Proof of Concept for a Universal Identification System for Medical Devices.

ABSTRACT

Medical devices need a unified way of accessing information that uniquely identifies them. This can provide traceability to specifications, lot numbers, recalls, and the like. Such a system would have applications for devices both in and out of the body. Common barcodes, such as a UPC code, can only be read in plain sight, when nothing comes between the scanner and the code. UPC coding is not suitable for all medical devices because some are implanted in the body or are otherwise inaccessible without invasive techniques. This article demonstrates a proof of concept for XRF coding on devices. Material codes were made and read externally by an XRF reader. The reading showed trace amounts of the chemicals that compose the medical device in the background signal. The energy levels of the chemicals were assigned values to build a readable code correlated with information about the medical device it is attached to. Attachment can be made during material synthesis, part or product manufacture, or even after final assembly. The technique demonstrated here is a promising concept for the future of medical device detection.