06 July 2007
Celia Witten, MD, PhD
Food and Drug Administration
CBER/OCTGT/DHT Bldg WOC1
1401 Rockville Pike, Room 207S
Rockville, MD 20852
Dear Dr. Witten,
On behalf of the AABB Tissue Committee I am writing in response to the recently released Report of the Human Tissue Task Force. The Task Force is to be commended on the thoroughness of its evaluation and consideration of additional steps to further improve recipient safety.
AABB has been a leader in advocating for safe handling of human tissues for transplantation. AABB Standards for Blood Banks and Transfusion Services has included requirements for handling, storage, issuing and tracking tissues since 1993. In particular I would like to bring to your attention one requirement that corresponds with the Task Force recommendation to develop a plan to facilitate tissue tracking from donor to recipient and recipient to donor. The 24th edition of the Standards contains the following language:
220.127.116.11 For recipients of tissue, the recipient’s medical record shall include the type of tissue, the numeric or alphanumeric identifier, the quantity, and the date of use.
AABB supports the storage and issuance tissue standards implemented by The Joint Commission in 2005, and collaborated with the Centers for Disease Control and Prevention in a hospital survey to gather data on how tissues are managed within the hospital. As you know the AABB Tissue Committee has developed Guidelines for Managing Tissue Allografts in Hospitals and is currently writing a tissue handbook, both designed to improve safe handling of human tissues for transplantation.
Voluntary standard setting organizations such as AATB, EBAA and AABB have the ability to enforce standards among their accredited members. As noted in one recommendation in the Report – Tracking of tissue from donor to recipient/patient – it is necessary to “[examine] legal authority and current practices to study whether additional regulations in this area would be effective at protecting and promoting public health.” The question of ‘Who and How’ to enforce oversight from the donor to the recipient is one that we all struggle with. To date FDA has proceeded with tiered, risk-based approaches to regulatory oversight based on allograft types. We encourage FDA to maintain this approach in any future considerations.
AABB has been a leader in hosting and participating in workshops to improve recipient safety through improved management of tissues in the hospital setting and has taken a leadership role in the international effort to improve Biovigilance by extending existing program goals for blood product safety (Hemovigilance) to cellular and tissue products (Biovigilance). Most recently AABB participated in the CDC workshop “Preventing organ- and tissue allograft-transmitted infection: priorities for public health intervention”. AABB is focused on “closing the loop” between the donor and the recipient and improve reporting of untoward events, including unexpected, new and emerging infections.
As noted in the Report – Topic 2: Partnering, Leveraging, Education, and Outreach – “industry itself [has] important roles and responsibilities in protecting and advancing public health by having a safe supply of tissue available.” AABB is in a unique position to complement the progress made by AATB and EBAA in providing safe tissue by working with hospitals to ensure they develop the policies necessary to use tissue safely, including the ability to trace tissue from the donor to the recipient. As such we look forward to working with the agency in future efforts to improve recipient safety.
A. Bradley Eisenbrey
Chair, AABB Tissue Committee