HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:

This Article Full Text Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Google Scholar Articles by Holtzclaw, D. Articles by Callan, D. PubMed PubMed Citation Articles by Holtzclaw, D. Articles by Callan, D.

A Review

Background. Recent media reports concerning "stolen body parts" have shaken the public’s trust in the safety of and the use of ethical practices involving human allografts. The authors provide a comprehensive review of the safety aspects of human bone allografts.

Methods. The authors reviewed U.S. government regulations, industry standards, independent industry association guidelines, company guidelines and scientific articles related to the use of human bone allografts in the practice of dentistry published in the English language.

Results. The use of human bone allografts in the practice of dentistry involves the steps of procurement, processing, use and tracking. Rigorous donor screening and aseptic proprietary processing programs have rendered the use of human bone allografts safe and effective as a treatment option.

Conclusions. When purchasing human bone allografts for the practice of dentistry, one should choose products accredited by the American Association of Tissue Banks for meeting uniformly high safety and quality control measures.

Clinical Implications. Knowledge of human bone allograft procurement, processing, use and tracking procedures may allow dental clinicians to better educate their patients and address concerns about this valuable treatment option.

Key Words: Bone; bone grafting; disclosure; doctor-patient relationship; documentation; patient education

Abbreviations: AATB: American Association of Tissue Banks. • BTS: Biomedical Tissue Services. • CBER: Center for Biologics Evaluation and Research. • CFR: Code of Federal Regulations. • CGTPR: Current good tissue practice rule. • CLIA: Clinical Laboratory Improvement Amendment. • DEFR: Donor eligibility final rule. • DFDBA: Demineralized freeze-dried bone allograft. • FDA: U.S. Food and Drug Administration. • FDBA: Freeze-dried bone allograft. • HBcAb: Hepatitis B core antibody. • HBsAg: Hepatitis B surface antigen. • HBV: Hepatitis B virus. • HCT/P: Human cellular and tissue-based product. • HCV: Hepatitis C virus. • HCVAb: Hepatitis C antibody. • HIV: Human immunodeficiency virus. • HIV-1/2Ab: Human immunodeficiency virus 1 antibody/human immunodeficiency virus 2b antibody. • HTLV: Human T-lymphotropic virus. • HTLV-1/2Ab: Human T-cell lymphotrophic virus 1 antibody and human T-cell lymphotrophic virus 2 antibody. • ISO: International Organization for Standardization. • NAT: Nucleic acid test. • RPR/STS: Rapid plasma reagin/serologic test for syphilis. • SAL: Sterility assurance level.