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Bar Coding

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Introduction of new technologies, such as ISBT 128 bar coding, can save patient lives. ... Encoding of special testing results ... – PowerPoint PPT presentation

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Learn more at: https://www.fda.gov
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Title: Bar Coding


1
Bar Coding Blood Products

  • Kay Gregory MS, MT(ASCP)SBB
  • Director of Regulatory Affairs, AABB

2
Why are we here?
  • Primary problem in transfusion medicine Need to
    reduce human error.
  • Introduction of new technologies, such as ISBT
    128 bar coding, can save patient lives.

3
FDA Should Consider
  • Electronic Data Interchange
  • Definition and use of Standard Data Structures

4
ISBT 128 Advantages
  • Internationally agreed upon placement of labeling
    information
  • Internationally unique numbering system
  • Internationally standardized product codes
  • Encoding of date and time of collection,
    production and expiration

5
ISBT 128 Advantages
  • Encoding of special testing results
  • Encoding of the manufacturer, catalog number and
    lot numbers of blood
  • Mechanism for maintenance and growth of standard

6
 
Identification Number
ABO/Rh Type
                         
Product Number
Expiration Date Time
Expiration date and time
Special Testing Results
7
Mistransfusion of blood is the most common
cause of morbidity and mortality related to
transfusion.
8
Right patient must receive the right unit of
blood!
9
Recommendations to FDA
  • 1. Require the blood banking community to adopt
    ISBT 128, or comparable system, for labeling of
    blood blood components.
  • a. Significant time and resources for
    implementation.

10
Recommendations to FDA
  • 2. Encourage the development of
    patient and product ID systems for blood products
    that are compatible with drug and pharmacy
    systems.
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