Docket Management
Docket: 02N-0204 - Bar Code Label Requirements for Human Drug Products
Comment Number: EC -26

Accepted - Volume 13

Comment Record
Commentor Mr. Bruce Wray Date/Time 2003-04-17 16:20:11
Organization Computpye, Inc.
Category Company

Comments for FDA General
1. General Comments (From page 55) “We considered whether the proposal should specify the use of ABC Codabar, ISBT 128, a different symbology or standard, or simply require the use of “machine-readable information” approved by the CBER Director. Each approach has its advantages and disadvantages.” I would like to summarize the advantages and disadvantages of these four approaches, speaking from a rather unique perspective: In October of 1989 I was asked to make a recommendation to the ISBT Working Party on Automation and Data Processing regarding a possible change in bar code symbology. Computype’s long history of providing label products to the international blood bank community, and the expertise we developed in the use of bar codes in blood banks equipped me, in the view of the Working Party, to offer objective advice regarding the limitations they were encountering with ABC Codabar. I recommended that the blood bank community convert to Code 128 to address the performance problems inherent in ABC Codabar. The rest, as they say, is history. Approaches outlined in proposed rule: 1. Specify the use of ABC Codabar. Several limitations of Codabar caused the blood bank community to seek a replacement symbology beginning in the late 1980s: · Susceptibility to substitution errors, and the lack of space to incorporate a check character to reduce the likelihood of such an error; · Consolidation of testing facilities increasing the possibility of duplicate numbers being received, specifically because of limitations of the seven (7)-digit field; · Product code structure had not been updated to reflect the proliferation of new blood products. In fact, many blood-testing labs are already using a modified version of ISBT 128 to uniquely identify test tubes shipped to their facilities from throughout their service region. There are no advantages to continuing the use of Codabar; it is no longer the best symbology for the application, it’s propensity for mis-reads cannot be addressed because of space constraints, and its product codes are incomplete and inadequately defined. 2. Specify the use of ISBT 128. The international blood bank community invested significant time and money in developing ISBT 128. Community blood centers, hospital blood banks and transfusion services, label suppliers, software vendors, instrument companies, and the FDA were all involved in writing the specifications, dealing with the technical issues, wrestling with implementation issues, and agreeing upon a course of action. Every technical limitation of Codabar was addressed via ISBT 128. There are no disadvantages to mandating the use of ISBT 128 within the blood bank community. While the FDA’s proposed rule notes (page 54) that there were concerns expressed “regarding implementation time frames and costs of implementation to hospital transfusion services,” these are far outweighed by the safety and efficiency benefits of the new standard. All new standards require funds to be spent; while maintaining the status quo might be least costly in the short-term, the American people expect their blood banks and hospitals to use the best technology available to provide them with a safe blood product. 3. Specify the use of a different symbology or standard. Blood is often referred to as a drug with a lot number of one—clearly different from most other items within the scope of the proposed rule. As such, it requires a more comprehensive and precise identification than other drugs. ISBT 128 was developed specifically for blood and blood products; there is no satisfactory alternative to it. There are no advantages to specifying the use of a different symbology or standard. The proposed rule notes a potential disadvantage (page 55) as “we would have to institute new rulemaking if a new symbology, standard, or technology was adopted.” The key to ISBT 128 is its data structures; they were designed with an eye towards the future, when some other technology might become more cost-effective than a simple, linear bar code. While additional rule making might be required as technologies evolve, it is expected the job would be much easier and quicker than last time; the hard work has already been done. 4. Require the use of machine-readable information. The primary life-and-death issues ISBT 128 addresses are commonality in symbology and data structure. A “standard” that allows any type of machine-readable information is no standard at all, and fails to assure accurate decoding and information processing throughout the blood product supply chain. If an institution is unable to accurately read a critical blood label because their system doesn’t support it, we have failed our own patients and the entire global community. Blood is often shipped across state and national boundaries; the only way to prevent errors is for the entire healthcare community that handles the blood to agree upon one common standard. There are no advantages to generically requiring the use of machine-readable information.

EC -26