Life After The Submission Deadline:

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Dortha Jasmin Merritt
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1 Life After The Submission Deadline: GUDID Maintenance and Downstream Value June 7, 2017 Moderator: John Lorenc, Reed Tech Speakers: Pauline Maralit, Medline Industries, Inc. Mike Pantelich, Varian Medical Systems Slide 1

2 Happily UDI After: Post Submission Life Pauline Maralit, Medline Industries, Inc. Slide 2

3 From Compliance Challenges to Compliance Strengths Slide 3

4 UDI Timeline Slide 4

WHO MUST MEET UDI REQUIRENTS? First is the organization. This is the highest corporate level of a company. The GUDID account is registered to the organization.

5 WHO MUST MEET UDI REQUIRENTS? First is the organization. This is the highest corporate level of a company. The GUDID account is registered to the organization. It is the organization that is ultimately responsible for meeting the data submission requirements for a particular device. The labeler, which is the company or firm whose name appears on the device label. It is responsible for submitting the data to the GUDID, and its name and address is associated with the device record in the database. Slide 5

6 WHAT S YOUR RELATIONSHIP STATUS? Manufacturing Plants Contract Manufacturers Co-Labelers OEM Customers Private Labeling Distributors Slide 6

THE JOURNEY TO UDI COMPLIANCE Determining Impact & Responsibility: The Assessment Is my product a Medical Device? What is the correct Product Code?

7 THE JOURNEY TO UDI COMPLIANCE Determining Impact & Responsibility: The Assessment Is my product a Medical Device? What is the correct Product Code? What FDA Class correlates to that Code? Is it Implantable, Life Sustaining/Supporting? Is it Reusable or Single Use/Patient? Is it a Class I GMP Exempt Product Code? Slide 7

8 Medline Industries, Inc. Click to enla Footplate system (Class 2- implantable) Patient Exam Gown (Class 1) AAMI Level 3 Isolation Gown (Class 2) Sterile Cardiovascular Access Surgical Tray (Class 2) Gravity Feeding Set with ENFit Connector (Class 2) Collagen Dressing with Silver (Unclassified) SensiCare Green Aloe PF Surgical Gloves (Class 1) Rollator (Class1) Bandage (Class 1) Commodity Slide 8

9 Finding The Answers Design History Files Sourcing Forms Data Systems Labeling Files Current Packaging Slide 9

The Bridges Medline has Crossed: Defining Relationships across our Channels UDI Education: Internal and External Stakeholders Policy and Messaging with our Partners Item Creation and

10 The Bridges Medline has Crossed: Defining Relationships across our Channels UDI Education: Internal and External Stakeholders Policy and Messaging with our Partners Item Creation and Configuration Labeling Creation and Maintenance Data Integrity and Management System Flow and Submission Good Practices, SOPs & Documentation Barcoding: Capability and Integrity Slide 10

11 CURRENT STATE: MEDLINE TODAY Slide 11

12 NEW ITEMS: UDI relevancy Net Content Lowest Unit of Sale Printing Capability GS1 Leveling Slide 12

13 LABELING TEAM - TAKING A CLOSER LOOK Labeling Job Queue Labeling Reporting Database UDI Label Asset Capture Branding Slide 13

14 Product Information Management and Digital Asset Management New Item Creation Sourcing Forms and Asset Information Labeling History UDI Information and Audit Slide 14

15 Data Integrity Data Reporting Data Analysis Business Value Slide 15

16 Why Material Things and Grades Really DO MATTER Slide 16

17 UDI Slide 17

18 New Catalog #s UDI Maintenance Lifecycle Packaging Materials Listing #s Labeling Updates Packaging Levels Slide 18

19 Single Source of Truth Inventory Management Tracking and Billing Slide 19

20 Slide 20

21 Slide 21

22 Life After UDI Submission Mike Pantelich RA/QA Program Manager Varian Medical Systems Slide 22

23 Background: Varian Medical Systems is the world s leading manufacturer of medical devices and software for treating and managing cancer. Varian makes a variety of products at several locations around the globe, including the United States, Canada, Europe, Brazil, and China. All of the products I ll be discussing are Class II medical devices. The implantables were compliant by September 2015, and The others by September Slide 23

24 Some UDI-significant products are: Permanently implanted beacons. Multi-use beacons. Multi-patient, multi-use applicators. Slide 24

25 Stand-alone software that may be loaded and upgraded remotely, with no Varian personnel on site. Slide 25

26 Linear accelerators that fill a room. Proton therapy systems that take up an entire city block. These devices can have a service life of years. Slide 26

27 To define the DIs and PIs for each type of device, we assigned them to one of 4 groups: 1. Stand-alone software. 2. Bundled software. 3. Hardware only. 4. Hardware with an upgradable software component. Slide 27

28 Varian had a 2-year UDI project. We determined how to make our 900+ Class II products UDI-compliant. We wrote and implemented plans for each design type and manufacturing location. And after all the products had UDIs, everyone moved on to the next big thing. But UDI goes on forever It s a program, not just a project. Slide 28

29 People new to UDI occasionally found some problems with our processes and procedures. And so we corrected them (sometimes the process, sometimes the people). Slide 29

30 Here are some sample issues: Minor changes does making changes to the device, accessories, or components change the UDI. Usually yes. Spare parts does replacing a bad part with a spare (at a customer site) change the UDI? Usually no, but maybe. Software or Hardware Upgrades When we upgrade the device at the customer site do we also need to change the UDI? Yes. Does a bug-fix or maintenance release for stand-alone software change the UDI? Yes, but only the PI, not the DI. Slide 30

31 Varian has set a goal of marking all of our products with a UDI barcode, even those that are not medical devices. This includes the Help-About boxes for software. Slide 31

32 Varian is also in the process of enhancing our data collection systems, in both the back office and in the field, to capture and use UDI as the primary means of identifying a product. Slide 32

33 The main lessons that we ve learned about staying UDI-compliant: Be aware and be persistent. In a company where innovation is a key part of what we do, new products and updates to old products are constantly in the works. This means new DI s and PI s are always needed. As regulations and requirements change, the UDI team must continue to work closely with the Regulatory team. Slide 33

34 Questions? Slide 34

Unique Device Identification (UDI) Status, Learnings, Next Steps

Unique Device Identification (UDI) Status, Learnings, Next Steps Jeffrey Shuren, M.D., J.D. Center for Devices and Radiological Health (CDRH) US Food and Drug Administration (FDA) IMDRF September 2016