Regulatory Labels - Imprint Enterprises - Since 1975 https://imprint-e.com Barcode Experts for Your Business And Industry Needs. Wed, 07 Dec 2022 16:30:09 +0000 en-US hourly 1 https://imprint-e.com/wp-content/uploads/2020/08/cropped-IMPRINT-ENTERPRISES-Logo100-SQ-32x32.png Regulatory Labels - Imprint Enterprises - Since 1975 https://imprint-e.com 32 32 BarTender® 2022: Keeping up with Business Demands by Updating Features https://imprint-e.com/bartender-2021-keeping-up-with-business-demands/?utm_source=rss&utm_medium=rss&utm_campaign=bartender-2021-keeping-up-with-business-demands https://imprint-e.com/bartender-2021-keeping-up-with-business-demands/#respond Wed, 07 Dec 2022 16:15:39 +0000 https://imprint-e.com/?p=295735

With the rise of omnichannel shopping and on-demand requests, it is important for businesses to keep up to date. Customers need updated and reliable barcode software that can easily and efficiently identify, track, and manage products that are coming and going.

BarTender® 2022 helps with traceability by keeping up with technological advances which help you keep up with these demands while maintaining top security and reliability. From label design to security and management, BarTender® 2022 has updated several features for your satisfaction and ease of use.

Pharmacist scanning price on a red medicine box with barcode reader in pharmacy store

BarTender® 2022 is an extension of the existing BarTender® code base and has been fully tested and supported. The newest feature and performance updates improve security and the Enterprise Edition database support, and updates barcode support for RFID and GS1 Version 21 and 22 specifications.

BarTender® Cloud and Mobile App

Man with the Bartender cloud on his laptop

BarTender® Cloud, one of the newest technological advancements from Seagull Scientific, provides barcode labeling capabilities without the ties of maintaining a hardware and software infrastructure. For businesses that do not require their own special design of barcode labels, the Cloud has over 140 predesigned label templates to choose from.

BarTender® has released updates to their Mobile App capabilities, expanding the program to run on Apple devices. Devices must be running on Android 11 or later or operating on iOS. The Mobile App is ideal for warehouse and logistics, field service, and retail. Printing barcode labels can be completed at the source of the work, reducing steps in label printing. The driverless printing provides greater flexibility.

Print Portal

An improved Print Portal creates streamlined functionality. Print Portal has been extended in the Professional and Automation Editions, though the Enterprise Edition still has specific features unavailable in other editions. The Enterprise Edition has a Librarian integration and Print Portal Authentication, with the Librarian workflow having an electronic signature support.

With the Print Portal, there is a new Security Properties page and settings, with the Advanced Property page having new options. Root Folder custom images can make it easier for administrators to find the root folders that users need. Users can also specify custom folder colors to personalize their own experience.

Print Station

BarTender Box - Professional

The redesigned Print Station has the same responsive modern user interface as the Print Portal with greater streamlined functionality. Print Station can be run from any computer that has BarTender® installed, accessing root files on any local or network directory. Security has been enhanced with additional security settings in the Administrative Setup page.

 

Looking for files is easier with enhanced file searching, grouping, and sorting. Folder customization can set different colors for individual folders for a personalized experience. Custom corporate branding can is now supported, replacing the default Print Station branding with your company’s branding.

Print Station now supports a standalone kiosk mode using Microsoft Windows 10 Kiosk Mode. The Enterprise Edition has been integrated with Librarian to provide a content management system for documents, including a revision history. Librarian also has workflows to easily manage a document’s status from start to finish.

Expanded Database Options and REST API Improvements

Database types screenshot from Bartender®

Easily find and access data stored in SAP HANA® databases, supporting connections to SAP HANA 2.0 SPS 03 and later versions. A database connection configuration can be used to apply a custom configuration to new or existing database connections. Database Setup performance has been improved with a more responsive interface.

