Implementation of Unique Device Identification Demonstration Project – A Report from - PowerPoint Presentation

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Implementation of Unique Device Identification Demonstration Project – A Report from MDEpiNet

Joseph P. Drozda, Jr., M.D., F.A.C.C.

Director, Outcomes Research

Mercy Health

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Mercy Health

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

$4.05

OPERATING REVENUE

(

Billions USD)

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UDI

Demonstration

Project AimsImplement 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 4

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UDI Demonstration Timeline

Began work on system design: April, 2012

Identify 1 device and a multi-stakeholder group: Sep, 2012Develop IT infrastructure : Oct, 2012Processes & systems for surveillance: Feb, 2013Demonstrate surveillance capabilities: May, 2013Complete demonstration of surveillance capabilities: Oct, 2013

Final report: Dec, 2013

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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 databaseCreate UDI data flow through ERP to cath lab to EHR to UDI data setCreate UDI fields in the CathPCI RegistryPerform studies to demonstrate validity and reliability of dataIdentify obstacles to incorporating UDIs into EHR and explore solutions 6

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The Expert Work Group

The Expert Panel: Five interventional cardiologists appointed in conjunction with ACC and SCA&I

“Ex officio” membersFDA representativesCoronary Stent manufacturer representativesHTG system representativesNCDR representatives

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Tasks for Expert Work Group

Develop a constrained list of coronary stent clinical attributes to supplement the GUDID attributes (Expert Panel)

Propose a permanent home for UDI clinical attribute database (SUDID)Recommend a governance structure for the SUDIDDevelop a proposal for an organization and processes for ongoing maintenance of the SUDID

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Table 3: SUDID Clinical Attributes and Parameters

Attribute

Definition

ParameterData TypeLengthNominal length per manufacture specificationFractional dimension in mm4 significant digits, w/1 precisionDiameterNominal (inner) diameter per manufacturer specificationFractional dimension in mm4 significant digits, w/2 precisionNon-conventional PropertyStent having nonconventional design, variable or multiple length/diameter parametersCovered stentBifurcation StentTapered StentAlphanumericStructural MaterialComposition of principal structural elementConstrained liste.g. L605 cobalt chromium-- Constrained list to be developedAlphanumericCoating(s)Non-Structural material covering surface of structural elementConstrained 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 coatingsAlphanumericDrug(s)Active agent released from stentNDC directory (default)--Use name if no applicable NDC code—do it uniformlyAlphanumericStrut ThicknessMaximum nominal thickness of stent struts on a radius from the center of the stentDimension in microns4 integer digitsSurface to Artery Ratio*Percentage of the surface area of the artery covered by the stent at nominal expansion of the stent3 significant digits, w/1 precisionExpansion MethodMethod used to achieve nominal stent deploymentBalloonSelfAlphanumericMRI CompatibilityMRI compatibility category per testing4 categories per existing standard:--Safe--Conditional--Unsafe--Not tested4 Categories

*This attribute was originally selected by the Expert Panel but subsequently withdrawnSUDID = Supplemental Unique Device Identifier Database; IFU = Instructions for Use; NDC = National Drug Code; MRI = Magnetic Resonance Imaging

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UDI Demonstration Project High Level Architecture

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Single EHR UDI Tracking System Data Flow

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The Reference Data Set of Procedures and Coronary Stents

Patients and stents included in dataset if found in any one of the following datasets

Cath Lab Data table in UDIRInventory Data table in UDIRBilling Data table in UDIRRegistry Data from Registry submissionCompleteness of each data set measured against the reference dataset

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Unique Coronary Stent Procedure Counts (percent of procedures in reference datasets)

St. Louis

Springfield

Rogers(All Sites)Registry Data291 (88%)566 (87%)-857Cath Lab Data281 (85%)546 (84%)236 (83%)1063Inventory Data301 (91%)608 (93%)253 (89%)1162Billing Data291 (88%)565 (87%)212 (75%)1068Reference Dataset3306532831266

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Patient Counts by Month and System for St. Louis and Springfield

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Percent Agreement by System Combinations for St. Louis and Springfield

System

%

Registry DataCath Lab DataInventory DataBilling DataYYYY73%YNYY9%NYNN4%NNYN3%YYYN3%NYYN2%NNNY2%YYNY1%NYYY1%NNYY0.4%YNYN0.3%

YNNY0.1%YNNN0.1%NYNY0.1%YYNN0.1%

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Stent Counts by Site and System (percent of stents in reference datasets)

St.

