Free webinar on Unique Device Identification

presents
Unique Device Identification (UDI):
What & How within overall Medical What & How within overall Medical
Device Value Chain
By Jim Petragnani
Planning and Implementation of the Medical Device Regulation (UDI)
© 2015 MakroCare. All Rights Reserved. www.makrocare.com

About MakroCare
Awards
Year
Established
Over 15 years of Life Sciences Core Consulting experience
Global Access ClientsEmployees
Proprietary
Frameworks/Tools
1996
(HQ:NJ USA)
p y
650+ FTEs
140+ C lt t
Frameworks/Tools
NAVA
Vistaar
(HQ:NJ,USA)
Privately held
14
Global Offices 8 of Global Top 20
140+ Consultants RIMtrack
jarTree
TULA
ClinMetanoia
mNAAMGlobal Offices 8 of Global Top 20
150+ Small/Mid‐level
mNAAM
mEDC
mIRT
2© 2015 MakroCare. All Rights Reserved. www.makrocare.com
ISO 9001 ISO 14155ISO 27001 ISO 20000

About MakroCare
Medical Device Practice
Regulatory Compliance
Regulatory Intel & Regulatory Strategy
Development
Advisory Support and Roadmap Consulting
Biocompatibility Assurance cases Testing
Quality management system consulting
and implementation
SOPs and Quality Manual Development
h d d d hBiocompatibility, Assurance cases, Testing
requirements
Regulatory Writing and Submissions Development
(510k, PMA, , Technical Files, DHF, etc.)
Establishment Registration and Product Listing
Third Party Audits and Oversight
Systems and Utilities Validation
Design Control
Risk Management
Clinical Development Post Market Support
Clinical Strategy, Study Designing and
management
Monitoring (Central / Onsite)
Clinical Data Management, Stat, Analysis,
Post market Follow‐Up Studies (Regulatory
and Marketing)
Scientific / Medical advisory
MDR / Annual Reports / Supplements
Clinical Data Management, Stat, Analysis,
Writing
eClinical technology
MDR / Annual Reports / Supplements

MakroCare’s Approach
Design > Implement > Train > Transferg p
UDI Compliance Solution
C lti d Ad i
Phase 1:
Design
Phase 2:
Implement
Phase 3:
Report
Consulting and Advisory
Support from
Serialization, Supply
Chain and Compliance
Experts
Source Data
Identification
Data Mapping
SOP and Procedure
Plan Development
Implementation
Guidance
Implementation
Database Set‐up
Migration / Integration
Initial work volumeInitial work volume
management
Data Quality and
Compliance team

MakroCare’s Approach
Design > Implement > Train > Transferg p
UDI Compliance Solution
Phase 3: Phase 1: Phase 2:
l ReportDesign Implement
HL7 SPL UDI xml tool
Web Based / On‐premise
Generate XML FDA
Submissions
Manage Submission
Lifecycle
Easy‐to‐Use
Integrated dashboard
Pay‐as‐per use
Ongoing development forOngoing development for
global compliance
requirements
Part 11 Compliant

UDI: Planning and Implementation
St 1 D l i th UDI li lStep 1. Developing the UDI compliance plan
1. Brief senior management on project scope and provide resource requirements with cost
2. Receive senior management project approval
3. Build the right team members who are dedicated and have the right complement of
product/process knowledge
4. Define clear roles, accountabilities and responsibilities
5. Understand the requirements of the Medical Device Regulation
6. Engage in an approach that will confirm assumptions early and allow for joint agreed
adjustment to the plan
7. Evaluate the supply chain business processes
8. Produce gap assessment and generate gap findings and conclusions
9. Prepare for innovative and sustainable change to the go‐forward environment ‐ monitor
publications
10. Plan and provide that product experts enable knowledge transfer
11. Develop a plan for Change Management

St 2 U d t di th M hi R d bl T h lStep 2. Understanding the Machine Readable Technology
1. That number on the medical device, It's not just a number....It means something
2. Standard product identifier
3. Reach out to the global community
4. Benefit to the medical community
5. Better traceability
6. Expedite recalls

St 3 Ch M tStep 3. Change Management
1. Create compelling story or business case
2. Build a team who are fully committed to the change initiative
3. Create the vision
4. Communication, Communication, Communication
5. Start with "short term" wins

