An Overview of Medical Device Labeling
Rene van de Zande
Euro The issue of medical device labeling and language translations for Europe can be perplexing for medical device manufacturers. Both are intertwined, and in the April issue we specifically addressed translations. Therefore, in this column it seems appropriate to follow up and discuss other facets of labeling—namely the symbols used on labels and the growth of electronic labeling (“e-labeling”).
First, let’s define what we mean by labeling, because the term is deceptive. The “labeling” of a medical device includes the label that may go on the product itself, plus its packaging, the Instructions for Use (IFU) and marketing materials. Aside from translations, there are a couple of issues that garner a fair amount of attention with regard to labeling. The first is the use of symbols, and the second is the desire to adopt e-labeling.
Use of Symbols
The use of symbols in medical device labeling has been common for many years. In 1996, the European Union introduced legislation to provide some sort of harmonization to the use of symbols. The goal was to reduce the number of translations of words into the myriad languages used in the European Union and, in doing so, to simplify labeling. The result was the adoption of European Standard (EN) 980, which was released in 1996 and modified in 2003. There also is another standard, called ISO 15223, that covers much the same material as EN 980, with some additional symbols.
By necessity, Europeans always have been far ahead of the United States in the adoption of symbols as a means of communicating basic concepts. Ten new countries joined the European Union in 2002, adding even more languages to a union that already included more than a dozen official languages. With so many languages, it became increasingly important to ensure safety among the public and professionals, and one way to do this was through the use of symbols to communicate important concepts such as Use By, Sterility, Temperature Limitation and so on.
Advantages of Symbols
Using symbols on your labeling offers several advantages. First, symbols reduce your costs. A symbol that shows “See Instructions for Use” takes up much less room than 20+ translations of the phrase. As we all know, the more you have to read on a package, the less likely you are to read anything at all. Naturally, symbols also save space and make your packaging and products more attractive. Most important, of course, when used properly symbols quickly communicate a concept to the user in a way that can transcend language.
Quite unfortunately, the driving factors behind the increased use of symbols have as much to do with safeguarding users as reducing the liability exposure to the manufacturer. Problems arising from medical device user errors far exceed those from device failure, yet the manufacturer certainly is not absolved of responsibility when user error results in injury or death. Case in point: Open an owner’s manual for a lawnmower and find two pages telling you not to stick your hands under the mower while it’s running.
A distributor often will learn about potential problems caused by poor labeling before you do. It is important that companies have Standard Operating Procedures to make sure that any and all proposed changes made to labeling (especially those by distributors) are run through the QA and RA department first.
The United States does recognize a handful of EN 980 symbols but only as they relate to IVDs for professional use. The FDA has been cautious in adopting symbols, because it believes most of them are not clear enough to stand on their own without English text accompanying them.
It should be noted that the use of symbols is voluntary but strongly encouraged in European directives for medical devices. Furthermore, if one of the symbols in EN 980 or ISO 15223 does not meet your needs, you can create your own symbol as long as it is fully explained in the IFU. Example, no symbol for “Do Not Shake” exists in EN 980 or ISO 15223, so you could create one, if desired. If you manufacture electrical equipment, you should also refer to EN 60601 for more information.
Growth of e-Labeling
The topic of e-labeling has been popular over the last few years—and for good reasons. Companies are exporting to more markets, with growth ultimately fueled by the explosion of the Internet as a communication tool. In addition, the European Union now has 25 countries, with more to come. This has driven the need to create ever-larger IFUs and, more perplexing, a need to accommodate ever more languages onto limited packaging real estate. Correspondingly, the cost of translating IFUs and other labeling has driven many device manufacturers to look for less expensive ways to distribute that information in a manner that allows for cost-effective updating.
The primary argument for e-labeling, aside from cost savings, is that the user will have the most up-to-date information at their disposal.
Web sites, IFUs and CD-ROMs also allow the manufacturer to demonstrate how their device is used in a way that static photos or illustrations cannot convey. A picture may be worth a thousand words, but a video is worth a thousand pictures.
The most current Medical Device Directive is somewhat confusing in addressing e-labeling. It refers to a “leaflet” and requires the IFU to accompany the device. So is a CD-ROM packaged with a device allowed? Can the IFU refer a professional user to a Web site for instructions or for download onto a Blackberry? Not yet. But many manufacturers are supplementing the paper trail with these tools, a move generally supported by users, according to surveys.
Fortunately, a new draft of the Medical Device Directive is being circulated that obliquely addresses the industry’s desire to adopt electronic labeling. Those changes are not expected to come into force until the revised Directive is adopted, perhaps in 2007 or 2008.
Even so, some of the national regulatory agencies in Europe have been reluctant to embrace
e-labeling; therefore, the language in the new Directive does not explicitly say it is allowed but does not rule it out, either. We shall see how it all shakes out within the next few years.
In the final analysis, reducing the cost of your translations and printing should not be the driving factor in your adoption of symbols and, eventually, e-labeling. Safety is key.
It is most important that you complete a risk analysis to determine what would happen if a user did not understand what a particular the symbol meant. Could injury or death result? If so, err on the side of caution by also providing a translation of that symbol in the IFU.
As for e-labeling, supplement your paper-based efforts if you feel it will add to the safety of your device for the user or offer you a competitive advantage.
While you have a regulatory responsibility to ensure the safety of your products, you also have a moral responsibility.