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As with many industries today, the life sciences industry is facing the challenge of stricter regulatory oversight in addition to the trend of increased automation, particularly in the laboratory. This oversight is essential for the safety of patients undergoing treatment and consumers who use anything that could be considered a medical device.
Let’s take a quick look at how traceability systems play a fundamental role in tracing medical devices and automating clinical laboratory testing.
Compliance requirements for medical devices have increased significantly in recent years. This has put pressure on companies to significantly upgrade their device traceability practices. In the United States, the FDA UDI mandate requires manufacturers to place a globally unique identification number on each medical device they produce.
The FDA UDI regulations categorize medical devices into classes based on their potential for causing harm to patients if they malfunction or are used improperly. Depending on the device’s class, manufacturers may be required to permanently affix a direct part mark (DPM) containing identifying information to the device itself.
Essentially, this is government-mandated traceability for the medical device industry. To ensure that the DPMs are durable and long-lasting, manufacturers must invest in high-quality laser marking equipment as well as comprehensive barcode and DPM verifiers. Some devices, such as surgical instruments, only have room for extremely tiny, high-resolution codes.
Automation provides significant benefits for clinical laboratories that are responsible for giving care providers accurate test results to support diagnoses and treatment plans. Error rates using automated devices are a tiny fraction of what they are when human operators perform the same tasks, and automation can speed up processes without sacrificing accuracy.
Traceability provides a solid foundation for increasing the level of automation in a laboratory. When specimens are thoroughly tracked during testing and storage, the potential for items to be lost or mixed up is dramatically reduced. Compact, embeddable barcode readers are a key solution for ensuring traceability within automated testing equipment.
Interested in learning more about how traceability can help reduce error rates, protect patients and improve productivity in the life sciences? Download our white paper to discover key solutions for traceability in laboratory automation, medical device manufacturing and more!