1. Data Standards and an FDA Update
Jean Sargent, CMRP, FAHRMM
Paste President AHRMM, CAHPMM

2. Jean Sargent… Currently, Director, MedAssets
Past President of the Association for Healthcare Resource and Materials Management of the American Hospital Association (AHRMM) and California Association of Healthcare Purchasing and Materials Managers (CAHPMM)
GS1 Healthcare US® & Global GS1 Healthcare Leadership Team
A recognized leader in supply chain management, having presented at many conferences at the national, state and local levels.
Over 36 years experience in hospital Central Service / Materials Supply Chain Management.

3. What if Data Standards in grocery stores worked liked they do in the health care supply chain?

4. Agenda GS1 Overview GS1 Healthcare Standards – GLN, GTIN, & GDSN
FDA UDI
Progress Overview
Industry
MedAssets/GPO’s
Resources
Questions

5. GS1 Overview

6. About GS1
The GS1 System is the most widely used supply chain standards system in the world, utilized in twenty-three sectors and industries including GS1’s core sectors of Healthcare and Fast Moving Consumer Goods (FMCG), as well as Transport, Defense and many others.
About GS1 Healthcare US
GS1 Healthcare US is an industry group that focuses on driving the adoption and implementation of GS1 Standards in the healthcare industry in the United States to improve patient safety and supply chain efficiency. GS1 Healthcare US brings together members from all segments of the healthcare industry to address the issues that most impact healthcare in the United States. Facilitated by GS1 US, GS1 Healthcare US is one of twenty-seven local GS1 Healthcare user groups around the world that supports the adoption and implementation of global standards developed by GS1.

7. IMPROVING HEALTHCARE BUSINESS PROCESSES WITH GS1 STANDARDS

8. Demand to Inventory: GS1 Standards ensure that the right product gets to the right location at the right time by making forecasting and replenishment activities visible throughout the supply chain with production and inventory deployment. By enabling the supplier to provide the buyer accurate and standardized data as part of the order, the buyer can subsequently source the correct product at the correct level of packaging.

9. Order to Cash: The use of GS1 product and location identifiers improves order and invoice accuracy by reducing confusion in the item’s unit of measure, orders, and pricing. By increasing item attribute accuracy, order processing is streamlined, reducing time and money spent correcting errors and discrepancies.

10. Account to Report: GS1 Standards enable the provision of accurate, valid, and supported accounting information, driving best practices and optimized performance over time. From general accounting activities to external reporting, fixed and liquid asset inventory, and cost accounting, GS1 Standards improve the quality of financial data in these areas.

11. Procure to Pay: The use of GS1 product and location identifiers streamlines the movement of goods/services into your order to cash cycle optimizing upstream activities. When integrated as part of your sourcing system, GS1 Standards enable you to efficiently and effectively move your products into inventory or make them consumables as quickly as possible.

12. Master Data Management: GS1 Standards ensure that the provision of accurate weights and dimensions for storage, handling, and warehousing purposes are consistent. While master data, such as these examples, rarely changes, it is often used across a multitude of applications. An error in this data can be proliferated across the supply chain resulting in untold damage and loss.

13. Product to Patient: Patient safety is improved with the use of GS1 Standards. Consistent data standards provide visibility and insight into every area that a healthcare product touches—from manufacturer, sourcing, and distribution to delivery, patient use, and electronic recording to billing, reimbursement, and beyond.

14. Logistics: GS1 Standards provide accurate dimensions and weights for warehousing and hospital storage optimization. Hospitals and other health facilities are finding that storage areas are being reduced as more space is claimed for patient facilities. As such, optimization of available storage space is critical, and the use of GS1 Standards greatly improves this process.

