Medical Device Makers Struggle With Label Readability

by Laura Johnson, on September 27, 2016

Medical device labels need to be easy to read - a challenge for some device makers.

Screen_Shot_2016-09-26_at_4.36.31_PM.pngIn order to meet the September 2016 UDI deadline, medical device manufacturers must label their products with individual device identifiers that denote specific models, as well as production identifiers that include batch numbers, serial numbers, date of manufacture and expiration dates.

Compliance is crucial for ensuring that cutting-edge medical devices are safe and easy for patients and care providers to use. But, as pointed out by a recent article in Packaging Digest, readability has proven to be a major roadblock in the way of progress.

"Compliance is crucial for ensuring that cutting-edge medical devices are safe."

In many cases, compliance isn't as simple as slapping a large label on the product. Medical devices come in all shapes and sizes, and traditional barcode labels do not always fit easily on all of them. Sometimes, the act of shrinking labels down to the proper size and shape ends up distorting their message. Improper resolution can make it hard to read the text on a label, and sometimes warped or misaligned printing can cut off important parts of the code.

The news source explained that laser etching is a potential solution for some medical devices, particularly metal ones. However, there are limits to this approach, as it can be difficult for small etching to still be legible. For most materials, barcode labels are the way to go.

At the end of August, the FDA announced that it would not enforce certain restrictions on National Health Related Item Codes of National Drug Codes until 2021. This will give device makers a little more time to adjust their labeling to ensure compliance. An Enterprise Labeling Solution can help meet their specific needs in the face of continued regulatory complexity.

For more on barcode labeling for medical devices download our brochure "Staying Compliant While Improving Supply Chain Operations" today!

Download Medical Device Brochure 

Topics:Medical DevicesRegulatory