FREYR UDI VISION SERIES SESSION 2 - BARCODING & LABELING


FREYR UDI VISION SERIES PART 2 – Labeling and Barcoding

Date: 21 Nov 2014

3 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING

Session 2 - Agenda

1. Freyr Fact Sheet

2. UDI Labeling & Barcode Standards

3. RFID in Medical Devices

4. UDI Labeling for Different Device Types

5. Exemptions and Highlights

6. Q&A SESSION 1 – AGENDA

1. Overview - UDI

2. GUDID Components

3. UDI – Master Data Management

4. Freyr Leverage – UDI Expertise

5. Freyr IDENTITY – UDI Software Solution

6. Freyr Corporate Overview DISCLAIMER: All images, pictures showcased are property of their respective legal owners (GS1, HIBCC & ICCBBA) and are used for illustrative/ information purposes only.


→ Headquartered in New Jersey, USA with Regulatory Operations & Data Centre in Cranbury, NJ, USA

→ Global Regulatory Operations & Development Centre in Hyderabad, India, Asia’s leading Bio-Tech Hub with an office in Maidenhead, UK

→ Robust Information Security and Quality ISO 9001 & ISO 27001 Certified Processes with state-of-the-art infrastructure and BCP & DR site

→ Best-in-class Regulatory Consulting, Technology and high-value/ low-cost Outsourcing Services

→ Rapidly growing strong 350+ team of regulatory, scientific, technology & consulting professionals

→ Freyr is the preferred partner to Top 10 Fortune 50 Bio-Pharma & Consumer Healthcare and several Small-Medium Pharma & Life Sciences Companies.

Freyr, is a fast-growing, Global Regulatory Solutions & Services company with an exclusive focus on the entire Regulatory value-chain

Freyr Consulting and Advisory Services

1. Freyr IDENTITY – Stand alone Software for UDI 2. Freyr ACCELERATE - Building custom validated

Enterprise scale applications coupled with Freyr Identity solution (Custom Bolt-on Solutions)

3. Operational Data Management

UDI READINESS ASSESSMENT/ GAP ANALYSIS

DI IMPLEMENTATION & SUBMISSION MANAGEMENT

LIFE CYCLE MANAGEMENT

Freyr in the UDI Space

Freyr Fact Sheet


UDI Labeling & Barcode Standards

Presenter : Alan & Prasanna


UDI Representation:

According to UDI final rule, the UDI must appear on every device as device label or direct marking.

It is presented in two forms:

(1) Easily readable plain-text or Human Readable Interpretation (HRI), and

(2) Automatic identification and data capture (AIDC) technology.

Direct Marking (DM):

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.

The UDI provided through a direct marking on a device may be:

(1) Identical to the UDI that appears on the label of the device, or

(2) A different UDI used to distinguish the unpackaged device from any device package containing the device.

Date Format:

The format is: the year, using four digits: followed by the month, using two digits; followed by the day, using two digits; each separated by hyphens. For example, January 2, 2014, must be presented as 2014-01-02.

UDI Compliant Labeling


CHALLENGES MITIGATION

• Selection of IA based on the device type and their applicability

• Profile the devices and based on their portfolio apply to respective IA

• Every device label marketed by the labeler needs to be reworked

• Based on the selected IA the artwork team needs to redesign the labels

• Inventories of preprinted stationery of labels

• Plan earlier to avoid wastage of labels

• Impact of DM (Direct Marking) on applicable devices

• DM applicability for devices needs to be identified and the production line must be equipped with infrastructure to support DM requirements. The production staff must be trained on the new infrastructure

Format of the numbering and the standard for AIDC is mandated by the Issuing Agency (IA).

Every IA has a different set of numbering and AIDC standards

Industry Challenges

Based on the IA selection, the labeler has to rework the label format through their artwork and publishing team to accommodate the UDI in both HRI and AIDC formats

This exercise needs to be done for each and every device that is marketed by the labeller

This again implies the need to start the UDI compliancy activity at the earliest


GS1 Labeling Standards

GUDID Data Date Lot

PI

DI

LINEAR SYMBOLOGY

15416:2000 – AIDC techniques -- Bar code print quality test specification -- Linear symbols

15417:2007 – AIDC - Code 128 bar code symbology specification

15423:2009 – AIDC techniques -- Bar code scanner and decoder performance testing

15426-1:2006 – AIDC techniques -- Bar code verifier conformance specification -- Part 1: Linear symbols

15426-2:2005 – AIDC techniques -- Bar code verifier conformance specification -- Part 2: Two-dimensional symbols

2D SYMBOLOGY

15415:2011 – AIDC - Bar code symbol print quality test specification - Two-dimensional symbols

16022:2006 – AIDC techniques - Data Matrix bar code symbology specification

Under GS1, the Global Trade Item Number™ (GTIN™) is used for the unique identification of trade items worldwide.


