Requiring medical device manufacturers who make non-sterile plates, screws, and other implantable orthopedic devices to mark each part with a data matrix code is in many ways counter productive. It misses the main FDA mission for UDI , is technologically difficult (if not impossible in some cases), will cost an enormous amount of money, and won’t improve patient care or safety in any measurable “real world” way.
This is because non-sterile orthopedic implants exist in a unique environment and have unique properties. Here are the details...
1. UDI Mission Challenge: Does Direct Part Marking Miss the Mark?
Pretty much the whole mission behind the FDA UDI initiative is patient safety: to track medical products so that they can be recalled in the event of a quality problem. Items that are found to have safety issues can be quickly identified and removed from the field. It’s a great idea for most medical products, especially pre-sterile devices which sit on shelves. However, for metallic surgical implants that wind up in hospital sets and trays, its functionally useless. Why?
Lack of manufacturing specification deviance/manufacturing process quality. Plates, screws, k-wires, and other orthopedic implants are almost all quite simple parts that are manufactured to incredibly tight specification tolerances. Because of their relative simplicity, and the sophistication of their manufacturing processes, specification deviances are extremely rare and tiny, and don’t measurably impact patient outcomes. Think of a screw with a thread pitch 1 degree off. It’s still going to work fine, and won’t impact the patient outcome in any measurable way. Given the quality systems employed in manufacture and the relative simplistic nature of metallic implants, direct part marking them with barcodes is a solution in search of a problem with regard to potential recalls.
Lack of “Recallability”. While these implants arrive at the hospital in packaging that has all UDI information, they are removed and placed in sets along with hundreds of other implants. Once they are removed from this packaging they lose all their associated UDI data. Assuming there was a recall of a lot number of a metallic non sterile implant, pulling the inventory out of the field set stock would be incredibly difficult if not impossible. A busy hospital might have up 4-12 of a certain type of orthopedic set, with thousands of screws, with no way of discerning which screws are to be removed.
2. Technological Challenge: Direct Part Marking Implants
Surface characteristics of small implants: Datamatrix/2D optical scanning marks (barcodes) require a relatively flat surface to work, otherwise the mark is distorted. They are also sensitive to external light sources (such as bright overhead surgical lights reflecting off stainless steel implants). As a result of this, marking smaller implants such as 1-2 mm diameter screws which have virtually no flat surfaces creates a significant challenge in direct part marking and realiable reading during surgery in the operating room.
Lack of space for production identifier: On implants that are large enough for a mark, many have only space for the UDI device identifier (DI), not the much larger production identifier (PI) number/datamatrix code.
Direct Part Mark contrast integrity. Datamatrix codes rely on binary color contrast (think of black and white squares) to create a scannable mark. These marks lose contrast when exposed to the harsh reprocessing environment (heat, steam, chemicals, abrasion) that surgical assets are repeatedly exposed to.
3. Cost Challenge
Replacing current field inventory: The current value of metallic non sterile implant inventory in the US hospital/surgery center market is measured in billions. None of these implants are marked. Swapping them out with DPM marked implants would be extraordinarily expensive, and very very difficult logistically.
4. Patient Safety/Care Challenge
Last but not least there is the consideration of metallic orthopedic implant recalls with regard to patient safety. With the aforementioned limited variance in manufacturing combined with in place rigid manufacturing QC procedures, the bottom line is that for any potential recall on implanted devices that have been implanted in patients, little could be practically done. If the patient is healed and fully functional with no comorbidity, an additional surgery to explant devices would not only be an unnecessary cost, but also would most likely not have assent from patients. The vast majority of these explant procedures would most likely do more harm than good if the patient is healed and healthy. Once bone is healed, there is no need for implant construct support. Going in to remove the devices would be fixing a problem that functionally doesn’t exist.
(Side note: It could also be argued that the biggest quality problem facing patient care with regard to non sterile metallic implants is incorrect tracking of what quantities and type of implants used in the patient - accurate collection of DI information at point of surgery. Studies show that almost half of all patient records on cases involving these implants contain errors - through incorrect number recording, or missed implants. Scanning usage at point of use helps solve this problem).
In summary, initiating a hugely expensive, difficult to implement program which would only work on a subsection of non-sterile orthopedic implants faces steep challenges, and limited return on investment relative to patient safety.
There is another solution, however, which would address DI implant scanning and tracking at point of surgery, cost a fraction of what other solutions do, and be non-disruptive to the entire non sterile device market and supply chain: Adapting existing orthopedic trays to enable implant usage scanning at point of use, in the field, during surgery.
It’s called set mapping.
What is set mapping?
Set mapping is adapting the sets and trays that hold the implants so that usage can be scanned during surgery. A good analogy would be a can of beans on the shelf at the supermarket. The individual can has both DI and PI information, while the shelf tag has just the DI information. Set mapping is using the shelf tag (or the mark on the set where the implant is located) to scan usage of the product (or implant) as it is used.
Summate has developed and patented a series of unique set tagging solutions called TAG marks. TAG marks’ are made from durable medical grade polycarbonate, and encapsulate a super tiny, light activated micro transponder called a p-Chip*. TAG marks come in different formats that can quickly and easily retrofit ALL existing field orthopedic sets, so that that implant usage can be scanned during surgery, in the field, at point of use. TAG marks last a minimum of 500 cycles and have proven durability far greater than optical barcodes. Our unique software set building workflows enable us to tag and load an average orthopedic set into our Velox software in 15-30 minutes.
TAGDots, TAGPegs, and TAGPins...
Scanning implant usage during surgery at point of use......
By tagging orthopedic sets for digital scanning, the orthopedic device industry potentially meets future FDA UDI/DI requirements, enables much easier customer use of their surgical sets, and automates their supply chain, saving both OEMs and hospitals hundreds of millions through efficiency gains. It’s a win win for all parties involved, including consumers..
Summate has published extensively on the business benefits of digital management of orthopedic sets and trays, please see our website for video and blog posts: