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Hosted by ICCBBA, an international non-profit standards organization.


Recommendations to Improve the Quality and Safety of Medical Products of Human Origin

Tim Pruett, Jeremy Chapman, Martin Hildebrandt, Diane Wilson, Paul Ashford, Matt Delgado, Luc Noel and Ineke Slaper-Cortenbach

on behalf of the ICCBBA Board of Directors

Executive Summary

In September 2019, ICCBBA organized an international Forum, bringing 90 participants from more than 45 international professional and governmental organizations together to share their views on how to enhance the quality and safety of Medical Products of Human Origin (MPHO). Important topics including traceability, patient safety, ethics, biovigilance and surveillance, and new technologies were based on the WHO Guiding Principles on human cell, tissue and organ transplantation, as endorsed at the Sixty-third World Health Assembly. The goal of the Forum 25 was to identify the current challenges in the area of MPHO and define actions, that will optimize donation and clinical application practices.

This paper describes the overall discussions that took place and identified 16 actions and the involved stakeholders.

It was concluded that while MPHO do already save lives and improve the quality of life for many individuals, it is clear that they are becoming an increasingly important and successful part of the treatment for people worldwide. As the range and reach of MPHO increases, the development and application of reliable traceability systems that preserves individual privacy and yet provide clear documentation of the various steps from donation to use of specific products, is both important and urgent. It is the human product that links a donor to a recipient. The wide variety of products that are possible after a single donation necessitates usage of an unique identifier that will meet public expectations for quality and safety of all MPHO derived from the donation and preserve the intimacy and altruism inherent in organ and tissue donation event.

Endorsing Organizations

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