15. An opportunity for a new kind of healthcare innovation
‘‘ Implementing global standards across the entire healthcare supply chain could save 22, ,000 lives and avert 0.7 million to 1.4 million patient disabilities ‘‘
‘‘ Rolling out such standards-based systems globally could prevent tens of millions of dollars’ worth of counterfeit drugs from entering the legitimate supply chain. ‘‘
“ Today, the healthcare industry has half a trillion dollars tied up in inventory, but better collaboration enabled through global standards could reduce obsolescence and inventory redundancy”
“[We] estimate that healthcare cost could be reduced by $40 billion - $100 billion globally” from the implementation of global standards
(Source: McKinsey report, “Strength in unity: The promise of global standards in healthcare”, October 2012)
A new and independent report by McKinsey & Company has estimated the benefits - in lives and value - of implementing one single global standard in Healthcare.
The Healthcare industry faces major challenges: counterfeiting, ineffective product recall, medication errors and lack of inventory visibility resulting in high inventory costs and supply chain inefficiencies. At the same time, Healthcare costs have been rising for several years and are still expected to grow faster than national income in most of the countries, and regulators are defining new supply chain requirements to protect patients.
The situation will be unsustainable in the long run as these challenges affect the entire supply chain, from manufacturers through to wholesalers, distributors, group purchasing organizations and Healthcare providers.
The McKinsey & Company report, voicing the view of 80 thought leaders in the Healthcare industry, highlights the need to align on a single global standard to ensure patient safety and explains the urgency of driving adoption across all supply chain stakeholders.
To download the report, visit

16. GLN, GTIN and GDSN

17. GS1 Standards 1. Location Identification: Global Location Number (GLN)
This unique 13-character number is an industry-wide standardized location identifier that replaces custom account and location numbers. This ensures that the right product arrives at the right place at the right time.
2. Product Identification: Global Trade Identification Number (GTIN)
The GTIN is the unique GS1 System Identification Number used for any product or service upon which there is a need to retrieve pre-defined information; this product or service may be priced, ordered, or invoiced at any point in the supply chain. This includes individual items as well as all of their different packaging configurations (1 product could have multiple GTIN’s).
3. Product Definition: Global Data Synchronization Network (GDSN)
The GDSN is an authoritative source of standardized healthcare product information. With this network, all supply chain partners will be able to access identical, up-to- date, reliable product data efficiently. The GDSN plays an integral role in the adoption of GTINs.

18. Global Location Number (GLN)

19. What is a GLN? A globally unique 13-digit number that identifies:
Legal entities
- Whole companies, health systems, divisions
Functional entities
- Specific department within a legal entity, (e.g., pharmacy, receiving department, etc.)
Physical locations
- Clinics, units, warehouses, loading docks, etc.

20. Why is a GLN Needed?
Today, there are too many identifiers for the same healthcare location. This causes confusion, finger pointing & inefficiency.
ST JOHN'S QUEENS HOSPITAL Hospital ID: SAINT JOHNS QUEENS HOSPITAL Hospital ID: JAOE SAINT JOHN'S QUEEN HOSPITAL Hospital ID: SAINT JOHN'S QUEEN’S HOSPITAL Hospital ID: CA2053 ST. JOHN'S QUEENS HOSPITAL Hospital ID: OM 12345
SAINT JOHN'S QUEENS HOSPITAL
GLN:

21. GLN Benefits - Providers
Simplifies location identification with a single identifier used across all supply chain partners
Enables providers to define and manage their own account and location information to ensure accuracy
Provides an accurate view of the organization as a customer to ensure correct contract pricing eligibility and to streamline rebate processing
Reduces mis-shipments and time spent resolving order and invoice errors
Provides the foundation for traceability to improve product recall processes

22. GLN Benefits - Suppliers
Improves customer data management processes
Streamlines sales tracing, administration fee reporting, rebate and chargeback processes
Reduces time spent resolving order, pricing and invoice errors
Improves customer satisfaction by enabling a smooth purchasing experience
Provides a competitive advantage in meeting customer contract requirements
Provides the foundation for traceability to improve product recall processes

