Unique Device Identifiers (UDIs) The Next Big Step for Effective Analysis. Bill A. Bobbie President, Cook (Canada) Inc.

Transcription

1 Unique Device Identifiers (UDIs) The Next Big Step for Effective Analysis Bill A. Bobbie President, Cook (Canada) Inc. May 16, 2017

2 Agenda UDI Background A Manufacturer s Journey Implemen;ng UDI Labels & Packaging Using UDI Around the Globe

3 Cook Medical Overview 50+ years in business 8 manufacturing companies 10 clinical divisions Coverage in 135 countries 16,000 SKUs

4 UDI Background

5 Data Standard vs. UDI Data standard: A common language for trading partners to use about products that pass through the supply chain. SAME DATA. DIFFERENT NAMES. UDI Unique Device Iden;fica;on DI Device Iden;fier PI Product Iden;fier (if applicable) GS1 Standards Product Iden;fica;on GTIN Global Trade Item Number AI Applica;on Iden;fier Expira;on Date AI(17) e.g., Lot/Batch AI(10) e.g., 1234AB Serial Number A(21) e.g., 12345XYZ Product iden3fier data will vary by medical device type and manufacturer current prac3ce. DI + PI = UDI GTIN or GTIN + AI(s) = UDI Other standards

6 UDI A UDI will be required to appear on the label of a medical device and be composed of two parts: DI Device Iden;fier (GTIN) A unique number assigned to the devices, which combines a labeler ID and a number unique to the device. PI Product Iden;fier Information specific to the production of the particular product and can include the manufacturing lot and/or serial number, the date of expiration or date of manufacturing. UDI Unique Device Iden;fier

7 UDI Rule THREE ESSENTIAL ELEMENTS TO THE RULE! Product labeling UDI in human & machine readable forms! GUDID Global Unique Device Iden;fica;on Database! Direct Part Marking (DPM) of reusable, reprocessed devices PRODUC T LABELIN G GUDI D DIRECT PART MARKIN G

8 Improved Pa;ent Safety Iden;fies: Right product, right pa;ent, right ;me Is scanned at the bedside Helps prevent medica;on errors Combats counterfeit products Facilitates recalls Image source:

9 It s Not Just for Manufacturers UDI for Manufacturers Assign Label Publish Data to Global UDI Database (GUDID) UDI for Providers and EHRs Capture UDI Store UDI in list of patient s implantable devices in EHRs Work with UDI Extract data from GUDID Share UDI as part of common clinical data set

10 A Manufacturer s Journey

11 Not an easy task for manufacturers/suppliers!!!

12

13 GTIN Challenges Manufacturers had to change barcode labeling logic Manufacturers had to develop a product database Supply Chain had to change EDI systems had to be altered to pass data through all systems Packaging changed, resul;ng in going from a 1-to-1 rela;onship to a 1-to-many rela;onship between product number and packaging UOM changed, requiring inventory conversions

14 An Approach to Implemen;ng UDI

15 The Steps We Took Recognized that we needed a standard product language 376,000 sku s to >20,000 sku s Consolidated our global product catalog Chose a standard and assigned GTINs to all of our products Labeled inventory with GTINs Published data to GDSN

16 Implemen;ng a Global Standard

17 What are We Trying to Accomplish? To advance Cook s systems and processes to meet the requirements for the FDA Unique Device Identification (UDI) implementation. PROBLEMS TO BE SOLVED Our systems did not capture all of the data required for the FDA. We have inconsistent methods for printing labels and managing label data. Product data is often manually reentered into multiple systems, rather than pulling data from a central source. FDA is the first to implement, but it is not a global standard. 17

18 Data Standards in Use

19 Use of Datamatrix Bar Code for Small Label Packaging

20 Using UDI Around the Globe

21 The Next Step Global Data Systems

22

23 The UDI must be incorporated into the health informa;on systems of healthcare enterprises, from point of entry in the supply chain through billing. Unique pa;ent iden;fica;on.are (SIC) cri;cal in order to associate device follow-up and pa;ent outcomes across most systems. The value of UDI goes well beyond the requirement to include a unique ID number; it is more than another Track & Trace metric; it is a plan calling for op;mizing meaningful data collec;on and analysis. UDI will allow a pa;ent to be no;fied when a medical device issue needs to be addressed and the ability of healthcare providers to take appropriate and bener focused correc;ve and preventa;ve ac;ons.

