Michael R. Roberts

4:35 Trends in recalls of musculoskeletal tissue allografts

Abstract Purpose of study: This poster provides an analysis of data collected and disseminated by the US Food and Drug Administration (FDA) concerning recalls of musculoskeletal tissue allografts and includes a discussion of the implications for patient safety. Methods used: The FDA collects and publishes information concerning recalls of regulated products, including musculoskeletal tissue allografts, on a weekly basis. For each recall, data are provided concerning the specific products involved in the recall, the “recalling” firm or manufacturer, the reasons for the recall, the volume of products and the geographic distribution of the recalled products. All FDA reports from 1994 through 2001 were reviewed to identify those recalls that involved musculoskeletal tissue. The reasons for recall, numbers of grafts recalled, trends over time and implications for patient safety were analyzed. of findings: From 1994 through 2001, a total of 15,338 musculoskeletal tissue allografts were recalled in the United States. The most common reasons for recall include “improper donor evaluation” (10,929 grafts; 71.3%), and/or presence of positive serology results (3,140 grafts; 20.5%), results (976 grafts; 6.4%). Analysis of trends over time show that improper donor screening and testing, mishandling of positive serology results and other human errors continue to occur quite commonly (to date, 1,235 musculoskeletal tissue grafts have been reported as recalled in 2001). Relationship between findings and existing knowledge: Case reports document that transmission of disease to allograft recipients has occurred because of graft contamination with each of the following pathogens: bacteria, fungi, human immunodeficiency virus, hepatitis B virus, hepatitis C virus, and human T-lymphotropic virus. Although it remains uncertain how many of the recalled allografts had already been implanted in recipients at the time of the recalls, data from the current analysis indicate that many recipients are being placed at risk each year because of human errors in screening, testing and processing donor musculoskeletal tissue. Overall significance of findings: Recent reports from the Centers for Disease Control emphasize that disease transmission to recipients through use of contaminated allografts represents an ongoing and serious public health problem. Some of the risk is the result of the inherent limitations of current methods of donor screening and testing (eg, false-negative test results) as well as lack of validation studies for most methods of processing musculoskeletal tissue to verify whether the allografts are not contaminated. Unfortunately, data from the current study document that human errors in screening and testing donors of musculoskeletal tissue represent an additional important source of risk for recipient exposure to various serious diseases. Adoption of quality improvement initiatives by the tissue bank industry might be useful in reducing the number of human errors. Also, there is a great need for validated methods of sterilizing allografts to prevent transmission of disease when donor screening and testing fail. Disclosures: No disclosures. Conflict of interest: Randal Mills, PhD, stockholder; Randal Mills, PhD, other support; Dayna Buskirk, employee of Regenerations Technologies, Inc.

4:41 Prevalence rates of human immunodeficiency virus, hepatitis B virus and hepatitis C virus among musculoskeletal tissue donors

Abstract Purpose of study: The purpose of this study was to determine the prevalence rates of human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) among potential musculoskeletal tissue donors tested during the period July 1996 through June 2001. Limitations of the methods of acquiring, screening and testing tissue donors that contribute to higher risk for viral contamination (relative to the risk of contamination of donated blood) were evaluated. Methods used: Data concerning the results of testing for HIV, HBV and HCV were collected from more than 19,000 potential donors recovered by 39 agencies and tested at various CLIA-certified laboratories within the United States. Consequently, the information is representative of trends throughout the United States both because of the very large sample size and because donors from all regions of the United States are represented in the findings. Generally, serological testing was performed after the potential donors had already passed the screening physical examination and review of medical records. of findings: From July 1996 through June 2001, a total of 6 of 19,329 (0.03%) potential musculoskeletal tissue donors tested positive for HIV 1/2 antibody, 56 of 19,297 (0.29%) tested positive for HBV and 205 of 19,300 (1.06%) had a positive result on HCV testing. Because many blood donors make repeated donations (and are therefore tested on multiple occasions), the prevalence rates of disease among such blood donors are only about one tenth as great as among first-time blood donors. Published prevalence rates among first-time blood donors are 0.015% for HIV, 0.2% for HBV and 0.4% for HCV. The data suggest that the prevalence rates of HIV, HBV and HCV are about 10 times greater or even somewhat higher among potential musculoskeletal tissue donors than among repeat blood donors. Relationship between findings and existing knowledge: Use of musculoskeletal allografts has grown dramatically in the United States in the past few years. Also, case reports document that disease transmission to recipients from allograft contamination with HIV, HBV or HCV has occurred. Our findings indicate that the risk of allograft contamination with those pathogens is much higher than the risk levels associated with donated blood. Because aseptic methods of processing musculoskeletal tissue have not been validated to inactivate and remove viruses and because current methods of testing for viruses have important limitations, recipients are placed at risk for exposure to contaminated allografts. Overall significance of findings: The risks of recipient exposure to a contaminated allograft and of disease transmission are directly proportional to the prevalence rates of HIV, HBV and HCV among potential musculoskeletal tissue donors. Our findings indicate that the likelihood of allograft contamination is about 10 times greater than the risk of contamination of donated blood. Because of the shortcomings of conventional methods of screening, testing and processing donor tissue, a validated method for sterilizing musculoskeletal allografts is needed to eliminate the risk of transmitting infectious diseases to recipients. Disclosures: No disclosures. Conflict of interest: Robert Kennedy, consultant; Randal Mills, stockholder; Michael Roberts, stockholder.