Free Webinar on Unique Device Identification (UDI): What & How within overall Medical Device Value Chain. Planning a...
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
About MakroCare Over 15 years of Life Sciences Core Consulting experience Year Established
Global Access
1996 (HQ:NJ USA) (HQ:NJ,USA) Privately held
Employees p y
Proprietary Frameworks/Tools
Clients
650+ FTEs 140+ Consultants C lt t
14 Global Offices Global Offices
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8 of Global Top 20 of Global Top 20 150+ Small/Mid‐level
ISO 27001
ISO 20000 2
Awards
NAVA Vistaar RIMtrack jarTree TULA ClinMetanoia mNAAM mEDC mIRT
ISO 14155 www.makrocare.com
About MakroCare Medical Device Practice
Regulatory
Compliance
Regulatory Intel & Regulatory Strategy Development
Quality management system consulting and implementation
Advisory Support and Roadmap Consulting
SOPs and Quality Manual Development
Biocompatibility Assurance cases Testing Biocompatibility, Assurance cases, Testing requirements
Third Party Audits and Oversight h d d d h
Regulatory Writing and Submissions Development (510k, PMA, , Technical Files, DHF, etc.)
Systems and Utilities Validation
Design Control
Establishment Registration and Product Listing
Risk Management
Clinical Development
Post Market Support
Clinical Strategy, Study Designing and management
Post market Follow‐Up Studies (Regulatory and Marketing)
Monitoring (Central / Onsite)
Scientific / Medical advisory
Clinical Data Management, Stat, Analysis, Clinical Data Management, Stat, Analysis, Writing
MDR / Annual Reports / Supplements MDR / Annual Reports / Supplements
eClinical technology
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MakroCare’s Approach Design > Implement > Train > Transfer g p
UDI Compliance Solution Phase 1: Design Consulting and Advisory C lti d Ad i
Support from Serialization, Supply Chain and Compliance Experts Plan Development Implementation
Guidance
Phase 2: Implement
Phase 3: Report
Source Data
Identification Data Mapping SOP and Procedure
Implementation Database Set‐up Migration / Integration Initial work volume Initial work volume
management Data Quality and
Compliance team
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MakroCare’s Approach Design > Implement > Train > Transfer g p
UDI Compliance Solution Phase 1: Design
Phase 2: Implement l
Phase 3: Report 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 Ongoing development for
global compliance requirements Part 11 Compliant
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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
UDI: Planning and Implementation St 1 D l i th UDI Step 1. Developing the UDI compliance plan li l 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
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UDI: Planning and Implementation St 2 U d t di th M hi R d bl T h l 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
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UDI: Planning and Implementation St 3 Change Management Step 3. Ch M t 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
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UDI: Planning and Implementation St 4 Risk Assessment keeping the system agile for future changes Step 4. Ri k A t k i th t il f f t h 1.
Proactively identify and manage risks
2.
Assess Labeling changes ‐ Global Packaging
3.
Supply Chain continuity planning
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UDI: Planning and Implementation St 5 Implementation of UDI plan across the value chain Step 5. I l t ti f UDI l th l h i 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
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UDI: Planning and Implementation St 6 Identifying the data sources for FDA reporting Step 6. Id tif i th d t f FDA ti 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)
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UDI: Planning and Implementation C Compliance Dates li D t 1 year after publication of The labels and packages of class III medical devices and devices licensed under the Public Health Service the final rule (September Act (PHS Act) must bear a UDI. § 801.20. 24, 2014) 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 labels and packages of implantable, life‐supporting, and life‐sustaining devices must bear a the final rule (September UDI. § 801.20. 24, 2015) 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 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 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 UDI must be submitted to the GUDID database. § 830.300.
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UDI: Planning and Implementation C Compliance Dates (Cont.) li D t (C t ) 3 years after publication of Class III devices required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the final rule (September 24, the device is a device intended to be used more than once and intended to be reprocessed before each use. § 2016) 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 q database. § 830.300. 5 years after publication of A class II device that is required to be labeled with a UDI must bear a UDI as a permanent marking on the device the final rule (September 24, itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. 2018) § 801.45. The labels and packages of class I medical devices and devices that have not been classified into class I, class II, or 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 b l b l d be labeled with a UDI must be submitted to the GUDID database. h b b d h d b § 830.300. Class I stand‐alone software must provide its UDI as required by § 801.50(b). 7 years after publication of Class I devices, and devices that have not been classified into class I, class II, or class III that are required to be the final rule (September 24, labeled with a UDI, must a bear UDI as a permanent marking on the device itself if the device is a device intended 2020) to be used more than once and intended to be reprocessed before each use § 801.45. to be used more than once and intended to be reprocessed before each use. 801 45
