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Why Labelling Processes Need to Start Early in Design Controls

By John Gagliardi

Mislabeled, misbranded medical devices are one of the top three causes for recalls in the U.S.

I started writing articles about these recalls in the 1980s and, believe it or not, during the 30+ years, this same statistic has barely budged off of this FDA measurement. Here we are in early 2018 and yet again, medical device companies are still making labelling mistakes. One would think that our compulsory relationships with computer software (our friend) would assist this effort. 

Unfortunately, this is not the case.

Today, when companies make labelling errors it results in a “wildfire” because our friend spreads the mistake quickly in the wrong directions—sometimes without the humans even knowing it! Admittedly, many of the labelling issues occur because of errors produced during the manufacturing phases after product development and then into distribution. Mistakes can include, but are not limited to, the following: wrong lot number; wrong label on an immediate container; smudged print; failed adhesive; incorrect product name; typographical errors; wrong product in the rightpackage and vice versa; non-sterile product in a package that indicates “sterile.”

On the flip side, some issues concerned with labels and labelling can also stem from design controls. Where is our friend when we need support?  

When considering preventive measures, robust design controls are a major advantage if handled properly. First, let’s establish some definitions and regulatory positions before we discuss labels and labelling in a more prevention-based mindset. Yes, there are steps you can take to minimize mislabeling and misbranding of medical devices. It comes down to being in control.

Definitions and Regulatory Positions: The Federal Food, Drug and Cosmetic Act (FD&C Act) is the law under which FDA takes action against regulated products. Specifically:

Section 201(k) defines “label” as a:

  • “Display of written, printed or graphic matter upon the immediate container of any article, e.g. a medical device”

Section 201(m) defines “labeling” as “All labels and other written, printed or graphic matter:

  • Upon any article or any of its containers or wrappers, or
  • Accompanying such article at any time while a device is held for sale after shipment or delivery for shipment in interstate commerce.”

The term “accompanying” is interpreted liberally to mean more than physical association with the product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instruction books, direction sheets, videos, fillers, etc. “Accompanying” also includes labeling that is brought together with the device after shipment or delivery in interstate commerce. The larger concept word “labelling” is defined as basically everything you say and, in some cases, don’t say.

Read more from John Gagliardi at BONEZONE®