An MD&DI January 1997 Feature Article
Meeting the international requirements for medical device labeling
is a bigger headache than you thought--and it's getting bigger.
The problem of labeling medical devices is no small matter. Simple as it might seem to do so, medical device manufacturers don't just slap a label on their devices and send them off to the marketplace. And that's especially true when the marketplace in question is the European Union (EU).
"Despite EU harmonization, language requirements have become more restrictive than ever in terms of respecting national boundaries," says Hal Miller, director of packaging technology for Johnson & Johnson (New Brunswick, NJ). Device companies seeking to reach all the countries of the EU may have to provide labeling and product information in as many as 15 different languages.
Figure 1. Advanced computer tools are making it possible for device manufacturers to economically create labels on-line, even for split lots requiring multiple languages.
For many in the U.S. industry, the complexity that results from these language requirements is not well understood. "Marketing personnel at U.S. companies tend to deal exclusively with the domestic market," says Miller. "They don't need to address multilingual issues, and they commonly don't understand them. But technical and operations personnel who are charged with meeting the requirements for the European market understand well the types of difficulties those requirements cause."
One of the key problems faced by companies that are attempting to meet the EU's language requirements is how to do so within the limited space allowed by a product label. As a practical matter, it is usually not possible to include all product information on a small label, and doing so in multiple languages is even more challenging.
On a technical level, this consideration can cause some serious disruptions to a manufacturer's packaging and distribution systems. "In the past, labels were provided as model-specific sets that were produced by outside vendors," says Denny Zanto, senior principal packaging engineer at Medtronic, Inc. (Minneapolis). "All the manufacturer had to imprint was variable information such as serial numbers, use-before dates, and so on."
Now, meeting the language needs of smaller, regional markets in the EU is making it difficult to use such a one-label-fits-all approach. "The biggest issue for companies in this situation is the splitting of production lots," says Miller. "That's what they would have to do in order to print just one language on the primary packaging."
According to Miller, within the past year the individual Johnson & Johnson companies in the United States have "pretty well settled on how they're going to handle the problem of multilingual labeling requirements." Typically, where space is available, the companies have decided to imprint only six languages--English, French, German, Italian, Portuguese, and Spanish--on a device's primary packaging. "But the product insert is a different story," Miller notes. "There, the companies are printing 12 to 15 languages--enough to cover all the member states of the European Union (EU) and to include such languages as Flemish and Dutch."
Medtronic's Zanto has another solution--one that relies on technologies that are just beginning to appear in the marketplace. Called labeling-on-demand, it makes use of computer software packages to design product labels, which are then printed on-line using laser, dot-matrix, or thermal printers (see Figure 1). The system can produce text and graphics on primary, secondary, and tertiary packaging.
"Now, instead of relying on model-specific labels, we're doing a lot more work using computer firmware files, and we're doing a lot more printing on-line using generic label stock," says Zanto. "This is a lot quicker for us, and we're not faced with having to throw away unused label inventory. It's also a lot easier to have many computer files than it is to have to store and keep track of prepared label stock. So even though we're dealing with split lots and many more languages, the new process is a lot more flexible than the old one."
Zanto admits that the new process has some limitations. "We're only printing in black, so anything that has to be in color--color codes and logos, for instance--must be preprinted on the label stock." But otherwise, he says, "we're printing about 99% of the information on the labels."
To drive the Medtronic system, Zanto selected an off-the-shelf software package, which was then supplemented by an internally written program that imports variable information and links it to the label program. A laser printer is used to create the final label.
According to Zanto, the equipment and operational costs of the new system are "tremendously less" than the equivalent costs for labels produced by an outside vendor. "When all the appropriate factors are taken into account, preprinted labels might cost as much as 70 or 80 cents apiece," he says. "The new system can produce custom labels for just pennies apiece."
Miller is more skeptical about the current status of the technologies required to create labels on-line. "The software drivers for such labeling-on-demand systems are adequate for creating labels, but sometimes they lack the interfaces needed to drive sophisticated printers," he says. "The interfaces for thermal printing, for instance, are not yet adequate. And on-line creation of pressure-sensitive labeling is currently limited to one color and text. Inks or colored ribbons suitable for the task haven't yet been brought together in a system."
Matching printing technologies to the varied substrates that are used in medical packaging--including films, Tyvek, and paper--is also a problem. "Each of these materials raises its own issues," says Miller. "Films, for instance, need to be corona-treated so that inks will adhere to them, and Tyvek and paper each raise issues related to porosity.
"Right now manufacturers have to mix and match to get what they need, but it won't be too long before integrated systems will begin to emerge. Multicolored thermal printing may be available in the next six months to a year, and laser printing of secondary and tertiary packaging probably sometime after that."
In the meantime, Johnson & Johnson's Ethicon franchise in Europe is actively adopting such technologies to meet the needs of its native marketplace. "In Europe," Miller notes, "Ethicon is doing what the U.S.-based companies have decided not to do--splitting its production lots in order to print single-language labeling for each package, and using labeling-on-demand to do so." Ultimately, Miller says, the biggest obstacle to implementing labeling-on-demand is the need to balance the expense of splitting lots against the savings created in the labeling process. "Sometimes, the economics won't favor a shift to labeling-on-demand. There are also technical hurdles to overcome; the process has to be easy and reliable enough so that splitting lots doesn't raise big changeover issues.
"Good technologies for labeling-on-demand are coming slowly, but because of the changeover issues related to multilingual labeling, current systems aren't yet meeting the needs of device manufacturers."
If something as small as an individual product label can put packaging engineers through so many gyrations, consider the potential other types of product literature have to cause design and engineering headaches. While companies sometimes attempt to distinguish such materials by calling them product inserts or technical manuals, they still fall within the scope of what FDA defines as labeling.
Although the agency's definition of labeling embraces a wide variety of product-related communications--in media ranging from fliers to TV advertising, and beyond--it is the printed user manual that is most directly in the path of the EU's language requirements. Multilingual labeling requirements mean that package inserts and manuals will have to get larger--and in some cases packages are getting larger to accommodate inserts.
"For some of our products now, the size of the package is being determined by the size of the product literature rather than the size of the product," says John Spitzley, associate fellow of packaging for Medtronic.
"This trend is in direct conflict with the direction Europe has taken over the past decade on environmental issues," says Miller. "It reduces the potential for source reduction to meet the requirements of the EU's packaging waste directive. As a result, some companies are looking very hard at the text that has traditionally been included in their inserts, and reevaluating what is really necessary."
Eliminating printed manuals is not an option. "FDA is always going to require that companies ensure the distribution of information about the safe and effective use of their products, and printed inserts are the best way of doing this," says Miller.
Write It Right, to help device manufacturers create them. Although it was written particularly for home-use medical devices, Write It Right includes many principles that can be adapted for use in creating any type of user manual.
But even when user manuals are properly prepared there can be problems, says Write It Right coauthor Patricia Kingsley, a supervisory public health adviser with the Division of Device User Programs and Systems Analysis of FDA's Center for Devices and Radiological Health. In an informal survey of health-care professionals, FDA discovered that manuals often are not seen or referenced by those who should have access to them.
"The two most common ways that health-care professionals learn about a new device are by relying on their own experience with a similar device, or by relying on the experience of a colleague with the new one," says Kingsley. "Despite manufacturers' best efforts, labeling is not the primary source of information that professionals use either to determine whether the device should be used on a given patient, or to learn how to operate it."
Moreover, the survey revealed that oftentimes manuals are locked away or can't be found when needed. In either case, users are not getting the information they are supposed to have. Professionals also indicated they were not sure they were receiving appropriate updates to the product information.
"People recognize that manuals are often not read by users, especially when they have read them the first time they received them," agrees Miller.
"We've got to change our whole approach to transmitting product information so it doesn't have to be on hard copy with each and every device," says Spitzley, "particularly when it is going to the same professional for the hundredth time. The regulations should permit manufacturers to issue updates to a revision-controlled manual for use in the operating room, or to issue them periodically on CD-ROMs or computer disks, or to make them available on-line. But there's no point in continuing to send copies of a technical manual that get thrown away each and every time. There's got to be a different approach."
In addition to the problems related to lack of use, the expense and difficulties involved in producing lengthy multilingual user manuals are leading many device manufacturers to consider other ways of presenting their product information.
Apparently, these efforts have the full support of users. According to Spitzley, focus groups conducted by Medtronic generated one response again and again: "Quit sending so much paper with your products."
"Users are willing to explore some of the other technological possibilities for getting information," agrees Zanto. "Most users don't see any problem with getting the information on a computer disk."
