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Notice to Readers: FDA Rule for Current Good Tissue Practice for Human Cells, Tissues, and Cellular and Tissue-Based Products

On May 25, 2005, the Food and Drug Administration (FDA) will issue its Current Good Tissue Practice (CGTP) for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), representing the last of three FDA rules* that have been developed to improve the safety of HCT/Ps by preventing the introduction, transmission, and spread of communicable disease.

The CGTP regulations will require HCT/P establishments to recover, process, store, label, package, and distribute HCT/Ps in a way that prevents the introduction, transmission, or spread of communicable diseases. HCT/P establishments must also maintain complaint files and evaluate each complaint relating to core CGTP requirements. Such establishments will also be required to 1) investigate any adverse reaction involving a communicable disease related to an HCT/P they made available for distribution and 2) report to FDA any serious adverse reactions involving a communicable disease. Serious adverse reactions are defined by FDA as fatal, life-threatening, resulting in permanent impairment of a body function or permanent damage to body structure, or necessitating medical or surgical intervention, including hospitalization. The establishments will be required to use the FDA MedWatch mandatory reporting form (Form FDA-3500A) and submit each report to FDA within 15 days of initial receipt of the information. This will be the first federal requirement for reporting of adverse reactions from transplanted HCT/Ps.

Nearly simultaneously with the CGTP rule, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) revised its standards for the Laboratory Accreditation Program (revised standards QC.5.300, QC.5.310, and QC.5.320) and adopted these standards for the Ambulatory Care, Office-Based Surgery, Critical Access Hospital, and Hospital Accreditation programs (new standards PC.17.10, PC.17.20, and PC.17.30) (1,2). Effective July 1, 2005, these standards will apply to accredited organizations that store or issue tissue. These new standards will require that organizations assign oversight responsibility for a tissue program, use standardized procedures in all tissue handling, maintain traceability of all tissues, and have a process for investigating and reporting adverse events. All adverse events involving tissues, including disease transmission or other complications suspected of being directly related to tissue use, are to be investigated and reported to the HCT/P establishment from which the tissue was received.

Improved HCT/P adverse event surveillance from these two mandatory reporting rules is anticipated to improve the overall safety of HCT/Ps and reduce risk to HCT/P recipients. A successful surveillance system will be contingent upon reporting by physicians, infection-control practitioners, risk managers, and others who identify adverse events. Along with receiving mandatory reports from establishments, FDA continues to encourage direct voluntary reports through its MedWatch program by using MedWatch Form FDA-3500, available at http://www.fda.gov/medwatch. Additional information about FDA and HCT/Ps is available at http://www.fda.gov/cber/tiss.htm.

References

  1. Joint Commission on Accreditation of Healthcare Organizations. Revised laboratory standards: QC.5.300, QC.5.310, and QC.5.320. Oakbrook Terrace, IL: Joint Commission on Accreditation of Healthcare Organizations; 2005. Available at http://www.jcrinc.com/subscribers/perspectives.asp?durki=9162&site=10&return=6066.
  2. Joint Commission on Accreditation of Healthcare Organizations. Standards for tissue storage and issuance: PC.17.10, PC.17.20, and PC.17.30. Oakbrook Terrace, IL: Joint Commission on Accreditation of Healthcare Organizations; 2005. Available at http://www.jcrinc.com/subscribers/perspectives.asp?durki=9160&site=10&return=6065.

* Federal Register 66 FR 5447, January 19, 2001; 66 FR 29786, May 25, 2004; and 69 FR 68612, November 24, 2004.

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Date last reviewed: 5/18/2005

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