Docket Management
Docket: 02N-0204 - Bar Code Label Requirements for Human Drug Products
Comment Number: EC -14

Accepted - Volume 6

Comment Record
Commentor Mr. Richard Kriozere Date/Time 2003-03-31 17:03:19
Organization Digi-Trax Corporation
Category Company

Comments for FDA General
1. General Comments Digi-Trax Corporation would like to commend the Department of HHS and the FDA for its efforts to require the use of bar codes on Human Drugs and Blood Products. After attending the July meeting at NIH and reading the proposal we would like to comment on the particular areas dealing with blood. As some background, Digi-Trax has been involved actively in the development of the ISBT128 Bar Code Standard since 1989 as a consulting commercial provider of on-demand blood labeling systems. Digi-Trax developed the first 1985/89 US Compliant on-demand, Codabar ABO print system, being used today by most US donation centers and many transfusion services. Most notably, we have recently provided the Dept. of Defense with their ISBT128 compliant labeling systems. We believe that the development of a clear consistent policy is most important. Your decision to support the NDC bar code as is, a specific symbology, marks a significant recognition by the FDA. If we are to get the long overdue compliance utilizing bar codes more actively in blood banking to promote safety through error reduction some similar compromises must be made. Frankly, for blood products the FDA ought to use the same rationale and adopt the same consistent policy. If the FDA’s objective is to have full compliance and uniformity internationally then ISBT128 must be the current choice for the FDA and the only outcome. After years of non-action by blood banking the FDA can expect the same “no action” by donor centers and transfusion centers if the rule only requires “a machine readable code.” You will unintentionally have different symbologies competing as is the case today and have delayed the use of bar codes to promote public safety once again. All this industry needs is a sliver of ambiguity and they will not act. Currently most donor centers and hospitals use Codabar; however, the Puget Sound Blood Center (as example) is using Code39. And, although successful it is not consistent with the published guidelines. We need a standard rule that is universal and under the control of the Director of CBER even though some resources and extra effort will be required to keep technology flexible and current. The public should expect no less. ISBT128 was developed by a group of industry representatives over many years. Certainly any new technology would be evaluated by the ICCBBA and only if it passes their muster would it go to CBER for approval. It is also our belief that since this ISBT128 Standard has been in existence and approved by CBER and the AABB since 2000 that the FDA should only allow a one year implementation period. Even the 1988 AABB implementation task force, which Digi-Trax participated in, came up with an 18 month formal implementation plan. Much of the work has been completed today. All blood bank computer systems can now read in ISBT128 bar codes. This was a major hurdle that has been crossed. Now, if other codes are allowed under the “machine read” concept the software vendors will have no standard and have a major problem. This would also impact Digi-Trax as a supplier of on-demand printers and software. The cost now after more then ten years of investment would be too great. We need to start with only ISBT128 in order to afford to be players in the long run as technology evolves. Almost 100% of scanners now in use “auto-discriminate” and thus all (1-D) bar codes used in health care can be read. In fact, many can be programmed or updated in the field to read specific codes only. We think scanning of a linear (1-D) code is a non-issue. ISBT128 has recognized unique data identifiers, which adds security by eliminating the possibility of reading another code symbology into the host software. ISBT128 has had the support of the entire blood banking community including the AABB, ABC and the ARC. Why move us closer to the goal with a machine read standard when we can get predictable certain compliance with a specific standard like ISBT128? Certainly some hospitals may not have bar code scanners or printer, but those costs are manageable. A Laser or CCD scanner which reads ISBT128 can be purchased for between $300 and $700 today and on-demand printers set up specifically for ISBT128 cost less then $2500. Our on-demand label print software that has been interfaced with most every 510(k) cleared blood bank management system’s software. Digi-Trax’s TCP/IP server product costs $5000 for site one and $2500 for additional sites. We do not know if there is any additional cost from the software vendors for this ISBT128 print functionality. The use of bar coding has become common practice throughout American business and industry therefore, we urge the FDA to adopt a more balanced paradigm, moving from one that allows institutions to stay in business today whether they meet minimum automation standards or not to one that encourages patient safety through the application of automation like bar coding. If an institution cannot bar code let them ask for an exception from the FDA, not let them jeopardize the public’s safety interest by not adopting this minimum application of automation. We sincerely hope our comments will be helpful to the FDA in constructing its final rule and if we can assist in any way please feel free to contact me.

EC -14