UDI Data Enrichment & Innovation: Leveraging UDI to Provide Extended
Value
Dr. Joseph Drozda Director of Outcomes Research, Mercy Health
Dr. James Tcheng Professor of Medicine, Duke University
Patrick Lupinetti First Databank, Inc.
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UDI – Not Just a Regulatory Requirement
• What problems can it address, even solve?
• What developments will it promote?
• What opportunities will it create in the future?
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Current State • GUDID provides a catalog of UDI numbers
• What else is needed by potential users?
• How and where will the additional data be accessed?
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Clinical Use • Access to clinically relevant attributes at point of
care
• Ease of entry into EHR – UDI number that can be linked to variety of attributes
• Facilitate decisions about previously implanted devices, e.g., MRI compatibility
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BUILD Redux
Search or sort by UDI-DI or attribute
Primary DI Catalog Number Company Name Brand Name Nominal Stent
Diameter Nominal Stent
Length Maximum Stent
Diameter Rated Burst
Pressure (atm) Structural Material Coating
Drug Eluted – Name
Drug Eluted Content (µg)
Expansion Method
IsPackagedAsSteril
e
IsSingleUse
MRI Safety
08717648199059 1125225-08 Abbott Vascular,
Inc. XIENCE ALPINE 2.25 mm 8 mm 3.25 mm 18 L-605 Cobalt Chromium PBMA, PVDF-HFP Everolimus 40 Balloon TRUE TRUE MR Conditional
08717648162060 1074225-28 Abbott Vascular,
Inc. XIENCE
XPEDITION SV 2.25 mm 28 mm 3.25 mm 18 L-605 Cobalt Chromium PBMA, PVDF-HFP Everolimus 137 Balloon TRUE TRUE MR Conditional
08714729828853 H7493925216220 Boston Scientific
Corp. Promus PREMIER 2.25 mm 16 mm 2.75 mm 18
Platinum chromium alloy (PtCr)
PVDF-HFP Everolimus 72.7 Balloon TRUE TRUE MR Conditional
08714729840022 H7493926012220 Boston Scientific
Corp. SYNERGY 2.25 mm 12 mm 3.5 mm 18
Platinum chromium alloy (PtCr)
PLGA Everolimus 58.3 Balloon TRUE TRUE MR Conditional
08717648063855 1009539-23 Abbott Vascular,
Inc. XIENCE V 2.50 mm 23 mm 3.50 mm 16 L-605 Cobalt Chromium PBMA, PVDF-HFP Everolimus 113 Balloon TRUE TRUE MR Conditional
08714729386759 H7493505008220 Boston Scientific
Corp. Express2 2.25 mm 8 mm 4.25 mm 18 316L stainless steel None None Balloon MR Conditional
08714729844211 H7493927512400 Boston Scientific
Corp. REBEL 4.0 mm 12 mm 5.75 mm 18
Platinum chromium alloy (PtCr)
None None Balloon TRUE TRUE MR Conditional
08714729810414 H7493902416220 Boston Scientific
Corp. ION 2.25 mm 16 mm 2.75 mm 18
Platinum chromium alloy (PtCr)
SIBS Translute polymer Paclitaxel 74 Balloon TRUE TRUE MR Conditional
07290107013529 LUN250R12US Medinol, Ltd. EluNIR 2.50 mm 12 mm 3.00 mm 18 L-605 Cobalt Chromium,
annealed, ASTM F90
Poly n-Butyl Methacrylate (PBMA) ,
Carbosil 20 55D Ridaforolimus 50 Balloon TRUE TRUE MR Conditional
00643169037373 RSINT25018UX Medtronic, Inc. Resolute Integrity 2.50 mm 18.00 mm 3.50 mm 16 Cobalt Alloy Parylene C, BioLinx
Polymer System Zotarolimus Balloon TRUE TRUE MR Conditional
00613994539267 ENSP35018UX Medtronic, Inc. Endeavor sprint 3.50 mm 18.00 mm 4.00 mm 16 Cobalt Alloy Phosphorylcholine
Polymer Zotarolimus 180 Balloon TRUE MR Conditional
00643169037090 RSINT35009UX Medtronic, Inc. Resolute Integrity 3.50 mm 9.00 mm 4.75 mm 16 Cobalt Alloy Parylene C, BioLinx
Polymer System Zotarolimus Balloon TRUE TRUE MR Conditional
07640130435025 383881 Biotronik AG PRO-Kinetic
Energy 2.25 mm 18 mm 3.5 mm 16
L-605 cobalt chromium alloy
proBIO (Amorphous Silicon Carbide)
Balloon TRUE TRUE MR Conditional
EHR Documentation in Cath Lab
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Patient: John Smith Male, 74 y.o., 10/03/1945
MRN: 104930 PCP: Dr. Stan Lee
Procedure: Coronary Artery Disease ICD: 125.10
RSINT25018UX Catalog Number:
00643169037373 DI:
Medtronic, Inc.
