On June 17th, 1974 at the checkout counter of Marsh's Supermarket in Troy, Ohio, a 31-year-old checkout assistant named Sharon Buchanan swiped a 10-pack of Wrigley's juicy fruit chewing gum across a laser scanner, automatically registering the price of $0.67.
This first use of a little barcode to scan and buy a pack of gum was the proverbial butterfly flapping its wings that eventually turned into a hurricane, a hurricane which altered the global trade winds of commerce. If you think about it, point of use scanning via barcodes has been really transformational - it’s led to lower costs and greater availability of goods and services in all corners of the world. It’s benefited manufacturers, it's benefited retailers and service providers, and most of all it has benefited you and I as consumers. From UPS to Krogers, from Walmart to Amazon, it doesn’t make a difference what industry we’re talking about, scanning at transaction and data analysis and management has revolutionized every aspect of commerce through efficiency gains in the supply chain.
All due to a little barcode and point of use scanning.
The Big Exception: Metallic Orthopedic Implants
Studies have shown that up to 50% of O.R. orthopedic implant records contain errors from incorrect numbers, missed items, and incorrect totals. One would think that for something as important as items being placed inside your body there would be better tracking accuracy, but there simply is not. Ask anyone in hospital purchasing, or a device rep, and they will tell you this is true. At the average hospital there are daily mistakes and inaccuracies. It’s a huge quality problem for healthcare, but not a lot of people know about it.
The Big Question: Why Is This Tolerated?
The simple answer is there has been no technology for scanning orthopedic implants at point of use (the sterile field). So, think about this: The supply chain technology that is used to buy a pack of gum at your local Piggly Wiggly is more advanced than that which is used by hospitals to record and track metallic implants that are put inside your body during orthopedic surgery. The implant tracking process is entirely manual, performed by hospital staff that are often very busy and often multitasking. It relies on often guessing at part numbers at point of use, and then pens, pencils, scraps of paper, followed by 2-3 manual entry steps between 4-5 different people in different locations. To be clear, it’s not the fault of the O.R. staff. The tracking system stinks.
The root of the problem lies in the fact that for many reasons, metallic orthopedic implants used in the sterile field (often stainless steel) are difficult to barcode, as they are removed from their packages and put into large sets and trays to be sterilized and used in the operating room. We have outlined the problems of direct part marking orthopedic non-sterile implants in a separate blog post (summate.NET), but the nettlesome fact remains that the system is broken, and should be fixed. And now it can be through a process called set mapping and scanning usage as items are implanted during surgery.
Summate Technologies has developed an alternative to bar code/optical scanning technology, called TAG marks. TAG marks don’t use optical or barcode scanning to record numbers, but instead use a propriety, light powered microchip called a p-Chip® (PharmaSeq, Monmouth Jct NJ). The p-Chip® is super small (about the size of a piece of glitter) and super durable. It can work in environments where barcodes don’t because it relies on a very short field radio signal and not optical imaging (as barcodes do). However, it is not RFID, which has a host of challenges for use on surgical assets. Summate’s proprietary TAG marks are used to retrofit existing implant trays so that implant usage is scannable process - from the field, during surgery, at point of use.
Set Mapping; A Simple Solution to a Complex Problem
Instead of directly marking the actual implants, TAG technology marks each unique implant site within the set. The TAG marks are then associated with their respective implant device identifiers in Summate’s Velox software. Usage is then tracked by the surgical technician via scanning as implants are selected during surgery. This process is called “set mapping”. Summate set mapping holds the promise to be the first functional, economical and practical system to provide device identifier point of use demand automation for non sterile orthopedic implants. In short, Summate can automate the sterile field implant supply chain at low cost, with no disruption to patient care or OEM supply chain function, and can do it NOW.
There are extremely compelling reasons for implant supply chain automation that not only benefit patients, but also hospitals and device makers through greater inventory transparency, usage data, and operational data metrics that will optimize asset distribution and supply chain efficiency. There are also FDA UDI regulation compliance considerations. With up to 5 billion dollars in waste in the global implant supply chain due to inefficiency, it’s not hyperbole to think that the savings could amount to hundreds of millions if not billions of dollars per year. Set mapping and implant supply chain automation is literally a win-win-win: for patients, for hospitals, and for the device industry.
We’re a little biased, but we think it should be adopted.
For more information on Summate Technologies, and the coming Digital Operative, please see our website and blog at summate.NET.