Beth Wells, Senior Director, Community Engagement, Healthcare, GS1 US02.08.21
Orthopedic devices are a critical part of musculoskeletal care because they keep patients mobile and healthy. Staying aware of U.S. Food and Drug Administration (FDA) guidance on labeling and tracking these products has become increasingly important to those who design, manufacture, distribute, and use medical devices, as the responsibility for patient safety should be shared along the entire supply chain.
The FDA’s 2013 Unique Device Identification (UDI) Rule sets specific requirements for medical device labeling to improve traceability and patient safety. While deadlines passed in 2014 for Class III devices, in 2015 for implantable, life-sustaining, life-supporting products, and in 2016 for Class II medical devices, the enforcement deadline for Class I and unclassified medical devices has been extended for a second time to Sept. 24, 2022. This deadline for UDI compliance is last because these products are deemed to pose the lowest patient safety risk.
Much work still needs to be done to fully meet these requirements, so companies not already labeling their products in accordance with the UDI Rule must quickly move forward. The industry also should be preparing for the possibility that future UDI labeling exceptions for certain Class II and III product components could resurface for resolution.
Products Subject to the UDI Rule
Class I medical devices include a wide array of products, ranging from surgical instruments to bandages and braces. To determine whether a product qualifies as a Class I medical device (and therefore subject to the rule) its generic product name (e.g., “walker” or “splint”) can be entered in the FDA’s database for matching among a list of examples and their corresponding device classifications. The database has proven useful because medical device classifications are not always self-evident.
Rule Requirements
The UDI Rule requires all medical products to be marked with a unique device identifier (UDI) on labels and packages, though there are a few exceptions. The UDI must include two segments: a “device identifier” (DI) and “production identifier(s)” (PI). A standardized format (YYYY-MM-DD) is also required for any date specified on the label, and the UDI must appear in both human- and machine-readable formats (e.g., barcodes). If a device is intended for more than one use and must be reprocessed before each use, the UDI must also be marked directly on the product.
Finally the device informCoation, including product attributes in addition to the device identifier, must be uploaded to the FDA’s Global Unique Device Identification Database (GUDID).
Doing the Work
To meet the UDI Rule’s labeling requirements, device manufacturers and labelers must begin by obtaining unique device identifiers for their products if they don’t already have them. Most medical device manufacturers are leveraging GS1 Standards to implement the unique identification requirements: About 86 percent of DIs currently published in FDA’s GUDID use a GS1 Global Trade Item Number (GTIN) for the product identifier.
With DIs in hand, companies must then upload those identifiers and other required attributes to the GUDID—but first they must gather the necessary information. Since many companies make hundreds of different products that are subject to the UDI Rule, data collection may take considerable time. Some companies will tackle this effort using internal resources; others will use a third-party service provider. That decision will depend on each company’s resources and the volume of products that must be registered. For firms that choose to upload the information themselves, the process is relatively straightforward. Once logged into the FDA website (using the FDA Labeler Account obtained from the FDA), the interface leads users through a series of questions that must be answered.
Several resources are available to help guide medtech companies through the process. The FDA offers guidance in its “FDA UDI Basics” and “Global Unique Device Identification Database (GUDID): Guidance for Industry” resources available online. For companies that have chosen GS1 as their Accredited Issuing Agent, GS1 US offers an “Implementation Guideline – Applying the GS1 System of Standards for U.S. FDA Unique Device Identification (UDI)” and a “Quick Start Guide” that explains how GS1 Standards can be applied to meet certain UDI requirements.
Exceptions for Non-Sterile Orthopedic Implants
The FDA allows for some exceptions to the rule. Specifically, exceptions are granted for certain components known as “non-sterile orthopedic implants.” They include tiny items like screws, pins, and other bits of hardware used in orthopedic procedures or incorporated in the placement of larger implantable devices such as artificial hips.
