How Medical Device Classification Drives Category Logic

How Medical Device Classification Drives Category Logic


Defining categorization & classification

In order to determine how classification drives category logic, it’s important to define the difference between categorization and classification. Categorization is considered more subjective and is a general way of logically grouping similar items together. Clinical products can be categorized by size, color, shape or purpose. For example, in healthcare, supply chain teams can categorize spend of all pacemakers, or all cardiac catheters, or by spend on supplies by a certain supplier. However, categorization does not allow for robustness in the analysis of clinical products.

Conversely, classification is a more systematic approach to organizing data as it follows a structure and a rigid set of criteria. Classification allows supply chain teams to resolve differences or define similarities based on having or lacking certain characteristics, which allows for apples-to-apples comparisons among clinical products. Generally, classifications need a governing body above it to oversee the classification to ensure accuracy. Good classifications also need to be easily navigable and hierarchical, so that supply chain teams can group items at a high-level or drill down into key differentiators. Classifications also must have enough differentiators to drive good insights – not too few where too many factors are lumped together, but not too many where every clinical product essentially becomes unique. In all, classifications are designed to meet the needs of patients, physicians and the healthcare supply chain.

Use cases for medical device classification driven categorization: catheters & cardiac rhythm management devices

To demonstrate how medical device classification and physician preference item (PPI) categorization work together, catheters are a great example. Supply chain teams can be told that a catheter is just a tube that either puts things in or takes things out of the body, and while this is true, any clinician knows that it is an oversimplification of the product. While looking at spend or use based on “all catheters” could be helpful, it can be very limiting. Catheters are not all used in the same parts of the body due to size, length, coating, material and steerability. For example, a foley catheter is very useful for its intended purpose, but it is not interchangeable with a cardiac catheter, and grouping them together would not make sense in all situations. While both could be used in the operating room (OR), a foley catheter is used in many other areas of the healthcare facility, so grouping catheters by area of use also has its drawbacks. Similarly, a Percutaneous Transluminal Coronary Angioplasty (PTCA) catheter is used in the catheterization laboratory for coronary angioplasty procedures, but a clinician would not use it for a cardiac mapping study done in the same lab.

The categorization vs. classification debate is also applicable when classifying cardiac rhythm management (CRM) devices. The more knowledge the supply chain team gains on the subject matter around this type of device, the clearer the need for a true categorization becomes. While the differences between a pacemaker and a defibrillator are obvious with little clinical knowledge, the number of differences in the range of devices and leads require including and excluding various attributes in the classification. Without a robust classification system, supply chain teams are unable to make the beneficial apples-to-apples comparisons for clinical products.

Finding the right classification system

A few types of common classification systems include the United Nations Standard Products and Services Code (UNSPSC), FDA product code, the Global Medical Device Nomenclature (GMDN), the Universal Medical Device Nomenclature System (UMDNS) and the Generic Implant Classification (GIC). These classification systems are helpful across all areas of a health system, but the GIC classification is considered the gold standard as it supports the calculation of constructs at the procedural level and its multidimensional system allows it to work with accuracy in clinical product data.

Read more about the benefits of the GIC classification here