2D Data Matrix for Reusable Surgical Instruments

2D Data Matrix for Reusable Surgical Instruments

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 with a scannable 2D Data matrix. The GUDID provides a database of manufacturers and their product listings so hospital buyers can verify the authenticity of their purchase. This is done by comparing the product label to the one directly marked on the instrument. 

2 Dimensional Data Matrix are not new, they have been used in the aviation industry since 2014. They are also 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 through the the intense cleaning and sterilization cycles that pass 270°. This temperature must be met to have a sterile instrument. 

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. This is 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.

Instruments

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 most hospitals current inventory tracking systems. It allows for easy scanning and traceability at the individual instrument level. This mark is present on both the instrument, and it’s 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 reprocessing environment. If placed correct, marks can be read for many years giving an instrument its total life in service. This 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 equipment.

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 matrix directly on your product label that will 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. This will apply to all of our single use devices as applicable to FDA regulation.