Louis

SpringfieldRogersAll SitesCath PCI514 (76.3%)877 (81.1%)--1391Merge603 (89.5%)902 (83.4%)412 (80.6%)1917OptiFlex539 (80.0%)929 (85.9%)432 (84.5%)1900Billing496 (73.6%)768 (71.0%)344 (67.3%)1608Reference Dataset6741082511

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Coronary Stent Count Comparison at Mercy Hospital St. Louis and Springfield

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Overall Scan Compliance

Inventory Data

Cath

Lab DataInventory/Cath LabRogers74485686.9% (744/856)Springfield1996227987.6% (1996/2279)St Louis897109781.8% (897/1097)Total3637423285.9% (3637/4232)

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Inventory /

Cath

Lab (%)Scan Compliance – by Month

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Scan Compliance – by Month

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Scan Compliance – by Month

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Scan Compliance – Non Regular Hour

vs

Regular HourInventory/Cath

Lab (%)

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Scan Compliance –

Emergent (AMI)

vs

Non-emergentInventory/Cath Lab (%)

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Options for Device Comparisons in the UDIR

Baseline patient characteristics

DemographicClinical (lab, diagnoses, etc.)DevicesProduct identifier +/- production identifierAttributesOutcomes (MACE)IndividualCombined

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Statistical Analyses

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Case Selection Flow Diagram

2484 procedures performed between 1-Nov-12 and 26-Oct-13 (total 2250 patients)

1808 procedures with 1963 stents (total 1657 patients)

1640 procedures with 1772 stents (total 1545 patients)Stents:1166/1545: Everolimus drug176/1545: Zotarolimus drug19/1545: Paclitaxel drug184/1545: Bare metal 676 procedures excluded:482 no stent attributes189 blank drug attribute in SUDID5 invalid medical records112 patients excluded:73 had >= 2 stents with different drug attributes at initial procedure39 had stents with different drug attribute at subsequent procedure

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Step 1a:

Device attribute: Drug

Patient characteristics: AllOutcome: Mortality

MortalityPaclitaxel: 19 patients with 0 deathsZotarolimus: 176 patients with 7 deathsEverolimus: 1166 patients with 28 deathsBare metal: 184 patients with 18 deaths

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Mortality

Drug eluting stent: 1361 patients with 35 deaths

Bare metal: 184 patients with 18 deaths

Step 1b:Device attribute: DES CombinedPatient characteristics: AllOutcome: Mortality

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Step 2: Investigate Mortality in Different Follow-up Periods

Mortality (Total

53)

DESBMSP-value30 days (N=1405, 35 deaths)1.6% (20/1230)8.6% (15/175)<0.000160 days (N=1246, 40 deaths)2.2% (24/1096)10.7% (16/150)<0.000190 days (N=1111, 43 deaths)2.8% (27/982)12.4% (16/129)<0.0001120 days (N=947, 45 deaths)3.4% (28/832)14.8% (17/115)<0.0001150 days (N=798, 49 deaths)4.6% (32/702)17.7% (17/96)<0.0001180 days (N=665, 50 deaths)5.6% (33/586)21.5% (17/79)<0.0001210 days (N=539, 51 deaths)7.2% (34/472)25.4% (17/67)<0.0001240 days (N=374, 52 deaths)10.6% (34/322)34.6% (18/52)<0.0001270 days (N=281, 52 deaths)14.2% (34/240)43.9z% (18/41)<0.0001300 days (N=202, 52 deaths)20.4% (34/167)51.4% (18/35)0.0004330 days (N=129, 52 deaths)33.3% (34/102)66.7% (18/27)0.0035360 days (N=61, 53 deaths)85.4% (35/41)90.0% (18/20)NA

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Step 3: Identify Selection Bias

Baseline Characteristics

(N=1405)