St 4 Ri k A t k i th t il f f t hStep 4. Risk Assessment keeping the system agile for future changes
1. Proactively identify and manage risks
2. Assess Labeling changes ‐ Global Packaging
3. Supply Chain continuity planning

St 5 I l t ti f UDI l th l h iStep 5. Implementation of UDI plan across the value chain
1. Review with project team key points of requirement
2. Identify the representative products for assessments
3. Build implementation road map, resourcing including cost
4. Identify low impact product device for implementation as pilot project
5. Present implementation recommendations and validate with stakeholders
6. Parallel process low impact product device
7. Evaluate and communicate results of "pilot" product

St 6 Id tif i th d t f FDA tiStep 6. Identifying the data sources for FDA reporting
1. Develop UDI data source map
2. Develop UDI database for FDA Reporting
3. Submit information to FDA which will be used to populate the Unique Device
Identification Database (GUDID)

C li D t
1 year after publication of
the final rule (September
24, 2014)
The labels and packages of class III medical devices and devices licensed under the Public Health Service
Act (PHS Act) must bear a UDI. § 801.20.
Dates on the labels of these devices must be formatted as required by § 801.18. Data for these devices
Compliance Dates
must be submitted to the GUDID database. § 830.300.
A 1‐year extension of this compliance date may be requested under § 801.55; such a request must be
submitted no later than June 23, 2014.
Class III stand‐alone software must provide its UDI as required by § 801.50(b).
2 years after publication of
the final rule (September
24, 2015)
The labels and packages of implantable, life‐supporting, and life‐sustaining devices must bear a
UDI. § 801.20.
Dates on the labels of these devices must be formatted as required by § 801.18.
A device that is a life‐supporting or life‐sustaining device that is required to be labeled with a UDI must a
bear UDI as a permanent marking on the device itself if the device is intended to be used more than oncebear UDI as a permanent marking on the device itself if the device is intended to be used more than once
and intended to be reprocessed before each use. § 801.45.
Stand‐alone software that is a life‐supporting or life‐sustaining device must provide its UDI as required by
§ 801.50(b).
D t f i l t bl lif ti d lif t i i d i th t i d t b l b l d ith UDIData for implantable, life‐supporting, and life‐sustaining devices that are required to be labeled with a UDI
must be submitted to the GUDID database. § 830.300.

C li D t (C t )
the final rule (September 24,
2016)
Class III devices required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if
the device is a device intended to be used more than once and intended to be reprocessed before each use. §
801.45.
Compliance Dates (Cont.)
The labels and packages of class II medical devices must bear a UDI. § 801.20.
Dates on the labels of these devices must be formatted as required by § 801.18.
Class II stand‐alone software must provide its UDI as required by § 801.50(b).
Data for class II devices that are required to be labeled with a UDI must be submitted to the GUDID q
database. § 830.300.
2018)
A class II device that is required to be labeled with a UDI must bear a UDI as a permanent marking on the device
itself if the device is a device intended to be used more than once and intended to be reprocessed before each use.
§ 801.45.
The labels and packages of class I medical devices and devices that have not been classified into class I class II orThe labels and packages of class I medical devices and devices that have not been classified into class I, class II, or
class III must bear a UDI. § 801.20.
Dates on the labels of all devices, including devices that have been excepted from UDI labeling requirements, must
be formatted as required by § 801.18.
Data for class I devices and devices that have not been classified into class I, class II, or class III that are required to
b l b l d h b b d h d b §be labeled with a UDI must be submitted to the GUDID database. § 830.300.
Class I stand‐alone software must provide its UDI as required by § 801.50(b).
2020)
Class I devices, and devices that have not been classified into class I, class II, or class III that are required to be
labeled with a UDI, must a bear UDI as a permanent marking on the device itself if the device is a device intended
to be used more than once and intended to be reprocessed before each use § 801 45
2020) to be used more than once and intended to be reprocessed before each use. § 801.45.

