For example, when implanted medical devices can be quickly and easily identified in the event of a recall, quality and safety are vastly improved. This not only reduces liability risks, protecting OEM brand reputation and increasing return on investment (ROI), but also enhances patient safety and care.
How RFID Improves Compliance Management for Medical Devices
One critically important feature is the ability to trace products for improved chain of custody and lifecycle management. Permanent, unobtrusive RFID tags can be seamlessly embedded into nearly any medical device, and the RFID tag unique ID (UID) is then matched with the FDA unique device identifier (UDI) number. This includes all medical devices requiring UDI compliance – from beds and surgical instruments to implantable devices such as breast implants. And with support for cryptographic security protocols and tamper detection, RFID provides a secure method for reliable tracking, tracing and authentication.
With the RFID tag UID matched to the device’s UDI, this ensures complete, reliable tracking and tracing of the manufacturer name, device production date and materials throughout the entire lifecycle. This highly valuable information is critical for patient safety in the event of a product recall; however, the patient is completely unaware of the tiny RFID tag’s presence.
Caryn Mills, Medical Device Sales Director, U.S.A.
Why RFID is Ideal for Medical Device UDI Compliance Management
Accurate capture of UDI data is vital for ensuring the consistent identification and tracking of medical devices and supplies throughout their lifecycle, from manufacturing to patient care. Yet, the reality is that many patients lose the manufacturer’s registration card they receive with their implant. The use of secure, permanent, imperceptible RFID tags helps ensure complete traceability and UDI compliance, which is why one well-known breast implant manufacturer already relies on RFID for peace of mind.
Because rugged RFID tags resist degradation from rough handling, abrasion, cleaning, autoclave sterilization, high humidity or other hazards, they typically last as long as the implant or device. That means that unlike the alternative option of physically etching a UDI onto a device, which can easily wear off or become illegible over time, RFID tags enable reliable tracking throughout the product lifecycle for maximum accuracy, traceability and accountability.
