145) Alcohol used (Y) 28.3% (41/145) 31.0% (45/145) Illicit drug used (Y) 10.3% (15/145) 10.3% (15/145) NA 0 Acute MI (Y) 53.1% (77/145) 52.4% (76/145) Shock (Y) 9.0% (13/145) 8.3% (12/145) COPD (Y) 20.7% (30/145) 20.7% (30/145) NA 0 Diabetes mellitus (Y) 28.3% (41/145) 29.7% (43/145) EF < 30% (Y) 4.8% (7/145) 6.2% (9/145)

15 Step 5: Examine Matched-pair Samples Matched-pair BMS Death Alive Total DES Death Alive Total McNemar s Test Statistic (1 degree of freedom) (p=0.2850) Simple Kappa Coefficient Kappa (ASE) (0.1348) Test for Kappa = 0 Statistic (two-side p-value) (p=0.0316)

16 Obstacles Technical: Biggest problem so far is Merge Agreeing on: Industry-wide standards Device attributes Organizational infrastructure and support for designing and maintaining a UDI system The business case for all stakeholders 136

17 MDEpiNet is Evolving

18 MDEpiNet Evolution Duke Clinical Research Institute (DCRI) is the coordinating center National Medical Device Surveillance System Planning Board (Brookings) National Medical Device Registries Task Force

19 The Planning Board is intended to help develop a framework for how a more systematic approach to postmarket medical device surveillance could be implemented in the United States. Mark McClellan, Brookings Institution

20 National Medical Device Surveillance System Planning Board Harlan Krumholz, Yale University David Flum, University of Washington Patricia Shrader, Medtronic Kathleen Blake, AMA-PCPI Michael Mack, Society of Thoracic Surgeons Joseph Drozda, Mercy Health Jo Carol Hiatt, Kaiser Permanente Nancy Dreyer, Quintiles Natalia Wilson, Arizona State University Dale Nordenberg, Novasano Health and Science Alan Rosenberg, WellPoint Inc. Edmund Pezalla, Aetna Inc. J. Marc Overhage, Siemens Leslie Kelly Hall, Healthwise Carol Walton, The Parkinson Alliance Mike Crompton, ReVision Optics

21 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. 141

22 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) 142

23 Coronary Stent Distributed Data Sharing Network

24 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 144

25 Thanks! Joseph P. Drozda, Jr., M.D., F.A.C.C. Director, Outcomes Research Mercy South Outer Forty Chesterfield, MO Mobile:

26 Unique Device Identification (UDI) ICOR Global Standardization Database: Total Joint Clinical Attributes System Liz Paxton Director Kaiser Permanente National Implant Registries National Implant Registries 146

27 National Device Postmarket Surveillance System 1. Establish UDI system and incorporate into electronic health information 2. Promote development of national/international device registries 3. Modernize event reporting 4. Develop and use new methods for evidence generation/synthesis/appraisal 147

28 Global UDI Database Primary DI Number An identifier that is the main (primary) lookup for a medical device and meets the requirements to uniquely identify a device through its distribution and use. Enter the Device Identifier (DI) Number. Data type and field length are determined by the individual Issuing Agency structure. Device Count Unit of Use DI Number Labeler DUNS Number Company Name Company Physical Address 148 Number of medical devices in the base package. An identifier assigned to an individual medical device when a UDI is not labeled on the individual device at the level of its unit of use. Its purpose is to associate the use of a device to/on a patient. Business number issued by Dun & Bradstreet (D&B) that is used to associate the Labeler (Company) name and address to a given version of model of a device in GUDID. Company name associated with the labeler DUNS Number entered in the DI Record. Company physical address associated with the labeler DUNS Number entered in the DI Record. GS1: Numeric (Num.), with 14 digits HIBCC: Alphanumeric (Alphanum.), with 6-23 characters ICCBBA: Alphanumeric, with 10 or 16 characters