23. GLN Benefits – Realized Today
Reduction in supplier account numbers for providers, reported between 40% to 60%
Elimination of duplicate GPO member records for providers on rosters, reduction estimated at 10%
Elimination of 50,000 unnecessary, obsolete, duplicate and bad address records
- Based on the top 5 GPOs and the Registry measures, therefore cleaned up by GPOs and suppliers
Increase in EDI business transactions, up to 20%
Improved alignment of GPO rosters implementing a standardized format and system for reporting
Increase in accuracy of reporting for rebates and charge backs resulting in increase of revenue for the provider
Decrease in mis-shipments due to accurate location identification
Reduction in pricing discrepancies resulting from better organizational alignment
Increase in collaboration between providers, GPO’s, distributors and suppliers

24. Global Location Numbers (GLN’s) - Steps
Call your GPO to obtain an editor password for the GLN Registry to view your GLNs
Participating GPOs include: Amerinet, Ascension Health, HealthTrust, MedAssets, Novation, Premier, and Sisters of Mercy/Roi
2. Take advantage of the GLN training and support provided by your GPO
3. Utilize implementation tools provided by GS1 Healthcare US
Healthcare Provider GLN Tool Kit:
Industry GLN Initiative:
GLN Industry Implementation Plan:
Use Cases on the GS1 US website:
GLN Industry Readiness Scorecards:
— Complete Healthcare Provider GLN Readiness Scorecard
4. Review your GLN hierarchy and refine as needed
Assume the Approver role from the GPO
Check the “Validated” box in the Registry

25. Global Location Numbers (GLN’s) - Steps
5. Attend the GLN Registry User Group meetings
Meets bi-monthly, 3rd Tuesday, 11:00 AM EST , open to all
— Contact Bob DeRosier at GS1 US for more information,
6. Align hierarchy in the following order:
GPO (roster)
Distributor (rebates and charge-backs)
— Find a partner and use GLNs in business transactions
— The GLN Industry Readiness Scorecards provide a list of experienced organizations implementing GLNs
Manufacturer (drop shipments)
Exchange
7. Exchange Electronic Data Interchange (EDI) documents
Begin using GLNs in EDI business transactions

26. Global Trade Identification Number (GTIN)

27. Global Trade Identification Number’s (GTIN’s)
One of the main building blocks of the GS1 System, a Global Trade Item Number (or GTIN) is a number that uniquely identifies trade items as they move through the global supply chain to the ultimate end-user.
WHAT IS A TRADE ITEM?
Any product or service that may be priced, ordered, or invoiced at any point in the supply chain.
Key Attributes of the GTIN
Uniqueness: The GTIN uniquely identifies trade items at all item and package levels, thus ensuring that they are always identified correctly anywhere in the world.
UNIQUENESS
The GTIN uniquely identifies trade items at all item and package levels, thus ensuring that they are always
identified correctly anywhere in the world. Each trade item that is different from another is allocated a separate,
unique GTIN. The rules for assigning GTINs ensure that every variation of an item is allocated a single number
that is globally unique. A GTIN can be assigned by a GS1 Company Prefix licensee anywhere in the world and
can be used throughout the world.
DATA QUALITY
The GTIN delivers trade item data using a standardized format and structure. The GTIN does not contain any
meaningful information in itself; rather it is simply a pointer to database information that can be directly used in
any company and in any country.
An item can be looked up in a database and its associated information retrieved at any point or location. The
uniqueness of GTINs is provided through a standardized format that includes a Check Digit. The Check Digit
ensures the integrity of data passing through the system.
Data Quality: The GTIN delivers trade item data using a standardized format and structure.
- 8, 12, 13, or 14 digits

28. Why a Global Standard?
3M™ DuraPrep™ Surgical Solution mL Surgical Skin Prepping Solution with Applicator, 20 Kits/Case 3M
Cardinal - M8630
Owens & Minor
BBMC-Colonial
BBMC-Durr
Kreisers - MINN8630
Midwest - TM-8630
Pacific - 3/M8630
UnitedUMS
The package has:
6 machine readable codes (5 barcodes, 1 Data Matrix).
17 flags (UK, Ireland, Malta, Netherlands, Belgium, Germany, Austria, France, Spain, Portugal, Greece, Cyprus, Norway, Sweden, Denmark, Iceland, Finland) (not Italy)
12 different language texts (English, French and German are used in more than one country).

