Design, fabrication and evaluation of laser written unique device identification for medical applications
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Date
2024-07-24
Authors
Πανταζή, Αναστασία
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Abstract
In the modern age we now live in, every facet of our lives has been augmented by tremendous technological advancements. Medicine is no different, with modern medical devices being essential to public health, aiding in prevention and treatment of a myriad of ailments. As such, it is critical for risks regarding these devices to be minimized, lest they threaten the survival of patients.
The Food and Drug Administration (FDA) is a US federal agency that holds paramount importance to not just the American, but medical and health services internationally. It is often the responsibility of the FDA to cover the entire life cycle of a medical device and prevent potentially dangerous devices from going to market. Since testing may sometimes prove insufficient in determining the exact adverse effects medical equipment may cause before it is distributed and used under real world conditions, a system for quick identification is of grave need. An efficient solution is a universal Unique Device Identification (UDI) system, which reduces medical errors and helps professionals detect and recall defective medical devices from the market earlier than they otherwise would have.
A UDI is a code, usually numeric or alphanumeric and provides information regarding the specific model of the device and other parameters characterizing it as a product, such as the batch number or the expiration date. Labelers are responsible for providing the UDI on labels and packaging, and sometimes mark it directly on the device. The most common methods of fabrication include ink-based printing, sticker labels or laser engravings, each one offering different advantages. The information provided by a UDI is uploaded to a central database accessible to both medical professionals and manufacturers. This data allows appropriate actions to be taken quickly and malfunctioning devices to be tracked and recalled from the market before causing any severe events, ensuring patient safety.
The motivation of this Master Thesis is to design and fabricate a Unique Device Identifier with enhanced security. Specifically, the design is compliable with FDA regulations and guidelines but at the same time, going beyond standard practices, integrates a second level of security. This is accomplished by engraving an optical Physical Unclonable Function (PUF) in the shape of a quick-response (QR) barcode that encodes a UDI. Our PUF takes the form of a computer generated holographic mask that ensures uniqueness. After reviewing existing literature, we determined that laser written UDIs are the optimal solution, and we chose biomaterials of significant scientific interest to engrave our markings. Once the fabrication process is complete, we need to assess its traceability and authenticity, since our research aims to advance UDI technology, ensuring robustness, reliability, and improved patient safety.
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Keywords
Unique device identification, Laer written, Medical applications