unique device identification (udi) · under 21 cfr 801.45, “[a] device that must bear a unique...
TRANSCRIPT
Tom Jones UDI Program Director, Supply Chain Visibility Johnson & Johnson Supply Chain June 14, 2018
Unique Device Identification (UDI)US Implementation and Benefits of Global Harmonization
SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00, 0000
2
Today’s Discussion
Food and Drug Administration’s (FDA) UDI regulation Activities, current progress, benefits and lessons learned Impact to Medical Device Manufacturers Scope and effort to achieve compliance UDI Evolved into Global Requirement Challenges, opportunities and benefits with gaining alignment across global UDI requirements
© Johnson & Johnson Services, Inc. All rights reserved. Reproduction without permission is prohibited
SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00, 0000
3
Authentication Identify counterfeits and ensure only genuine products are used
Product Availability Improve supply chain efficiencies
Safety Only appropriate devices are used for the procedure
Knowledge Accurate identification of devices for performance analysis
Pre- Surgery
During Surgery
Post- Surgery
UDI Benefits Patient benefits before, during, and after their surgical procedure
© Johnson & Johnson Services, Inc. All rights reserved. Reproduction without permission is prohibited
SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00, 0000
4
UDI Overview Common components included in UDI regulations
UDI regulations published by FDA and European Commission include a series of compliance milestones by device class and regulation components displayed above
Data Repositories
Label Requirements
Direct Marking
© Johnson & Johnson Services, Inc. All rights reserved. Reproduction without permission is prohibited
SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00, 0000
5
FDA UDI Milestones Progress to date Final
RuleSept24,2014
Sept24,2015
Sept24,2016
Sept24,2017
Sept24,2018
Sept24,2019
Sept24,2020
ProductsmustbesubmittedtoFDAUDIDatabase
Fina
lRulePu
blishDa
te
Septem
ber2
4,2013
ClassIII
NonClassIIIImplantable,
LifeSupporting,
LifeSustaining
ClassII(remainder)
ClassIandNoClass
(remainder)Label&PackagingmustcontainUDI
Non-SterileproductsmanufacturedmusthaveUDIinformationavailableatpointofuse
ClassIII
NonClassIIIImplantable,
LifeSupporting,
LifeSustaining
ClassII(remainder)
ClassI(remainder)
ProductsintendedtobeusedmorethanoncemusthaveDPM
ClassIII ClassII ClassI
P P P
Achieving compliance provides insights into efforts related to data collection, labeling, and direct marking
Enforcement Discretion
© Johnson & Johnson Services, Inc. All rights reserved. Reproduction without permission is prohibited
SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00, 0000
6
Operating Companies Participating in UDI Program
Our efforts spanned the entire company We have products defined as medical devices in all of our franchises:
Consumer, Medical Device, Pharmaceutical, and Vision Care
© Johnson & Johnson Services, Inc. All rights reserved. Reproduction without permission is prohibited
SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00, 0000
7
Implementation Details - Timing Lessons Learned
US FDA first regulatory body to implement their UDI regulation. Their use of staggered milestones, based upon device class, worked well.
• Implementation lead time ‒ 12 months: publish to 1st milestone ‒ Scramble to design, develop, and test
• Staggered milestones ‒ FDA: worked well for GUDID ‒ EU MDR: Eudamed ‘big bang’
• Other considerations: ‒ Pilot ‒ Awareness of device class
Risk Device Class Low A
Low to Medium B Medium to High C
High D
© Johnson & Johnson Services, Inc. All rights reserved. Reproduction without permission is prohibited
SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00, 0000
8
Implementation Details – Treatment of Existing Inventory Lessons Learned
• Disposition of existing, non-compliant product ‒ FDA: 3 year consumption period ‒ Linked to compliance milestones
• Impact on existing inventory ‒ Devices with long shelf life ‒ Product already in commercial distribution
US FDA UDI regulation included 3 year window to deplete existing, non-compliant product. Given many devices have a 5-10 year shelf life, a 5 year window would have helped mitigate significant inventory remediation efforts.
© Johnson & Johnson Services, Inc. All rights reserved. Reproduction without permission is prohibited
SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00, 0000
9
Implementation Details – Data Elements Lessons Learned
• Global Unique Device Identification Database ‒ Mandatory / Optional ‒ Fields that trigger new Device Identifier (DI) ‒ Business rules, free text, list of values (LOV)
• Value of Pilot ‒ Opportunity to review data / process ‒ Does submitted data match expectations? ‒ Can Providers use this data?
