GS1 Standards in Use in Healthcare

  • There are a lot of moving parts in healthcare. With medications and devices moving through the healthcare supply chain and patients needing varying types of care, it’s essential that there is a common language in place to help identify products and locations to support interoperability between different systems and applications. GS1 Standards can streamline processes to help provide better patient care at every level. With everything from medication tracing to unique device identifiers (UDI) and location identification, authentic barcodes will greatly increase efficiency, assist with meeting regulatory requirements, and help streamline your supply chain and care operations.

Who Do We Serve?

GS1 Standards ensure you use a common language within the healthcare supply chain to track medications, locations, and help improve the patient care experience. With help from GS1 Standards, you can make a positive impact by ensuring safer patient care, improving operational efficiencies, and enhancing data quality. This is done by properly managing inventory, sharing quality data, and proactively managing recalls.

Pharmacist reviewing medications and data with tablet

Pharmaceutical Supply Chain

Increasing visibility of pharmaceuticals through the healthcare supply chain ensures timely delivery and authenticity. The U.S. Food and Drug Administration (U.S. FDA) Drug Supply Chain Security Act, or DSCSA, regulates the supply chain to address dangers in counterfeiting, contamination, and stolen drugs. By using a 2D barcode, like a GS1 DataMatrix, encoded with a Global Trade Item Number® (GTIN®), manufacturers can provide required data including the National Drug Code (NDC), serial number, lot number, and expiration date. Assigning locations, like a pharmacy dispenser or distribution center, with a Global Location Number (GLN) can help identify the “Who” and “Where” of the product movement. Utilizing Electronic Product Code Information Services (EPCIS), a GS1 Standard, will help trading partners share data across different systems and speak the same language. Monitoring movement through the supply chain ensures authenticity and protects patients with unique barcodes and data that’s automatically shared from end to end along the supply chain.

As the regulatory landscape around pharmaceuticals evolves, GS1 Standards can help ensure critical medicine continues to flow through the supply chain. With proposed changes to the NDC, the continued adoption and use of 2D barcodes and GTINs will help the industry prepare for any new regulations.

Physician reviewing data on a tablet

Healthcare Providers

Modernize and streamline your receiving and distribution of products while promoting patient safety and enhancing care with help from GS1 Standards. Healthcare providers are always looking for ways they can:

  • Add value and quality to patient care

  • Reduce costs

  • Eliminate waste

  • Optimize clinical operations

  • Achieve financial stability

  • Improve performance with help from IT

With help from GS1 barcodes, providers can capture devices and production information at the point-of-care to help ensure every patient receives the correct treatment. By monitoring medication type and dosage as well as the use of equipment, hospitals can enhance care and reduce costs.

Scanning medical device for data carrier

Medical Device Supply Chain

The U.S. FDA requires a unique identifier that appears on the package and label of medical devices. The Unique Device Identification (UDI) Rule mandates that the code be printed in both a human-readable format and a machine-readable format, like a barcode. Using 2D barcodes, like a GS1 DataMatrix, encoded with a GTIN can help ensure accuracy and streamlined recalls. Also, leveraging the Global Data Synchronization NetworkTM (GDSN®) allows companies to electronically share standardized, up-to-date product data to the U.S. FDA Global Unique Device Identification Database (GUDID). For instance, if a product is recalled, trading partners can leverage the unique identifier, in this case a GTIN, to help identify where the product is or has been used and remove it from the shelf or alert patients.

We Are Ready to Help You Succeed

It doesn’t matter if you’re an independent pharmacy or a multinational manufacturer, GS1 Standards can help with your everyday operations. As a not-for-profit organization, our mission is to work with our members to bring the business community together to identify issues impacting businesses or industries and build consensus around best practices using standards-based solutions. We’re happy to provide solutions, advisory services, educational materials, and training to help you grow your brand into a successful business.

Making changes within your business can be challenging. Work with those who have been there before to find the best way GS1 Standards can improve efficiency and help you share data with business partners and understand your target audience. Learn how best to adopt and implement GS1 Standards in your processes to ensure you efficiently manage inventory in your supply chain from end to end through visibility and quality data.

