implementation of unique device identification demonstration project – a report from mdepinet...
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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
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 Aims
1. Implement a coronary artery stent UDI-based surveillance system in the EHR in a multi-hospital system (Mercy)
2. Identify obstacles to implementation of UDI in clinical information & to characterize the effectiveness of interventions to overcome them;
3. Assess the validity and utility of data obtained from the EHR and incorporated UDIs for purposes of post-market surveillance
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
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 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” members• FDA representatives• Coronary Stent manufacturer representatives• HTG system representatives• NCDR 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 SUDID
• Develop a proposal for an organization and processes for ongoing maintenance of the SUDID
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 specification Fractional dimension in mm 4 significant digits, w/2
precision
Non-conventional Property
Stent having nonconventional design, variable or multiple length/diameter
parameters
Covered stentBifurcation Stent
Tapered StentAlphanumeric
Structural Material Composition of principal structural elementConstrained list
e.g. L605 cobalt chromium-- Constrained list to be developed
Alphanumeric
Coating(s) Non-Structural material covering surface of structural element
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
Alphanumeric
Drug(s) Active agent released from stentNDC directory (default)
--Use name if no applicable NDC code—do it uniformly
Alphanumeric
Strut Thickness Maximum nominal thickness of stent struts on a radius from the center of the stent Dimension in microns 4 integer digits
Surface to Artery Ratio*
Percentage of the surface area of the artery covered by the stent at nominal expansion of
the stent
3 significant digits, w/1 precision
Expansion Method Method used to achieve nominal stent deployment
BalloonSelf Alphanumeric
MRI Compatibility MRI compatibility category per testing
4 categories per existing standard:--Safe
--Conditional--Unsafe
--Not tested
4 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
UDI Demonstration Project High Level Architecture
Single EHR UDI Tracking System Data Flow
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 UDIR• Inventory Data table in UDIR• Billing Data table in UDIR• Registry Data from Registry submission
• Completeness of each data set measured against the reference dataset
Unique Coronary Stent Procedure Counts (percent of procedures in reference datasets)
St. Louis Springfield Rogers (All Sites)
Registry Data 291 (88%) 566 (87%) - 857
Cath Lab Data 281 (85%) 546 (84%) 236 (83%) 1063
Inventory Data 301 (91%) 608 (93%) 253 (89%) 1162
Billing Data 291 (88%) 565 (87%) 212 (75%) 1068
Reference Dataset
330 653 283 1266
Patient Counts by Month and System for St. Louis and Springfield
November December January February March2012 2013
0
50
100
150
200
250
CathPCIMergeOptiflexBilling
Month
Patie
nt C
ount
s
Registry
Cath Lab
Inventory
Billing
Registry
Cath Lab
Inventory
Billing
Percent Agreement by System Combinations for St. Louis and Springfield
System
% Registry Data Cath Lab Data Inventory Data Billing Data
Y Y Y Y 73%
Y N Y Y 9%
N Y N N 4%
N N Y N 3%
Y Y Y N 3%
N Y Y N 2%
N N N Y 2%
Y Y N Y 1%
N Y Y Y 1%
N N Y Y 0.4%
Y N Y N 0.3%
Y N N Y 0.1%
Y N N N 0.1%
N Y N Y 0.1%
Y Y N N 0.1%
Stent Counts by Site and System (percent of stents in reference datasets)
St. Louis Springfield Rogers All Sites
Cath PCI 514 (76.3%) 877 (81.1%) -- 1391
Merge 603 (89.5%) 902 (83.4%) 412 (80.6%) 1917
OptiFlex 539 (80.0%) 929 (85.9%) 432 (84.5%) 1900
Billing 496 (73.6%) 768 (71.0%) 344 (67.3%) 1608
Reference Dataset
674 1082 511
Coronary Stent Count Comparison at Mercy Hospital St. Louis and Springfield
November December January February March2012 2013
0
50
100
150
200
250
300
350
400
CathPCIMergeOptiflexBilling
Month
Sten
t Cou
nts
Registry
Cath Lab
Inventory
Billing
Overall Scan Compliance
Inventory Data Cath Lab Data Inventory/Cath Lab
Rogers 744 856 86.9% (744/856)
Springfield 1996 2279 87.6% (1996/2279)
St Louis 897 1097 81.8% (897/1097)
Total 3637 4232 85.9% (3637/4232)
Nov-12
Dec-12
Jan-13 Feb-13
Mar-13
Apr-13
May-13
Jun-13 Jul-13 Aug-13
Sep-13
Oct-1360
65
70
75
80
85
90
95
100
77
92
83
90
85
96
85
93 95
83
88
81
Rogers
Time
Inventory /Cath Lab (%)
Scan Compliance – by Month
Scan Compliance – by Month
Nov-12
Dec-12
Jan-13 Feb-13
Mar-13
Apr-13
May-13
Jun-13 Jul-13 Aug-13
Sep-13
Oct-1360
65
70
75
80
85
90
95
100
89 8885
81
9188
83
90 89 88
93
85
Springfield
Time
Inventory/Cath Lab (%)
Scan Compliance – by Month
Nov-12
Dec-12
Jan-13 Feb-13
