Unique Device Identification
Challenges for Manufacturers – Focus UDID
GS1 Healthcare Conference
Copenhagen, Oct 22, 2014
Volker Zeinar
Global UDI Project Leader
FDA’s UDI Requirements (Medical Devices)
1 2 3
• unambiguous device identification • data assoc. with med device • machine-readable identification
(distribution + use) identification + labeling • device ID + production IDs
• accredited issuing agencies only • > 60 data elements per device • package levels / device itself
(GS1, HIBCC, ICCBA)
UDI UDID AIDC
GS1 (numbering) (database) (coding)
• DI Device Identifier machine –
GTIN Static Data Elements
static data readable data
• DI = primary access carrier
Lot No. • PI Production Ident. key • Bar Code
Serial No. •…
dynamic data • RFID
Expiry Dt.
•…
Manuf. Dt.
•…
risk-based
class 3 : Sep 2014 class 2-IMP : Sep 2015 class 2 : Sep 2016 class 1 : Sep 2018
implementation
B. Braun Melsungen AG | Page 2
Challenge UDID
The major aspects :
Data Sources and Owners
Internal Data Administration
Data Exchange
UDI Database(s)
1 analysis and planning
be sure identify analyze assess define create install
to understand data data data life-cycle DM business technical
the required ownership sources format data quality model solution
information
sources : ERP System, LotusNotes-DBs, Excel-files, Access-files, drawings, paper work, ...
SAP Regulatory
Regulatory
Single UDID(s)
Source of UDID
2 Truth
data 3 data exchange
consolidation (electronically)
B. Braun Melsungen AG | Page 4
global Master Data
incl. UDI
„Single Source of Truth“
SAP Landscape
CMS
4 regional operative SAP Systems
1 global SAP Master Data System
B. Braun Melsungen AG | Page 5
Material Master Data Management
• several departments
CMS • around the world Marketing
• global + local data R&D
• autom. workflows
>1.4 Mil new products
records data changes Life-cycle
finished
SCM Data Labeling
goods Management
further aspects
>150.000
Medical • risk classes (3, 2IMP, 2, 1)
Devices • PFG and OEM ! ???
Regulatory
>85.000 relevant
UDI US
>30.000
Introcan Safety
• material no • xxx • xxx • xxx
Need to figure out : • xxx • xxx • xxx
• brandname
1. Master data records relevant for UDI • pack. hierarchy • xxx • xxx • xxx
2. Data attributes relevant for UDI • weight • xxx • xxx • xxx
• length • xxx • xxx • xxx
• sterility • xxx • xxx • xxx >250 data
• single-use • xxx • xxx • xxx
• latex • xxx • xxx • xxx attributes
• GTIN • xxx • xxx • xxx per record
• MR Safety • xxx • xxx • xxx
B. Braun Melsungen AG | Page 6
Material Master Data – UDI Relevance
SAP data concept
relevant
UDI US SAP classification (3)
Introcan Safety global UDI data (core)
>30.000 • material no • xxx • xxx • xxx local UDI data
• brandname • xxx • xxx • xxx monitoring
• pack. hierarchy • xxx • xxx • xxx
• weight • xxx • xxx • xxx
• length • xxx • xxx • xxx monitoring attributes
• sterility • xxx • xxx • xxx >250 data
• single-use • xxx • xxx • xxx attributes per
responsibilities
• latex • xxx • xxx • xxx
record labeling status
• GTIN • xxx • xxx • xxx
• MR Safety • xxx • xxx • xxx data completeness
+
“Ready to GUDID”
Why to figure out attributes relevant for UDI ?
FDA GUDID needs to be updated
How to recognize changes at attributes relevant for UDI ?
SAP change pointer concept flag triggers
Actions? Data Selector
change pointers trigger data exchange process important for initial data upload
into FDA GUDID
B. Braun Melsungen AG | Page 7
Classification
SAP Material Master Data
1 2
‚Ready to GUDID‘ - Flag
Ready to GUDID Yes / No • initial data load (legacy data)
• creation new MedDev
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UDI Data Consolidation in SAP
a) SAP
Material Master
Data Fields XLS
Monitoring Class initial load
• DI‘s (Prim, UoU, Pack)
• Device Count SAP
• Version/Model No c) remaining
• Controlled-by-… UDI Classes UDI Data
•… autom. • Global Data
derivation • Local Data US manually • Labeler DUNS
b) data existing • Dev. exempt DM
in other SAP • Local Data EU • FDA Listing No
• Local Data JP, BR, • …
Classes • …
MA
R&D
• GMDN
• Clinic. relevant sizes 65 % 35 % SCM
WF
• Single-Use Lab
• Latex ?
RA
•…
data available in SAP data w/o SAP source
covered by existing WF maintenance via new WF
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SAP Classification
Example :
product category ‚cannula‘
autom.
derivation
into UDI classes
acc. rules (BRF)
UDI relevant
information
in SAP classification
different data
depending on
the product category
available
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UDI Data Selection, Monitoring and Exchange
flags B. Braun
a) Ready to GUDID IT landscape
SAP
b) change pointers pull UDI
Data Selector Data
(SAP process)
XML file • delta recognition
• data validation (GDSN)
• create CIN messages
• User Interface (data steward)
Middle Ware release submissions
(SAP add-on) monitor submission results (CIC)
error handling (e.g. email trigger)
CIC CIN
GDSN
• data validation 1WorldSync UDI data separated from commercial data
different Info-Prov-GLNs
(GDSN + FDA) GDSN
• create HL7-SPL
• routing back submission results FDA
HL7-SPL
• reporting functions GUDID
FDA ESG
ACK 1/2/3
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Process Overview
Material
Master Middle Ware
Data XML
Selector
CMS
GDSN CIN
UDI data GDSN Response
• MD fields GDSN
• classification CIC
attributes
Standard FDA
GDSN
Mapping Service
GDSN
Messaging CIN HL7-SPL
GUDID
GDSN FDA
CIC Response
ACK 1/2/3
DataSyncEngine
Reports
/Alerts
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UDI Implementation Challenges
B. Braun IT
in partnership with
Organisational
B. Braun internal
•workflows Data
Data
•process validation Manage-
Exchange
•SOP‘s ment
•people
•education
•etc
AIDC
Implementation
Technical
B. Braun Engineering / Labeling
in partnership with printer system providers
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Before you start UDI implementation
Compliance Group
to interpret the regulation …
… and to create an internal
implementation guide !
B. Braun Melsungen AG | Page 14
Thank you for your time.
Questions ?