29. Global Trade Identification Number’s (GTIN’s) Benefits of Using GTIN’s
Patient Safety: The right products, in the right location, at the right time to ensure the proper patient treatment.
Drives E-commerce: Using the GTIN facilitates the global flow of trade items and associated information used in electronic commerce.
Enhances Compatibility: Because GTINs work within any business and across business sectors, companies can trade goods and services knowing that the identification will be compatible.
Facilitates Accuracy: Use of the GTIN improves scanning at checkout, in a warehouse, or in a hospital. It is also essential for accurate stock control and order replenishment.
Fosters GDSN Compliance: The GTIN identifies trade items for electronic data exchange between trading partners as a required component of a GDSN.
Provides Flexibility: Use of GTINs offers companies the ability to include additional information such as date codes, weight, batch numbers, etc.

30. GTIN Checklist for Providers
Identify all the software systems that comprise your inventory and materials management processes.
Determine requirements you have for your systems’ integration with other systems (e.g., clinical, patient billing, financial accounting).
Determine how barcode scanning works / will work in your business process.
Create timelines to move towards GS1 Standards adoption.
Create a GS1 standards adoption team.
Consult with GS1, your GPO or a data pool.
Engage supplier community and ask about readiness.

31. Global Data Synchronization Network (GDSN)

32. What is the GDSN?
The GDSN connects trading partners to the GS1 Global Registry via a network of interoperable GDSN-certified data pools. Within this Network, trade items are identified using GTIN’s and GLN’s.
The GDSN:
Improves efficiency and accuracy
- Trading partners speak in a common language
- Ability to react quickly to consumer or patient needs
Provides Complete, Consistent, Accurate, Time-stamped and Industry Standard Data
Builds consumer / patient trust
- Access to up-to-date product information

33. GDSN
There are five simple steps that allow trading partners to synchronize item, location and price data with each other:
Load Data: The seller registers product and company information in its data pool.
Register Data: A small subset of this data is sent to the GS1 Global Registry.
Request Subscription: The buyer, through its own data pool, subscribes to receive a seller’s information.
Publish Data: The seller’s data pool publishes the requested information to the buyer’s data pool.
Confirm & Inform: The buyer sends a confirmation to the seller via each company’s data pool, which informs the supplier of the action taken by the retailer using the information.

34. Unique Device Identifier (UDI)

35. FDA’s Unique Device Identification (UDI) System –The Final Regulation
Jay Crowley
Senior Advisor for Patient Safety
Food and Drug Administration

36. FDA Amendments Act of 2007
September 27, 2007, the FDAAA signed into law:
The Secretary shall promulgate regulations establishing a unique device identification system for medical devices requiring the label of devices to bear a unique identifier, unless the Secretary requires an alternative placement or provides an exception for a particular device or type of device. The unique identifier shall adequately identify the device through distribution and use, and may include information on the lot or serial number.

37. The Rule is Divided Into Two Parts
1. Labeling Requirements
2. The Global Unique Identification Database (GUDID)
The rule is divided into two parts: a section outlining UDI labeling requirements and a section outlining the requirements relating to issuing agencies and the submission of data to the newly established Global Unique Device Identification Database (GUDID). The labeling requirements stipulate the required information for a UDI for the three classes of devices. In the proposed rule, the FDA stipulates which kinds of organizations may be accredited as UDI issuing agencies and what would be required of their respective UDI systems. Lastly, the proposed rule discusses the necessary information to be published to the GUDID, an FDA-operated medical device database, for each particular device.

