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

http://www.makrocare.com/med-tech

http://www.makrocare.com/

About MakroCare

AwardsYear

Established

Over 15 years of Life Sciences Core Consulting experience

Global Access ClientsEmployeesProprietary

Frameworks/Tools

1996(HQ:NJ USA)

p y

650+ FTEs140+ C lt t

Frameworks/Tools

NAVAVistaar

(HQ:NJ,USA) Privately held

14 Global Offices 8 of Global Top 20

140+ Consultants RIMtrackjarTreeTULAClinMetanoiamNAAMGlobal Offices 8 of Global Top 20

150+ Small/Mid‐levelmNAAMmEDCmIRT

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 SolutionPhase 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




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)




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 )


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 qdatabase. § 830.300.


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).


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 issuingagency. Each FDA‐accredited issuing agency has a unique UDI format that has been approved by FDA during the initial accreditationprocess. Any changes to the format of the UDI by an issuing agency must be approved by FDA before implementation. Please contact theissuing 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 informationare currently working on recommendations for UDI representation and transmission. When available, links to these documents will be availableat the UDI webpage: www.fda.gov/udi

GS1® Issuing Agency

Issuing Agency

Data Delimiters

Identifier Data typeHuman Readable

Database Field SizeAgency Delimiters

Field SizeField 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 AgencyData Delimiters

Identifier Data typeHuman Readable Field Size

Database Field size

HIBCC + DI Alphanumeric 7 to 24 6 to 23HIBCC $ Lot Number Only Alphanumeric 19 18HIBCC $$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 typeHuman 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 18also 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 75Ex 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 typeReadable 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 DatabasBlood Bags Only

Identifying Symbol

Identifier Data typeEye Readable Barcode Field Size

Database Field Size

ICCBBA =) DI for blood containers (bags) Alphanumeric 12 10

ICCBBA &)Lot Number for blood containers (bags) Alphanumeric 12 10

ICCBBAMaximum 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: GS1Address: Princeton Pike Corporate Center, 1009 Lenox Drive, Suite 202, Lawrenceville, NJ 08648Address: Princeton Pike Corporate Center, 1009 Lenox Drive, Suite 202, Lawrenceville, NJ 08648Contact Person: Siobhan O’Bara, Senior Vice President ‐ Industry EngagementPhone: (609) 620‐8046Email: [email protected] Site: http://www.gs1.orgDate of Initial Accreditation: December 17, 2013Initial Accreditation Granted through: December 17 2016Initial Accreditation Granted through: December 17, 2016

ApplicationApproval LetterInformation 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 85016Contact Person: Robert A. Hankin, PhD., President and CEOPhone: (602) 381‐1091Email: [email protected] b Sit htt // hib

3. Firm Name: ICCBBAAddress: PO Box 11309, San Bernardino, CA 92423‐1309Contact Person: Pat Distler, Technical DirectorPhone: (909) 793‐6516Email: [email protected] b Sit htt // i bbWeb Site: http://www.hibcc.org

Date of Initial Accreditation: December 26, 2013Initial Accreditation Granted through: December 26, 2016

ApplicationApproval Letter

Web Site: http://www.iccbba.orgDate of Initial Accreditation: February 12, 2014Initial Accreditation Granted through: February 12, 2017

ApplicationApproval 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 TIMELINED 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

[email protected]

+19734810100 extn 3043

www.makrocare.com

One Washington Park, Suite 1303, Newark, ‐ 07102, NJ (USA)


(USA)




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