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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.
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.
Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of
Health and Human Services.References to non-CDC sites on the Internet are
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endorsement of these organizations or their programs by CDC or the U.S.
Department of Health and Human Services. CDC is not responsible for the content
of pages found at these sites. URL addresses listed in MMWR were current as of
the date of publication.
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