GS1 – Barcoding Standards

1 2 3 4

Device Identifier Expiration Date 2

1

Lot number Serial number 4

3

AIDC format: Example using GS1-128:

AIDC format: Example using GS1-Datamatrix:

2

4 3

1


HIBCC Labeling Standards

DI

PI

GUDID Data

GUDID Data

LINEAR SYMBOLOGY

15416:2000 – AIDC techniques -- Bar code print

quality test specification -- Linear symbols

15417:2007 – AIDC - Code 128 bar code symbology specification

16388 – AIDC – techniques – Code 39 bar code symbology specification

2D SYMBOLOGY

15415:2011 – AIDC - Bar code symbol print quality test specification - Two-dimensional symbols

16022:2006 – AIDC techniques - Data Matrix bar code symbology specification

18004:2006 – AIDC – techniques - QR Code bar code symbology specification

24728 – AIDC techniques – MicroPDF417 bar code symbology specification

24778 – AIDC techniques -- MicroPDF417 bar code symbology specification

Labeler identification Code (LIC) is assigned by HIBCC and it Identifies the labeler.


HIBCC - Barcoding Standards

Primary and Secondary Data in a 2D Symbol

HIBC LIC Secondary Code Data Structure

+A99912345 / $$59901510X3J 5 3 2 2 9 8 7 6 1 4

+A99912345 / $$59901510X3J 5 3 2 2 9 8 7 6 1 4

HIBC Supplier Labeling flag LIC 2

1

Product ID 3

5

4

6 7

8

Unit of Measure Data delimiter Exp. Date Flag Expiration Date Lot Number

9 Check Character


ICCBBA Labeling Standards

GUDID Data

GUDID Data

LINEAR SYMBOLOGY 15416:2000 – AIDC techniques -- Bar code print quality test specification -- Linear symbols 15417:2007 – AIDC - Code 128 bar code symbology specification 2D SYMBOLOGY 15415:2011 – AIDC - Bar code symbol print quality test specification - Two-dimensional symbols 16022:2006 – AIDC techniques - Data Matrix bar code symbology specification

ISBT 128 is the global standard for the terminology, identification, labeling, and information transfer of medical products of human origin (including blood, cell, tissue, and organ products) across international borders and disparate health care systems.


ICCBBA - Barcoding Standards

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

Ex of Human Readable Barcode:=/A9999XYZ100T0944=,000025=A99971312345600=>014032=}013032&,1000000000000XYZ123

ISBT 128-Linear Barcode

2 5 3 4 1

Facility identification code Year of collection-donation

3

1

Serial number 2

5

4 Flag character-turned 90⁰ Check digit


RFID in Medical Devices

Presenter : Alan


Radio Frequency Identification (RFID) RFID has the potential in healthcare to achieve improvements in both supply chain productivity and patient safety applications.

The ISO approach to RFID implementation is based upon healthcare product supplier migration from existing barcode or 2-D symbologies to RFID.

Barcoding will continue to be used in the future, and will co-exist with RFID. As with all technologies, each will be utilized in the functions for which it offers the highest benefit/cost ratio and comparative advantage.

RFID utilizes data chips that do not have to be visible to be scanned. RFID tags are unique serial numbers that allow tracking of the lowest unit of measure that is tagged.

The volume of data contained within RFID tags is dependent on size and type, containing up to 128 kilobytes of data.

An RFID tag can be one-time use or re-useable. RFIDs are the most expensive of the barcode options.

RFID technology enables manufacturers of reprocessed or reusable medical devices to comply with the direct part marking requirement of the FDA Final Rule for UDI.

ISO/IEC 15418 (Incorporating ANS MH10.8.2 Data Identifiers), and ISO/IEC 15961, 15962 and 15963 are normative references for UDI RFID data protocols.


RFID Visibility to UDI Inventory

Device Manufacturer

3 PL or DC

Hospital or Medical

Facility RFID Event

LEAVE_MANUFACTURER

RFID Event ARRIVE_DISTRIBUTION

UDI ‘SmartLabels’ on Packaging Known ‘PI’ Inventory at

Customers location

RFID Event Management

Software

Event Data

RFID Event ARRIVE_CUSTOMER

UDI RFID Deployment in Supply Chain

Track & Trace

Customer Enterprise


Presenter : Prasanna

UDI Labeling for Different Device Types


Single Use Devices Single-use devices (SUDs) come under an exception of not having an UDI, provided that:

• The UDI appears on the device package

• All SUDs of a single version/model are distributed together in a single device package

• They are to be stored in that device package until removed for use

• They are not meant for individual commercial distribution

• Implants that fall under SUDs do not have this exception

If the devices are intended for individual commercial distribution, the device label and package for these individual devices is required to bear a UDI

Single-use devices that are implants which are subjected to additional processing and manufacturing are exempted from having a permanent UDI on the device


Combination Products / Kits

Combination products are required to have an UDI, however the device constituent part of that

combination product or kit are exempt from the UDI requirement. Combination products include;

Convenience Kits, in-vitro diagnostic kits, and HCT/Ps, etc.

