title: Reported infections after human tissue transplantation before and after new Food and Drug Administration (FDA) regulations, United States, 2001 through June, 2010.
abstract: Processors distributed about 1.5 million human tissue allografts in the U.S. in 2007. The potential for transmitting infections through allografts concerns clinicians and patients. In 2005, FDA implemented Current Good Tissue Practice (CGTP) rules requiring tissue establishments to report to FDA certain serious infections after allograft transplantations. We describe infection reports following tissue transplants received by FDA from 2005 through June, 2010, and compare reporting before and after implementation of CGTP rules. We identified reports received by FDA from January 2001 through June, 2010, for infections in human tissue recipients, examining the reports by tissue type, organism, time to onset, severity, and reporter characteristics. Among 562 reports, 83 (20.8/year) were received from 2001-2004, before the CGTP rules, 43 in the 2005 transition year, and 436 (96.9/year) from 2006 through June, 2010, after the rules. Tissue processors accounted for 84.2% of reports submitted after the rules, compared to 26.5% previously. Bacterial infections were the most commonly reported organisms before (64.6%) and after (62.2%) the new rules. Afterward, 2.5% (11) of reports described deaths, and 33.7% (147) involved hospitalizations. Before the rules, 13% (11) described deaths, and another 72% involved hospitalizations. Reports received by the FDA quadrupled since 2005, suggesting that CGTP regulations have contributed to increased reporting and improved tissue safety surveillance. However, these data do not confirm that the reported infections were caused by suspect tissues; most reports may represent routine post-surgical infections not actually due to allografts.
authors.affiliation: Office of Biostatistics and Epidemiology, FDA/CBER, 1401 Rockville Pike, Suite 400 S, Rockville, MD 20852, USA.
authors.forename: Tarun K
authors.initials: TK
authors.lastname: Mallick
authors.forename: Alexis
authors.initials: A
authors.lastname: Mosquera
authors.forename: Craig E
authors.initials: CE
authors.lastname: Zinderman
authors.forename: Laura
authors.initials: L
authors.lastname: St Martin
authors.forename: Robert P
authors.initials: RP
authors.lastname: Wise
mesh_terms: D003643:Death; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D007239:Infections / Q000453:epidemiology* / Q000209:etiology* / Q000382:microbiology / Q000821:virology; D058028:Research Report / Q000331:legislation & jurisprudence*; D012926:Social Control, Formal; D013997:Time Factors; D014184:Transplantation, Homologous / Q000009:adverse effects / Q000331:legislation & jurisprudence; D019737:Transplants / Q000009:adverse effects* / Q000382:microbiology / Q000706:statistics & numerical data / Q000821:virology; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*