simple steps to udi compliance - microscan...

© Microscan Systems Inc.© Microscan Systems Inc.

Simple Steps to UDI Compliance

© Microscan Systems Inc. 2

Barbie LaBine

Microscan Training Coordinator

A Certified GS1 Standards Professional, Barbie LaBine has

provided training to global medical device manufacturers on UDI

compliance and UDI code and label verification for the past two

years. LaBine comes to Microscan from the industry-leading

barcode verification systems manufacturer Label Vision Systems,

Inc., (acquired by Microscan Systems, Inc., in August 2015), and

now offers a range of training on LVS® brand barcode verification

and other Microscan technology and applications.

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The FDA has established a unique device identification system to thoroughly identify and log medical devices throughout

manufacturing, distribution, and use.


Regulated medical devices

must have a unique device

identifier (UDI) printed on

the label and/or directly

applied to the device

Labelers must submit

certain information about

each device to FDA’s Global

Unique Device Identification

Database (GUDID)


Each UDI must be provided in a

plain-text form (readable to

humans) and in a form that can

be interpreted by automatic

identification and data capture

(AIDC) technology (readable to

machines):

• Barcode readers

• Machine vision cameras

• RFID


UDI is a unique numeric or alphanumeric code assigned to a unique device. A UDI code consists of two parts:

Device Identifier (DI) – a mandatory, fixed portion that identifies the labeler and the specific version or model of a device.

Production Identifier (PI) –a conditional, variable portion of a UDI.


Must be issued by an FDA-accredited Issuing Agency such as:

GS1

Health Industry Business Communications Council (HIBCC)

ICCBBA or ISBT 128


As part of the UDI rule, device labelers are required to submit UDI

information to the FDA-administered Global Unique Device

Identification Database (GUDID).

The GUDID will include a standard set of basic identifying elements

for each device with a UDI, and contain ONLY the DI, which will

serve as the key to obtain device information in the database.

PIs are not part of the GUDID. These should be maintained

internally by the manufacturer.


Identifies one or more of the

following pieces of data when

included on the label of a device:

• Lot or batch number with which a

device was manufactured.

• Serial number of a specific device.

• Expiration date of a specific device.

• Date a specific device was

manufactured.


Accurate reporting, reviewing, and

analyzing of adverse event reports so

that problem devices can be identified.

• Allows manufacturers, distributors, and

healthcare facilities to more effectively

manage medical device recalls.

Reduce medical errors by enabling

healthcare professionals and others to

more rapidly and precisely identify a

device and obtain important

information concerning the

characteristics of the device.


Enhance the analysis of devices on the market by providing a

standard way to document device use in electronic health records,

clinical information systems, claim data sources, and registries.

A more robust post-market

surveillance system can

also be leveraged to support

pre-market approval or

clearance of new devices

and new uses of currently

marketed devices.


Providing a foundation for a global, secure distribution chain,

helping to address counterfeiting and diversion and prepare

for medical emergencies.

Promote development of

a medical device identification

system that is recognized

around the world.


The final UDI rule provides the regulatory

framework for implementation of a UDI

system by the device industry.

The benefits offered by such a system will

only be fully realized with the adoption and

use of UDIs by manufacturers, distributors,

payers, providers, patients, healthcare

systems and other stakeholders with

important roles to play throughout the

medical device lifecycle.


The requirements of the FDA UDI rule apply to labelers of

medical devices.

A “labeler” is defined as:

• Any person or agency who causes a label to be applied to a device

with the intent that the device will be commercially distributed

without subsequent modification

• Any person or agency who causes the label of a device to be

replaced or modified with the intent that the device will be

commercially distributed without any subsequent modification


The U.S. FDA rules apply to

any medical devices sold

in the U.S.

International medical

device manufacturers

must comply with these

rules as well if the device

is being sold in the U.S.,

regardless of where the

device is manufactured.


1. Review UDI guidance documents and resources to create an internal

action plan/timetable for preparing important device and

manufacturing data to submit.

2. Use FDA-accredited issuing agencies to assign and maintain UDIs.

3. Establish processes for physical labeling.

4. Establish standard operating procedures for records management.

5. Gather data required for your DI records based on the GUDID.


6. Understand the

GUDID Account

structure and User

Roles as shown in

GUDID Guidance.

• Identify individuals for

the GUDID User Roles

and ensure they

understand their

responsibilities.


7. Identify/obtain Dun and Bradstreet (DUNS) numbers.

8. Determine a GUDID submission option. (GUDID Web Interface or

HL7 SPL submission).

• If choosing HL7 SPL submission, establish a FDA ESG account

and complete required testing.