BarTender® 2022 has a newly expanded REST API for automating systems on a non-Windows platform or across a network, a standard for all BarTender® products for a unified platform. BarTender® 2022 also now supports HTTPS for BarTender® REST API and the Print Portal REST API.

BarTender® 2022 is a Globally Trusted Barcode Software

The Bartender® mobile app on devices

Why wouldn’t you want to increase productivity and speed efficiency by doing more in less time? The enhanced regulatory and compliance labeling programing can help reduce fees while also minimizing legal exposure.

BarTender® 2022 can meet any organization’s needs with multiple edition options to choose from: Cloud, Professional, Automation, or Enterprise. Get the label generating software that will enable you to create any type of label on-demand, across any location. And with the new BarTender® Cloud edition, creating and printing barcode labels is fast, secure, and efficient without being tied to a software or hardware system.

 

Enhance your BarTender® experience with the upgraded Print Portal, Print Station, and the mobile app. Explore your options with the new BarTender® Cloud deployment and expanded features in other Editions. Customize your user experience with greater options while making your barcode labels more efficiently.

Contact Imprint today to get you on your way to a more effective and efficient labeling software system.

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BarTender® 2022 will Improve Label Lifecycles while Meeting Compliance https://imprint-e.com/bartender-2021-will-improve-label-lifecycles-while-meeting-compliance/?utm_source=rss&utm_medium=rss&utm_campaign=bartender-2021-will-improve-label-lifecycles-while-meeting-compliance https://imprint-e.com/bartender-2021-will-improve-label-lifecycles-while-meeting-compliance/#respond Wed, 07 Dec 2022 16:01:44 +0000 https://imprint-e.com/?p=295711

Barcodes improve efficiency and are vital to supply chains, inventory management, transportation, asset management, and more. Barcodes provide a means of knowing what a product is, where it originated, and where it goes. That is why when a barcode is unreadable for any reason, it decreases your efficiency, can cause chargebacks and lost shipments, and creates legal exposures that could have been avoided.

From labels, barcodes, RFID tags, and more, BarTender® 2022 has an integrated system that allows you, and anyone you want, to review and approve workflows from any web browser, on any device. Anytime, anywhere. All without risking the security of your systems.

Pharmacist scanning price on a red medicine box with barcode reader in pharmacy store

BarTender® 2022 can create and print more commercial-quality label designs with increased quality assurance measures through Administration controls. These measures can accelerate label design and production. 

With ecommerce only expected to rise to about $5.4 trillion in 2026, why wouldn’t you want a trusted barcode labeling software system?

Improved Label Designs

Checking the freezer with a thermometer

Create simple and straightforward label designs with a WYSIWYG editor without having to mess with complicated coding or X/Y coordinate adjustments. By using templates, you can save on the time it takes to manually enter all the information and replace thousands of printer code files with just one file.

BarTender® 2022 still has the wide range of data sources to add more content to your template objects and images, including the Color Picker. A database connection configuration file can also be used to apply a custom configuration to a new or existing database connection.

BarTender® Cloud increases label accuracy and catches errors before they happen. The streamlined label design process reduces the need for complex IT processes by using the label template library or uploading your own labels.

Printing Options

Printing can be done from any operating system, device, or browser to any network connected printer, whether hard wired or via an in-house internet connection. There is no need to install BarTender® on every device (or be trained on using the software itself) just to print released labels.

Printing with BarTender® Cloud uses Intelligent Printing to automatically discover connected printers, without requiring printer driver management. Printing can even be done at the source of where the work is being performed.

Bartender screenshot

This secure central barcode label manageability system also has a licensing server redundancy solution that provides automatic failover to maintain a seamless print production even when one of the servers goes down.

BarTender® 2022 can be easily integrated into any current labeling system or upgraded from any previous version of BarTender®, and BarTender® Cloud requires updating to BarTender® 2022. A smooth integration improves productivity and minimizes downtime.

