Forum 30: Advancing Global Standards for Medical Products of Human Origin

REDLANDS, Calif., Jan. 22, 2025 /PRNewswire/ -- The International Council for Commonality in Blood Banking Automation ("ICCBBA"), in partnership with the Italian national competent authority for blood Centro Nazionale Sangue ("CNS") and for cells/tissues Centro Nazionale Trapianti ("CNT"), hosted Forum 30 The MPHO Safety and Traceability Summit on 14-15 November 2024. The event convened over 100 health professionals, patients, regulators, and other stakeholders from 34 countries around the world. They addressed critical challenges and opportunities concerning safety, and traceability of Medical Products of Human Origin (MPHO). Key discussions highlighted the importance of global cooperation to safeguard patients and foster innovation in the application of these therapies. Celebrating ICCBBA's 30th anniversary, the event reaffirmed the transformative role of the ISBT 128 Standard in ensuring the safety and traceability of MPHOs worldwide.

Forum 30 Summit

The event emphasized the life-saving and life-changing nature of MPHO, common characteristics of otherwise diverse therapeutic products and the importance of nurturing global cooperation in safeguarding patients receiving MPHO.

Discussions also emphasized technical interoperability to ensure safe management of MPHO and the need to address challenges through global regulatory alignment. Experience was shared of investigations of MPHO-related adverse events and how harm to recipients and healthcare professionals could be minimized.

The conference also celebrated the 30^th anniversary of the founding of ICCBBA in 1995 and the continued evolution of the globally recognized ISBT 128 Standard, which provides unique coding and traceability standards for MPHOs.

Highlights and Action Steps

A diverse group of international experts presented on

• The need for traceability to support MPHO safety and efficiency in their management
• How technical innovation and informational interoperability supports safe access to MPHO
• The need for global regulatory alignment to address evolving challenges in the therapeutic application of MPHO

Key announcements included the preparation by the World Health Organization (WHO) of a global strategy for MPHOs including regional consultations with member states. The goal is to present the strategy for adoption at the 2026 World Health Assembly.

Events like Forum 30 help strengthen international collaboration among standards development organizations, professional associations and governmental organizations to enhance implementation and global impact. Participants called for similar multi-stakeholder events like Forum 30 to be repeated at national or regional levels.

Executive Reflections

Eoin McGrath, ICCBBA Executive Director, emphasized the collaborative nature of the event: "The Forum 30 conference was designed to reflect the complex landscape of transplantation, with multiple stakeholders and actors all having a role to play. ICCBBA understands the importance of partnering with diverse organizations to advance safety and traceability of substances of human origin. Working with CNT and CNS was one of the success factors behind Forum 30 given their extensive experience and the high respect in which they are held by their peers in the European Union and further afield."

CNS Director Vincenzo De Angelis, remarked on the significance of robust regulatory standards: "The critical importance of robust regulatory standards and traceability in the management of MPHOs was underscored as a cornerstone of patient safety. With human-derived products playing an integral role in modern medicine, ensuring their safe collection, processing, and distribution through stringent protocols is essential for protecting both donors and recipients, while fostering trust in healthcare systems worldwide. We were deeply honored to host this event where global experts gathered to advance the standards that safeguard lives and drive innovation in this vital field."

CNT Director Giuseppe Feltrin highlighted Italy's leadership in transplantation: "It has been an honor for the National Transplant Centre to host this meeting. Italy plays a strategic role in the safety and oversight of organs, tissues, and cells as a WHO collaborating center for the Notify Project. Our National Transplant Information System is at the forefront of this field, thanks to the systematic implementation of international standards like the ISBT 128 Standard, which ensures globally unique identification of donations and a robust data structure to safeguard patients and guarantee care traceability. Our aim is to continue investing in safety and oversight to strengthen the global leadership of Italy's transplant network."

A Path Forward

Discussions highlighted the necessity to facilitate collaboration, advocacy, and standardization to ensure safe, and administration of MPHOs globally. Through its continued partnership with the WHO and other stakeholders, ICCBBA is committed to supporting advances in safety, and traceability through standards to improve patient safety and global health outcomes. Presentations from the event will be made available on the Forum 30 website.

About ICCBBA
ICCBBA is the international standards organization responsible for the management and development of the ISBT 128 Standard.
The acronym ISBT was originally derived from the important role played by the International Society of Blood Transfusion in the development of the Standard. Today it expands as Information Standard for Blood and Transplantation. The number 128 reflects the 128 characters of the ISO/IEC 646 7-bit character set. The acronym ICCBBA is derived from the International Council for Commonality in Blood Banking Automation. ISBT 128 | ICCBBA

About CNS
The Italian national competent authority for blood and blood components acting as coordinator of the national system. Among others, it is responsible for regulatory blood inspectors' qualification through training activities. Homepage - Centro Nazionale Sangue

About CNT
The Italian national competent authority for organs, tissues, cells, and MAR coordinating activities from donation to transplantation. Among others, it is responsible for regulatory inspector's qualification through training activities. Trapianti (salute.gov.it)

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For More Information
Forum 30 Homepage

Press Contact and other inquiries: 
Christina Salinas
Global Development Manager
ICCBBA
[email protected]