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

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Presentation on theme: "Data Standards and an FDA Update Jean Sargent, CMRP, FAHRMM Paste President AHRMM, CAHPMM."— Presentation transcript:

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

2 CONFIDENTIAL Property of MedAssets 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. 2

3 CONFIDENTIAL Property of MedAssets What if Data Standards in grocery stores worked liked they do in the health care supply chain?

4 CONFIDENTIAL Property of MedAssets Agenda 1.GS1 Overview 2.GS1 Healthcare Standards – GLN, GTIN, & GDSN 3.FDA UDI 4.Progress Overview -Industry -MedAssets/GPO’s 5.Resources 6.Questions

5 GS1 Overview

6 CONFIDENTIAL Property of MedAssets 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.


8 CONFIDENTIAL Property of MedAssets 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 CONFIDENTIAL Property of MedAssets 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 CONFIDENTIAL Property of MedAssets 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 CONFIDENTIAL Property of MedAssets 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 CONFIDENTIAL Property of MedAssets 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 CONFIDENTIAL Property of MedAssets 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 CONFIDENTIAL Property of MedAssets 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 CONFIDENTIAL Property of MedAssets An opportunity for a new kind of healthcare innovation To download the report, visit ‘‘ Implementing global standards across the entire healthcare supply chain could save 22,000 - 43,000 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)


17 CONFIDENTIAL Property of MedAssets 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 CONFIDENTIAL Property of MedAssets 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 CONFIDENTIAL Property of MedAssets 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: 100084547 SAINT JOHNS QUEENS HOSPITAL Hospital ID: JAOE SAINT JOHN'S QUEEN HOSPITAL Hospital ID: 50003000431 SAINT JOHN'S QUEEN’S HOSPITAL Hospital ID: CA2053 ST. JOHN'S QUEENS HOSPITAL Hospital ID: OM 12345 SAINT JOHN'S QUEENS HOSPITAL GLN: 1100004570208

21 CONFIDENTIAL Property of MedAssets 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 CONFIDENTIAL Property of MedAssets 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 CONFIDENTIAL Property of MedAssets 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 CONFIDENTIAL Property of MedAssets Global Location Numbers (GLN’s) - Steps 1.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 CONFIDENTIAL Property of MedAssets 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) — Find a partner and use GLNs in business transactions — The GLN Industry Readiness Scorecards provide a list of experienced organizations implementing GLNs Exchange 7. Exchange Electronic Data Interchange (EDI) documents Begin using GLNs in EDI business transactions

26 Global Trade Identification Number (GTIN)

27 CONFIDENTIAL Property of MedAssets 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. 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. WHAT IS A TRADE ITEM? Any product or service that may be priced, ordered, or invoiced at any point in the supply chain. Data Quality: The GTIN delivers trade item data using a standardized format and structure. - 8, 12, 13, or 14 digits

28 CONFIDENTIAL Property of MedAssets Why a Global Standard? 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). 3M™ DuraPrep™ Surgical Solution 8630 - 26mL Surgical Skin Prepping Solution with Applicator, 20 Kits/Case 3M - 8630 Cardinal - M8630 Owens & Minor - 4509008630 BBMC-Colonial - 045098630 BBMC-Durr - 081048 Kreisers - MINN8630 Midwest - TM-8630 Pacific - 3/M8630 UnitedUMS - 001880

29 CONFIDENTIAL Property of MedAssets 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 CONFIDENTIAL Property of MedAssets 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 CONFIDENTIAL Property of MedAssets 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 CONFIDENTIAL Property of MedAssets GDSN There are five simple steps that allow trading partners to synchronize item, location and price data with each other: 1.Load Data: The seller registers product and company information in its data pool. 2.Register Data: A small subset of this data is sent to the GS1 Global Registry. 3.Request Subscription: The buyer, through its own data pool, subscribes to receive a seller’s information. 4.Publish Data: The seller’s data pool publishes the requested information to the buyer’s data pool. 5.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 CONFIDENTIAL Property of MedAssets FDA’s Unique Device Identification (UDI) System –The Final Regulation Jay Crowley Senior Advisor for Patient Safety Food and Drug Administration 301-796-5995 35

36 CONFIDENTIAL Property of MedAssets 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. 36

37 CONFIDENTIAL Property of MedAssets The Rule is Divided Into Two Parts 37 1. Labeling Requirements 2. The Global Unique Identification Database (GUDID)

38 CONFIDENTIAL Property of MedAssets UDI Update – Labeling Requirements 38 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 Example of what a universal device identifier (UDI) would look like on a medical device label.

39 CONFIDENTIAL Property of MedAssets 39 Standardized Date Format Final rule – if label includes a date (e.g., expiration): All numeric: YYYY-MM-DD (2013-06-19) 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.

40 CONFIDENTIAL Property of MedAssets Public UDI Access via the Global Unique Device Identification Database (GUDID) 40 The Global Unique Device Identification Database (GUDID), will be a publicly available database operated by the FDA with the following information:

41 CONFIDENTIAL Property of MedAssets UDI Compliance Dates 41 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 CONFIDENTIAL Property of MedAssets UDI’s and GTIN’s 42 Per the FDA: “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… 1.The industry is still requesting suppliers to publish to the GDSN. 2.GTIN’s are the easiest path to UDI compliance. 3.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 CONFIDENTIAL Property of MedAssets 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.

