Recent Food and Drug Administration (FDA) guidance and the need for a Global Unique Device Identification Database (GUDID) is requiring manufacturers direct mark surgical instruments so they can be traced and located should a product recall(s) be involved. The GUDID provides a database of manufacturers and their product listings so hospital purchasers can verify the authenticity of their purchases by comparing the product label to the one directly marked on the instrument.
2 Dimensional Data Matrix are not new, it has been used in the aviation industry since 2014 and is seen on labels of many common products today. Medical applications were difficult to begin due to the extreme nature of reprocessing. Mark’s needed to be durable to withstand the intense cleaning cycles and sterilization cycles that pass 270° that must be met to have a sterile instruments.
Manufacturer’s, labeler’s and or distributors must purchase and maintain a prefix that is assigned by one of three companies. This prefix is often referred to as the Production Identifier (PI). Once obtained, individual part numbers are then assigned by sequence, unique to the individual device, also known as the Device Identifier (DI). PI + DI = the Global Trade Item Number (GTIN) and can be confirmed on the FDA GUDID website for authenticity.
Each instrument is assigned a lot number according to production. When combined, the GTIN + LOT # = a Unique Device Identification (UDI). Current guidance allows for the device to be marked either in a Human Readable (HR) or 2D Data matrix. The latter is the preferred format, as the number is easily scanned in with the most hospitals current inventory tracking systems for easy scanning and traceability at the individual instrument level. This mark is present on both the instrument, and it’s associated label. The UDI is stored with the manufacturer and all records of distribution are maintained in a digital easily accessible file that efficiently aids in product recalls.
Several of advancements in both laser and scanning technology have made both very reliable and durable in the very demanding reprocessing environment. If placed correctly, marks can be read for many years giving an instrument its total life in service and can serve as a reference point for underperformance. It also has the potential to track and record dates and frequency of repairs giving hospitals better data of lifetime and spend for each instrument. These metrics will give data that can track total cost of ownership over the life of the instrument.
You can find Two Dimensional Data matrix on all ACE Medical instruments, Wiggins Medical Kerrison’s, Caspar Pituitary Rongeurs, Laminectomy Instruments and our Decker Micro pituitaries. You can also find the corresponding matrix directly on your product label that will both scan with any hospitals inventory management systems. We continue to evolve our understanding of the laser, and will have all class I medical devices marked by the end of 2021 and this will apply to all of our single use devices as applicable to FDA regulation.