9. If needed, select a third-party submitter. For information on

third-party submission, please refer to GUDID Guidance.

10. Subscribe to the UDI mailing list to be notified about updates for

the UDI program.

11. Subscribe to the GUDID mailing list to be alerted to database

changes and GUDID system status updates.


1. Contact an accredited issuing agency to be issued your DI.

All UDIs are to be issued under a system operated by an FDA-

accredited issuing agency:

GS1

Health Industry Business Communications Council (HIBCC)

ICCBBA or ISBT 128


A DI is comprised of a unique

Company Identifier and a unique

number assigned to a specific

model or version of a manufactured

device.

If you are manufacturing and

labeling devices and you have 20

different models or versions, you

would need to obtain 20 unique

Device Identifiers (DIs), one for each

version or model.


Per the UDI label and GUDID submission requirements, a “device

package” is a package that contains a fixed quantity of a unique

version or model of a device.

• If a device is sold in

a unit-level device

package (bottle, box,

or other package),

and then packaged

as a box of 20, and

then ten boxes of

20 are shipped in

the carton, each

level of packaging

would require its own UDI.


2. Create a GUDID account.

• The GUDID account identifies the

labeler in GUDID and is required for

all labelers under the UDI rule.

• Labelers must submit a GUDID

account request on the FDA website:

http://www.fda.gov.

3. Submit your DI to the GUDID database.

• To ensure UDI compliance, labelers must submit their DI to the GUDID.

http://www.fda.gov/


A GUDID account must be set up to submit DIs.

Beginning February 1, 2016, the FDA accepts GUDID account requests

from labelers of Class II devices.

• These labelers are encouraged to obtain a GUDID account as soon as possible to

allow adequate time for system compatibility testing and data submission.

The FDA will also continue to accept GUDID account requests from

labelers of Class III devices; devices licensed under the Public Health

Service Act (PHS Act); and implantable, life-supporting and life-

sustaining (I/LS/LS) devices.


The GUDID provides two options for submitting DI:

1. GUDID Web Interface –Input device information one DI record at a time

2. HL7 SPL Submission – Submit device information as .xml file

Currently open only to labelers of marketed Class III medical devices;

devices licensed under the Public Health Service Act (PHS Act); and

implantable, life-supporting, or life-sustaining devices.

GUDID accounts are NOT required for a public search and retrieval of

published information in AccessGUDID, the public portal for GUDID data.


3. Read and understand your issuing agency’s standards.

Barcode types, data formatting, and other UDI

specifications are all agency-dependent

GS1 Specification Standards:https://www.GS1.org

HIBC Standards:https://www.HIBCC.org

ICCBBA Standards:https://www.ICCBA.org

https://www.gs1.org/

https://www.hibcc.org/

http://www.iccba.org/


4. Create your UDI barcode using your DI and PI data.

• There are many different barcode generators available.

• Research your options and find a software that is compliant with your issuing agency’s standards and offers ease of use.

Choose a software capable of creating a GS1, HIBCC, or ICCBBA barcode

Some software interfaces contain GS1 wizards that make entering your barcode data extremely easy


5. Select a data carrier (barcode type) that is in compliance with your issuing agency’s application standards.

Data Matrix Code 128

Code 128 CC/A

Databar Stacked,

Omni-directional

UPC-A


Be sure you know the approved

data carriers (barcode types) for

your agency’s standards and

properly enter the data in the

format as it is specified by the

agency’s standards.

These three codes have the same

data carrier (Code 128), but the

way the data is encoded defines

the barcodes as GS1, HIBCC, or

ICCBBA.

GS1

HIBCC

ICCBBA-ISBT 128


6. Verify your barcode.


Verification is a method of

analyzing a printed code against a

published specification (like those

of GS1) to determine:

• Whether the barcode is compliant

to specifications.

► Verify data structure

• Whether the barcode will be read.

► Inspect print quality


Microscan’s LVS-95XX series of verifiers

grades barcode print quality and data

format to ensure compliance with

specifications for:

• Print Quality: ISO/IEC 15415, ISO/IEC 15416

• Data Format: GS1, HIBCC

For example: If GS1 is selected as your

application standard in the LVS-95XX

system it will automatically confirm

whether your data is GS1 compliant.


A barcode scanner or

barcode reader will

report the data it sees,

but it does not have the

ability to tell you that the

data in your code is not

compliant to your

selected standards, or

whether it is formatted

correctly.


It is best to plan for more than one verification step.

Are you adding the code to label artwork?

• The barcode must be exported correctly at a consistent aspect

ratio and at the same DPI that it will be printing to.