Meeting Compliance Minimizes Chargebacks and Fines

Scanning a label in the healthcare industry

You and your customers may have specific barcode label standards that must be adhered to for multiple reasons. From manufacturing, through supply chains, to business and/or consumer, BarTender® 2022 barcode labeling software can meet virtually any compliance labeling requirement:

      • Medical devices meet UDI compliance labeling
      • Pharmaceutical and Healthcare meet global serialization regulations
      • Automotive meets AIAG requirements for traceability
      • ANSI and ISO requirements are met for grading

Whether it is a simple traceability requirement or a complex regulatory compliance code, this labeling software has flexible serialization to create the unique serial identifiers your organization needs to keep track of everything. And the information is saved directly into a BarTender® document, BarTender® Global Data Field, or into your own SQL-based database.

Unique Device Identifier (UDI)

The US Food and Drug Administration (FDA) requires using a unique device identifier (UDI) on barcode labels in food, beverage, and medical fields. These labels must be readable by man and machine (scanners). If the labels are not done to specific standards, your company is liable for more than just fines and chargebacks. Private label distributors are susceptible to the possibility of a legal exposure.

 All labels must be readable in plain text, as well as machine readable with scanning using AIDC (automatic identification and data capture) technology. With barcode labels having to comply with ISO/IEC 15415 or ISO/IEC 15416, it is important to get a barcode labeling software system that can meet these requirements from the start.

 

Global Serialization for Pharmaceuticals 

The United States, European Union, China, and Brazil have specific serialization requirements, with more countries joining to include this requirement. Examples of the requirements include DSCSA, FMD, and 21 CFT Part 11. BarTender® supports pharmaceutical companies with built-in compliance standards.

The easy to learn platform can add accurate data with a simple drag and drop method. The standards are built into BarTender®, including GS1’s linear and Data Matrix pharma barcodes and traditional linear, two-track, 2D and color Pharmacodes.

Close-up view on red laser is scanning label with barcode on product. 3D rendered illustration.

Automotive Industry Action Group (AIAG)

The AIAG created standard industries to improve efficiency and accuracy. A single alphanumeric symbology, called Code 39, was established in 1984. This symbology included information like part numbers, purchase order numbers, quantity, and other data identifiers.

Proper barcode labeling tracks automotive parts from manufacturing, through distribution, to the end user. This can impact automotive safety and tracking for accountability during recalls. One wrong digit misprint can have a huge financial impact on everyone involved in the chain. 

 

BarTender® eases that by having the compliance requirements built into the software.

Letter and Numerical Graded Barcodes 

ANSI and ISO are barcode label grading systems based on a letter or a numerical score. These standards play a key role in identifying, tracking, and tracing products as they move through supply chains across the world. With more than 6 million barcode labels being scanned every day, why not have a software system that has this compliance requirement already build into the system? 

Scanning a label in the healthcare industry

BarTender® 2022 is a Globally Trusted Barcode Software

Why wouldn’t you want to increase productivity and speed efficiency by doing more in less time? The enhanced regulatory and compliance labeling programing can help reduce fees while also minimizing legal exposure.

BarTender® 2022 can meet any organization’s needs with multiple edition options to choose from: Cloud, Professional, Automation, or Enterprise. Get the label generating software that will enable you to create any type of label on-demand, across any location. And with the new BarTender® Cloud edition, creating and printing barcode labels is fast, secure, and efficient without being tied to a software or hardware system.

Contact Imprint today to get you on your way to a more effective and efficient labeling software system.

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Superior Label Printing With Armor Ribbons https://imprint-e.com/superior-label-printing-with-armor-ribbons/?utm_source=rss&utm_medium=rss&utm_campaign=superior-label-printing-with-armor-ribbons https://imprint-e.com/superior-label-printing-with-armor-ribbons/#respond Thu, 24 Jun 2021 20:47:10 +0000 https://imprint-e.com/?p=295935

Are you a manufacturer or distributor who needs to print-on-demand labels for your business? Do those labels need to be sustainable in all types of weather conditions and various degrees of handling?

