The use of allograft bone in spine surgery: is it safe?

Spine Journal

Volumn 9, Issue 4, 2009, Pages 303-308

  Mroz, Thomas E ^a   Joyce, Michael J ^a   Lieberman, Isador H ^a   Steinmetz, Michael P ^a   Benzel, Edward C ^a   Wang, Jeffrey C ^b  

^a LERNER RESEARCH INSTITUTE   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

Allograft bone; Allograft recall; Allograft tissue; Disease transmission; Spine fusion

Indexed keywords

ARTICLE; BONE ALLOGRAFT; DISEASE TRANSMISSION; DONOR SELECTION; FOOD AND DRUG ADMINISTRATION; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; PRIORITY JOURNAL; SPINE SURGERY; VIRUS TRANSMISSION;

BONE TRANSPLANTATION; HUMANS; INCIDENCE; INFECTION; INFECTION CONTROL; RETROSPECTIVE STUDIES; RISK FACTORS; SAFETY; SPINAL DISEASES; TRANSPLANTATION, HOMOLOGOUS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 62649086001     PISSN: 15299430     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.spinee.2008.06.452     Document Type: Article

References (12)

1. Mroz T.E., Joyce M.J., Steinmetz M.P., et al. Musculoskeletal allograft risks and recalls in the United States. J Am Acad Ortho Surg 16 (2008) 559-565
2. Centers for Disease Control and Prevention. Invasive Streptococcus pyogenes after allograft implantation-Colorado. Morb Mortal Wkly Rep 52 (2003) 1173-1176
3. Centers for Disease Control and Prevention. Update: allograft-associated bacterial infections-United States. Morb Mortal Wkly Rep 51 (2002) 207-211
4. Simonds R.T., Holmberg S.D., Hurwitz R.L., et al. Transmission of human immunodeficiency virus Type 1 from a seronegative organ and tissue donor. N Engl J Med 326 (1992) 726-732
5. US Food and Drug Administration. Human tissue intended for tranplantation: final rule 21; CFR Pats 16, 1270. Fed Regist 62 (1997) 40429-40447. http://www.compliancehome.com/resources/FDA/Regulations/10154.htm Accessed September 8, 2006
6. US Food and Drug Administration. Human cells, tissues and cellular and tissue based products: establishment registration and listing; final rule. Fed Regist 66 (January 19, 2001) 5447-5469. http://www.fda.gov/cber/rules/frtisreg011901.htm Accessed January 19, 2001
7. US food and Drug Administration. Eligibility determination for donors of human cells tissues, and cellular and tissue base products; final rule 21 CFR 210, 211, 820, 1271. Fed Regist 69 (May 25, 2004) 29786-29834. http://www.fda.gov/cber/rules/suitdonor.htm Available at:
8. US Food and Drug Administration. Current good tissue practice for manufacturers of human cellular and tissue-based products. Establishment: inspection and enforcement; final rule 21CFR Parts 16, 1270 and 1271 (DEF). Fed Regist 69 (November 24, 2006) 611-68688. http://www.fda.gov/cber/rules/suitdonorcor.htm Available at:
9. The Joint Commission on Accreditation of Healthcare Organizations. Standards for tissue storage and issuance: PC.17.10, PC.17.20, and PC.17.30 (2005), The Joint Commission on Accreditation of Healthcare Organizations, Oakbrook Terrace, IL. http://www.jointcommission.org/NR/rdonlyres/36B194EA-A44B-9875-E53221A3CB87/0/OBS_TS_09_to_08.pdf Accessed September 4, 2008
10. Department of Health and Human Services, Office of the Inspector General. Oversight of tissue banking. January 2001: OEI-01-00-00441.
11. Joyce MJ. Seven simple questions to ask your tissue processor. AAOS Bulletin, Version date 4/26/05.
12. US Food and Drug Administration. Eligibility determination for donors of human cells, tissues and cellular and tissue-based products (HCT/Ps). Available at:. http://www.compliancehome.com/resources/FDA/Regulations/10154.html Accessed September 28, 2007