UDI f t b FDA A dit d I i AUDI formats by FDA‐Accredited Issuing Agency
This document contains information and links related to the format of the unique device identifier (UDI) for each FDA‐accredited issuing
agency. Each FDA‐accredited issuing agency has a unique UDI format that has been approved by FDA during the initial accreditation
process. Any changes to the format of the UDI by an issuing agency must be approved by FDA before implementation. Please contact the
issuing agency directly to obtain a UDI and for any additional questions regarding the creation or implementation of the formatsissuing agency directly to obtain a UDI and for any additional questions regarding the creation or implementation of the formats.
Please note that standards development organizations that are helping to promote standard adoption of UDI in electronic health information
are currently working on recommendations for UDI representation and transmission. When available, links to these documents will be available
at the UDI webpage: www.fda.gov/udi
GS1® Issuing Agency
Issuing
Agency
Data
Delimiters
Identifier Data type
Human
Readable
Database
Field SizeAgency Delimiters
Field Size
Field Size
GS1 (01) DI Numeric 16 14
GS1 (11)
Manufacturing/
Production Date numeric [YYMMDD] 8 6
GS1 (17) Expiration Date numeric [YYMMDD] 8 6
GS1 (10) Batch/Lot Number alphanumeric 22 20
GS1 (21) Serial Number alphanumeric 22 20
GS1 Maximum Base UDI alphanumeric 76 66
ex: (01) 51022222233336(11)141231(17)150707(10)A213B1(21)1234

H lth I d t B i C i ti C il® (HIBCC) I i AHealth Industry Business Communications Council® (HIBCC) Issuing Agency
Issuing Agency
Data
Delimiters
Human
Readable
Field Size
Database
Field size
HIBCC + DI Alphanumeric 7 to 24 6 to 23
HIBCC $ Lot Number Only Alphanumeric 19 18
HIBCC $$7 Lot Number Only (alternative option) Alphanumeric 21 18
HIBCC $$ Expiration Date followed by Lot Number Exp Date: numeric [MMYY] 6 4
Lot Number: alphanumeric 18 18
HIBCC $$2 Expiration Date followed by Lot Number Exp Date: numeric [MMDDYY] 9 6
HIBCC $$3 Expiration Date followed by Lot Number Exp Date: numeric [YYMMDD] 9 6
HIBCC $$4 Expiration Date followed by Lot Number Exp Date: numeric
[YYMMDDHH]
11 8
HIBCC $$5 Expiration Date followed by Lot Number Exp Date: numeric [YYJJJ] –
Julian Date format
8 5
b l h i 8 8Lot Number: alphanumeric 18 18
HIBCC $$6 Expiration Date followed by Lot Number Exp Date: numeric [YYJJJHH] –
Julian Date format with Hour
option
10 7
$ l b l l h
HIBCC $+ Serial Number only Alphanumeric 20 18

H lth I d t B i C i ti C il® (HIBCC) I i A (C t )
Issuing Agency Data Delimiters Identifier Data type
Human
Readable
Field Size
Database
Field size
Health Industry Business Communications Council® (HIBCC) Issuing Agency (Cont.)
HIBCC $$+7 Serial Number only (alternative option) Alphanumeric 22 18
HIBCC $$+ Expiration Date followed by Serial Number Exp Date: numeric [MMYY] 7 4
Serial Number: alphanumeric 18 18
HIBCC $$+2 Expiration Date followed by Serial Number Exp Date: numeric [MMDDYY] 10 6
HIBCC $$+3 Expiration Date followed by Serial Number Exp Date: numeric [YYMMDD] 10 6
HIBCC $$+4 Expiration Date followed by Serial Number Exp Date: numeric
[YYMMDDHH]
12 8
HIBCC $$+5 Expiration Date followed by Serial Number Exp Date: numeric [YYJJJ] 9 5
HIBCC $$+6 Expiration Date followed by Serial Number Exp Date: numeric [YYJJJHH] 11 7
HIBCC /S Supplemental Serial Number, where lot number Alphanumeric 20 18
also required and included in main secondary data
string
HIBCC /16D Manufacturing Date (supplemental to secondary
barcode)
numeric [YYYYMMDD] 12 8
HIBCC Maximum Base UDI Alphanumeric 70 to 87 58 to 75
Ex of Human Readable Barcode: +H123PARTNO1234567890120/$$420020216LOT123456789012345/SXYZ4567890123 45678/16D20130202C
Ex of Human Readable Barcode: +H123PARTNO1234567890120/$$420020216LOT123456789012345/SXYZ4567890123 45678/16D20130202C