24 Everyone Can Benefit from a Standard Product Language Simplifies supply chain management Accurately iden;fy specific products with unique numbers Improves informahon quality Informa;on is iden;cal among all supply chain partners Reduces labor and supply costs Eliminates custom cross-reference tables to keep track of proprietary iden;fica;on numbers More efficient payment/reporhng Fewer errors and improved accuracy of electronic transac;ons $ Government Manufacturers Payers Providers Clinicians Patients GPOs Distributors

25 Take away Manufacturers have always been to the forefront of calling for and par;cipa;ng in harmoniza;on in the field of Medical Device manufacturing. UDI works! Numerous benefits to the Pa;ent, Healthcare Professionals, Regulators, and Industry. UDI has been implemented across the country at a considerable cost and use of manpower. Regulators across the globe are seeking to adopt a global approach to UDI.

26 Q&A

27 GUDID Submissions OVERVIEW The Global Unique Device Iden;fica;on Database (GUDID) is an FDA-managed database to which the label manufacturer must submit the DI por;on of each UDI, plus a number of addi;onal data anributes specific to the product. SUBMISSIONS SYSTEM The data has to be collected and verified globally, and integrated through a single gateway for submission. Data submined to the GUDID is considered a formal regulatory submission. The label manufacturer for each product is responsible for entering and approving the data to be submined to the GUDID.

28 Class III Devices Class III devices available at NADC Class III devices unavailable at NADC HQ Total part numbers registered as Class III globally Single company en;ty (Note: does not including products in clinical trial.)

29 Submission Structure! One account with mul;ple label manufacturers.! The informa;on will be managed in a centralized system for submission to the GUDID. COOK INC COOK IRELAND GUDID ACCOUNT SUBMITTER CMI COOK DENMARK COOK AUSTRALIA

30 Speaking the Same Language Calling the same product the same thing across healthcare, no matter who you are or what you are doing with the product. Supply chain Clinician Researcher Regulator Finance Patient 3 0

31 Quality System A Quality System Plan was developed to provide detailed direc;on for UDI implementa;on. The Quality System Plan includes:! Overview (Background and Scope)! Product Classifica;on! Labeling Impact! GUDID Submissions Process! Direct Part Marking Process! Timeline

32 Areas of Engagement IDENTIFY COMPLIANCE DATES Final determina;on of implantable, life-sustaining, or life-saving devices required to be compliant by September Determine compliance dates for all products. LABELING CHANGES Date of manufacture Expira;on date Barcode/format changes GUDID SUBMISSIONS Define submissions process and system capabili;es Required data Who is responsible for each piece of data and where should it be maintained Changes requiring a new DI (GTIN) and new DI process QUALITY Quality system plan Quality system conforming amendments change control, MDR, DHR, etc. Changes requiring a new DI (GTIN) and new DI process DIRECT MARKING Iden;fy products requiring direct part marking Marking technologies & implementa;on SUPPLY CHAIN Product out of compliance must be phased out of inventory arer three years. COMMUNICATION Internal communica;on/training External/customer communica;on

33 Label Changes While Cook has been has been using the GS1 Standard in labeling and is compliant with FDA requirements, there are addi;onal changes that need to be made to product labels and systems to be compliant. DATE OF MANUFACTURE (DOM) and DATE OF EXPIRATION (DOE)! Human readable date (YYYY-MM-DD) will be added to the label grid for DOM and DOE. LINEAR BARCODES! The barcode date format will NOT change for the DOE, remaining compliant with GS1 barcode standards.! 2D DATA MATRICES! 2D will not replace 1D barcodes, but will be included in addi;on to 1D. Data will be the same.! Customer-readable informa;on will be iden;cal in 1D and 2D barcodes ini;ally.

34 Label Changes Addi;on of 2D barcode Expira;on date format change Manufacture date format change 6 digit expira;on date (including day)