29 Global UDI Database Brand Name Version or Model Catalog Number Device Description The Proprietary/Trade/Brand name of the medical device as used in device labeling or in the catalog. This information may 1) be on a label attached to a durable device, 2) be on a package of a disposable device, or 3) appear in labeling materials of an implantable device. The brand name is the name that is typically registered with USPTO and have the and/or TM symbol. The version or model found on the device label or accompanying packaging used to identify a category or design of a device. The version or model identifies all devices that have specifications, performance, size, and composition within limits set by the labeler. The catalog, reference, or product number found on the device label or accompanying packaging to identify a particular product. Additional relevant information about the device that is not already captured as a distinct GUDID data attribute. Enter the Brand Name. Enter the Version or Model. Version/Model can be any distinguishing string of letters and/or numbers. Catalog Number can be entered if device does not currently have a Version or Model. If the device does not have a version, model or catalog number, enter a concept that can be used to identify all devices that have specifications, performance, size, and composition within limits set by the labeler. Enter the Catalog or Reference Number. Catalog/Reference number can also serve as Version/Model if it represents the devices that have specifications, performance, size, and composition within limits set by the labeler. Enter device description. Device description should include any description found on the device label to support user comparison of the device label to the GUDID device record. Otherwise, include any additional description or text found in the device labeling. 149

30 Implant Clinical Classification: Important? Permutations of NexGen CR insert - 13 footprints (i.e. width and length) - 5 thicknesses: 10, 12, 14, 17, 20mm - With & without inflection (2 options) - With cross-linked poly (2 options) 13 footprints x 5 sizes x 2 degrees x 2 polys = 260 unique parts for this variation 19,354 tibial inserts for all manufacturers and designs. Each has a unique part number- link to UDI Millions of possible combinations based on part numbers/udi 150

31 Classification Challenges: Sample Tibial inserts Zimmer NexGen CR 301 different parts Zimmer NexGen LCCK (constrained) 194 different parts Stryker Scorpio PS 87 different parts Each part will have a different part number assigned by company 151 Optetrak PS (Exactech) -125 different parts

32 Linking Clinical Attributes to UDI 1. Patient safety Are total hip MOM implants failing? Does a specific knee have a high revision rate? 2. Post market surveillance of devices when new device features are added to market 3. Comparative effectiveness research Which has a lower survival function: modular or monoblock MOM hips? Do fixed or mobile total knees have best performance over time? Which total hip bearing surface has the lowest revision rate? 152

33 Kaiser Permanente UDI Application Monitor outcomes of over 1.3 million devices in our registries Device recalls/notifications Identify best performing/outlier devices for our patients Identify patients at risk for poor outcomes Identify clinical best practices for quality improvement Implants scanned into EPIC optime module Standardized documentation in EPIC Implant attributes library to enhance monitoring and evaluation of devices 153

34 Kaiser UDI implementation: GS1/UDI Barcoding Standard GTIN s flowing between Item Master and Point of Care System Interfaces between Kaiser Permanente s (KP) PeopleSoft Item Master (OneLink) and Epic (KP HealthConnect) built Scanning GTIN s at Point of Care 154 Kaiser Permanente. All Rights Reserved. 154

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36 Implant Data Elements Extracted from EHR Optime Company Optime Catalog # Optime LotNo Optime ImplantName COMPONENT FEMORAL E- L68 MM X W59.4 MM RIGHT KNEE CEMENTED CRUCIATE RETAINING NEXGEN CR-FLEX ZIMALOY PRECOAT STERILE - ZIMMER LOG ZIMMER SURFACE ARTICULAR YELLOW L66 MM X W42 MM NEXGEN CR-FLEX 10 C-H 3-4 STANDARD TIBIAL KNEE PROLONG UHMW POLYETHYLENE CRUCIATE RETAINING STERILE - LOG Optime Qty Optime Laterality 1RIGHT 1RIGHT Implant Components Company Name Catalog # Lot/Serial # Quantity Material Fixation Size Mobility Stability Catalog # Implant Reference Library Registry SQL Database COMPANY NAME CATALOG # ZIMMER DESCRIP- TION IMPLANT NAME CATE-GORY INSERT MATERIAL FEMORAL MATERIAL NEXGEN CR FLEX FEM COMP PRECOAT NEXGEN FEMORAL COCR CEMENTED SIZE E CEMENT FIXATION SIZE STABILITY MOBIL-ITY MINIMALLY STABILISED 156 ZIMMER ZIMMER ARTICULAR SURFACE CR PROLONG ZIMMER INSERT HIGHLY CROSS- LINKED SIZE 2 MINIMALLY STABILISED FIXED

