Regulatory frameworks for medical devices mandate a Unique Device Identifier (UDI) system be put in place to allow for identification and facilitate traceability of devices. To ensure all markings on a medical device or its’ packaging continues to meet labelling regulatory and statutory requirements throughout its lifetime we perform assessments to validate their readability and durability.
Unreadable and misread barcodes can cause a breakdown in the supply chain, delaying deliveries and even put patients at risk meaning that verification should be considered as part of the risk management of a device. This can include ensuring that the etching/marking process successfully produces a compliant barcode or testing the corrosion and/or fading of the markings due to stresses that could occur during its life cycle.
Advances in technology mean there are now a range of types of barcodes and different printing/finishing methods that can be selected to add markings containing essential information to devices and their packaging. When selecting the method to be used during production, the manufacturer must ensure there is no negative impact on product safety or the effectiveness of the device throughout its life cycle. Once the methods have been selected, proof of compliance against the requirements must be repeatably produced as well as evidence that it can withstand the different stresses the product may be exposed to.
Frequently Asked Questions
What is Label Durability Validation?
Label Durability Validation ensures that labels, barcodes, and other important regulatory markings on medical devices are legible throughout a device’s life cycle and across different batches.
Which labelling method is suitable for my medical device?
This can be a complex question, depending on the medical device and the materials and methods of its construction. Test Labs can review your device, suggest a suitable method, and then perform validation to ensure you’ve made the right choice.
Why is Label Durability Validation required for regulatory compliance?
Manufacturers must use a Unique Device Identifier (UDI) system to identify and trace medical devices. They must also provide proof that these identifiers can withstand the wear and tear the device is expected to go through throughout its life cycle, including manufacturing, shipping, and use. Label Durability Validation provides this proof, but simulating the stresses the device is expected to undergo.
Can label testing be performed on packaging as well as devices?
Yes, this is an important part of Label Durability Validation, as it is a crucial stage in the traceability of medical devices. Whether it is the medical device or the packaging, labels should be designed and applied so that they remain in place and legible during distribution, storage, and use.
Why not just use a barcode scanner?
While barcode scanners are invaluable tools for tracking packages and devices throughout the supply chain, their capabilities are limited when compared to the comprehensive nature of label verification. Barcode scanners excel at reading and capturing barcode data at a specific point in time with a particular device. However, they lack the ability to provide insights into the symbology and structural intricacies of the label.
In contrast, label verification goes beyond the mere act of reading. It ensures that the label and its associated data can be universally interpreted by all scanners throughout the supply chain. The specialised equipment used in label verification undergoes regular calibration and employs specific lighting setups to meticulously assess parameters defined by international standards and industry groups. This meticulous process guarantees a level of quality and compliance that surpasses the capabilities of a standard barcode scanner.