Company Name:
Resolute Integrity Brand Name:
Stent RSINT25018UX MicroTrac 2.50X18RX
Device Name:
2.50 mm Nominal Stent Diameter :
8 mm Nominal Stent Length:
3.50 mm Maximum Stent Diameter:
Cobalt Alloy Structural Material:
Parylene C, BioLinx Po Zotarolimus Coating:
MRI Safe: Yes
Outcomes/Research • Simplifies identification of cases involving
devices with relevant attributes
• Supports comparison analyses/CER
• Enables general data access for exchange, review and assessment
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“All cases involving paclitaxel-eluting stents”
Primary DI Device Name Drug Eluted –
Name Drug Eluted Content (µg)
Strut Thickness (µ - micron)
08714729811459 Paclitaxel-Eluting Platinum Chromium Coronary Stent System, Over-the-Wire (OTW) Paclitaxel 39 81
08714729811466 Paclitaxel-Eluting Platinum Chromium Coronary Stent System, Over-the-Wire (OTW) Paclitaxel 40 81
08714729811473 Paclitaxel-Eluting Platinum Chromium Coronary Stent System, Over-the-Wire (OTW) Paclitaxel 40 81
08714729811480 Paclitaxel-Eluting Platinum Chromium Coronary Stent System, Over-the-Wire (OTW) Paclitaxel 43 81
08714729811497 Paclitaxel-Eluting Platinum Chromium Coronary Stent System, Over-the-Wire (OTW) Paclitaxel 43 81
08714729811503 Paclitaxel-Eluting Platinum Chromium Coronary Stent System, Over-the-Wire (OTW) Paclitaxel 57 86
08714729810926 Paclitaxel-Eluting Platinum Chromium Coronary Stent System, Over-the-Wire (OTW) Paclitaxel 58 81
08714729810933 Paclitaxel-Eluting Platinum Chromium Coronary Stent System, Over-the-Wire (OTW) Paclitaxel 62 81
08714729810940 Paclitaxel-Eluting Platinum Chromium Coronary Stent System, Over-the-Wire (OTW) Paclitaxel 62 81
08714729810957 Paclitaxel-Eluting Platinum Chromium Coronary Stent System, Over-the-Wire (OTW) Paclitaxel 61 81
08714729810964 Paclitaxel-Eluting Platinum Chromium Coronary Stent System, Over-the-Wire (OTW) Paclitaxel 61 81
08714729810971 Paclitaxel-Eluting Platinum Chromium Coronary Stent System, Over-the-Wire (OTW) Paclitaxel 82 86
08714729811008 Paclitaxel-Eluting Platinum Chromium Coronary Stent System, Over-the-Wire (OTW) Paclitaxel 74 81
08714729811015 Paclitaxel-Eluting Platinum Chromium Coronary Stent System, Over-the-Wire (OTW) Paclitaxel 80 81
08714729811022 Paclitaxel-Eluting Platinum Chromium Coronary Stent System, Over-the-Wire (OTW) Paclitaxel 80 81
08714729811039 Paclitaxel-Eluting Platinum Chromium Coronary Stent System, Over-the-Wire (OTW) Paclitaxel 86 81
Supply Chain
• Definitive identifier for ordering
• Promotes coordination and communication between supply chain, clinical, claims
• Internal tracking
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Multiple catalog numbers – one UDI-DI
Available information for ordering and billing
Catalog No. Catalog No. Manufacturer Brand Name Device Description PrimaryDI
42870 7140-14-0.8 Avanos Medical Halyard MIC-KEY* SF Gastrostomy Feeding Tube
10680651428704
G22002 MWB-2X4 Cook Memory Basket Memory Hard Wire Basket 00827002220027
BO-T 36503 701065590 DataScope Isolated Prime Circuit 00607567205529
2999-66-258 299966258 DePuy Orthopaedic
GLOBAL ADVANTAGE
AOA Mask Small 40X15 Left 10603295489627
T3018-1004 23038016 Fisher Scientific Sure-Vue Sure-Vue Color Mono 24T 00006136471196
450-SBA-090 450SBA090 Integra York PA Integra® Jarit® Side Blade/Assembly for Dingman Mouth Gag
10381780458760
T6N3G01-1 6.N3G01 Medartis Medizi Syntacer Synthacer® 1000 powder, “negative
04250971403911
07579 76091-ACM757 O&M Halyard Halyard HYH-KREMER KSM DRAPE 10680651075793
03.007.019 03007019 Synthes (U.S.A) NA NAIL REMOVAL ALIGNMENT DRILL
10886982066756
2480-40-41 00-2480-040-41 Zimmer NA Cancellous Screw 00889024510968
Primary DI Catalog No. Manufacturer Brand Description Size CPT Code CPT Desc. HCPCS Code
HCPCS Desc
8453729673223 34-56788A Pittsburg Mathematics, Inc.
ENTROPY®
Everolimus-Eluting Co-CR Coronary Stent
5mm x 12 mm
92937 Percutaneous transluminal resvascularzation…
C1874 Stent, coated/covered…
Safety/Safe Use • UDI as link to patient-facing information
• Definitive identifier for recall, adverse event reporting, product validation
• Surveil by attribute, e.g., defibrillator wire diameter, metal on metal hips, paclitaxel containing balloons and stents
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UDI Implementation • Where in healthcare facility?
• Which users?
• What associated data will they need?
• How will they leverage it?
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