38. UDI Update – Labeling Requirements
1. General Requirements
Package Labels
Plain-text (human readable)
and Automatic Identification
and Data Capture (machine
readable)
2. The Device Identifier
Version or Model Number
3. The Production Identifier
‘Lot or batch’ Number
Serial Number
Expiration Date
Manufacture Date
The FDA defines a UDI as consisting of a device identifier and a production identifier, both of which contain different sets of information. The proposed rule identifies the particular placement of UDI labels for different kinds of devices. In general, a device’s packaging must contain a UDI label, as well as the device itself. The UDI must be available in plain-text and Automatic Identification and Data Capture (AIDC) formats (such as barcodes or radio-frequency identification). As for the UDI itself, the device identifier portion specifies the version or model of the device, as well as the labeler of that device. The production identifier specifies more information particular to a certain device including the lot or batch number, the serial number, the expiration date, and the date of manufacture. There are exemptions to the labeling requirements however. For example, Class I medical devices are not required to present a production identifier in their UDI. Devices that are sold at retail establishments such as drug stores are also exempt from the labeling requirements, as they contain a Universal Product Code (UPC), which may substitute for a UDI. Some devices will require direct marking on the device itself. Implantable devices and sterile devices intended for multiple uses must have the UDI displayed directly on the body of the device.
Example of what a universal device identifier (UDI) would look like on a medical device label.

39. Standardized Date Format
Final rule – if label includes a date (e.g., expiration):
All numeric: YYYY-MM-DD ( )
Day must always be included
Same Compliance Date as other UDI requirements
Applies to all labels (even if exempt from UDI)
If not subject to UDI – applies at year 5
A combination product with NDC number is exempt. 39

40. Public UDI Access via the Global Unique Device Identification Database (GUDID)
The Global Unique Device Identification Database (GUDID), will be a publicly available database operated by the FDA with the following information:
The Device Identifier
Statement of Direct Marking
Proprietary, Trade, or Brand Name
Version or Model Numbers
Statement of Device Sterility (if applicable)
Latex Notification (if applicable)
Size Classification (if applicable)
Any Production Identifiers
Premarket Submission Number
FDA Listing Number
Global Medical Device Nomenclature (GMDN) Code
Number of Devices Within a Device Package
The GUDID will be an FDA-operated medical device database. The GUDID will be open to the public. It is intended to be a means to track devices more easily. The GUDID, which may be connected to patient EHRs, will also help in making device recalls more efficient. Such a database would allow the FDA or health providers to track a device from its manufacturer, to its retail outlet or provider outlet, to a specific patient. For implantable devices, where the device labeling is not in plain sight, the GUDID will be particularly beneficial with regard to patient safety and awareness.
Data and information for all UDI systems (if operated by multiple issuing agencies) used by device makers are required to be submitted to GUDID. The FDA proposes to require electronic submission of this data, but will provide further guidance on two different means of electronic submission: data submitted as part of a structured product label (SPL) that meets FDA specifications and data submitted through a secure Internet site.

41. UDI Compliance Dates
Implementation (compliance) timeframes:
Year 1: Class III and devices licensed under PHS Act
Year 2: Class II/I implants and life-supporting/sustaining
Year 3: Rest of class II
Year 5: Class I
Effects a wide variety of medical products and “devices”
Traditional hospital based devices (beds, ventilator, monitors, infusion pumps)
Implants
Patient/home use devices (glucometers)
Disposables, accessories (glucose test strips, catheters)
In vitro diagnostic devices (IVDs) – both clinical lab and Point of Care (POC).
Health Information Technology (HIT)
Convenience kits, Combination products
Those used in alternative sites – e.g., homecare, dental

42. UDI’s and GTIN’s Per the FDA: Bottom Line…
“The International not-for-profit association known as ‘‘GS1’’ operates a system that uses a Global Trade Identification Number (GTIN) to identify a device...
Because these existing systems include tightly-integrated functions that go far beyond simply identifying devices—functions such as inventory management and enabling commercial transactions that are not part of FDA’s public health responsibilities and are outside our statutory authority—FDA believes it would be inefficient and counterproductive to try to replace the existing systems with a single, FDA designed system of device identifiers. ”
Bottom Line…
The industry is still requesting suppliers to publish to the GDSN.
GTIN’s are the easiest path to UDI compliance.
FSEnet+ and other cerified data pools are in the process of implementing a UDI solution so suppliers can support GDSN and UDI at the same time.

