AIDC Data & Serialisation - GS1...AIDC Data & Serialisation Orlando, Florida June 6, 2007 Tom Heist,...
Transcript of AIDC Data & Serialisation - GS1...AIDC Data & Serialisation Orlando, Florida June 6, 2007 Tom Heist,...
Healthcare
AIDC Data & Serialisation
Orlando, Florida
June 6, 2007
Tom Heist, GS1 GO
©2007 GS12
Healthcare
Introduction
� Overview – Work Group Relationships
� Auto-ID Data Work Group
� Serialisation Work Group
©2007 GS13
Healthcare
Work Group Relationships
©2007 GS14
Healthcare
GS1 Healthcare Work Groups
We intend to create a healthcare application standard that meets
our users’ requirements.
©2007 GS15
Healthcare
A Healthcare Standard
Must be created to meet:
� Business Requirements
� Data Requirements
� Serialisation Requirements
� Carrier Requirements
©2007 GS16
Healthcare
Work Teams versus Roadmap
200820072006
Packaging/Direct Marking
AutoID Data
Serialisation
Carriers
AIDC Application Standards
©2007 GS17
Healthcare
The Deliverables
Business & Data
Requirements
Serial & Lot #Size and Capacity
AUTO-ID Data Team Serialisation Team
CARRIER
Work
Group
©2007 GS18
Healthcare
The Deliverables
Change Request Change Request
AUTO-ID Data Team Serialisation Team
GSMP
©2007 GS19
Healthcare
Auto-ID Work Group
©2007 GS110
Healthcare
AIDC Data Work Group’s Objective
… identify the business and data requirements
for the automatic identification of healthcare products
with the goal of improving patient safety
©2007 GS111
Healthcare
Vaccines BiologicsTherapeutic nutritional productsPharmaceuticalMedical DevicesInstrumentsImplants
ScopeHealthcare Product Areas
©2007 GS112
Healthcare
ScopeSupply Chain Boundaries
Care FacilityManufacturing Distribution
From: Finished Goods To: End of Treatment
©2007 GS113
Healthcare
The GS1 HUG™ Auto-ID Data Work Team A closer look
• Gathered the business requirements for data on healthcare products
• Compiled and condensed a list
• Agreed upon content
The approved business requirements have been used to
establish data requirements
©2007 GS114
Healthcare
Business Requirements
I Manufacturer, Wholesaler, Distributor, Hospital, Retailer
NEED a statement of the requirement
BECAUSE the business rationale
to ensure an
expired product is not
given to the patient.
needs to know the
expiration in time (not just
YYMMDD) for products
with a short life cycle
Manufacturer
©2007 GS115
Healthcare
Collection
Over 166 business requirements collected from
• Hospital Survey
• Sub – Teams (by product type)
• Manufacturers
• Distributors
• Wholesalers
• Retailers
• Hospitals
• Local/Regional HUGs
• Healthcare Organisations
• Regulatory Agencies
©2007 GS116
Healthcare
Analysis & Disposition
• Combined (similar)
• Split (smaller, clearer)
• Scope (in or out of scope)
• Approved
• Parking Lot
• Deleted
YIELD = 60 Final Approved Business Requirements
©2007 GS117
Healthcare
Data Analysis
Gap and Map
Business
RequirementsGS1 Stds Products
Marking
Levels
©2007 GS118
Healthcare
Gap Analysis
�GTIN
�GLN
�GSRN
�SSCC
�Serial #
�Lot #
�Expiration Date
�OTHER = time
to ensure an
expired product is not
given to the patient.
needs to know the
expiration in time (not justYYMMDD) for products with
a short life cycle
Manufacturer
©2007 GS119
Healthcare
Mapping Example
for Hospital
for Retailer
for Wholesaler
for Repacker
Data Reqmts
for Manufacturer
Business
Requirement
Numbers
Pallet
Case /
ShipperCartonUnit of Use
Direct Part
MarkMarking Level
Product Class
Product
#1
AI(01)
GTIN
AI(01)
GTIN
#1
©2007 GS120
Healthcare
Current Status
GAP ANALYSIS IS COMPLETE
MAPPING IS UNDERWAY
DRAFT REPORT PREPARED
NEED ONLY ……..
• Final Data Analysis Charts
• Team Review and Approval
THEN…. Develop A Plan For Parking Lot Issues
©2007 GS121
Healthcare
Serialisation Work Group
©2007 GS122
Healthcare
Serialisation Work Groups Objectives
To determine the size and structural requirements
for lot numbers and serial numbers to support
patient safety and product authentication
for healthcare products
©2007 GS123
Healthcare
SCOPEHEALTHCARE PRODUCT AREA
• Vaccines
• Biologics
• Therapeutic nutritional products
• Pharmaceutical
• Medical Devices (e.g.,Instruments, Implants)
©2007 GS124
Healthcare
ScopeSupply Chain Boundaries
Care FacilityManufacturing Distribution
From: Finished Goods To: End of Treatment
©2007 GS125
Healthcare
SCOPE
The Serialisation WG will review and document business and regulatory requirements for serialisation by:
• Meaningful numbers versus randomization & capacity affect
• Decentralization/centralization of allocation & affect on capacity
• Structure
• Numeric length
• Alpha-numeric length
©2007 GS126
Healthcare
Scope Review
The Serialisation WT will review and document business and regulatory requirements
for serialisation by Size (capacity needed).
Number Product Company Industry
Serial # all one any
Serial# all one healthcare
Serial# largest one healthcare
Lot # largest one healthcare
©2007 GS127
Healthcare
DATA COLLECTION
Number Structure and Capacity Data Collected
�By Company
�By Product Types
�By Number (Lot number & Serial number)
�By Number Selection (Intelligent number or
Random number)
�By Number Assignment (Centralized or
Decentralized)
�By Number Structure (Numeric or Alpha-
numeric)
©2007 GS128
Healthcare
Over 39 Responses
Representing: � All product types
� Manufacturers
� Distributors
� Hospitals
� North America
� Europe
� Australia
� New Zealand
©2007 GS129
Healthcare
Largest Numbers Collected
Number of serial numbers needed if 1 is assigned to
every product “instance” produced for:
any channel healthcare highest volume
vaccines
biologics
therapeutic nutritional
pharmaceuticals
medical devices
instruments
implants
2 Billion 2 Billion 2 Billion
10 Million
10 Million
2 Billion
4 Billion
2 Billion
5 Billion
10 Million
10 Million
50 Billion 50 Billion
50 Billion50 Billion
2 Billion
3 Billion
1 Billion
400 Million
20 Thousand
20 Thousand
©2007 GS130
Healthcare
STATUS
Data Collection Is Closed
Data Study Started
• Serialisation Factors
Conclusions To Be Reported
©2007 GS131
Healthcare
Thank You