Clarification of FDA and The Joint Commission reporting requirements for US tissue recipient adverse reactions
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LETTER TO THE EDITOR
Clarification of FDA and The Joint Commission reporting requirements for US tissue recipient adverse reactions Tina Khoie Æ Craig E. Zinderman Æ Ruth Solomon Æ Robert P. Wise Æ Karen C. Lee Æ Klaus Nether
Received: 16 February 2007 / Accepted: 3 April 2007 / Published online: 2 May 2007 Ó Springer Science+Business Media B.V. 2007
In the September issue of Cell and Tissue Banking, Ted Eastlund’s article1, ‘‘Bacterial infection transmitted by human tissue allograft transplantation,’’ reviews important issues related to tissue transplantation and transmission of communicable disease. We would like to clarify the Food and Drug Administration (FDA) and The Joint Commission reporting requirements for tissue products and a difference in the types of reports each requires. Effective May 25, 2005, tissue establishments must report to FDA any serious adverse reaction2 that involves transmission of a communicable disease from a tissue product that they made available for
1
Eastlund (2006).
2
An adverse reaction is defined as a noxious and unintended response for which there is a reasonable possibility that the tissue caused the response. It is serious if it is fatal, life-threatening, results in permanent impairment of a body function or permanent damage to body structure, or necessitates medical or surgical intervention, including hospitalization.
T. Khoie (&) C. E. Zinderman R. Solomon R. P. Wise K. C. Lee Food and Drug Administration, Center for Biologics Evaluation and Research, Rockville, MD, USA e-mail: [email protected] K. Nether Division of Standards and Survey Methods, The Joint Commission, Oakbrook Terrace, IL, USA
distribution in the United States (US). FDA issued this reporting requirement as part of its Current Good Tissue Practice3 final rule. Mandatory reports must be submitted to FDA on MedWatch Form FDA 3500A within 15 days of initial receipt of the information. Tissue establishments can refer to FDA guidance, available online, for additional instructions on how to complete a mandatory MedWatch form.4 FDA also requires these establishments to investigate any tissue recipient adverse reaction that involves transmission of communicable disease. In contrast, organizations accredited by The Joint Commission that store or issue tissue in the US are required to report all tissue recipient adverse reactions. All recipient adverse reactions, including communicable disease transmission or other complications suspected of being directly related to tissue use, are to be investigated and reported directly to the establishment that supplied the tissue product. The Joint Commission implemented its new standards 3
Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments; Inspection and Enforcement, Final Rule. Federal Register 69 FR 68612, November 24, 2004.
4 Guidance for Industry: MedWatch Form FDA 3500A: Mandatory Reporting of Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/ Ps), Nove
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