Labeling in the Medical Device Industry

Mar 29, 2023 at 04:45 pm by Staff


 

The medical device industry is a hugely important part of the healthcare world, producing an array of life-saving devices, from dialysis machines and IV pumps to syringes and more. All of these devices have the potential to help patients in various ways, but they have to be labeled correctly. A look at how and why labeling matters so much on medical devices.

Importance of Labeling

Every device needs to have a clear, reliable, and informative label attached to it to provide the user with vital information, and here are just some ways in which medical labels for devices can be of great use:

Protection for Users

One of the main advantages of medical device labels is how they help to keep people safe. Labels can provide clear information about a device, such as how to use it correctly, how to store it while it’s not in use, and details about any expiry dates, if appropriate. All of this helps to ensure that every medical device is used correctly and safely, with minimal risk of injuries.

Warning Labels

Some medical devices can be very dangerous if used incorrectly or if they’re not stored properly. Some of them emit radiation or pose a serious threat to human life and have to be handled with care. Medical warning labels help to let people know about possible risks posed by a medical device and how to avoid those risks.

Instructions for Use

Of course, every medical device also needs to be used correctly to help patients. Some devices can be quite complicated to use, even for experienced medical personnel. Labels can help to provide clear instructions about how each device should be used, making it clear and simple for the user.

What Are the Common Mistakes in Medical Device Labeling

These small items have a big part to play in ensuring that healthcare organizations and practices function effectively, and they’re useful throughout the medical world, from hospitals and clinics to labs, pharmacies, and more. However, various mistakes can be made with medical labels, and here are a few examples:

Failure to Meet Regulatory Requirements

When it comes to medical labeling, there are very strict regulations in place. Labels need to be made according to highly precise guidelines, with appropriate measurements, font choices, font sizes, and pieces of information. Sometimes, due to errors or oversights, labels can be produced which simply do not meet these guidelines.

Poor Visual Design or Placement

Labels need to be clear and simple, conveying information to the user in the most efficient way. They also need to be placed in the right area of a device so that they’re not awkward to locate and so that they don’t interfere with the functionality of the device in any way. Sometimes, labels may have obtuse designs that make them hard to understand or could be placed in awkward spots.

Illegible Font or Font Size

When producing medical labels, font is of the utmost importance. The text should always be written in a font that is simple and easy to read. In addition, the font size also needs to be correct; it shouldn’t be too small, as this could make the text very hard to read, but it also shouldn’t be too large to take up an excessive amount of space.

Lack of Multilingual Labeling

It’s quite common for hospitals, clinics, and other healthcare organizations to employ people who may have different native languages to one another, and there are many countries with more than one official language. Medical labels may therefore need to be produced with multilingual texts so that everyone can understand.

Ways to Avoid Common Mistakes in Medical Device Labeling

There are quite a few common and costly errors that can be made when making and attaching medical device labels. Here are some ways to counter those mistakes and reduce the risk of them occurring.

Choose the Most Appropriate Technologies for Medical Device Labeling

One of the best ways to ensure you only have long-lasting, clear, and reliable medical device labels is to make use of the best labeling technologies. Modern labeling methods like polymer fusion can be particularly effective, for example, as this method allows for the creation of truly permanent labels on plastic devices.

Adhere to Regulatory Requirements and Standards

When producing medical device labels, it’s important to always keep the industry regulations and standards in mind. Label makers need to comply with the strict guidelines of the medical world in order to make sure that their labels are as safe and useful as possible, with minimal risks of any incomprehension or accidents.

Conducting Usability Testing

Finally, one of the simplest ways to verify that your medical device labels are worthy of use is to actually test them out. Sample labels can be produced and affixed to medical devices, and then exposed to various conditions to see how well they can withstand the harsh environments of a medical space.

Labels are only effective and useful if they're made correctly. This is why it's vital for medical organizations to partner with trusted label providers who can meet industry guidelines and produce the safest labels for every device.

Polyfuze Graphics® Corporation is a leading provider of innovative labeling and decoration solutions for a wide range of industries. With over 30 years of experience in the field of plastic decoration, Polyfuze Graphics® has developed a proprietary fusion process that allows for permanent labeling and branding of plastic products.

 

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