HIBC Labeling Standards and FDAï¿½s Bar Code Rule
The alphanumeric structure is critical to safety.
by Robert C. Sprung
|Robert A. Hankin, PhD|
President and CEO
Health Industry Business
Communications Council (HIBCC)
Bar code technology has been widely implemented as a mechanism for streamlining business processes in every major industry. The automation of product identification, ordering, and inventory has facilitated efficiency and cost savings and has provided significant safeguards against human error. Within healthcare, the benefits from the reduction of error have the potential to be even more profound.
This year, FDA confirmed the importance of automated identification as a tool for reducing medical error and improving patient safety with its final rule, ï¿½Bar Code Label Requirements for Human Drug Products and Biological Products.ï¿½ The ruling mandates the inclusion of linear bar codes on most prescription drugs used in hospitals and supports the use of the alphanumeric Health Industry Bar Code (HIBC) Supplier Labeling Standard for that purpose.
In the final rule, FDA explained its decision to include HIBC standards, stating, ï¿½We decided to give firms the option of using HIBC data formats because ï¿½ we cannot preclude the possibility that some firms may prefer using alphanumeric code formats, which HIBCC uses.ï¿½
The preference for alphanumeric data is prevalent among industries with concerns for consumer safety and sensitivity to error. Many industries, such as aerospace, automotive, telecommunications, electronics, shipping, and aviation, have all chosen alphanumeric identifiers for product and process labeling because of their unique data security characteristics. These include:
ï¿½ A larger set of identifiers (0ï¿½9, Aï¿½Z) than all-numeric standards, thereby reducing the risk of duplication;
ï¿½ Literal encoding of product data, eliminating product ID modification and the resulting cross-referencing practices that introduce opportunity for error;
ï¿½ Facilitation of efficient and accurate product tracking and recall processes through precise product identification.
In 1983, a task force of prominent U.S. healthcare organizations, led by the American Hospital Association (AHA), also recognized the importance of alphanumerics when it determined that the existing all-numeric retail standards were inadequate for the specific applications and needs of healthcare environments. Retail standards, developed for point-of-sale, cash register needs, did not adequately address patient and consumer safety concerns. As a result of the healthcare industryï¿½s decision, the alphanumeric HIBC standards were developed.
HIBCC was founded by the AHA-led task force in 1984 with the initial mandate of developing two labeling standards: the Provider Applications Standard for automation of internal hospital processes (including patient/ clinician identification, specimen tracking, and asset tag marking) and the Supplier Labeling Standard for identification of healthcare products.
Utilizing the HIBC Supplier Labeling Standard for product identification, labelers are provided a method for encoding both a primary label and an optional secondary label. The primary label comprises four components: the Labeler Identification Code (LIC), a four-character alphanumeric identifier assigned by HIBCC to registered labelers; the labelerï¿½s product ID (1ï¿½13 characters); a one-character unit of measure; and a Modulus 43 check character. The HIBC Supplier Labeling Standard also provides the option of a secondary label for encoding additional data, such as expiry date, lot number, quantity, batch number, and serial number. These attributes can be of critical importance for pharmaceutical and medical device products whose use can have a direct impact on the health and safety of a patient.
The HIBC standards continue to evolve and incorporate emerging technologies, such as 2-D symbologies and radio-frequency identification (RFID) through the consensus-based process of HIBCC technical committees. Committee participation is open to the public, and all interested parties are encouraged to join.
HIBCC and the HIBC standards are accredited by the American National Standards Institute and the European Committee for Standardization. The HIBC Supplier Labeling Standard is one of two data structures that make up the Universal Product Number (UPN) initiative. The HIBCC mission is extended globally via IHIBCC, an international network of affiliate offices. HIBCCï¿½s mission has continually evolved to encompass numerous e-commerce applications that allow the industry to communicate efficiently and accurately, including the Health Industry Number (HIN) system and the UPN Repository. For more information on the HIBC standards or to obtain an LIC registration, please contact the HIBCC office at 602/381-1091 or at email@example.com, or visit www.hibcc.org.