FDA's Kingsley agrees that getting information electronically is high among the priorities of health-care professionals. "When we asked physicians what form of information they would most like to have in a perfect world, their response was that they'd like to be able to get product information electronically. They'd like to have it on some sort of computer-based compendium."
Kenneth Ross, an attorney with the firm of Bowman and Brooke (Minneapolis), notes that manufacturers are exploring a variety of innovative techniques for communicating with end-users. Product information, he says, is no longer the preserve of printed manuals. "Companies are developing in-service videos, creating interactive computerized manuals that make use of touch screen technologies, and even using the Internet to distribute product updates and safety alerts."
Barbara Camm, international sales manager for Dashe & Thomson, Inc., Technical Writing (Minneapolis), agrees that user manuals are fertile ground for innovative communications. "It is not uncommon for companies to produce versions of their manuals in large print or Braille for the visually impaired, to make them available in TDD format for the deaf, or even to make their text readable by speech synthesizers."
But each of these innovative presentations has its own set of challenges. "Formatting a manual for onscreen presentation is very different from preparing it for printing," Camm notes, "but whatever the format, the key is to make the information accessible to the user."
Unfortunately, there is no manual to guide manufacturers on how best to prepare and present information using electronic media. "You can't use Write It Right as a guide for creating videos because it wasn't designed or tested for that purpose," says Kingsley. "New research would have to be conducted to create and validate appropriate principles--to determine what works and what doesn't."
Knowing what works could be very useful to manufacturers that are exploring new possibilities for communicating with users, Kingsley continues. "In general, adult learning theory says that messages are communicated more effectively if they are reinforced through the use of different media. But it would be useful to know what types of media are being considered, and why. Not everything works for every purpose. For a home-use device, for instance, how many users would have access to the equipment needed to use an instruction manual provided only on CD-ROM?"
"Use of CD-ROMs has been discussed as a concept, but there is a barrier based on accessibility," agrees Miller. "If a company were going to replace its package inserts with CD-ROMs, it would have to know that every single user would have access to that technology. Putting information on the Internet has the same limitation."
Using the Internet to provide information to customers has its own pitfalls, not the least of which is the attention the medium has recently received from FDA. Concerned that some material posted on the Internet by device companies may be promoting off-label uses, the agency has recently been looking into ways to regulate the dissemination of such information.
Kingsley says that the Internet is not yet a reliable means of reaching many health-care professionals, even in hospital settings. "When we asked professional organizations how many of their constituents could be reached via the Internet, the numbers that came back were pretty low."
That situation may soon improve, as hospitals invest in information technologies designed to facilitate communications between and among sites. But Kingsley cautions that there are still many other nonhospital settings where Internet technologies have yet to make inroads.
Whatever the media used by device manufacturers, the practices that are followed in developing product labeling could play an important role in protecting companies in product liability suits. According to Bowman and Brooke's Ross, plaintiff's attorneys are closely monitoring FDA's expectations for product labeling, especially for home-use devices. "If a device-related event leads to a product liability suit, manufacturers should be prepared to show that they have observed state-of-the-art practices in developing their labeling--including their instruction manuals," says Ross.
Following the instructions in Write It Right and other state-of-the-art practices is essential if companies are to protect themselves from product liability suits, Ross notes. "Juries can be swayed against the manufacturer if they find that it did not follow accepted practices for writing, developing, and testing its labeling information. Companies should at least match what others are doing."
Observing that labeling plays a key role in ensuring product safety, Ross notes that companies have an obligation to consider alternative technologies for communicating with end-users. "Companies that do not explore all options could be putting themselves at risk in liability cases," he says.
With the increasing globalization of the medical device marketplace, U.S. manufacturers are sure to remain interested in penetrating new markets, wherever they may be. But there's no reason to think that such penetration can be obtained without some cost, and, in the case of the EU, one of those costs is complying with national language requirements.
At the same time, emerging technologies could make it possible for device manufacturers to respond more effectively to the needs of such markets. On-line printing technologies promise to make it economical for companies to produce even very small lots using labeling that is specially designed to meet the needs of their customers. Meanwhile, new information technologies promise to supplement and improve existing methods of communicating with users, whether they are health professionals or patients in their own homes. The future will tell how effectively manufacturers can bring these new technologies to bear on the packaging dilemmas they are increasingly facing in the international market.