Docket Management
Docket: 02N-0204 - Bar Code Label Requirements for Human Drug Products
Comment Number: EC -7

Accepted - Volume 6

Comment Record
Commentor Dr. Jukka Koistinen Date/Time 2003-03-17 07:13:54
Organization FRC Blood Transfusion Service
Category International

Comments for FDA General
Questions
1. General Comments FDA should require the use of ISBT 128 for blood products. It is an international coding standard that allows unique identification of blood components drawn in any of the organizations registered as a user of the code. It is a definite improvement in the quality of blood component identification and tracing. It is extremely useful in any situation where blood components may be transferred between hospitals or blood transfusion services both nationally and internationally, not to speak of exceptional conditions (like the Kuwait conflict or in the potential Iraq conflict), where blood components may be needed from many different sources. The standard has been taken in use in many European countries (UK, the Netherlands, Belgium, Norway, Sweden, Denmark, Finland) and the experience is positive. The registration and licensing costs are negligible. This is the first time ever we may be able to make a standard really global with all its advantages. The example of the United States in the use of it would be the final sign to all the countries to join and thus globally improve the safety of blood transfusion.




EC -7