The Recurring Insanity Of Med Device Labeling Recalls

We’re all familiar with Einstein’s definition of insanity: doing the same thing over and over and expecting different results. It’s a logic that translates beautifully to medical device labeling, where companies’ continued reliance on manual processes and disparate labeling systems often culminates in pricey product recalls. In 2018, 9% of all medical device recall events – and the return of over a million units – were due to labeling issues. As global regulations stiffen and the cost of non-compliance climbs, manufacturers must find a method to end the madness.