These items are typically packaged in storage trays and sterilized by hospitals before use. Hundreds of individual devices may be stored in a single tray. During surgery, the surgeon uses only what is needed. Then, the tray is replenished, disinfected, and returned to storage to be used for the next surgery.
Because of their size, number, and grouped packaging, non-sterile orthopedic implants are difficult to label. Physical space for labeling or applying a direct mark is insufficient and doing so can, in some cases, impact device integrity.
Recognizing the difficulty of labeling or direct marking these small reprocessed devices, the FDA made an exception to UDI Rule requirements for them. Even a tiny part of an implanted device could be implicated in an adverse event or recall, so the industry should continue investigating solutions in case the exception is revised in the future.
Key challenges and considerations for labeling these components are identified in a white paper, “Non-Sterile Orthopedic Implants & UDI Capture,” developed by device manufacturers, healthcare providers, and hardware and software solution providers with the GS1 US Orthopedic Implant Workgroup.
UDI Promotes Better Healthcare
Industry-wide implementation of UDIs will enable tremendously improved visibility into medical products within the supply chain. Providers’ ability to identify the supplies they need—quickly, accurately, and efficiently—will help ensure they continue to deliver the best care possible. Patient safety will be improved by accurate tracking and removal of expired or recalled products. And physicians will be better equipped to monitor a product’s effects in patient or consumer use.
The FDA’s two-year enforcement discretion for Class I devices is a welcome reprieve for those manufacturers not already meeting UDI requirements but it provides time that should be used wisely in preparation for full implementation and all the benefits it will afford the healthcare system and patients.
As senior director of Community Engagement for GS1 US, Beth Wells leads U.S. healthcare trading partners to actively engage, adopt, and implement GS1 standards. With a focus on providers and the medical device industry, she also collaborates with companies to address the FDA’s Unique Device Identification requirements for enhanced patient safety. Wells has more than 30 years of experience in healthcare distribution and supply chain operations. She held numerous leadership roles focused on business growth and development at a leading healthcare distribution organization, where she managed the company’s most strategic medical manufacturing partner relationships. She also supervised teams of master product data and supply chain specialists focused on identifying, developing, and managing supply chain improvement projects with both upstream and down steam trading partners. Wells earned her bachelor of science degree in biology from James Madison University.
The FDA’s 2013 Unique Device Identification (UDI) Rule sets specific requirements for medical device labeling to improve traceability and patient safety. While deadlines passed in 2014 for Class III devices, in 2015 for implantable, life-sustaining, life-supporting products, and in 2016 for Class II medical devices, the enforcement deadline for Class I and unclassified medical devices has been extended for a second time to Sept. 24, 2022. This deadline for UDI compliance is last because these products are deemed to pose the lowest patient safety risk.
Much work still needs to be done to fully meet these requirements, so companies not already labeling their products in accordance with the UDI Rule must quickly move forward. The industry also should be preparing for the possibility that future UDI labeling exceptions for certain Class II and III product components could resurface for resolution.
Products Subject to the UDI Rule
Class I medical devices include a wide array of products, ranging from surgical instruments to bandages and braces. To determine whether a product qualifies as a Class I medical device (and therefore subject to the rule) its generic product name (e.g., “walker” or “splint”) can be entered in the FDA’s database for matching among a list of examples and their corresponding device classifications. The database has proven useful because medical device classifications are not always self-evident.
Rule Requirements
The UDI Rule requires all medical products to be marked with a unique device identifier (UDI) on labels and packages, though there are a few exceptions. The UDI must include two segments: a “device identifier” (DI) and “production identifier(s)” (PI). A standardized format (YYYY-MM-DD) is also required for any date specified on the label, and the UDI must appear in both human- and machine-readable formats (e.g., barcodes). If a device is intended for more than one use and must be reprocessed before each use, the UDI must also be marked directly on the product.
Finally the device informCoation, including product attributes in addition to the device identifier, must be uploaded to the FDA’s Global Unique Device Identification Database (GUDID).
