Selecting Right Medical Device Classification System For Your Hospital
As the medical industry continues to improve the devices used in procedures, healthcare supply chain teams need to have a medical device classification system that is robust enough to identify the variables that determine the success – or, unfortunately, the failure – of a device. But with several classifications systems to choose from, it can be a daunting process to select the right system or combination of systems.
In this article, we’ll outline five of the most common classification systems and make our recommendation for which one we at Curvo believe stands out as the best for hospital supply chain’s unique needs.
For continuity throughout this article, we’ll examine the different classifications for the same product: An orthopedic bone screw from Depuy Synthes 02.118.522.
Classification System #1: UNSPSC
UNSPSC, otherwise known as the United Nations Standard Products and Services Code, is a taxonomy for products and services in eCommerce. This system works well for most items that can be purchased as it has a built-in hierarchy, which is a huge plus. Each time two digits are added to the original two, it provides a deeper level of classification. As the UNSPSC classification system is widely used in eCommerce, it’s used for almost everything that can be purchased.
Let’s take a look at how UNSPSC supports our orthopedic bone screw example:
42321506 – Bone screws or pegs
Our conclusion: Unlike the other systems we’ll list below, the UNSPSC system was not designed specifically for medical devices and is not robust enough to support the intricate needs of medical devices. This can pose significant risks, such as not being able to determine the critical details of each item. We discussed the risks in more detail in a recent article and shared why relying on a UNSPSC classification for medical devices can be problematic for supply chain teams.
Classification System #2: FDA Product Code
The FDA product code is an alphabetical three character code that is assigned to medical device classes I/II/III. The Food and Drug Administration defines their medical device classification system as “the name and product code identify the generic category of a device for FDA.”
Listed above each product code is the Regulation Number, which shows a description of the product and details its class. Every device is assigned a regulation number, and below the Regulation number is the three letter Product code which shows variations of the products under the Regulation Number.
FDA classification for Depuy Synthes part number 02.118.522:
- HRS: Plate, fixation, bone
- HWC: Screw, fixation, bone
The product we are using as an example is a screw, but under the FDA product code we have two classifications. This is because the “system” includes plates and screws. And vice versa, the plates include the screw classification. This is because they are used in combination with each other.
Our conclusion: A good classification system would have a one to one relationship between the queried item and the result. When you search for a screw, you don’t want any ambiguity in whether the result is a screw or a plate. This appears to be the case with this Depuy Synthes part. And it may be the case with other products that supply chain sources.
Classification System #3: GMDN
The GMDN, or Global Medical Device Nomenclature, is a much more granular classification system for medical products. The GMDN preferred term names are much more suited for hospital supply chains and clinicians, which you can see from the bone screw example:
GMDN classification for Depuy Synthes part number 02.118.522:
- Orthopaedic bone screw, non-bioabsorbable, non-sterile
Our conclusion: The problem with this robust system is that there is not a hierarchical structure to the classification system. For instance, if you want to find all the products that relate to Intervention Cardiology, you would need to string searches for stents, atherectomy, and guidewires. These products also occur in peripheral vascular procedures. In order for this system to work, you would need to have a working knowledge of medical procedures to find what you are looking for. With the codeset at the time of this article at over 12,000 unique definitions for medical devices, the margin of search error is significant. On a positive note, the GMDN does provide an excellent description of the devices, that often time is lacking in other classifications.
Classification System #4: UMDNS
Universal Medical Device Nomenclature System™ (UMDNS) is the classification developed by the ECRI Institute. UMDNS is a nomenclature that has been officially adopted by many nations, and assists in identifying, processing, filing, storing, retrieving, transferring, and communicating data about medical devices.
In our bone screw example, the UMDNS system lists the product as:
- 36614 – Screws Bone Orthopedic Trauma
Our conclusion: While the classification makes use of a five digit code and corresponding description name – and also has a hierarchical aspect to the data, it is dependent on their software. It is not built into the codeset like UNSPSC. This means that supply chain professionals have to rely on the method in which UMDNS normalizes data. If the UMDNS classification system is unable to classify a part, there is no data available for the supply chain.
Classification System #5: GIC
The GIC (Generic Implant Classification) was developed by Stan Mendenhall at Orthopedic Network News, and is a robust classification for orthopedics (arthroplasty, spine, trauma, and sports medicine). The hierarchical structure allows for sub-classification of parts. For example, with GIC, a knee femur prosthesis can be classified as a primary or revision part.
For example, a total hip construct is made up of a femoral stem, femoral head, acetabular cup, and shell liner. This construct logic is exclusive to the GIC – and is valuable to supply chain teams, as this is the basis for most arthroplasty contracts.
GIC classification for Depuy Synthes part number 02.118.522:
- GIC 53 – Trauma Screw
- Type 1 – Cortical
Our conclusion: GIC is a standout from other medical device classifications because the combinations of categories correlate to a medical construct, allowing classification at the procedural level. This level of detail in classifications is exceedingly important. As this system was developed specifically for medical devices, GIC is both flexible and robust.
Medical Device Classification Systems Chart
As we’ve now reviewed each of the five most common medical device classifications systems and how our bone screw example plays out in each scenario, this chart will help you visualize the pros and cons of each:
|Hierarchical||Open Source**||All Medical Devices||Corresponds to Construct||Specifically Medical|
*The GIC is being upgraded to accommodate other medical specialities such as cardiology.
**Open source or easily derivable from public databases.
Is Your Hospital Supply Chain Using the Best Classification System?
What if switching to a different medical device classification system could help your team communicate better with clinicians – and make better purchasing decisions with a more granular approach? Reviewing the pros and cons of each system is the first step in understanding if there may be a better system available to meet your hospital’s intricate needs.
Orthopedic Network News (ONN) has been the gold standard for orthopedic medical device classification since 1991. That’s why Curvo relies on their data to power benchmarking and sourcing projects for hospital supply chain teams. After all, classification improves human life. Why not use the best classification system available for orthopedics? If you’re ready to discuss the options available to you, one of our supply chain experts would love to chat with you when you schedule a demo today!