25 Years of Change: Medical Device Labeling

Originally Published MDDI August 2004

Labeling



Labeling techniques have undergone many changes since 1979.  As a result, the industry has been required to develop new regulations and attitudes toward medical device labels.

Dave Olson

When you consider it, 25 years is a fairly momentous anniversary. It encompasses what we would call a generation of humanity and is a time when we middle-aged folks can look back over our shoulders with a little more insight and understanding than we could when we were 25 years younger. Twenty-five years ago, MD&DI was first published. Ronald Reagan announced his candidacy. Iran underwent a revolution, and the Russians invaded Afghanistan. On a personal level, my oldest son was born, and I entered the wonderful world of labels with my degree in political science and history—making me a uniquely qualified candidate for the labeling field. 

Forces of Change

Changes in medical device labeling are driven by the same forces that have changed the world at large: computerization and globalization. In many companies 25 years ago, an employee entered variable data on registration forms and labels using exceptional block-lettering skills and a marker. The 9-pin impact printer, driven by a word processor using a 5.25-in. floppy disk, was a huge improvement. But even then, all the forms and labels still needed to be entered individually. The error rate was unacceptably high.

Now, high-speed laser printers and thermal-transfer printers can enter all the variable data on all labels and literature simultaneously, consistently, and accurately. Software and hardware have followed a prescribed qualification path, resulting in a documented and validated system. Many device companies have installed automatic packaging lines to collate all parts and literature and generate a complete package, ready for sterilization. 

Actual label stocks and adhesives have changed dramatically also. High-gloss, clay-coated stocks with solvent-based adhesives were the order of the day during Carter's presidency. Since then, EPA and EU requirements, as well as functionality issues involving different demand-printing methods such as dot matrix, laser, and thermal transfer, have made label stocks stronger, thinner, and printer-friendly. Chlorine-free bleaching processes, the use of post-consumer waste, and coatings that accept a variety of printing techniques are significant improvements in an industry that has been around since Gutenberg.

Adhesives have changed from solvent-based to mostly water-based acrylic emulsions and some hot melts. Such adhesives have the performance characteristics to survive extreme conditions. These include humidity and chemical exposure of ethylene oxide, the heat of autoclaving, and the nasty electrons blasting around in gamma and E-beam sterilization. The adhesive's sticking to what it is supposed to in the exposure environment is the key physical property of label stock. So this is a very important step. The message saying, “I got a call from our warehouse and half of our labels are lying on the floor” can be a thing of the past—if the proper qualification and validation procedures are followed.

Regulating Labels

Regulatory issues are a key area of change in the labeling process. In 1979, we listened to recording artists like Elton John struggle to jump on the disco bandwagon. Meanwhile, the Medical Device Amendments of 1976 and the 1978 GMP regulation had been in effect for only a short time. 

One of the biggest challenges for regulators in 1979 was creating exact definitions for labels, labeling, and advertising. Traditionally, FDA tried to establish the highest degree of control over labeling through the preapproval process.

Typically, devices followed drugs in the regulatory hierarchy. Congressional investigations of generic-drug issues—some involving labeling and advertising claims—filtered down to a largely naïve device industry. They came in the form of more-dogmatic and -controlling labeling and advertising rules and regulations. 

Since about 1997, this trend has been reversed to some extent. This is due to a series of First Amendment commercial free-speech cases that FDA lost, including the one brought by the Washington Legal Foundation. Since then, FDA's attitude on labeling has evolved into more of a risk-benefit analysis rather than its customary cautious, protective, enforcement model.

This attitude has led to a policy similar to the Federal Trade Commission's approach, and indeed, there have been productive talks between the two agencies. The end result for medical device labeling is a trend toward outlining and defining the parameters and substantiation needed for labels, labeling, and advertising. FDA action is then only initiated with a device manufacturer if the agency actually identifies problems. 

Bar Codes

Bar codes are another area of progress during the last 25 years. Since the first 10-cent pack of Wrigley's Juicy Fruit was scanned at Marsh's Supermarket in Troy, OH, on June 26, 1974, bar codes have become indispensable. This is especially true in medical device labeling.

Initially, the move to bar coding was customer-driven, especially by hospitals. But even today, relatively few hospitals are taking advantage of bar code systems.

Device manufacturers have found that using bar codes in their manufacturing process reduces cost, reduces errors, and streamlines the supply chain. They can also track products economically and accurately from manufacturing through finished goods, distribution, and inventory. In March 2003, FDA issued a proposal that would mandate bar codes on all prescription drugs and biologics, as well as any OTC drugs commonly used in hospitals. 

Medical devices are not included at this time; most manufacturers oppose the mandatory inclusion of devices because they present a different set of issues from drugs, biologics, and blood products. At this time, there is not even an agreed-upon standard for a bar code format. 

The Health Industry Bar Code Supplier Labeling Standard was specifically developed for healthcare manufacturers and distributors. The standard has been in existence since 1984. Both retail and manufacturing have used the UCC EAN standard for roughly 25 years, however, and it is widely accepted in more than 100 countries. No effort is currently apparent to consolidate the two standards, although it does appear that more users and countries are increasingly accepting the UCC EAN standard. 

