Designing Orthopedic Device Labels—Lessons from the Line

Although the orthopedic device is the critical instrument, its label is nearly as vital to the process. A medical device label provides detailed information about the batch of equipment manufactured at the same time, as well as the name of the factory and its location. This information can help hospitals and device users to trace the device in the event of a recall.

The FDA requires these details on the label, which must be able to handle the high sensitivity of a surgical environment and the extreme conditions of repeated sterilization. With this guide, manufacturers of orthopedic devices will understand the importance of prioritizing accurate and compliant label use as part of the design process.

What Is UDI?

The Unique Device Identification System is a set of standards implemented and enforced by the FDA, which requires that all medical device units sold in the United States must use a unique device identifier (UDI). UDI compliance requires the addition of various pieces of information, including:

• Brand name
• Description and size of the device
• Catalog and lot number for the device
• Expiration date, where applicable
• Indication that it is a single-use device or not
• Storage and handling requirements
• A UDI code that can be scanned to provide these details

The device manufacturer must include plain text information on the label for the user and some form that allows automatic identification and data capture technology to get the data.

How Does UDI Promote Patient Safety?

The chief aim of UDI guidelines is to promote transparency and end-to-end traceability among medical device manufacturers, with standards that can be implemented worldwide. Many countries follow similar sets of UDI standards, so that device manufacturers can better ensure that they meet these guidelines in their labeling.

UDI guidelines help to reduce risk and improve patient safety by providing a streamlined path to tracing medical devices. If a particular device fails, a UDI-compliant label can provide the catalog and lot number for the device, as well as the location where it was manufactured. This information can help the manufacturer trace device failure through the system, identifying if it was a fault of production or another process.

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Requirements of UDI-Compliant Labels

UDI-compliant labels must provide useful data to the user and the healthcare system while meeting strict requirements for label quality and safety in extreme environments. The ideal labeling system will meet these benchmarks for quality and usability.

Withstand Rigorous Sterilization

Medical devices typically require rigorous sterilization before use to eliminate contaminants and prevent the spread of pathogens. The type of sterilization depends on the need, the device, and the best method to achieve a sterile environment. Clinics and hospitals may use a variety of approaches. For example, gamma sterilization uses radionuclides that emit gamma rays as they decay. The rays kill bacterial DNA, but they can also fade or break down the adhesive on the label. The label must maintain its readability and hold on the device, despite the extreme conditions of steam, dry heat, high temperatures, or sterilizing chemicals.

Maintain High Readability

Precision is key in a surgical environment when seconds make a significant difference in outcomes, and clarity is a matter of life and death. Readability helps clinicians identify proper sizing and other details about the device, with or without access to UDI code readers. When designing device labels for use in surgical applications, manufacturers must ensure that the label maintains high readability. Some devices provide very little space for plain text, which means that the manufacturer must create a label with a lot of information shared quickly. The quality of healthcare labels can help ensure that the content remains readable, despite repeated use and application in harsh conditions.

Accurately Encode UDI Data

The supply chain is increasingly becoming a critical component of consumer protection, and the medical device manufacturing industry is no exception. UDI data on the label, plain text as well as barcodes, provides a tool that clinicians and patients can use to ensure the transparency and traceability of the supply chain. People need to be able to identify, with simple research, the origin of a particular medical device. This information can help them establish the supply chain for components and devices, hastening progress on recalls and other unexpected events. Accurately encoded data on UDI-compliant labels, along with registration of those devices through the Global Unique Device Identification Database or other official data repository, can ensure that the data remains accessible to anyone who can search these databases.

Conclusion

For users of medical devices, the label is only marginally less important than the device itself. Patients, doctors, and medical teams rely on labeling to provide critical information about the device, particularly batch numbers and other details about the manufacturing environment. This information can help clinics and hospitals maintain high standards for orthopedic device applications, as well as help to trace the manufacturing of failed devices. With a label that fades or loses adhesion, the hospital may not be able to identify the information. Designing labels that can handle extreme environments without losing readability or adherence can help manufacturers improve UDI compliance and patient outcomes.

Bibliography

• https://sterilogix.com/blog/durability-testing-of-udi-labeling/
• https://barcode-labels.com/blog/common-challenges-medical-device-labeling/
• https://www.biopharminternational.com/view/understanding-gamma-sterilization
• https://computype.com/sterilization-labels/