I t ti l C il f C lit i Bl d B ki A t ti (ICCBBA) I iInternational Council for Commonality in Blood Banking Automation (ICCBBA) Issuing
Agency
Human
Readable Database
Issuing Agency Data Delimiters Identifier Data type
Readable
Barcode
Field Size
Database
Field Size
ICCBBA =/ DI Alphanumeric 18 16
ICCBBA =, Serial Number Alphanumeric 8 6
ICCBBA = Donation Identification Number Alphanumeric 16 15
ICCBBA => Expiration Date numeric [YYYJJJ] 8 6
ICCBBA =} Manufacturing Date numeric [YYYJJJ] 8 6
ICCBBA &,1 MPHO Lot Number Alphanumeric 21 18
ICCBBA Maximum Base UDI for HCT/Ps Alphanumeric 79 67
Ex of Human Readable Barcode:=/A9999XYZ100T0944=,000025=A99971312345600=>014032=}013032&,1000000000000XYZ123

I t ti l C il f C lit i Bl d B ki A t ti (ICCBBA) I iInternational Council for Commonality in Blood Banking Automation (ICCBBA) Issuing
Agency (Cont.)
Eye Readable Databas
Blood Bags Only
Identifying
Symbol
Eye Readable
Barcode Field
Size
Databas
e Field
Size
ICCBBA =) DI for blood containers (bags) Alphanumeric 12 10
ICCBBA &)
Lot Number for blood
containers (bags) Alphanumeric 12 10
ICCBBA
Maximum Base UDI for Blood
Bags Alphanumeric 24 20ICCBBA Bags Alphanumeric 24 20
Ex of Human Readable Barcode: =)1TE123456A&)RZ12345678

UDI I i A iUDI Issuing Agencies
1. Firm Name: GS1
Address: Princeton Pike Corporate Center, 1009 Lenox Drive, Suite 202, Lawrenceville, NJ 08648Address: Princeton Pike Corporate Center, 1009 Lenox Drive, Suite 202, Lawrenceville, NJ 08648
Contact Person: Siobhan O’Bara, Senior Vice President ‐ Industry Engagement
Phone: (609) 620‐8046
Email: sobara@gs1us.org
Web Site: http://www.gs1.org
Date of Initial Accreditation: December 17, 2013
Initial Accreditation Granted through: December 17 2016Initial Accreditation Granted through: December 17, 2016
Application
Approval Letter
Information on Using the GS1 System for UDI Requirements
2. Firm Name: Health Industry Business Communications Council (HIBCC)
Address: 2525 E. Arizona Biltmore Circle, Suite 127, Phoenix, AZ 85016
Contact Person: Robert A. Hankin, PhD., President and CEO
Phone: (602) 381‐1091
Email: rhankin@hibcc.org
W b Sit htt // hib
3. Firm Name: ICCBBA
Address: PO Box 11309, San Bernardino, CA 92423‐1309
Contact Person: Pat Distler, Technical Director
Phone: (909) 793‐6516
Email: pat.distler@iccbba.org
W b Sit htt // i bbWeb Site: http://www.hibcc.org
Date of Initial Accreditation: December 26, 2013
Initial Accreditation Granted through: December 26, 2016
Application
Approval Letter
Web Site: http://www.iccbba.org
Date of Initial Accreditation: February 12, 2014
Initial Accreditation Granted through: February 12, 2017
Application
Approval Letter

P j t Ti liProject Timeline
Week
1
Week
2
Week
3
Week
4
Week
5
Week
6
Week
7
Week
8
Week
9
Week
101 2 3 4 5 6 7 8 9 10
Enterprise Program Management Office
N R l i C liNew Regulation Compliance
TASK OR ACTIVITY TIMELINE
D l i h UDI li Pl W k 1 W k 2Developing the UDI compliance Plan Week 1 ‐ Week 2
Identifying the data sources for FDA Reporting Week 3 ‐ Week 4
Understanding the Machine Readable Technology
Week 5
Change Management Plan Week 6Change Management Plan Week 6
Risk Assessment Register Week 7
Implementation of UDI Week 7 ‐ 10

Contact:Contact:
Jim Petragnani and Aaryak JoshiJ g y J
medtech@makrocare.com
+19734810100 extn 3043
www.makrocare.com
One Washington Park, Suite
1303, Newark, ‐ 07102, NJ
(USA)
© 2015 MakroCare. All Rights Reserved. www.makrocare.com
(USA)

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