44 CONFIDENTIAL Property of MedAssets UDI Benefits: Patients/Consumers 44 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 CONFIDENTIAL Property of MedAssets UDI Benefits: Industry 45 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 CONFIDENTIAL Property of MedAssets UDI Benefits: FDA 46 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 CONFIDENTIAL Property of MedAssets 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 CONFIDENTIAL Property of MedAssets GS1 Membership by Industry

50 CONFIDENTIAL Property of MedAssets 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 CONFIDENTIAL Property of MedAssets GTIN Adoption Voluntary GTIN Scorecard Reporting: 2,732 Hospitals and other healthcare provider facilities 112 Healthcare manufacturers and distributors 4 GPOs 4 Solution Providers

52 CONFIDENTIAL Property of MedAssets 52

53 CONFIDENTIAL Property of MedAssets 53

54 CONFIDENTIAL Property of MedAssets 54

55 CONFIDENTIAL Property of MedAssets 55

56 MedAssets/GPO Update

57 CONFIDENTIAL Property of MedAssets 57 MedAssets successfully met the GTIN 2012 sunrise date. 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

58 CONFIDENTIAL Property of MedAssets 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 CONFIDENTIAL Property of MedAssets GTIN Acquisition 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: 1.Have you assigned GTIN’s? 2.Have you published? 3.Have you updated labels? 4.UDI is coming. Are you prepared?

60 CONFIDENTIAL Property of MedAssets GTIN is Only One of the Requested Attributes 60 1.GTIN 2.Trade Item Unit Descriptor 3.Additional Trade Item Identification Type/Value 4.Parent GTIN 5.Child GTIN 6.Quantity of Children/Total Quantity of Next Lower Level Trade Item 7.Information Provider of Trade Item Name/GLN 8.Target Market Country Code 9.Brand Owner Name/GLN 10.Manufacturer Name/GLN 11.Functional Name 12.Brand Name 13.Additional Trade Item Description 14.Height +UoM 15.Width + UoM 16.Depth + UoM 17.Gross Weight +UoM 18.Net Content +UoM 19.Is Trade Item a Consumer Unit? 20.Is Trade Item an Orderable Unit? 21.Is Trade Item an Invoice Unit? 22.Is Trade Item a Dispatch Unit? 23.Is Trade Item a Base Unit 24.Is Trade Item a Variable Unit? 25.Is Packaging Marked Returnable? 26.Has Batch Number? Is Non Sold Trade Item Returnable? 27.Bar Code Type 28.Classification Category Code 29.Additional Classification Agency Name, Category Code, Category Code Version, Category Description 30.Start Availability Date Time 31.Effective Date 32.Minimum Trade Item Lifespan from Time of Production 33.Minimum Trade Item Lifespan from Time Arrival 34.Healthcare Trade Item Reusability Information 35.Does Trade Item Contain Latex? 36.Is Trade Item Sterile? 37.Unique Device Identification (UDI) - Y or N? 38.Model Number 39.System Name 40.Age Group 41.Degree 42.Ply 43.Material 44.Coating 45.Powder Status 46.Color 47.Shape 48.Is this product free of intentionally added latex (Y/N) 49.Is this product free of intentionally added mercury (Y/N) 50.Is this product free of intentionally added polyvinyl chloride (PVC)? (Y/N) 51.Is this product free of intentionally added phthalates: DEHP, BBP, DnHP, DIDP, and DBP? (Y/N) If no, please specify the phthalate(s) 52.Does this product contain less than 1000 ppm halogenated organic flame retardants by weight of homogenous material (Yes/No) 53.Does this product contain postconsumer recycled content (excluding steel)? (Y/N) If yes, what percentage by weight? 54.Is this product recyclable? (Y/N) 55.Does the product's primary packaging contain postconsumer recycled content? (Y/N) If yes, what percentage? 56.Is this product packaged without polystyrene? 57.Is this product sold as a multi-use product or device (not single patient use?) (Y/N) 58.Is this product free of intentionally added Bisphenol A (BPA) or BPA derived from plastics (such as polycarbonate plastic and resins)? (Y/N) 59.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 261.31 - 33)? (Y/N) 60.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) 61.Product Description 62.Unit Size 63.Unit Quantity 64.Unit Size UOM

61 CONFIDENTIAL Property of MedAssets Requested Attributes 61 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 CONFIDENTIAL Property of MedAssets Global Trade Identification Number’s (GTIN’s)

63 CONFIDENTIAL Property of MedAssets 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 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 PHASE 3 Once item matching is complete, GDSN data is placed into the MedAssets Master Data Management (MDM) system PHASE 3 Once item matching is complete, GDSN data is placed into the MedAssets Master Data Management (MDM) system PHASE 2 Once data subscription is approved, FSEnet+ receives supplier data FSEnet+ and MedAssets match data to MedAssets catalog PHASE 2 Once data subscription is approved, FSEnet+ receives supplier data FSEnet+ and MedAssets match data to MedAssets catalog PHASE 1 Suppliers submit items into the GDSN via their data pool provider partner FSEnet+ requests a data subscription on behalf of MedAssets PHASE 1 Suppliers submit items into the GDSN via their data pool provider partner FSEnet+ requests a data subscription on behalf of MedAssets PHASE 1 PHASE 2 PHASE 3 PHASE 4 MedAssets MDM System MedAssets GDSN Data Process Supplier GDSN MedAssets MDM System Customer Interface

64 Resources

65 CONFIDENTIAL Property of MedAssets 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 CONFIDENTIAL Property of MedAssets 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 CONFIDENTIAL Property of MedAssets GS1 Healthcare US gs1healthcareus@GS1US.o rg gs1healthcareus@GS1US.o rg e e GS1 Community Groups Medical Device Community Group Pharmaceutical Community Group Provider Community Group

68 Questions?

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