The US FDA UDI provided a list of fields required for GUDID submissions. Many of these
fields had strict requirements, while others were ‘free text’ and could vary based upon
interpretation.
GUDID Data Elements Reference Table - FDA https://www.fda.gov/downloads/medicaldevices/ucm396592.xls
© Johnson & Johnson Services, Inc. All rights reserved. Reproduction without permission is prohibited
SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00, 0000
10
Implementation Details – Barcode Standards Lessons Learned
• Linear and 2D ‒ Both are acceptable by FDA
• Considerations ‒ 2D helpful, especially on small packages ‒ Can providers scan 2D barcodes?
Source: https://www.gs1us.org/documents?Command=Core_Download&EntryId=160
The US FDA UDI regulation allows for either a linear or 2D
barcodes. Many manufacturers include both on their labels as many providers may not yet have the capability
to scan 2D barcodes.
© Johnson & Johnson Services, Inc. All rights reserved. Reproduction without permission is prohibited
SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00, 0000
11
Implementation Details – Direct Marking Lessons Learned
• US FDA Definition: Under 21 CFR 801.45, “[a] device that must bear a unique device identifier (UDI) on its label must also bear a permanent marking providing the UDI on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.”
• Observed differences ‒ US FDA: Human Readable (HR) or
Automatic Identification and Data Capture (AIDC)
‒ EU MDR: Needs both HR and AIDC
Including either of these markings would satisfy the US FDA UDI regulation. The EU
MDR regulation requires both
© Johnson & Johnson Services, Inc. All rights reserved. Reproduction without permission is prohibited
SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00, 0000
12
Implementation Details – Issuing Agency Lessons Learned
• GS1, HIBCC, ICCBBA ‒ Varies by product type (traditional device vs.
blood / tissue) ‒ Significant majority of GUDID uses GS1
• June 6th Query of US FDA GUDID ‒ GS1: 1,446,969 (~83%) ‒ HIBC: 295,200 (~17%) ‒ ICCBBA: 56 (<0.01%) ‒ NDC / NHRIC: 146 (<0.01%) ‒ Source: https://accessgudid.nlm.nih.gov/
GS1 appears to be the universally accepted issuing
agency for Global UDI regulations. Future
regulations should include GS1 as an option.
© Johnson & Johnson Services, Inc. All rights reserved. Reproduction without permission is prohibited
SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00, 0000
13
Implementation Details – Nomenclature Lessons Learned
• Global Medical Device Nomenclature (GMDN): From the www.gmdnagency.org website:
• Considerations ‒ Recommended by International Medical Device Regulators Forum (IMDRF) ‒ Some countries have expressed concern related to cost.
© Johnson & Johnson Services, Inc. All rights reserved. Reproduction without permission is prohibited
SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00, 0000
14
Implementation Details – Help Desk Lessons Learned
• Established Help Desk ‒ Account setup assistance ‒ GUDID and UDI specific questions
• Ongoing Support ‒ Training (webinars) ‒ Online documents
The US FDA UDI developed a support system to assist users in establishing accounts and
address educational needs when changes are implemented.
Source: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/ucm368904.htm
© Johnson & Johnson Services, Inc. All rights reserved. Reproduction without permission is prohibited
SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00, 0000
15
Implementation Details – Exceptions / Exemptions Lessons Learned
• Need for exceptions / exemptions ‒ Difficult to create ‘one size fits all’ ‒ Medical devices – very diverse
• Consideration for impact to patient ‒ Critical need ‒ Availability
The US FDA UDI established a mechanism for device
manufacturers to share their insights with the FDA
regarding specific situations where elements of the legislation may not be
appropriate for a given device.
Examples: • Contact Lens • Implants • Use of UPC for certain products
© Johnson & Johnson Services, Inc. All rights reserved. Reproduction without permission is prohibited
SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00, 0000
16
Impact to Device Manufacturers Scoping to Achieve Compliance
• Accurate Inventory of Commercially Available Products
• Determining Device Class
• Determining Data “Source of Truth” Scoping this effort begins with determining the products available for sale in that country, confirming their respective device classes, and identifying the ‘source of truth’ for data elements.