Doing the Work
To meet the UDI Rule’s labeling requirements, device manufacturers and labelers must begin by obtaining unique device identifiers for their products if they don’t already have them. Most medical device manufacturers are leveraging GS1 Standards to implement the unique identification requirements: About 86 percent of DIs currently published in FDA’s GUDID use a GS1 Global Trade Item Number (GTIN) for the product identifier.
With DIs in hand, companies must then upload those identifiers and other required attributes to the GUDID—but first they must gather the necessary information. Since many companies make hundreds of different products that are subject to the UDI Rule, data collection may take considerable time. Some companies will tackle this effort using internal resources; others will use a third-party service provider. That decision will depend on each company’s resources and the volume of products that must be registered. For firms that choose to upload the information themselves, the process is relatively straightforward. Once logged into the FDA website (using the FDA Labeler Account obtained from the FDA), the interface leads users through a series of questions that must be answered.
Several resources are available to help guide medtech companies through the process. The FDA offers guidance in its “FDA UDI Basics” and “Global Unique Device Identification Database (GUDID): Guidance for Industry” resources available online. For companies that have chosen GS1 as their Accredited Issuing Agent, GS1 US offers an “Implementation Guideline – Applying the GS1 System of Standards for U.S. FDA Unique Device Identification (UDI)” and a “Quick Start Guide” that explains how GS1 Standards can be applied to meet certain UDI requirements.
Exceptions for Non-Sterile Orthopedic Implants
The FDA allows for some exceptions to the rule. Specifically, exceptions are granted for certain components known as “non-sterile orthopedic implants.” They include tiny items like screws, pins, and other bits of hardware used in orthopedic procedures or incorporated in the placement of larger implantable devices such as artificial hips.
These items are typically packaged in storage trays and sterilized by hospitals before use. Hundreds of individual devices may be stored in a single tray. During surgery, the surgeon uses only what is needed. Then, the tray is replenished, disinfected, and returned to storage to be used for the next surgery.
Because of their size, number, and grouped packaging, non-sterile orthopedic implants are difficult to label. Physical space for labeling or applying a direct mark is insufficient and doing so can, in some cases, impact device integrity.
Recognizing the difficulty of labeling or direct marking these small reprocessed devices, the FDA made an exception to UDI Rule requirements for them. Even a tiny part of an implanted device could be implicated in an adverse event or recall, so the industry should continue investigating solutions in case the exception is revised in the future.
Key challenges and considerations for labeling these components are identified in a white paper, “Non-Sterile Orthopedic Implants & UDI Capture,” developed by device manufacturers, healthcare providers, and hardware and software solution providers with the GS1 US Orthopedic Implant Workgroup.
UDI Promotes Better Healthcare
Industry-wide implementation of UDIs will enable tremendously improved visibility into medical products within the supply chain. Providers’ ability to identify the supplies they need—quickly, accurately, and efficiently—will help ensure they continue to deliver the best care possible. Patient safety will be improved by accurate tracking and removal of expired or recalled products. And physicians will be better equipped to monitor a product’s effects in patient or consumer use.
The FDA’s two-year enforcement discretion for Class I devices is a welcome reprieve for those manufacturers not already meeting UDI requirements but it provides time that should be used wisely in preparation for full implementation and all the benefits it will afford the healthcare system and patients.
As senior director of Community Engagement for GS1 US, Beth Wells leads U.S. healthcare trading partners to actively engage, adopt, and implement GS1 standards. With a focus on providers and the medical device industry, she also collaborates with companies to address the FDA’s Unique Device Identification requirements for enhanced patient safety. Wells has more than 30 years of experience in healthcare distribution and supply chain operations. She held numerous leadership roles focused on business growth and development at a leading healthcare distribution organization, where she managed the company’s most strategic medical manufacturing partner relationships. She also supervised teams of master product data and supply chain specialists focused on identifying, developing, and managing supply chain improvement projects with both upstream and down steam trading partners. Wells earned her bachelor of science degree in biology from James Madison University.
