Originally published September 1996
Walter W. Mosher
President, Precision Dynamics Corp., San Fernando, CA, and
Chairman, Health Industry Business Communications Council, Phoenix, AZ
For manufacturers of medical devices, the pressure to reduce the costs relating to their products has never been greater than it is today. Companies are actively exploring every place in the product life cycle where economies can be found, including areas related to the distribution of their products.
Bar coding systems have long been touted as a significant means for gaining such economies. But despite more than a decade of work by a number of organizations in the United States and abroad, the medical manufacturing industry has so far been unable to implement an acceptable universal standard for bar code labeling of medical products. Greater progress in this field is desperately needed, but manufacturers should first understand what has come before and what obstacles will need to be overcome.
THE GROWTH OF CODING STANDARDS
In the early 1970s, the Food Marketing Institute and the Grocery Manufacturers Association formed the Uniform Code Coun-cil (UCC) to develop and promote the use of bar code labels in the food distribution industry. The labeling standard that UCC developed was both a data and a bar code structure known as the Universal Product Code (UPC) symbol. This symbol is now used throughout the United States to identify the items sold in most major retail outlets.
It was not until the early 1980s that the health-care industry began to focus on automating data acquisition activities. The initial efforts were led by several distributors, including American Hospital Supply Corp. These distributors proposed that the UPC symbol be the standard for labeling medical products, but this recommendation did not take into account how using the data structure would affect medical product manufacturers. Significant opposition to labeling medical products with the UPC symbol developed quickly.
In an attempt to resolve the debate on medical product bar code structure, in 1983 the American Hospital Association hosted a meeting of interested distributors, manufacturers, and end-users. The meeting led to creation of an ad hoc committee consisting of manufacturers, distributors, providers, and technical experts charged with assessing the labeling needs of the medical manufacturing industry and its distribution partners. The committee, called the Health Industry Bar Code Council (HIBCC) and later renamed the Health Industry Business Communications Council, was sponsored by the Health Industry Manufacturers Association (HIMA), the Health Industry Distributors Association (HIDA), the Pharmaceutical Manufacturers Association, the National Wholesale Druggists' Association, and the American Hospital Association.
In 1984, HIBCC produced the first health industry supplier labeling standard and, subsequently, the first health industry provider labeling standard. These standards enabled manufacturers to include the National Health Related Industry Code (NHRIC) and the National Drug Code (NDC) numbers assigned by FDA and used by the pharmaceutical industry. They also recognized the need of the medical manufacturing industry to encode product identification using alphanumeric symbols and product numbers of greater length than the UPC symbol, which can accommodate a product identification segment of only five digits. Use of the HIBCC standards was expanded to foreign countries in 1988, when the European HIBCC was formed and began promulgating the standards throughout Europe.
Meanwhile, the UPC data structure was becoming more widely used in retail distribution, and other industries began to see the benefit of automated data capture techniques based on bar codes. In 1988, UCC and the International Article Numbering Association (EAN) began to develop a global standard for product identification in the retail, pharmaceutical, and medical product industries. Unfortunately, the initial attempts focused on using the UPC 12-digit manufacturing product number and progress was slow. In 1991, UCC established an Industrial Commercial Advisory Committee to study ways that the UPC standard could be used to meet the needs of additional industries. Today, that committee has significant influence over the development of coding standards and applications for many industries.
It is unfortunate that when HIBCC was formed in 1983, UCC had not yet expanded its charter beyond the grocery and general merchandise markets. As a result, the HIBCC standards were developed along wholly independent lines, without UCC's assistance or input. Inevitably, the HIBCC supplier standard was not compatible with that developed by UCC and EAN, leaving manufacturers with a difficult choice to make in selecting an appropriate coding structure.
In an attempt to end the confusion over the two conflicting standards, HIBCC and UCC joined forces in 1994 to revise the HIBCC supplier standard so that it could make use of the application identifiers (AIs) of the UCC/EAN standard for specifying manufacturer product number and secondary information. AIs had been introduced by UCC in 1988 to identify product attributes such as lot, batch, serial number, weight, and size. The AI(01) was developed to allow the UPC data structure to be encoded in symbologies other than the UCC/EAN format. The revised HIBCC standard called for concatenating the AI(01) with the AI(240).
As part of the 1994 revision, HIBCC suggested that the AI(01) could be filled with zeros and the entire product specification could be located in the AI(240) data structure. Other modifications to the standard included deleting the alternate method of identifying products using embedded NHRIC or NDC code numbers in an HIBCC-format label. UCC provided a means in the AI(01) for directly representing this information. Another change to both the HIBCC and UCC standards was to make the packaging-level indicator portion of the data structures identical in both formats.
While UCC and HIBCC were finding ways to work toward harmonization, however, other forces were exerting influences in the opposite direction. Lack of cooperation between EAN and the European HIBCC, for instance, had reduced the motivation of European medical manufacturers to bar code their products. UCC intervened in 1995 and was helpful in creating an agreement between the two organizations on how to mark products for the European market. This pact endorses the UCC/EAN standard as the primary product-marking methodology, but also allows for use of the HIBCC standard. It encourages migration to the UCC/EAN approach when possible.
In 1995, the U.S. Department of Defense (DOD) adopted a Universal Product Numbering (UPN) standard for all products sold to the government. Although HIBCC proposed the use of AI(240) with zero-filled AI(01) as a structure for the UPN database, DOD decided that this data structure was too long for manual data entry during the government's transition from manual to automated material management. The scheme finally approved by DOD calls for the use of either the UCC/EAN or HIBCC method of product identification and requires that all products sold to DOD after July 1996 be marked with the UPN.