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UDI: Planning and Implementation UDI f UDI formats by FDA‐Accredited Issuing Agency t b FDA A dit d I i A 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. 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
GS1
(01)
DI
Numeric
GS1
(11)
Manufacturing/ Production Date
GS1
(17)
GS1 GS1 GS1
Human Readable Field Size
Database Field Size Field Size 16
14
numeric [YYMMDD]
8
6
Expiration Date
numeric [YYMMDD]
8
6
(10)
Batch/Lot Number
alphanumeric
22
20
(21)
Serial Number
alphanumeric
22
20
Maximum Base UDI
alphanumeric
76
66
ex: (01) 51022222233336(11)141231(17)150707(10)A213B1(21)1234
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UDI: Planning and Implementation H lth I d t B i Health Industry Business Communications Council® (HIBCC) Issuing Agency C i ti C il® (HIBCC) I i A Human Database Readable Field size Field Size 7 to 24 6 to 23 19 18 21 18
Issuing Agency
Data Delimiters
Identifier
Data type
HIBCC HIBCC HIBCC
+ $ $$7
DI Lot Number Only Lot Number Only (alternative option)
Alphanumeric Alphanumeric Alphanumeric
HIBCC
$$
Expiration Date followed by Lot Number
Exp Date: numeric [MMYY]
6
4
Lot Number: alphanumeric
18
18
9
6
18
18
9
6
Lot Number: alphanumeric
18
18
Exp Date: numeric [YYMMDDHH] Lot Number: alphanumeric
11
8
18
18
Exp Date: numeric [YYJJJ] – Julian Date format Lot Number: alphanumeric b l h i
8
5
18 8
18 8
Exp Date: numeric [YYJJJHH] – Julian Date format with Hour option Lot Number: alphanumeric
10
7
18
18
Alphanumeric l h
20
18
HIBCC
$$2
Expiration Date followed by Lot Number
Exp Date: numeric [MMDDYY] Lot Number: alphanumeric
HIBCC
HIBCC
HIBCC
HIBCC
HIBCC
$$3
$$4
$$5
$$6
$ $+
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Expiration Date followed by Lot Number
Expiration Date followed by Lot Number
Expiration Date followed by Lot Number
Expiration Date followed by Lot Number
Serial Number only l b l
16
Exp Date: numeric [YYMMDD]
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UDI: Planning and Implementation H lth I d t B i Health Industry Business Communications Council® (HIBCC) Issuing Agency (Cont.) C i ti C il® (HIBCC) I i A (C t ) Issuing Agency
Data Delimiters Identifier
Data type
HIBCC
$$+7
Serial Number only (alternative option)
Alphanumeric
HIBCC
$$+
Expiration Date followed by Serial Number
Exp Date: numeric [MMYY]
HIBCC HIBCC
$$+2 $$+3
Expiration Date followed by Serial Number Expiration Date followed by Serial Number
18
7
4
Serial Number: alphanumeric
18
18
Exp Date: numeric [MMDDYY]
10
6
Serial Number: alphanumeric
18
18
Exp Date: numeric [YYMMDD]
10
6
Serial Number: alphanumeric
18
18
12
8
18
18
9
5
Serial Number: alphanumeric
18
18
Exp Date: numeric [YYJJJHH]
11
7
Serial Number: alphanumeric
18
18
$$+4
Expiration Date followed by Serial Number
Exp Date: numeric [YYMMDDHH] Serial Number: alphanumeric
HIBCC
$$+5
Expiration Date followed by Serial Number
Exp Date: numeric [YYJJJ]
HIBCC
$$+6
Expiration Date followed by Serial Number
Database Field size 22
HIBCC
HIBCC
Human Readable Field Size
/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 numeric [YYYYMMDD] 12 8 barcode) 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
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UDI: Planning and Implementation IInternational Council for Commonality in Blood Banking Automation (ICCBBA) Issuing t ti lC il f C lit i Bl d B ki A t ti (ICCBBA) I i Agency Human Readable Readable Barcode Field Size
Database Database Field Size
Issuing Agency
Data Delimiters
Identifier
Data type
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
Maximum Base UDI for HCT/Ps
Alphanumeric
79
67
ICCBBA
Ex of Human Readable Barcode:=/A9999XYZ100T0944=,000025=A99971312345600=>014032=}013032&,1000000000000XYZ123
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UDI: Planning and Implementation IInternational Council for Commonality in Blood Banking Automation (ICCBBA) Issuing t ti lC il f C lit i Bl d B ki A t ti (ICCBBA) I i Agency (Cont.)
Blood Bags Only
ICCBBA
ICCBBA
ICCBBA ICCBBA
Eye Readable Eye Readable Barcode Field Size
Databas e Field Size
Alphanumeric
12
10
Lot Number for blood containers (bags)
Alphanumeric
12
10
Maximum Base UDI for Blood Bags
Alphanumeric
24
20
Identifying Symbol
Identifier
Data type
=)
DI for blood containers (bags)
&)
Ex of Human Readable Barcode: =)1TE123456A&)RZ12345678
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UDI: Planning and Implementation UDI I i A UDI Issuing Agencies i 1. Firm Name: GS1 Address: Princeton Pike Corporate Center, 1009 Lenox Drive, Suite 202, Lawrenceville, NJ 08648 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:
[email protected] Web Site: http://www.gs1.org Date of Initial Accreditation: December 17, 2013 Initial Accreditation Granted through: December 17, 2016 Initial 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:
[email protected] W b Sit http://www.hibcc.org Web Site: htt // hib Date of Initial Accreditation: December 26, 2013 Initial Accreditation Granted through: December 26, 2016 Application Approval Letter
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3. Firm Name: ICCBBA Address: PO Box 11309, San Bernardino, CA 92423‐1309 Contact Person: Pat Distler, Technical Director Phone: (909) 793‐6516 Email:
[email protected] W b Sit http://www.iccbba.org Web Site: htt // i bb Date of Initial Accreditation: February 12, 2014 Initial Accreditation Granted through: February 12, 2017 Application Approval Letter
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UDI: Planning and Implementation P j t Ti li 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
N R New Regulation Compliance l i C li TASK OR ACTIVITY
TIMELINE
D l i Developing the UDI compliance Plan h UDI li Pl
W k 1 Week 2 Week 1 ‐ W k2
Identifying the data sources for FDA Reporting
Week 3 ‐ Week 4
Understanding the Machine Readable Technology
Week 5
Change Management Plan Change Management Plan
Week 6 Week 6
Risk Assessment Register
Week 7
Implementation of UDI
Week 7 ‐ 10
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Contact:
JJim Petragnani g and Aaryak y JJoshi
[email protected]
+19734810100 extn 3043 www.makrocare.com
One Washington Park, Suite 1303, Newark, ‐ 07102, NJ (USA)
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