free webinar on unique device identification (udi)

presents

Unique Device Identification (UDI): 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

2© 2015 MakroCare. All Rights Reserved. www.makrocare.com

About MakroCare

AwardsYear

Established

Over 15 years of Life Sciences Core Consulting experience

1996 (HQ:NJ,USA) Privately held

Global Access

14 Global Offices

Clients

8 of Global Top 20150+ Small/Mid-level

ISO 9001 ISO 14155ISO 27001 ISO 20000

Employees

650+ FTEs140+ Consultants

Proprietary Frameworks/Tools

NAVAVistaarRIMtrackjarTreeTULAClinMetanoiamNAAMmEDCmIRT

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About MakroCare

Medical Device Practice

Regulatory

Regulatory Intel & Regulatory Strategy Development

Advisory Support and Roadmap Consulting Biocompatibility, Assurance cases, Testing

requirements Regulatory Writing and Submissions Development

(510k, PMA, , Technical Files, DHF, etc.) Establishment Registration and Product Listing

Clinical Development

Clinical Strategy, Study Designing and management

Monitoring (Central / Onsite) Clinical Data Management, Stat, Analysis,

Writing eClinical technology

Compliance

Quality management system consulting and implementation

SOPs and Quality Manual Development Third Party Audits and Oversight Systems and Utilities Validation Design Control Risk Management

Post Market Support

Post market Follow-Up Studies (Regulatory and Marketing)

Scientific / Medical advisory MDR / Annual Reports / Supplements


MakroCare’s Approach

Design > Implement > Train > Transfer

UDI Compliance Solution

Consulting and Advisory Support from Serialization, Supply Chain and Compliance Experts

Plan Development Implementation

Guidance

Phase 1: Design

Phase 2: Implement

Phase 3: Report

Source Data Identification

Data Mapping SOP and Procedure

Implementation Database Set-up Migration / Integration Initial work volume

management Data Quality and

Compliance team


MakroCare’s Approach

Design > Implement > Train > Transfer

UDI Compliance SolutionPhase 3: Report

Phase 1: Design

Phase 2: 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 for

global compliance requirements

Part 11 Compliant

presents

Unique Device Identification (UDI): What & How within overall Medical

Device Value Chain

By Jim Petragnani

Planning and Implementation of the Medical Device Regulation (UDI)


UDI: Planning and Implementation


Step 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



Step 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



Step 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



Step 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



Step 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



Step 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)



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 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 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).

Data 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.

Compliance Dates




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.

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 database. § 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, 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 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.

Compliance Dates (Cont.)



UDI 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 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 Field Size

Database 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

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm?utm_source=Members-Only+Updates&utm_campaign=c7c1e8c870-Proposed_Rules_7_5_2012&utm_medium=email%20



Health Industry Business Communications Council® (HIBCC) Issuing Agency

Issuing Agency Data Delimiters Identifier Data type

Human 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


HIBCC $$6 Expiration Date followed by Lot Number Exp Date: numeric [YYJJJHH] – Julian Date format with Hour option

10 7


HIBCC $+ Serial Number only Alphanumeric 20 18



Issuing Agency Data Delimiters Identifier Data typeHuman Readable Field Size

Database Field size

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 also required and included in main secondary data string

Alphanumeric 20 18

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

Health Industry Business Communications Council® (HIBCC) Issuing Agency (Cont.)



International Council for Commonality in Blood Banking Automation (ICCBBA) Issuing Agency

Issuing Agency Data Delimiters Identifier Data type

Human 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



International Council for Commonality in Blood Banking Automation (ICCBBA) Issuing Agency (Cont.)

Blood Bags Only Identifying Symbol Identifier Data type

Eye 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

ICCBBA Maximum Base UDI for Blood Bags Alphanumeric 24 20

Ex of Human Readable Barcode: =)1TE123456A&)RZ12345678



UDI Issuing Agencies

1. Firm Name: GS1Address: 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, 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] Site: http://www.hibcc.org Date of Initial Accreditation: December 26, 2013Initial Accreditation Granted through: December 26, 2016

ApplicationApproval Letter

3. Firm Name: ICCBBAAddress: PO Box 11309, San Bernardino, CA 92423-1309Contact Person: Pat Distler, Technical DirectorPhone: (909) 793-6516Email: [email protected] Site: http://www.iccbba.org Date of Initial Accreditation: February 12, 2014Initial Accreditation Granted through: February 12, 2017

ApplicationApproval Letter

mailto:[email protected]

http://www.gs1.org/

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/UCM378709.pdf


http://www.gs1us.org/industries/healthcare/gs1-healthcare-us/fda-udi


http://www.hibcc.org/




http://www.iccbba.org/





Project Timeline

Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Week 10

Enterprise Program Management Office

New Regulation Compliance

TASK OR ACTIVITY TIMELINEDeveloping 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 6

Risk Assessment Register Week 7

Implementation of UDI Week 7 - 10


Contact:

Jim Petragnani and Aaryak Joshi

[email protected]

+1-973-481-0100 extn 3043

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

www.makrocare.com

free webinar on unique device identification (udi)

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