So far, neither HIMA nor HIBCC has endorsed migration to the UCC/EAN standard. UCC suggests that migration might be appropriate in certain instances, but supports both the UCC/EAN and HIBCC standards. HIDA endorses the use of either the HIBCC or UCC/EAN format and migration to the UCC/EAN standard when possible. Thus, at the present time, it is correct to use either the UCC/EAN or HIBCC standard. These standards will be accepted worldwide based on the agreement between the UCC/EAN and the European HIBCC, and will also be satisfactory for the DOD and many other government agencies, such as California's Medi-Cal.
A complicating factor for bar code choice, however, is that some European governments may be planning to require the use of the numeric UCC/EAN format, even though this requirement is not in conformity with the agreement between UCC/EAN and the European HIBCC or with the stated positions of any U.S. organizations. Therefore, the decision whether to change a product's labeling to the UCC/EAN standard must take into account where the product will be marketed.
PROBLEMS AND POSSIBLE SOLUTIONS
The most important problem with migrating to the UCC/EAN data structure is the substantial cost to manufacturers of changing their product identification numbers to a five-digit format. This change would require modifying all product literature, packaging, and catalogs as well as both the manufacturer and customer databases. Many companies assign important information to all the digits of their product identification numbers.
Another problem is that medical practitioners may be accustomed to asking for particular products by product numbers, and changing these could put patients at risk. Similarly, considerable scientific research has been conducted and reported using product identification numbers. Changing the numbers could make such previously published studies useless.
One proposal for making universal standardization less difficult is to use the zero-filled AI(01), as suggested by HIBCC in the 1994 revision of its standard. In 1995, however, UCC evaluated the impact of this approach on the UCC/EAN standard and concluded that the method was not consistent with the published definition of AI(01). UCC therefore requested that it be deleted from the HIBCC standard. Fortunately, an HIBCC survey of manufacturers found only two respondents that were considering using the AI(240) with zero-filled AI(01), and none that had yet begun to do so.
Another idea is to assign an alphanumeric AI for primary data. This AI would consist of 20 characters and would include a 4-digit manufacturer ID identical to the HIBCC Labeler Identification Code, a 13-character product ID, and space for other information that is contained in the HIBCC primary label. This plan would simply incorporate the entire HIBCC primary label, and would not require any changes in product identification or the creation of cross-reference tables.
UCC recently proposed that manufacturers use cross-reference tables to relate each manufacturer product number to a five-digit number in the AI(01) and then concatenate this with the AI(240), which would contain the existing alphanumeric catalog numbers. This would require that both manufacturers and customers modify their databases, and would undoubtedly be both costly and confusing. For instance, one major manufacturer of medical products surveyed its organization and discovered that among its 20,000 products bar coded using the HIBCC data structure, more than 10,000 have product codes longer than five digits, and more than 8000 have alphanumeric product codes. Also, many of the company's divisions include important information in their product numbers.
Other approaches to UCC/EAN migration problems may be forthcoming, as HIBCC, UCC, and HIMA continue to work toward a solution that will accommodate all segments of the health-care industry.
Another area of concern for medical product labeling is marking small products, such as unit-dose packages that have inadequate space even for a bar code as short as the UPC symbol. HIBCC proposed use of a two-dimensional symbology, but the method was not adequately supported by the manufacturers of bar code readers. UCC has begun to work toward adoption of 2-D symbologies by all industries, and may issue recommendations for this symbology soon.
In the interim, HIBCC has proposed that the UCC/EAN 14-digit number be truncated to the 10-digit NHRIC and NDC numbers. This plan could create confusion, because there would be no way to indicate that the 10 digits represent NHRIC and NDC numbers. Therefore, imported products could have the same values for these 10 digits. HIBCC intends to modify its standards when an appropriate 2-D symbology is chosen and adequately supported by the bar code reader industry.
With the worldwide acceptance of both the HIBCC and the UCC/EAN standards, there is no reason to delay bar code labeling of medical products. New products, or products that do not have meaningful information in their product identification numbers, should be coded using the UCC/EAN data structure as soon as possible.
For other products, however, there is no immediate need to migrate from the HIBCC to the UCC/EAN format--and there are some reasons not to do so. The cost associated with forcing all medical product manufacturers to conform to a five-digit product code is excessive and unnecessary, and not in keeping with the present societal emphasis on reducing the cost of health care. It would also create confusion.
Actually, a longer alphanumeric symbol for product identification could be easily accommodated. If UCC and EAN would issue an AI of 20 alphanumeric characters, the HIBCC data structure could be embedded in it at minimal cost. The result would be a single worldwide standard for health-care product identification. If a manufacturer now using the UCC/EAN structure did not wish to modify its database, it could simply ignore any extra information contained in the new AI.
Most grocery and retail databases in the United States are already obsolete and do not recognize all digits of the UCC/EAN data structures, a situation that creates the potential for misidentification of products. As international trade increases, misidentification will become an even more significant problem. These systems must be redesigned anyway, and when they are, a 20-character alphanumeric primary data structure could be provided at little extra expense.
Unless UCC modifies its restrictive 14-digit numeric format, wholesale migration to its proposed standard would not benefit the medical manufacturing industry and would cost it a great deal. More work is needed to ensure that the medical product manufacturing and distributing communities can have a coding standard that really meets their needs, wherever in the world it might be used.