Twenty-five years later: has ISBT 128 fulfilled its promise?

Area of Science:

• Medical Science
• Biotechnology
• Health Informatics

Background:

• Traceability is crucial for quality assurance in medical products of human origin (MPHO).
• Standardized systems are needed for accurate data collection and electronic readability.
• The ISBT 128 standard has been the global benchmark for MPHO labeling for 25 years.

Purpose of the Study:

• To review the historical development of the ISBT 128 Standard.
• To assess the current status and global adoption of ISBT 128.
• To explore potential future applications and advancements of the ISBT 128 Standard.

Main Methods:

• Literature review of ISBT 128 specifications and related publications.
• Analysis of ISBT 128's impact on MPHO traceability and data management.
• Examination of case studies and industry adoption trends.

Main Results:

• ISBT 128 has become the international standard for MPHO labeling and information transfer.
• Standardized coding enhances hemovigilance and aggregated data activities.
• The system has improved accuracy and efficiency in data collection.

Conclusions:

• The ISBT 128 Standard has significantly advanced MPHO traceability and quality.
• Continued development and adoption of ISBT 128 are vital for future healthcare innovations.
• The standard's adaptability supports evolving needs in medical product management.