Many device manufacturers have also begun using 2-D codes like data matrix or the RSS symbology. These codes hold much more information, have error detection and correction characteristics, and are printed like linear codes. 

Another step up is the use of RFID codes, which have gained a lot of publicity since Wal-Mart stores are requiring that all pallets be tagged with the codes by January 2005. Several device manufacturers, especially the pacing industry, are exploring the possible uses of RFID codes.

Multilanguage Labeling

One of the main labeling challenges today is multilanguage labeling. In 1979, there were no real requirements for multiple languages. The push to offer more than one language was mainly driven by individual countries and customers. Companies would compete for the market share in a given country—labeling their product in that country's language was a key element to entering the market.

Many companies offered English, and an international version of their package would contain perhaps three languages at most. This changed in 1993. An EU directive stated that medical device packages must include “instructions for use…in the packaging for every device” in the form of a leaflet in the country's language. There was a five-year window to implement this directive, but most companies, like a college student approaching a final exam, waited until the last minute. This resulted in a huge rush to become compliant in late 1997. It caused a logjam at translation firms, as well as in package engineering and regulatory affairs departments.
 
With the addition of 10 new EU countries in May of this year, these issues show no sign of going away. In many of these countries, language is the main source of a national identity, and the requirement is not likely to be relaxed. I experienced this first-hand when I realized I was lost in Vilnius, Lithuania, in 1976. I asked, in Russian, how to get to the hotel across from the train station. After a notable lack of success, I complained to my companions, in English, that I must not have been pronouncing it right. A guy walking by asked, in English, if we were Americans. He assured me that I had pronounced it correctly, but that Lithuanians disliked speaking Russian because of the annexation and forced “russification” by the then-USSR. 

We face several challenges with the additional language requirements, not the least of which is minimal real estate on the labels and labeling. If you have a 3-ft-long catheter package, you are probably okay. A heart-valve package is another story altogether.

The speed at which labeling changes can be implemented is also a concern. If a single change isn't crucial or life-threatening, it might take months or years to get a minor labeling change out to customers. In addition to the cost of translation, you have the added bulk and size of the package, which adds to the waste stream. 

Environmental concerns are addressed in yet another EU directive, Packaging Waste Directive 94/62/EC, which specifically requires manufacturers to reduce packaging. One of the ways to address this problem is through the use of symbols. This reduces translation time and costs, saves space, and visually enhances the label. It also allows for the addition of languages without major redesign to the printing software or the actual label itself.

Companies have been developing new symbols, with the pacing industry taking the lead. The European Union encourages the use of symbols—those that are commonly accepted are listed in ISO 15223. EN 980 also addresses symbols.

FDA's current view is cautious. But there is a draft guidance from October 23, 2003, which addresses the use of symbols on in vitro diagnostic (IVD) devices intended for professional use. In general, nothing stops manufacturers from creating symbols and submitting them for approval, as long as they are clearly explained in the instructions for use. Development of new symbols that can be used by the device industry should be encouraged and should be part of labeling submissions when they are created.

E-labeling

Earlier, in this article, I mentioned the twin forces of computerization and globalization as being the thread that runs through the last 25 years of label changes. These forces come together in the very current topic of e-labeling. This issue, along with the multilanguage challenge, is the labeling issue I have been questioned about the most in recent years.

In 1979, Ayatollah Khomeini returned to Iran and Margaret Thatcher was elected Prime Minister of Great Britian. Personal computers were in their infancy, and the Internet had not yet been mentioned in print. At that time, my stack of FORTRAN punch cards and the video Pong I played in the tavern were my main exposures to computerization.

E-labeling can be something as simple as a CD-ROM or a downloadable PDF document. It might also be a secure, reliable Internet site. It can also be something as high-tech as an external pacemaker programmer. It might display instructions for use in the operator's language on a built-in screen that can be accessed while the device operates. 

E-labeling was adopted by FDA as an accepted standard in October 2003. In general, prescription devices used within the confines of a healthcare facility may provide labeling for those devices solely in electronic form. A paper copy must be provided at no additional charge if the user requests it.

The European Union is a bit slower to come around. Eucomed, the European medical technology industry association, came out in strong support of e-labeling in a press release issued in April 2004. Actually, e-labeling is already in use in some European countries for a subset of medical devices. The In Vitro Diagnostic Directive (Dir 98/79/EC) took effect in January 2004. It appears to permit e-labeling for IVDs, because it really does not specify the format with which to supply instructions. 

Conclusion

There are signs of progress, but things are moving slowly. The one concern, especially with regard to some of the new member states, is that users must have the technology and infrastructure to support e-labeling. That which is taken for granted in advanced markets might not work at all in developing areas.

I do feel that this is the wave of the future and that the switch will happen quickly once the green light is given. There are two companies using 
e-labeling today, as well as pilot studies in progress by others demonstrating the feasibility and advantages of e-labeling for users. The industry will be watching for developments very closely in the coming months.

Globalization and computerization will continue to affect medical device packaging, labels, and labeling. Some say that the only person who really embraces change is a baby with a soiled diaper, but change is a fact of life and we will continue to lurch forward. As we do so, MD&DI will continue to be on the cutting edge of change, as it has been for the past 25 years.   

Copyright ©2004 Medical Device & Diagnostic Industry