43. Issuing Agency Accreditation
Final rule:
A [any] private organization may apply for accreditation as an issuing agency.
and
Will protect against conflicts of interest between the issuing agency and labelers… that may impede the applicant’s ability to independently operate a fair and neutral identifier system. 43 43 43

44. UDI Benefits: Patients/Consumers
UDI provides global visibility and supports:
Medical device recalls
Adverse event reporting
Tracking and tracing
Supply chain security
Anti-counterfeiting/diversion
Disaster/terror preparation
Shortages/substitutions
Reduction of medical errors (e.g., bedside scanning)
An easily accessible source of device information for patients and clinicians

45. UDI Benefits: Industry
Facilitate marketing clearance for new indications
Help purchasers to identify, order, and receive the correct device
Facilitate visibility of their products throughout the supply chain and improve logistics
Allow stakeholders to use the manufacturer’s identifier
Improve the efficiency/effectiveness of voluntary recall
Help to identify counterfeit or diverted devices
Facilitate importation activities
Allow manufacturers to use a single UDI to meet global regulatory requirements

46. UDI Benefits: FDA
Better data on actual product performance when used as standard of care
Improving FDA’s use and understanding of adverse event reports
Helping FDA to better understand the risk profile of particular devices
Allowing FDA to mine population-based data sets to better understand the risks and benefits of device use within certain patient populations and indications
In turn, this will allow FDA to better and more quickly address new concerns raised in premarket submissions

47. Industry Update

48. GS1 Standards Advocates
GS1 Standards Advocates actively drive adoption and implementation of GS1 Standards with the common goal of improving patient safety and supply chain efficiency.

49. GS1 Membership by Industry

50. GLN Adoption Voluntary GLN Scorecard Reporting:
3,814 Hospitals and other healthcare provider facilities
36 Healthcare manufacturers and distributors
6 GPOs
11 Healthcare software suppliers

51. GTIN Adoption Voluntary GTIN Scorecard Reporting:
2,732 Hospitals and other healthcare provider facilities
112 Healthcare manufacturers and distributors
4 GPOs
4 Solution Providers

56. MedAssets/GPO Update

57. MedAssets has chosen FSEnet+ to be our data pool partner.
GS1 Industry Knowledge and Connections
Past Performance in Other Sectors
Flexible Solutions
User Friendly Tools and Systems
Blend of Business and Technology Mentality
MedAssets successfully met the GTIN 2012 sunrise date.

58. First Steps… Supplier List
Contact Information
“Seed Data”
Internal Db Preparation
Resources
~6M items in the MedAssets database.
Approximately 80% of these items are flagged for GTIN acquisition.
To date, we have requested GTIN information from ~400 suppliers.

59. GTIN Acquisition A few questions: Have you assigned GTIN’s?
GSone
GSE-FSE
Global Standards1
G10
Gten
G11
GeeTen GDNS
GS1N
GDNS v2
GUDI
GNL
HIBCC-FSE-GS
Universal Decoder Index
UDII
GUDDIDD
2018 Sunrise Date
My product is not really a product…
What is a GS1?
FDA UDI initiative is optional…
“No thanks”
Think I will pass…
We don’t use data standards.
What’s a GTIN?
A few questions:
Have you assigned GTIN’s?
Have you published?
Have you updated labels?
UDI is coming. Are you prepared?