If printing on-demand labels is a requirement for your business, you want to be able to read the print to ensure deliverability. Ideally, it would be best to have something resistant to humidity, solvents, temperature, and tension. If you need to meet regulatory compliance or customer compliance, it is critical that your labels and barcode scan.

Armor Ribbons

You can enjoy labels that deliver when printing with a high-quality printer such as a Zebra or Honeywell and printing with Armor ribbons.

Many ribbons appear to provide quality printing, but they fail. When the label is not readable when the product is delivered, the entire shipment is returned. You may have saved a few dollars buying a cheaper ribbon, but it will cost thousands of dollars in fines and other costs. In the end, you lose money, and you could face legal ramifications.

As a global distributor of label printers, Imprint provides Zebra printers using high-quality Armor ribbons as part of their thermal transfer printing process to ensure labels will be easy to read when they arrive at their destination. Armor ribbons will save you money in the long run.

What Is Thermal Transfer Printing

Armor's three families: Resin, wax and resin and wax

Thermal transfer printers use ribbons. There are three types of Thermal Transfer ribbons: wax, wax-resin, or full resin. All three types have wax and resin but the ratios of wax and resin change as you progress through the durability scale. Even Armor's plain wax ribbon is “resin enhanced” to give better durability than a standard wax.

Thermal transfer printers use ribbons to create the image on the material. The ribbons are made of wax, wax-resin, or full resin ink that melts onto the surface of the print media (a label or other material) and creates a high-quality image that lasts, providing unmatched printing durability and quality.

Thermal transfer printing is perfect for long-term applications where the print media will be exposed to harsh conditions such as high temperatures, water, chemicals, and light. Or if it needs to last more than six months.

You can match different types of ribbons to various label materials for maximum durability.

Armor provides all three types of ribbons.

Wax Ribbons

Wax ribbons print on coated or uncoated paper stock. The least expensive of the three thermal transfer ribbons are also less durable than the other two.

Armor’s wax ribbon is more durable than most because it is “resin enhanced” to give better durability than the average standard wax ribbon. We use this enhanced product in 75% of all applications.

Armor ribbon and wax

Wax-Resin Ribbons

Wax resin ribbons are a popular choice. They are a bit more expensive than the wax ribbons but significantly more durable.

Wax-resin ribbons work great on a wide range of material types and provide a high-quality image suited for shipping labels, barcode labels, pharmaceutical labels, and shelf and bin labels.

Resin Ribbons

Resin ribbon is generally intended for use on non-paper, synthetic stocks and will offer the highest durability of any ribbon type.

The extreme durability offered makes pure resin ribbons a strong choice for labeling very sensitive medical applications, other regulatory applications, and chemicals.

Printing Problems

EdgeVue(tm) image

Manufacturers who use the wrong type of printing or printing ribbon can cause various problems for consumers and businesses.

  • What if you couldn't see the label on your car parts? Your mechanic won’t know what parts are needed to fix your car.
  • Expiration dates are missing on food products, so it ends up in the trash.
  • The printer ribbon's inferior print quality can lead to several causes that would shut down a line. Shutting lines down costs money and valuable time.
  • Products cannot be delivered due to smudged or blurred print and are returned.

These are just a few of the many problems that can be caused by inferior ribbon quality.

Who Should Use Thermal Transfer Printing?

Thermal transfer ribbons are more or a durable image than direct thermal printing on all label types.

If you have to meet regulatory compliance or customer compliance, it is critical that your labels and barcodes scan. You may face legal ramifications or fines if they are not scannable on delivery.

Ask yourself the following questions to determine whether printing with a thermal transfer ribbon is in your best interest.

      • Do you need to print on various mediums?
      • Do you need to include the UL symbol as part of the label?
      • Do you need to trace the product's life cycle from the manufacturer through use until destruction with a unique identification code?
      • Do you need to ensure deliverability?

If you answered yes to any of these questions, a thermal transfer ribbon is your best option.

