A Complex Practice
Medical device labeling is complex; there are many rules and regulations that must be followed when labeling medical devices. In the United States, the FDA regulates the
Unique Identification system (UDI). Meanwhile, the European Union is implementing Medical Device Regulations (MDR). There are also application regulations, which are systems that help standardize and identify medical devices through distribution and use. Thermal transfer is the most common way to label unit packs, inner packs, and master cartons for medical devices. The reliability of these labels is crucial for patient safety and supply chain efficiency.
Medical Device Labeling for Identification
There are generally three parts to medical packaging. The first is called a unit, which holds the actual product. Pill bottles, for example, are units because they contain the medicine that needs to be delivered. The second part of medical packaging is the inner pack, which is what holds the units in travel. Third is the master carton, the outer package that can sometimes hold multiple inner packs.
Different materials can be used for these medical packages, but the durability of the materials varies. Enhanced wax products like GP725 ribbon and paper labels are known for their standard performance. Wax or resin packaging materials like PM250 ribbon or paper and synthetic labels offer mid-range durability. The highest durability can be found in resin packaging materials such as SP330 ribbon and polyester labels.
Do’s and Don’ts for Medical Device Labeling
Medical device labeling is used for a variety of reasons in the medical world. Some of these include general surgery supplies, hospital supplies, respiratory care, and
patient monitoring. While local regulations for labeling vary, some general rules include using symbols in the labeling of the device. In the US, these symbols must also be accompanied by an explanatory note describing what the symbols represent. Additionally, you’ll want to make sure the labeling materials you use won’t smudge while the package is being delivered.
As for the don’ts, make sure not to include any marketing statements that can’t be supported by data you’ve gathered, as this can cause confusion. It is also not recommended to include any text that contradicts the intended use of the product. In the medical world, clarity is essential to make sure patients are given the correct treatment.
Are you looking for a new partner for your medical device labeling needs? At GCB Solutions, we are ready to assist your company through the entire production process: from packaging design through testing and ultimate delivery of packaging. To learn more, contact us today at (904) 263-2804 or schedule a free consultation to learn more.