60. GTIN is Only One of the Requested Attributes
Trade Item Unit Descriptor
Additional Trade Item Identification Type/Value
Parent GTIN
Child GTIN
Quantity of Children/Total Quantity of Next Lower Level Trade Item
Information Provider of Trade Item Name/GLN
Target Market Country Code
Brand Owner Name/GLN
Manufacturer Name/GLN
Functional Name
Brand Name
Additional Trade Item Description
Height +UoM
Width + UoM
Depth + UoM
Gross Weight +UoM
Net Content +UoM
Is Trade Item a Consumer Unit?
Is Trade Item an Orderable Unit?
Is Trade Item an Invoice Unit?
Is Trade Item a Dispatch Unit?
Is Trade Item a Base Unit
Is Trade Item a Variable Unit?
Is Packaging Marked Returnable?
Has Batch Number? Is Non Sold Trade Item Returnable?
Bar Code Type
Classification Category Code
Additional Classification Agency Name, Category Code, Category Code Version, Category Description
Start Availability Date Time
Effective Date
Minimum Trade Item Lifespan from Time of Production
Minimum Trade Item Lifespan from Time Arrival
Healthcare Trade Item Reusability Information
Does Trade Item Contain Latex?
Is Trade Item Sterile?
Unique Device Identification (UDI) - Y or N?
Model Number
System Name
Age Group
Degree
Ply
Material
Coating
Powder Status
Color
Shape
Is this product free of intentionally added latex (Y/N)
Is this product free of intentionally added mercury (Y/N)
Is this product free of intentionally added polyvinyl chloride (PVC)? (Y/N)
Is this product free of intentionally added phthalates: DEHP, BBP, DnHP, DIDP, and DBP? (Y/N) If no, please specify the phthalate(s)
Does this product contain less than 1000 ppm halogenated organic flame retardants by weight of homogenous material (Yes/No)
Does this product contain postconsumer recycled content (excluding steel)? (Y/N) If yes, what percentage by weight?
Is this product recyclable? (Y/N)
Does the product's primary packaging contain postconsumer recycled content? (Y/N) If yes, what percentage?
Is this product packaged without polystyrene?
Is this product sold as a multi-use product or device (not single patient use?) (Y/N)
Is this product free of intentionally added Bisphenol A (BPA) or BPA derived from plastics (such as polycarbonate plastic and resins)? (Y/N)
Will this product be classified (on its own or when aggregated) as non-hazardous waste according to EPA's RCRA when disposed (under 40 CFR )? (Y/N)
Does this product contain carcinogens or reproductive toxicants, as listed under the California Safe Drinking Water and Toxic Enforcement Act of 1986, Proposition 65, below Prop 65 Safe Harbor Levels? (Y/N)
Product Description
Unit Size
Unit Quantity
Unit Size UOM

61. Requested Attributes
Attributes being requested by Novation, Premier, and Amerinet align with MedAssets attribute requirements.
MedAssets – Requesting 55 Product Attributes
Novation – Requesting 44 Product Attributes
Premier – Requesting 45 Product Attributes
Amerinet – Requesting 44 Product Attributes
Suppliers have the ability to complete all GPO requirements simultaneously.

62. Global Trade Identification Number’s (GTIN’s)

63. MedAssets GDSN Data Process
PHASE 1
PHASE 2
PHASE 3
PHASE 4
MedAssets
MDM System
Customer
Interface
Supplier
GDSN
MedAssets
MDM System
PHASE 1
Suppliers submit items into the GDSN via their data pool provider partner
FSEnet+ requests a data subscription on behalf of MedAssets
PHASE 2
Once data subscription is approved, FSEnet+ receives supplier data
FSEnet+ and MedAssets match data to MedAssets catalog
PHASE 3
Once item matching is complete, GDSN data is placed into the MedAssets Master Data Management (MDM) system
PHASE 4
The MedAssets MDM system feeds the user interface and acts as the “single source of truth” of data for MedAssets Members and Employees

64. Resources

65. Tool Kits: GLN, GTIN and GDSN
Introduction to the Standards
Implementation Steps
Lessons Learned
Benefits to Healthcare Providers
ROI Hot Spots
FAQs
For Healthcare Providers
For Healthcare Suppliers

66. Industries Case Studies and Videos
Abbott Laboratories
Implementation of GTINs, Barcodes, GDSN and GLNs
CDC Case Study Better Immunization Management for Patient Safety
Mercy / BD Case Study
Perfect Order and Beyond
Intermountain Healthcare GLN Success Story
STERIS Corporation Success Story
Right Products to the Right Places at the Right Times
BJC HealthCare GS1 Standards Implementation
Print Media GLN Success Story
Mayo Clinic / Cardinal Health GLN Implementation White Paper
Available on the GS1 Healthcare US website at
Awareness Videos:
Standardization…Stat:

67. GS1 Healthcare US GS1 Healthcare US gs1healthcareus@GS1US.o rge
GS1 Community Groups
Medical Device Community Group
Pharmaceutical Community Group
Provider Community Group

68. Questions?