Thermal transfer printing with a ribbon does the following:

      • It gives you the ability to print on coated paper, synthetics, textile, or flexible packaging.
      • Passes all UL tests – the printed logo, UL, means that the components (printing material, adhesive, and printing ink) used for the labeling passed all UL tests.
      • Essential technical and or legal information is displayed on the name-plates and is required to remain fixed to the product and legible throughout its life cycle.

Provides traceability data to guarantee product compliance and quality throughout the product life cycle. Helping to ensure regulations are met to keep people and goods safe.

Thermal transfer ribbons also protect against premature printhead wear.

Top Quality Ribbons By Armor

Thermal Transfer is a robust, reliable, and competitive printing technology for marking barcode traceability data, serial and batch numbers, etc.

Using inks capable of withstanding handling, friction, heat, solvents, and other demanding environments for a long life-cycle provides the durability of secure traceability data.

All ribbons developed by Armor are tested on every thermal transfer printer available. Armor has the perfect ribbon for printing on rough, coated, plastic, synthetic, textile papers, and more.

All the requirements for print durability, fineness of characters, and printed information legibility for printing traceability labels are met with Armor thermal transfer ribbons.

Mike Hess, VP of Operations and HR at Imprint, commented, “Quality counts! People are paying fines every day because they don't purchase quality ribbons. You might think you are saving money by buying a $6 or $8 ribbon, but if you end up paying a $100,000 fine, you have lost money big time.”

Advantages of Using Armor Ribbons

In industrial environments, products are subject to significant stress. It is vitally important that the labels remain legible no matter what happens to the packaging. It needs to be delivered without errors, gaps, omissions, or deterioration. All messaging needs to be intact for delivery success.

Armor offers competitive ribbons for price-sensitive applications, standard ribbons for optimal performance, and specialized ribbons for highly demanding applications.

Armor ribbons are priced competitively, compatible with various printer configurations, and meet regulatory requirements in multiple industries, including distribution, household appliances, logistics, automotive, food processing, machine tools, health, cosmetics, electronics, chemicals (GHS Regulations), aeronautics, and textiles.

 

Deliverability Improves With Armor Ribbons

Three things are needed for a long-lasting label. You need to have a quality printer, template, and quality ribbon combined for success. At Imprint, we work with you to ensure your Zebra printer works correctly, your template is exemplary, and we supply Armor ribbons. When working with us and using Armor ribbons, you will have a quality image when printing labels to ensure deliverability.

Imprint uses Armor Thermal Transfer Ribbons to mark variable information on flexible packaging and labels such as barcodes, logos, expiry dates, batch numbers, and more. This data is essential to identify products, ensure traceability through varying life cycle stages, and provide vital information for the end-user.

You can enjoy improved deliverability and less downtime saving your business money with a minimal increase in costs by choosing Armor ribbons for your thermal transfer printing needs.

Contact Imprint for more information on Thermal Transfer Printing, Armor Ribbons, and how they can improve your printing.

For More Information

Contact: sales@Imprint-E.com

(855) 745-4464

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Get a Barcode Labeling System that Will Ease Operations and Worry: BarTender® 2021 https://imprint-e.com/get-a-barcode-labeling-system-that-will-ease-operations-and-worry-bartender-2021/?utm_source=rss&utm_medium=rss&utm_campaign=get-a-barcode-labeling-system-that-will-ease-operations-and-worry-bartender-2021 https://imprint-e.com/get-a-barcode-labeling-system-that-will-ease-operations-and-worry-bartender-2021/#respond Wed, 19 May 2021 15:13:30 +0000 https://imprint-e.com/?p=295674

Is the barcoding or labeling software program that your organization uses overly complex or not even fully integrated into your business systems? Do the labels your system currently prints last throughout the entire lifecycle of the label or meet every compliance requirement? Is your current labeling system set up with security measures with web integration?

