Medical Device Tracking and Recall With the Help of RFID

The Benefits RFID Delivers for Medical Device Tracking and Recall

Traditionally, medical device tracking and recall has been a highly complex process, particularly those devices that require a unique device identifier (UDI) and those subject to regulatory compliance and reporting. This applies to implanted devices, such as breast implants, as well as surgical instruments and devices that are regularly exposed to extreme temperature, pressure, gamma sterilization and humidity — from cryogenic embryo storage to autoclave sterilization. The ability to seamlessly embed nearly invisible RFID tags into medical devices offers a powerful combination of digital identity visibility and versatility, revolutionizing chain of custody and lifecycle management. Devices requiring upgrade, retrofit or replacement can be easily identified, enhancing quality controls and mitigating risks. And with the RFID tag’s unique ID (UID) matched to the device’s UDI, the device or implant can be reliably tracked and traced throughout its entire lifecycle, simplifying product recalls and automating data trails for regulatory inspections and reporting.

Why RFID is Ideal for Medical Device Recall Management

Increasing miniaturization of unobtrusive RFID tags enables complete, seamless tracking and tracing of implantable devices that can be quickly scanned without having to remove the device from the patient. Although the patient is completely unaware of the tag’s presence, intelligent RFID ensures reliable access to accurate data, such as a breast implant manufacturer name, UDI and implant lot and serial numbers, which is critical to regulatory reporting and patient safety in the event of a product recall. Because rugged RFID tags resist degradation from rough handling, abrasion, cleaning, sterilization or other hazards, the tag lasts the lifetime of the device without concern for faded laser etching or barcodes. Offering enhanced traceability, RFID also streamlines other compliance tasks including documentation of device cycle counts and maintenance records, providing automated data trails for regulatory inspections and reporting. As a result, RFID optimizes medical device tracking and greatly improves overall quality, streamlining product recalls and protecting the OEM from liability risks.