© Johnson & Johnson Services, Inc. All rights reserved. Reproduction without permission is prohibited
SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00, 0000
17
Impact to Device Manufacturers Activities to Achieve Compliance
• Data: Compiling Records
• Labels: Assessment and Updates
• Direct Marking: Assessment and Updates
• Steady State: Policies and Procedures: UDI becomes standard way to operating
Execution is a significant effort, requiring coordination across many functions to achieve compliance with data submissions, labeling, direct marking, and the creation of policies and procedures.
© Johnson & Johnson Services, Inc. All rights reserved. Reproduction without permission is prohibited
SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00, 0000
18
Moving to a Global Perspective Regulations and Customer Requirements
• Regulations
• Customer Requirements
US FDA UDI
EU MDR
Turkey (UTS)
South Korea UDI
India UDI
Many regulatory bodies have either published or have signaled that they will be publishing UDI Regulations
China UDI
Saudi Arabia UDI
© Johnson & Johnson Services, Inc. All rights reserved. Reproduction without permission is prohibited
SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00, 0000
19
Moving to a Global Perspective Regulations and Customer Requirements
• Regulations
• Customer Requirements
UK – National Health Service
Qatar – Hamad Medical Corporation
UAE - Cleveland Clinic
Many customers are requesting GS1 compliant barcodes
Major customers within a given region are also driving requirements similar to UDI, often with requirements associated with data pools and labeling
© Johnson & Johnson Services, Inc. All rights reserved. Reproduction without permission is prohibited
SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00, 0000
20
Challenges to Alignment Examples of key differences
Direct marking • FDA: May use plain text or barcode • EU MDR: Requires 2D Barcode
Data Fields: MRI Compatibility • FDA: List of Values • Turkey: Yes / No
Device Class • FDA: III, Implantable / Life Sustaining / Life Supporting, II, and I • UK NHS: III, IIb, IIa, and I
Human Readable 2D Barcode
MRICompatibilityUS FDA
• MR Safe • MR Unsafe • MR Conditional • Labeling does not contain MRI Safety
Information
Turkey UTS • Yes • No
Differences in regulations require manufacturers to continually evaluate their strategies and can create additional transformation efforts when trying to leverage work from
previously published regulations
© Johnson & Johnson Services, Inc. All rights reserved. Reproduction without permission is prohibited
SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00, 0000
21
Imagine – Sharing Data Globally Opportunities with alignment in UDI regulations
Country A
Country B
Country C
• Easier sharing of Outcomes data • Adverse events / recalls • Global vs. regional analysis
Given compatible device identifications across regions, practitioners, researchers and
manufacturers may consolidate data for a global, rather than a regional view
© Johnson & Johnson Services, Inc. All rights reserved. Reproduction without permission is prohibited
SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00, 0000
22
Imagine – Global rather than Regional Inventory Opportunities with alignment in UDI regulations
Global Inventory
Region A Inventory
Region B Inventory
Region C Inventory
Region D Inventory
versus
• Improved response to global surgery demands • Overall increase to product availability • Supply Chain efficiencies
Global alignment on labeling and direct marking standards will help mitigate the need for inventory dedicated solely for
a specific region, driving improved availability for
patient procedures
© Johnson & Johnson Services, Inc. All rights reserved. Reproduction without permission is prohibited
SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00, 0000
23
Imagine – Benefits for Patients and Hospitals Opportunities with alignment in UDI regulations
Common Data Elements
Common Labels and Direct Marking
Product Availability Easier to share inventory across regions if regional differences minimized
Supply Chain Integrity Global awareness to counterfeits is easier if fewer label varieties exist
Patient Safety Commonality in DM could reduce misinterpretations if HCP serves multiple regions
Patient Outcomes Analysis based on global rather than regional data
Easier Identification Common definitions and data elements allow patients to search multiple repositories for additional information on their device
© Johnson & Johnson Services, Inc. All rights reserved. Reproduction without permission is prohibited
SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00, 0000
24
7 Billion Reasons to Care
© Johnson & Johnson Services, Inc. All rights reserved. Reproduction without permission is prohibited
SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00, 0000
25 © Johnson & Johnson Services, Inc. All rights reserved. Reproduction without permission is prohibited