Medical Device Labeling Control

As I mentioned previously, the hardest part of labeling medical devices is the control of the labels. This really only applies to labels for disposables and packaging labels. Permanent labels for devices are fairly easy, you get them in, you check them out, then use them as you need. Labels for disposables are a whole different animal, the FDA has some guidelines, but mostly its related to the general quality system. Keep in mind these are only my limited experiences, other companies might have brilliantly simple ways to do this.

On a label for disposable products, you want at least the lot number and expiration date (or "use by"- I've spent more hours than I care to debating if the FDA thinks the terms "expiration date" and "use by" are the same thing) - and usually a bar code, mfg date, and whatever else you want- you'll have to print those parts yourself. So the printers print the logos and any warnings on the label and you'll print the rest. This is where the first challenge comes in, the partial label requires its own identification number (id#), then another id# after you print it. You generally like to have the label id# printed on the label so you have to make sure you do that in the second step and tell QA to stuff it if they complain about it not being on the label as received from the vendor (you know who you are). This is all well and good but the first of many challenges. You'll have to keep the label print program under control, the files it prints from and who uses it, not to mention the printer itself along with the ink. You'll also need a procedure and fabrication order for printing and various drawings for label locations on the product. And don't go thinking you can print labels out ahead of time, thats a no no, you want to use those labels right after you (or hopefully someone not you) print them.

So, just keep your received labels, printed labels, printing program, files, printer, ink, how to use them, and who can use them all under control and you're well on your way. The last thing you need is some way to keep track of sterile and unsterile product, usually a tear away label on the box or carton. Once you have all of that in line, I believe you are good to go.

There is still one part of labeling which I haven't covered, the Instructions for Use, Operator's Manual and other such literature. I'll probably leave that alone for now.