simple steps to udi compliance - microscan...
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© 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.
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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)
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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
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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.
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Must be issued by an FDA-accredited Issuing Agency such as:
GS1
Health Industry Business Communications Council (HIBCC)
ICCBBA or ISBT 128
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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.
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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.
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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.
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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.
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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.
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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.
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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
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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.
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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.
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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.
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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.
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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
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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.
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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.
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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.
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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.
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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.
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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
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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
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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
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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
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6. Verify your barcode.
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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
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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
Greatest risk upon failure.
Support or sustain human
lives; malfunction is
unacceptable. Pacemakers,
heart valves, implants, etc.
Plain-text
statement in
software
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Compliance Date Device Class What kind of device? UDI Application
2 years after publication
of the final rule
(September 24, 2015)
Implantable, Life-
Supporting, and
Life-Sustaining
Devices
Greatest risk upon
failure. Support or sustain
human lives; malfunction is
unacceptable. Pacemakers,
heart valves, implants, etc.
Printed on labels
and packaging;
permanent
marking on the
device
Stand-Alone
Software that is
a Life-Supporting
or Life-Sustaining
Device
Greatest risk upon failure.
Support or sustain human
lives; malfunction is
unacceptable. Pacemakers,
heart valves, implants, etc.
Plain-text
statement in
software
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Compliance Date Device Class What kind of device? UDI Application
3 years after
publication of the
final rule
(September 24,
2016)
Class III
Devices
Greatest risk upon failure.
Support or sustain human
lives; malfunction
is unacceptable. Pacemakers,
heart valves, implants, etc.
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
Minimal risk upon failure.
Complex design, minimal
risk. X-ray machines,
powered wheelchairs,
infusion pumps, surgical,
acupuncture needles.
Plain-text statement in
software
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Compliance Date Device Class What kind of device? UDI Application
5 years after
publication of the
final rule
(September 24,
2018)
Class II
Devices
Minimal risk upon failure.
Complex design, minimal
risk. X-ray machines,
powered wheelchairs,
infusion pumps, surgical,
acupuncture needles.
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
Little to no risk upon failure.
Tongue depressors, elastic
bandages, handheld
dental instruments,
examination gloves.
Plain-text
statement in
software
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Compliance Date Device Class What kind of device? UDI Application
7 years after publication
of the final rule
(September 24, 2020)
Class I Devices;
All Other Devices
Little to no risk upon failure.
Tongue depressors,
elastic bandages, handheld
dental instruments,
examination gloves.
Permanent
marking on the
device
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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
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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.
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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.
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