BarTender® is an all-in-one barcode software solution from Seagull Scientific that is simple and cost-effective. This software program makes it easy for businesses of all sizes to create, automate, and manage barcodes, labels, RFID tags, and more. BarTender® 2021 is the latest upgrade of a program that has been around for decades. It is a game-changer with upgraded automation, integration, and database capabilities with new design tools and greater security.

Pharmacist scanning price on a red medicine box with barcode reader in pharmacy store

Create any barcode label you need from any network printer. BarTender® 2021 can help any organization on a local or global scale to better manage their labeling lifecycle, increase label quality, integrate with existing business systems, and improve reliability, traceability, and compliance. 

With this integrated and network-connected software program, labels can be printed anywhere anytime, by anyone.

Improve the Lifecycle of Labels

Checking the freezer with a thermometer

With BarTender® 2021, organizations can create and print more commercial-quality designs that also adhere to any and all brand, industry, and regulatory guidelines your organization might have. This enhances quality assurance and accelerates label production. Review and approve workflows and printing from any web browser on any device, anytime, anywhere, without risking security.

BarTender® 2021 can be easily integrated into any current labeling system or upgraded from any previous version of BarTender®. This smooth integration improves productivity and minimizes downtime

Compliance Labeling for Any Industry

From manufacturing, through supply chains, to business and/or consumer, BarTender® 2021 barcode labeling software can meet any compliance labeling requirement:

      • Medical devices meet UDI compliance labeling
      • Pharmaceutical and Healthcare meet global serialization regulations
      • Automotive meets AIAG requirements for traceability
      • ANSI and ISO requirements are met for grading

Whether it is a simple traceability requirement or a complex regulatory compliance code, this labeling software has flexible serialization to create the unique serial identifiers your organization needs to keep track of everything. And the information is saved directly into a BarTender® document, BarTender® Global Data Field, or into your own SQL-based database.

 

BarTender® Editions to Best Suite Your Business Needs

BarTender Box - Professional

No matter how large or small your organization is, BarTender® has an edition that will best suit your needs. The three best options to choose from include the Professional Edition, Automation Edition, and Enterprise Edition.

The Professional Edition can print from spreadsheets and databases and create forms for entering manual data faster. The Automation Edition combines forms, actions, and system integrations to build a powerful automated printing solution. The Enterprise Edition lets you manage, secure, and control your entire enterprise labeling system from one location or across multiple continents.

What you need all depends on what you are doing and if you are in one location or spread across multiple continents (among other factors). If your organization expands, you can easily update or upgrade your BarTender® system without any hidden costs or complexity of add-on products.

Updated Features for BarTender® 2021

With the rise of omnichannel shopping and on-demand requests, it is important for businesses to keep up to date. BarTender® 2021 was developed based on technological advances and industry standards to help you keep up with these demands while maintaining top security and reliability.

From label design to security and management, BarTender® 2021 has updated several features for your benefit, satisfaction, and ease of use. Create and print more commercial-quality label designs. Increase label workflow and production with enhanced quality assurance and stronger Librarian document management integrations.

Data connectors have been expanded with more online spreadsheet options and templates to choose from. System automations for new and existing markets have been expanded with multiple imaging options. Even printing has been improved with Print Portal and Digital Die cutting.

Whether updating your current BarTender® system or upgrading your current system to integrate BarTender® 2021, it is imperative to make sure that you have the system requirements in place. Most organizations that already utilize a barcode labeling software program will have the minimal requirements met.

If there are any questions about having the right system requirements, it is always best to contact a professional. Your company needs will vary based on the specific details of each installation.

BarTender® 2021 is a Globally Trusted Barcode Software

Scanning a label in the healthcare industry

Why wouldn’t you want to increase productivity and speed efficiency by doing more in less time? The enhanced regulatory and compliance labeling can reduce fees while also minimizing legal exposure.

BarTender® 2021 can meet any organization’s needs with multiple edition options to choose from: Professional, Automation, or Enterprise. 

Get the label generating software that will enable you to create any type of label on-demand, across any location.