As a GS1 US® member, you’re never alone. Our advisory services can help you identify where and how to implement GS1 Standards, with support for meeting regulatory requirements, onboarding your team with standard practices, creating supply chain automation, and even ensuring quality data is shared between trading partners. Our team of experts can assist with maximizing the benefits of implementing standards-based processes to improve operational efficiencies.

Beyond implementation, GS1 US also offers virtual and on-site training. Learn more about some of the most popular topics, including:

  • GS1 Standards fundamentals

  • GS1 Standards for traceability

  • GTIN management standards

  • Data quality assessment and data governance

  • Package measurement rules
     

Education and training in healthcare from our experts can expedite GS1 Standards implementation, improving efficiencies across your business operations.

Key Resources: Implementation and Guides

GS1 US is happy to provide implementation guides to help you get started. You’ll find a variety of guides that include information regarding:

Guides and Tools

DSCSA Implementation Suite

Offers the most recent implementation guideline as well as reference documents containing additional guidance on business process applications.

Applying the GS1 System of Standards for U.S. FDA Unique Device Identification Guideline

Provides a foundation for the appropriate use of GS1 Standards for medical devices within the context of the U.S. FDA UDI Rule.

Sharing Vital Attributes in Healthcare Best Practices

Identifies the attributes needed to execute basic healthcare supply chain functions such as product identification, order to cash, traceability, and more.

GTIN Adoption & Usage Model

Defines five progressive levels of GTIN implementation and provides a roadmap to help extend the value of the implementation.

Implementing GLNs and GTINs in Order-to-Cash Transactions Guidance

Explains how to implement GTINs and GLNs in EDI order-to-cash transactions from purchase order to payment.

Implementing GLN in Trace, Chargeback & Rebate Processes Best Practices

Explains how to implement GLNs for use in trace, chargeback, and rebate processes and transactions.

RFID in Healthcare Manufacturing Guideline

Informs product manufacturers how to encode GS1 EPC-enabled radio frequency identification (RFID) tags for automatic data capture to be utilized across the healthcare supply chain.

Key Insights

Standards and Sensors for Visibility in the Pharmaceutical Cold Chain

Highlights how different sensor technologies have been deployed in the cold supply chain.

Unlocking Benefits of GS1 DataMatrix in Non-Retail Healthcare

Highlights how a coordinated 2D barcode approach can support labeling consistency and consolidation, bringing efficiency to all supply chain stakeholders.

The Barcode Dilemma

Barcode assessment uncovers the challenges and opportunities to increase hospital barcode scanning.

Success Stories

Fresenius Kabi

Infuses safety from production to patient with unit-of-use 2D barcodes.

Geisinger

Utilizes UDI information and enriched data for inventory innovations.

Siemens Healthineers

Takes UDI implementation to the next level for its digital transformation.

Education and Training

GS1 Foundations for Healthcare

Covers the basics of globally unique identification and barcoding in healthcare.

GS1 Standards for DSCSA Suppliers

Explains how GS1 Standards can be applied for product identification serialization and item-level traceability.

Overview of GS1 Standards for DSCSA Dispensers

Highlights how GS1 Standards help support regulations for pharmaceutical dispensers.

GS1 Standards for UDI

Offers the opportunity to learn key concepts related to product identification, medical device barcoding and labeling, and data submissions.


Whether you work in a practice that serves patients directly, are a supplier, or manufacture medical supplies or pharmaceuticals, you can learn from others who have implemented GS1 Standards and found success. Furthermore, we provide certification tests that ensure you have team members who are well-versed in providing quality data and utilizing GS1 Standards.

Member Contributions

Not only can our team help you implement GS1 Standards but our collaborative workgroups are here as an additional resource. No matter which industry you’re a part of, we have workgroups and industry initiatives where you can partner with experts to solve problems and find collaborative solutions. We’re happy to help you find professionals within your industry and build a community of experts to continually build your business.

At GS1 US, it’s our mission to provide a foundation that moves your business forward with data-sharing standards. Our team can help you with everything from teaching you how to get a barcode for food products to providing resources for implementing GS1 Standards in your organization. GS1 US can help you improve your inventory, supply chain, and industry partnership management with food traceability.

photo of two business people working on a laptop