Simple Steps to UDI Compliance

Simple Steps to UDI Compliance © Microscan Systems Inc. Barbie LaBine Microscan Training Coordinator A Certified GS1 Standards Professional, Barbie...
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Simple Steps to UDI Compliance

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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. Live Q&A Following the Presentation To ask a question during the following presentation, please use the Questions window on the right side of your screen. Questions will be queued and answered after the presentation. © Microscan Systems Inc.

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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) © Microscan Systems Inc.

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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 © Microscan Systems Inc.

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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 © Microscan Systems Inc.

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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. © Microscan Systems Inc.

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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. © Microscan Systems Inc.

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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 © Microscan Systems Inc.

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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. © Microscan Systems Inc.

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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. © Microscan Systems Inc.

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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. © Microscan Systems Inc.

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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. © Microscan Systems Inc.

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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 FDAaccredited 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. © Microscan Systems Inc.

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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. © Microscan Systems Inc.

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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. © Microscan Systems Inc.

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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 lifesustaining (I/LS/LS) devices. © Microscan Systems Inc.

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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

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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 © Microscan Systems Inc.

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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 CC/A

Code 128

Databar Stacked, Omni-directional

UPC-A © Microscan Systems Inc.

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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 © Microscan Systems Inc.

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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 © Microscan Systems Inc.

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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. © Microscan Systems Inc.

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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. © Microscan Systems Inc.

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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. © Microscan Systems Inc.

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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 StandAlone 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, LifeSupporting, 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 StandAlone 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 StandAlone 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. © Microscan Systems Inc.

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Thank You!

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