Mar-13
Apr-13 May-13
Jun-13 Jul-13 Aug-13
Sep-13
Oct-1360
65
70
75
80
85
90
95
100
8884 82 81
7880 79 79
8185
82
77
St Louis
Time
Inventory/Cath Lab (%)
Scan Compliance – Non Regular Hour vs Regular Hour
Inventory/Cath Lab (%)
Rogers St Louis Springfield0
10
20
30
40
50
60
70
80
90
100
83.278.4
61.7
82.6 81.288.3
Non regular hourRegular hour
Mercy’s Sites
Scan Compliance – Emergent (AMI) vs Non-emergent
Rogers St Louis Springfield0
10
20
30
40
50
60
70
80
90
10087.1
81.486.886.1 83.8
90.6
Not AMI EmergencyAMI Emergency
Mercy’s Sites
Inventory/Cath Lab (%)
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
Statistical Analyses
Step 1• Detect safety signal (a) with different
drug attributes, (b) combined drug attributes
Step 2 •Investigate MACE events in different follow-up periods
Step 3 •Identify selection bias
Step 4 •Reduce selection bias
Step 5 •Examine match-pair samples
Case Selection Flow Diagram2484 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 records
112 patients excluded:73 had >= 2 stents with different drug attributes at initial procedure39 had stents with different drug attribute at subsequent procedure
Step 1a:Device attribute: DrugPatient characteristics: AllOutcome: Mortality
Mortality
Paclitaxel: 19 patients with 0 deaths
Zotarolimus: 176 patients with 7 deaths
Everolimus: 1166 patients with 28 deaths
Bare metal: 184 patients with 18 deaths
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
Step 2: Investigate Mortality in Different Follow-up Periods
Mortality (Total 53) DES BMS P-value30 days (N=1405, 35 deaths) 1.6% (20/1230) 8.6% (15/175) <0.0001
60 days (N=1246, 40 deaths) 2.2% (24/1096) 10.7% (16/150) <0.0001
90 days (N=1111, 43 deaths) 2.8% (27/982) 12.4% (16/129) <0.0001
120 days (N=947, 45 deaths) 3.4% (28/832) 14.8% (17/115) <0.0001
150 days (N=798, 49 deaths) 4.6% (32/702) 17.7% (17/96) <0.0001
180 days (N=665, 50 deaths) 5.6% (33/586) 21.5% (17/79) <0.0001
210 days (N=539, 51 deaths) 7.2% (34/472) 25.4% (17/67) <0.0001
240 days (N=374, 52 deaths) 10.6% (34/322) 34.6% (18/52) <0.0001
270 days (N=281, 52 deaths) 14.2% (34/240) 43.9z% (18/41) <0.0001
300 days (N=202, 52 deaths) 20.4% (34/167) 51.4% (18/35) 0.0004
330 days (N=129, 52 deaths) 33.3% (34/102) 66.7% (18/27) 0.0035
360 days (N=61, 53 deaths) 85.4% (35/41) 90.0% (18/20) NA
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) 0.9549 -0.43
Age > 65 53.1% (653/1230) 53.1% (93/175) 0.9894 0
Caucasian 95.9% (1177/1227) 92.5% (161/174) 0.0505 14.58
Married 69.6% (854/1227) 59.2% (103/174) 0.0069 21.95
Alcohol used (Y) 37.4% (440/1178) 32.9% (53/161) 0.2964 9.44
Illicit drug used (Y) 6.0% (66/1106) 10.9% (16/147) 0.0319 -17.69
Acute MI (Y) 35.0% (431/1230) 53.1% (93/175) <0.0001 -37.08
Cardiac arrest (Y) 0.3% (4/1230) 1.1% (2/175) 0.1652 -9.61
Shock (Y) 1.9% (23/1230) 9.7% (17/175) <0.0001 -33.84
COPD (Y) 12.9% (158/1230) 18.9% (33/175) 0.0339 -16.46
Diabetes mellitus (Y) 37.0% (455/1230) 27.4% (48/175) 0.0144 20.66
Dialysis (Y) 1.9% (23/1230) 0.6% (1/175) 0.3482 11.72
EF < 30% (Y) 2.0% (25/1230) 5.7% (10/175) 0.0078 -19.32
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) 0.9012 -2.96
Age > 65 46.9% (68/145) 42.8% (62/145) 0.5550 8.25
Caucasian 95.9% (139/145) 94.5% (137/145) 0.7853 6.55
Married 57.2% (83/145) 56.6% (82/145) 0.9056 1.21
Alcohol used (Y) 28.3% (41/145) 31.0% (45/145) 0.6998 -5.91
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) 0.9064 1.4
Shock (Y) 9.0% (13/145) 8.3% (12/145) 0.8343 2.49
COPD (Y) 20.7% (30/145) 20.7% (30/145) NA 0
Diabetes mellitus (Y) 28.3% (41/145) 29.7% (43/145) 0.8971 -3.09
EF < 30% (Y) 4.8% (7/145) 6.2% (9/145) 0.7980 -6.14
Step 5: Examine Matched-pair Samples
Matched-pair BMS
Death Alive Total
DES Death 2 5 7
Alive 9 129 138
Total 11 134 145
McNemar’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)
MIPaclitaxel: 19 patients with 0 MACE MIEverolimus: 1166 patients with 34 MACE MIsZotarolimus: 176 patients with 6 MACE MIsBare metal: 184 patients with 5 MACE MIs
Step 1a:Device attribute: DrugPatient characteristics: AllOutcome: Myocardial Infarction (MI)
STPaclitaxel: 19 patients with 1 MACE STEverolimus: 1166 patients with 27 MACE STsZotarolimus: 176 patients with 6 MACE STsBare metal: 184 patients with 4 MACE STs
Step 1a:Device attribute: DrugPatient characteristics: AllOutcome: Stent Thrombosis (ST)
TRPaclitaxel: 19 patients with 1 MACE TREverolimus: 1147 patients with 113 MACE TRsZotarolimus: 172 patients with 17 MACE TRsBare metal: 182 patients with 18 MACE TRs
After 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 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
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 Scientific• Consumer groups/patient representatives
Coronary Stent Distributed Data Sharing Network
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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