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A correction has been published: N Engl J Med 2004;351(19):2025.
A correction has been published: N Engl J Med 2004;351(4):397.
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Background Allografts are commonly used in orthopedic reconstructive surgery. In 2001, approximately 875,000 musculoskeletal allografts were distributed by U.S. tissue banks. After the death from Clostridium sordellii sepsis of a 23-year-old man who had received a contaminated allograft from a tissue bank (Tissue Bank A), the Centers for Disease Control and Prevention initiated an investigation, including enhanced case finding, of the methods used for the recovery, processing, and testing of tissue.
Methods A case of allograft-associated clostridium infection was defined as a culture-proven infection of a surgical site within one year after allograft implantation, from January 1998 to March 2002. We traced tissues to tissue banks that recovered and processed these tissues. We also estimated the rates of and risk ratios for clostridium infections for tissues processed by the implicated tissue bank and reviewed processing and testing methods used by various tissue banks.
Results Fourteen patients were identified, all of whom had received allografts processed by Tissue Bank A. The rates of clostridium infection were 0.12 percent among patients who received sports-medicine tissues (i.e., tendons, femoral condyles, menisci) from Tissue Bank A and 0.36 percent among those who received femoral condyles in particular. The risk-ratio estimates for clostridium infections from tissues processed by Tissue Bank A, as compared with those from other tissue banks, were infinite (P<0.001) for musculoskeletal allografts, sports-medicine tissues, or tendons. Because Tissue Bank A cultured tissues only after treating them with a nonsporicidal antimicrobial solution, some test results were probably false negatives. Tissues from implicated donors were released despite the isolation of clostridium or bowel flora from other anatomical sites or reports of infections in other recipients.
Conclusions Clostridium infections were traced to allograft implantation. We provide interim recommendations to enhance tissue-transplantation safety. Tissue banks should validate processes and culture methods. Sterilization methods that do not adversely affect the functioning of transplanted tissue are needed to prevent allograft-related infections.
Source Information
From the Epidemic Intelligence Service, Division of Applied Public Health Training, Epidemiology Program Office (M.A.K.), and the Division of Healthcare Quality Promotion (M.A.K., D.N.W., H.T.H., W.R.J., D.B.J., L.K.A.), Centers for Disease Control and Prevention, Atlanta; the Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia (M.A.K.); and Wadsworth Center, New York State Department of Health, Albany (J.V.L.).
Address reprint requests to Dr. Kainer at the Tennessee Department of Health, 4th Fl., Cordell Hull Bldg., 425 5th Ave. N., Nashville, TN 37247, or at marion.kainer{at}state.tn.us.
Related Letters:
Infections Associated with Musculoskeletal-Tissue Allografts
De Andrade J. R., Ray G. S., Pruss A., Göbel U. B., Pauli G., Polder J. A., Wood J. J., Braun M. M., Kainer M. A., Jarvis W. R.
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N Engl J Med 2004;
351:1358-1360, Sep 23, 2004.
Correspondence
Correction: Infections and Musculoskeletal-Tissue Allografts
Kainer M. A., Archibald L. K.
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Full Text |
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N Engl J Med 2004;
351:397-398, Jul 22, 2004.
Correspondence
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