37 Extracted from Electronic Health Record Implant Components Company Name Catalog # Lot/Serial # Quantity Catalog # Patient Demographics Medical Record # DOB Gender Race Registry Forms Electronic SmartForm/Paper Procedures Diagnoses Surgical Characteristics Fixation Types Implant Reference Table Company Name Catalog # Description Name Attributes Registry SQL Database Other Data Systems Claims Diabetes Registries Membership Mortality GEMS Annual Reports Ad-Hoc Requests Web-Based Reports Registry Deliverables Risk Calculators Personalized Surgeon Profiles Research Projects Outlier Implants Recalls/Advisories Risk adjusted hospital outliers 157

38 THA Survival by Bearing Surface

39 ICOR Global Standardization Database Develop global, standardized classification system of hip and knee implantable devices based on their clinical attributes and characteristics to advance the implementation of UDI and FDA postmarket surveillance 159

40 ICOR Global Standardization Database 1. Each existing registry develops and maintains own clinical attributes reference database: No standardization 2. Standardization of international registries implant reference databases and clinical attributes with linkage to UDI based on catalog number 160

41 Total Knee Implants Major components: 1. Insert 2. Femoral 3. Tibial Tray 4. Patella 5. Stem 6. Cement Minor components: 7. Traystem 8. Allograft 9. Putty 161

42 Total Knee Implants Insert Material Thickness Size Stability Mobility Conventional Polyethylene XXXmm x XXXmm XXmm or S/M/L Cruciate Retaining Fixed Highly-Crosslinked Polyethylene Posterior Stabilized Rotating Vitamin E Infused Highly- Crosslinked Polyethylene Constrained/Hinged Sliding 162

43 FDA s UDI Database Manufacturer (Acme) The label of Medical Device 123 Size 45: Device Identifier (Device XYZ123) Production Identifier (Lot #ABC) Expiration date (MMDDYYYY) Sterile; Latex free Distribution Minimum Data Set For each Device Identifier: Manufacturer and model GMDN Code Other attributes FDA Managed ICOR Global Standardization Database Linkage by Catalog/reference# to UDI 3 rd Parties (GDSN) or Business Rules FDA s UDI Database 163 Web based tool or Bulk HL7 SPL Public User Interface 163

44 164 Fixed Posterior Stabilized (PS) vs. Non-PS Total Knee Arthroplasty Survival Across Registries

45 National Medical Device Registries Task Force Identify existing registries that may contribute to National System Set criteria for how/whether to include a registry in the National System Leverage successes of current registries - link to other data sources Promote collaboration and integration of registry data while encouraging unique registry development (each registry has its own purpose - e.g. quality improvement) How to use efforts to benefit patients - interdisciplinary use of registries Identify priority medical types for which the longitudinal registry is of significant public health importance high risk/high volume, new? Identify and prioritize successful registry governance and data quality best practices Develop strategies for use of registries for premarket decisions 165

46 Future Recommendations UDI alone is not sufficient for comparative effectiveness research Need linkage of UDI to implant libraries with clinical attributes of devices for translating UDI into clinically meaningful use Physician societies need to be involved Ownership, funding and governance need to be established Catalog numbers are essential for transition to UDI and historical implants 166

47 Discussion What are your barriers? What challenges do you still face? How can HTG help you?

48 Wrap Up Day 1 Gene Kirtser President/CEO ROi Mercy Supply Chain

49 HTG Summit 2014 Day 2 HTG - Confidential

50 Anti-Trust and Code of Conduct Anti-Trust and Code of Conduct HTG follows all US laws relating to antitrust and competition and there shall be no conduct that could artificially increase price, reduce output, or result in any type of boycott. If anyone believes the discussions are approaching antitrust boundaries, please say so and the discussion will be halted while a HTG participant checks with legal counsel before proceeding. You are also reminded that the Code of Conduct requires we respect one another s differences in opinion, act professionally and engage to work together for the common good of the community.

51 Anti-Trust and Code of Conduct This means: Participation must be voluntary, and failure to participate shall not be used to penalize any company. There shall be no discussion of prices, allocation of customers or products, boycotts, refusals to deal, or market share. If any participant believes the group is drifting toward impermissible discussion, the topic shall be tabled until the opinion of counsel can be obtained. Meetings shall be governed by an agenda prepared in advance, and recorded by minutes prepared promptly after the meeting. Agendas, where appropriate, and minutes are to be reviewed by counsel before they are circulated. Tests or data collection shall be governed by protocols developed in consultation with and monitored by counsel. The recommendations coming out of a HTG committee, task force, work group or task group are just that. Individual companies remain free to make independent, competitive decisions. Any standards developed must be voluntary standards.