Each component, sub-system or accessory that is considered a medical device and is commercially

available needs a separate UDI unless the components are part of a convenience, medical

procedure, IVD kit or configurable medical device system that is marked with its own UDI.

If the combination product instead has an NDC code, it is exempt from the UDI requirements

however in that case, the device constituent part must have the UDI unless the product is a single

entity combination product where the drug/device are physically, chemically or otherwise

combined.


Stand-Alone Software The UDI Rule does not provide any special requirements for a device that contains software as a component of the device, but does require stand-alone medical software to be labeled with a UDI.

All stand-alone software, whether packaged or unpackaged (e .g., software downloaded from a website), must provide its UDI through either or both of the following:

• An easily readable plain-text statement displayed whenever the software is started

• An easily readable plain-text statement displayed through a menu command (e.g., an “About...” menu command)

Stand-alone software that is distributed in packaged form is subject to the same UDI labeling requirements as any other medical device -- the device label and device package must bear a UDI in plain-text and AIDC formats.

Stand-alone software that is distributed in both packaged and unpackaged form may be identified with the same DI. Stand-alone software that is not distributed in packaged form must convey the version number in its production identifier.


Exemptions and Highlights

Presenter : Alan


General Exemptions Single Use Device Exception (multiple in 1 Package, any class/except implants): UDI required on device package, not required on device label.

Class III Extension +1 year, if request is approved.

GMP exempt Class I devices are exempt completely from the UDI requirements; however, the standardized date format requirement still applies.

Single-use contact lenses are subject to the exemption from the need to be individually labeled with a UDI under § 801.30(a)(3). Boxes or containers used explicitly for shipping and transportation are exempted from UDI requirements

Direct marking is now only required for devices that are reusable i.e. device intended to be reprocessed before each use. There are provisions for exemptions from direct marking if the marking would affect the device safety or effectiveness or if it is technologically not feasible.

Device constituents which are part of the combination product or kit and not commercially available are exempt from the UDI requirement.

A Medical device used solely for research, teaching, or chemical analysis, and not intended for any clinical use. Veterinary medical device need not to have a UDI. PI attribute information is optional for Class-I devices


Medical Device in Inventory

UDI requirements apply to devices placed into commercial distribution after the compliance date that

applies to the device.

A finished device manufactured and labeled prior to its compliance date and held in inventory is

excepted from UDI requirements for three years after the compliance date.

This exception applies to both products held in inventory by the labeler and those consigned to a

hospital or other potential purchaser and held in inventory, but not yet purchased, by the potential

purchaser.

This exception applies to all UDI requirements.


Implantable Devices

The UDI Rule does not require an implantable device to be directly marked with its UDI.

CDRH believes that the UDI label and package requirements will provide for adequate identification of an implantable device up to the point where it is implanted.

CDRH also acknowledges the common practice of recording information about implanted devices both in the patient's health record (EHRs and PHRs), and on a card provided to the patient, and they expect health care providers will incorporate UDIs into both of these types of records.

UDI – Small Labels The final rule does not specify the type of label that is required to bear a UDI. It is up to the labeler to determine an appropriate method to apply the UDI to the device label. An add-on label, in some instances, may be appropriate. However, a UDI must be included on the device label and every device package.

Device labels not able to accommodate both AIDC and HRI should “Request for an Exception from or Alternative to a Unique Device Identifier Requirement—Proposed § 801-35; § 801.55 of the Final Rule.”


Questions?

Please Post Questions in the Questions Panel


US Headquarters

1 Bell Street, Maidenhead, Berkshire, SL6 1BU Phone +44 1133 508632

103 Carnegie Centre, Suite 300, Princeton, NJ – 08540

1 Farr View Dr, STE 5E , Cranbury Township, NJ 08512

Phone +1 908 345 5984

UK

North America Operations Center

Lanco Hills Technology Park, Manikonda, Hyderabad, India Phone +91 40 4848 0999

India Global Operations Center

[email protected]

Thank You!

FREYR UDI VISION SERIES SESSION 2 - BARCODING & LABELING

Healthcare

Transcript of FREYR UDI VISION SERIES SESSION 2 - BARCODING & LABELING