Paul Ashford - Comment

ICCBBA is the international standards organization responsible for the ISBT 128 Information Standard for Blood and Transplant. This standard is used to provide globally unique identification of donations of human blood, cells and tissues. It is in widespread and growing use globally. ICCBBA is a registered issuing agency under ISO 15459. The following comments refer specifically to the subset of medical devices that contain human tissue. These products are prepared from tissue derived from donors whose donation may also be used to prepare tissue biologic products that are not classified as medical devices. The use of a consistent identification system for all donated tissue is essential to support recall events based on donor characteristics, and to allow effective biovigilance activities. For this reason, ICCBBA has developed a modification to their standard to support a product code that meets existing ISBT 128 coding requirements and also satisfies UDI requirements. We would urge FDA to recognize the importance of a consistent identification system across all human tissue derived products, and to recognize ICCBBA as a valid issuer of UDI for this specific subset of medical devices. In particular we would ask that ICCBBA be identified alongside GS1 and HIBCC where FDA make references to ISO 15459 and the allocation of UDI. Further information on coding and traceability can be found in the attached document. ICCBBA staff are available to discuss further.