52 Meeting Objectives Day 2 Transform

53 Applications of Use Cases for Standards People Process Systems

54 People Intermountain Healthcare GLN Actively maintain all Intermountain locations in the GLN Registry 500+ All Purchase Orders contain GLN GTIN 22,000 GTINs loaded GTINs sent on all transactions. 16 Suppliers actively receiving Utilize both GDSN and Supplier supplied worksheets Lot/Serial/Expiry captured at point of receipt and distribution as applicable Lot/Serial integrated from Surgical Services in consumption interface

55 People Geisinger Sharing between provider Portals X12 UDI Subgroup meeting Preparation for testimony to National Committee on Vital and Health Statistics (NCVHS) FDA/UDI SUDID Cath project

56 People Kaiser Permanente GS1 Standards education with Sourcing and Standards Teams; Clinical, Charge Capture, Product Recall, National Product Council, GPO and Quality groups Integrated GS1 requirements into all aspects of RFPs and contract review/approval processes We are now engaged heavily in increasing usage capture at the Point of Care utilizing our EMRs Increased scanning of implants to 29% driving product labeling standardization and data synchronization reducing manual work and increasing accuracy with our suppliers Loading GTIN numbers in our ERP and EMR Item Masters Driving a holistic Item Master Data Quality program and measurements to create a Unified Source of Truth for Products, Supplier and Location data across the End-to-End Supply Chain Assembling a Community of Practice (CoP) group to drive ongoing integration of the GTIN beyond EHR to billing, revenue cycle, etc. and incorporation into the various work flows

57 People Mayo Clinic GLN 75% of total med/surg spend 75 Suppliers All Purchase Order contain GLN GTIN 6% of total med/surg spend approximately 6,000 GTINs 4 Suppliers Utilize both GDSN and Supplier supplied worksheets

58 People Mercy Execution of Consumption based Model Magnitude of Consumption Based Model Mercy Hospital Patient Room Over $1.2B in Supply Spend Patient arm band is scanned identifying location and patient in point of care system Pharmacy ($215m) Operating Room ($350m) Cath Lab/Procedural ($200m) Nursing ($100m) GTINs on product packages are scanned at the point of care capturing critical information to drive: Product consumption Inventory replenishment Patient charging Cost accounting GTIN data tracked all the way from the point of order to the near exact time the product was applied to a specific patient Recall and Expired Product Notifications - Scanned to Patient & EMR - Documented in EHR - Scanned/Documented in EHR - Scanned/Documented in EHR Almost Mercy Hospital 70% of spend Procedural is documented Areas 10,000 Products Users used during on the POU procedure (over documented 25% of on all Mercy Coworkers) the patient chart In over 800 Locations

59 Geisinger Kaiser Permanente Mayo Process Operational Awareness around UDI: Has allowed us to rank the priority address UDI GAPs, such as: Insuring our systems are agnostic to UDI to minimize clinician point-of-care impact upon disposition of devices. Accepting non-gs1, but driving for all GS1 UDI Sharing to EHR to Billing to Patient Portal KP GS1 requirements are being enforced with our GPO GS1 in Sourcing & Contracting including RFP prerequisite GPO & GDSN alignment Accepting HIBCC but only as interim bridge to GS1 Expanded use of GTIN / GLN in Purchase Orders and Invoices Better understanding how UDI could be used in billing Item Data Lifecycle (End-to-End) alignment with GS1 Standards; Implement Data Governance. Scanning GTIN and serial number into OR System Project well under way to incorporate GTIN and Expiration date via. interface from OR System to EMR

60 Intermountain Mercy Process Using UDI to document in procedural areas UDI/Product Documentation in all Procedural Areas and Nursing Point of Use Scanning deployed to all Nursing and Procedural Areas (OR Deployment eminent) Information used to identify Expired Product Leveraging UDI in reporting to drive Comparative Effectiveness and track Adverse Events Working to better understand use of UDI in the Global Supply Chain thru to Product traceability, including Recalls Integration with OR system and project in progress for scanning during case Project in progress for scanning in Ambulatory, Med/Surg and Cath Lab areas Expiration and recall alert assessment