If you’re in the medical device and products manufacturing and distribution business, this little item is going to raise your blood pressure. It goes like this: In one of last week’s articles about the industry’s growing impatience with the FDA to announce product identification requirements, one of the online reports I saw (this one, in case you want to see it for yourself) included links to so-called ‘source information.’ One link, for example, took the reader to the FDA’s Amendment Act of 2007. OK, that’s helpful. But in the lead paragraph there was a link to the words “medical devices.” Being the curious sort, I decided to invoke that link to see what more I might learn about medical devices. Ok, here’s where you want to breathe deep and try to relax.
It takes you here to Parker Waichman Alonso LLP, a self-described leader in defective medical device litigation. Now that’s interesting, don’t you agree? How in the world is this link helpful in a story about medical device labeling. No label, no standard, and no amount of information on a medical device is going to cover a defective product. No, this link is here because lots of people just don’t get it still. Even some journalists live in an all black and white world: giant pharmaceutical and device manufacturers are the bad guys and ordinary people are the routine victims.
For the record, I’m all for due process. I’m way against defective medical devices. I’m sure you are, too. Labeling enters the picture as important because it can prevent the right product from being applied to the wrong patient. And while that doesn’t cover a ‘defect,’ technically speaking, it certainly covers an error that interests lawyers. This means that while a standardized global labeling solution like GS1 won’t solve every problem, it can eliminate or vastly reduce one type of error that can be dangerous to your health.