• If the barcode image is stretched or otherwise manipulated

incorrectly for artwork, your symbol may fall out of compliance.

• By verifying the barcode again after the artwork process, you can

be sure that your barcode is compliant, quality, and ready to print.


Once you have verified that your label

is UDI-compliant for barcode structure,

you must actively maintain print quality

to ensure that your label meets

ISO/IEC 15415 or ISO/IEC 15416 for

barcode legibility.

This can be achieved using an In-Line

Print Quality Verification System, which

can be custom-integrated onto your

line or within your printer.


The UDI system will go into effect in stages over a period of

seven years to ensure a smooth implementation and to

spread the costs and burdens of implementation over time.

The FDA UDI final rule was published on September 24, 2013

and stages will be rolled out until 2020.

It is important to understand what Class your device falls

under to understand when you are required to comply.


The FDA classifies medical devices based on the risks

associated with the device.

Devices are classified into one of three categories —

Class I, Class II, and Class III.

• Class I devices are deemed to be

low risk and are therefore subject

to the least regulatory controls.

For example, dental floss and

gauze bandages are classified

as Class I devices.


Class II devices are higher risk

devices than Class I and

require greater regulatory

controls to provide reasonable

assurance of the device’s

safety and effectiveness. For

example, syringes are

classified as Class II devices.


Class III devices are generally

the highest risk devices and

are therefore subject to the

highest level of regulatory

control. Class III devices must

typically be approved by FDA

before they are marketed. For

example, replacement heart

valves and other implantable

devices are classified as

Class III devices.


Compliance Date Device Class What kind of device? UDI Application

1 year after publication

of the final rule

(September 24, 2014)

Class III Medical

Devices;

Devices under the

Public Health

Service

Act (PHS Act)

Greatest risk upon failure.

Support or sustain human

lives; malfunction is

unacceptable. Pacemakers,

heart valves, implants, etc.

Printed on labels

and packaging

Class III Stand-

Alone Software






Plain-text

statement in

software



2 years after publication

of the final rule


Implantable, Life-

Supporting, and

Life-Sustaining

Devices

Greatest risk upon

failure. Support or sustain

human lives; malfunction is



Printed on labels

and packaging;

permanent

marking on the

device

Stand-Alone

Software that is

a Life-Supporting

or Life-Sustaining

Device






Plain-text

statement in

software



3 years after

publication of the

final rule

(September 24,

2016)

Class III

Devices



lives; malfunction

is unacceptable. Pacemakers,


Permanent marking on the

device

Class II

Devices

Minimal risk upon failure.

Complex design, minimal risk.

X-ray machines, powered

wheelchairs,

infusion pumps, surgical,

acupuncture needles.

Printed on labels and

packaging

Class II Stand-

Alone

Software


Complex design, minimal

risk. X-ray machines,

powered wheelchairs,



Plain-text statement in

software



5 years after

publication of the

final rule

(September 24,

2018)

Class II

Devices


Complex design, minimal

risk. X-ray machines,

powered wheelchairs,



Permanent

marking on the

device

Class I

Devices;

All Other

Devices

Little to no risk upon failure.

Tongue depressors, elastic

bandages, handheld

dental instruments,

examination gloves.

Printed on labels

and packaging

Class I Stand-

Alone

Software


Tongue depressors, elastic

bandages, handheld

dental instruments,

examination gloves.

Plain-text

statement in

software



7 years after publication

of the final rule


Class I Devices;

All Other Devices


Tongue depressors,

elastic bandages, handheld

dental instruments,

examination gloves.

Permanent

marking on the

device


If uncertain of the

Class of your medical

device, use the FDA

Classification

Database to search for:

• The name of the

product

• The device panel

(medical specialty) to

which your device

belongs


The UDI rule relies on 100% traceability to allow

actions to be taken based on device types,

origins, and statuses.

Traceability can be defined as an unbroken

record of a device lifecycle, from creation to

consumption.

To ensure traceability, it is critical that your

label complies with standard UDI requirements,

as well as verify that data on your label can be

interpreted and transmitted accurately as

devices move through the supply chain.


Microscan offers industry-leading LVS®

Barcode Verification Systems that check for

barcode and label compliance to standards

like GS1, ISO/IEC, and more.

We currently work with the Top 10 medical

device suppliers in the world to streamline UDI

compliance operations using software that is

pre-programmed for agency requirements.

Our verification experts offer personal training

to assist in the setup of UDI verification

systems specifically for your application to

make sure your codes stay up to code.

Remember to establish a verification plan for

UDI – Get expert help at www.microscan.com.

http://www.microscan.com/

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