UDI Data Enrichment & Innovation: Leveraging UDI to ... · 6/6/2019 · •Access to clinically...

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?

2

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?

3

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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5

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


Corp. SYNERGY 2.25 mm 12 mm 3.5 mm 18


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


Corp. Express2 2.25 mm 8 mm 4.25 mm 18 316L stainless steel None None Balloon MR Conditional


Corp. REBEL 4.0 mm 12 mm 5.75 mm 18


None None Balloon TRUE TRUE MR Conditional


Corp. ION 2.25 mm 16 mm 2.75 mm 18


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
















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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Areas for UDI Implementation

14

What Will Make It Happen?

• ROI

• Clinical safety benefits

• Infrastructure modifications

• Will to change

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UDI Data Enrichment & Innovation: Leveraging UDI to ... · 6/6/2019 · •Access to clinically...

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