DES (n=1230)BMS (n=175)P-valueStandardized Diff (DES-BMS) %Female32.4% (398/1230)32.6% (57/175)0.9549-0.43Age > 6553.1% (653/1230)53.1% (93/175)0.98940Caucasian95.9% (1177/1227)92.5% (161/174)0.050514.58Married69.6% (854/1227)59.2% (103/174)0.006921.95Alcohol used (Y)37.4% (440/1178)32.9% (53/161)0.29649.44Illicit drug used (Y)6.0% (66/1106)10.9% (16/147)0.0319-17.69Acute MI (Y)35.0% (431/1230)53.1% (93/175)<0.0001-37.08Cardiac arrest (Y)0.3% (4/1230)1.1% (2/175)0.1652-9.61Shock (Y)1.9% (23/1230)9.7% (17/175)<0.0001-33.84COPD (Y)12.9% (158/1230)18.9% (33/175)0.0339-16.46Diabetes mellitus (Y)37.0% (455/1230)27.4% (48/175)0.014420.66Dialysis (Y)1.9% (23/1230)0.6% (1/175)0.348211.72EF < 30% (Y)2.0% (25/1230)5.7% (10/175)0.0078-19.32

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Step 4: Reduce Selection Bias

Baseline Characteristics

(N=290)

DES (n=145)BMS (n=145)P-valueStandardized Diff (DES-BMS) %Female33.1% (48/145)34.5% (50/145)0.9012-2.96Age > 6546.9% (68/145)42.8% (62/145)0.55508.25Caucasian95.9% (139/145)94.5% (137/145)0.78536.55Married57.2% (83/145)56.6% (82/145)0.90561.21Alcohol used (Y)28.3% (41/145)31.0% (45/145)0.6998-5.91Illicit drug used (Y)10.3% (15/145)10.3% (15/145)NA0Acute MI (Y)53.1% (77/145)52.4% (76/145)0.90641.4Shock (Y)9.0% (13/145)8.3% (12/145)0.83432.49COPD (Y)20.7% (30/145)20.7% (30/145)NA0Diabetes mellitus (Y)28.3% (41/145)29.7% (43/145)0.8971-3.09EF < 30% (Y)4.8% (7/145)6.2% (9/145)0.7980-6.14

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Step 5: Examine Matched-pair Samples

Matched-pair

BMS

DeathAliveTotalDESDeath257Alive9129138Total11134145McNemar’s TestStatistic (1 degree of freedom)1.1429 (p=0.2850)Simple Kappa CoefficientKappa (ASE)0.1735 (0.1348)Test for Kappa = 0Statistic (two-side p-value)2.1494 (p=0.0316)

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MI

Paclitaxel

: 19 patients with 0 MACE MI

Everolimus: 1166 patients with 34 MACE MIsZotarolimus: 176 patients with 6 MACE MIsBare metal: 184 patients with 5 MACE MIsStep 1a:Device attribute: DrugPatient characteristics: AllOutcome: Myocardial Infarction (MI)

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ST

Paclitaxel

: 19 patients with 1

MACE STEverolimus: 1166 patients with 27 MACE STsZotarolimus: 176 patients with 6 MACE STsBare metal: 184 patients with 4 MACE STsStep 1a:Device attribute: DrugPatient characteristics: AllOutcome: Stent Thrombosis (ST)

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TR

Paclitaxel

: 19 patients with 1

MACE TREverolimus: 1147 patients with 113 MACE TRsZotarolimus: 172 patients with 17 MACE TRsBare metal: 182 patients with 18 MACE TRsAfter excluding 25 patients who had unmatched procedure dates:Step 1a:Device attribute: DrugPatient characteristics: AllOutcome: Total Revascularization (TR)

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Obstacles

Technical

: Biggest problem so far is MergeAgreeing on:Industry-wide standardsDevice attributesOrganizational infrastructure and support for designing and maintaining a

UDI systemThe business case for all stakeholders38

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UDI Phase 2

Purpose:

Build a national network of UDI enabled EHR data sets around national registries for device surveillance and research.The UDI Alliance:HTG Health Systems (Mercy, Mayo, Geisinger, Intermountain, and Kaiser)National medical societies and registries (ACC/NCDR)Industry (Medtronic, Abbott, Boston ScientificConsumer groups/patient representatives

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Coronary Stent Distributed Data Sharing Network

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Thanks!

Joseph P. Drozda, Jr., M.D., F.A.C.C.

Director, Outcomes ResearchMercy14528 South Outer FortyChesterfield, MO  63017

314-628-3864Mobile:  314-308-1732Joseph.Drozda@Mercy.net41