Contact Imprint today to get you on your way to a more effective and efficient labeling software system.

For more information, visit www.imprint-e.com  or contact us at (855)745-4464 or drop us an email at customer_service@imprint-e.com.

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5 Ways UDI Labeling Will Enhance Device Traceability https://imprint-e.com/5-ways-udi-labeling-will-enhance-device-traceability/?utm_source=rss&utm_medium=rss&utm_campaign=5-ways-udi-labeling-will-enhance-device-traceability https://imprint-e.com/5-ways-udi-labeling-will-enhance-device-traceability/#respond Mon, 17 Sep 2018 13:00:31 +0000 https://www.imprint-e.com/?p=284843 Medical device manufacturers have been in the process of rolling out Unique Device Identifiers (UDIs) on their products for the past several years in order to comply with the FDA’s UDI labeling requirements. On September 24 of this year, the UDI rule will reach its fourth milestone, when additional devices will be required to bear […]

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Medical device manufacturers have been in the process of rolling out Unique Device Identifiers (UDIs) on their products for the past several years in order to comply with the FDA’s UDI labeling requirements. On September 24 of this year, the UDI rule will reach its fourth milestone, when additional devices will be required to bear a permanent mark or label.

The UDI program was initiated in order to help improve traceability and recalls for medical devices, but there are other benefits as well. With better device tracking, hospitals can improve internal efficiencies, reduce medical errors, and better optimize the use of their devices.

From 2014 to 2016, a variety of device manufacturers were required to either implement UDI labeling or submit device data in order to populate the device database (Global UDI Database, or GUDID), which serves as the central repository for the data.

How UDI Labeling Benefit Healthcare Providers

With those devices now in use in hospitals and other facilities, providers and other healthcare stakeholders can potentially leverage the UDI to enable a number of benefits:

  • Reduced Medical Errors: By tying device data to patient identification and other data collection processes, providers can ensure that the right medical device has been issued for the correct patient. In the operating room, the UDI can help automate inventory counts before and after procedures to ensure that the equipment is on hand.
  • Enhanced Device Analysis: The UDI can provide a standard way to document device use in electronic health records and clinical information systems. UDI labeling can also help create a more robust post-market tracking system that could be leveraged to support approval or clearance of new devices or new uses of current devices.
  • More Accurate Device Reporting: Adverse events can be more accurately reported and linked to specific devices, which can more quickly uncover potential problems.
  • Reduced Counterfeiting/Diversion: Medical devices are highly valuable, and the supply chain is rife with fraud. UDI labeling can ensure that the device that arrives is not a counterfeit item and can also help identify stolen devices that are then re-sold in the aftermarket.
  • Improved Recalls: Having a standard identifier will also help manufacturers, distributors, and healthcare facilities more effectively manage medical device recalls. Specific devices can be tracked to the point of use, allowing recalls to be more targeted and effective.

UDI Milestones

As the final deadlines loom, even more medical devices will be required to bear a UDI mark or label. The upcoming September 24 deadline will include:

  • Class II devices required to be labeled with a UDI must bear a permanent UDI mark on the device itself, if it is to be used more than once.
  • Labels and packages of Class I devices and unclassified devices must bear a UDI.
  • Dates on labels of all devices (including those exempted from UDI) must be formatted per FDA requirements
  • Data for Class I and unclassified devices that fall under the UDI requirements must be submitted to GUDID; Class I standalone software must provide a UDI as well.

The next major milestone for UDI comes in September 2020 when all Class I devices or unclassified devices that fall under the requirements must bear the UDI as a permanent mark if the device will be used more than once.

Barcode labeling software can help ensure your labels are UDI compliant. Seagull Scientific’s BarTender software is already being used by medical device manufacturers. With the right labeling software in place, you can easily automate and manage UDI labeling requirements.

Companies that need assistance implementing UDI labeling requirements, or providers that want to better leverage the use of UDI-marked devices, can contact Imprint Enterprises for help with their labeling and direct marking needs.

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