title: Infections and human tissue transplants: review of FDA MedWatch reports 2001-2004.
abstract: BACKGROUND
  More than 1.5 million tissue allografts are transplanted annually in the U.S. As part of the federal effort to improve tissue safety, FDA's May 2005 Current Good Tissue Practices (CGTP) Rule requires tissue establishments to report to FDA serious infectious adverse events following allograft transplantation. To provide baseline data, we summarize reports of such infections received by FDA prior to the CGTP Rule.
  
  
  METHODS
  We reviewed reports received by FDA's MedWatch adverse event reporting system during 2001-2004. Our case definition was a reported infection in a human tissue transplant recipient within 1 year of transplantation. We examined demographics, tissue type, clinical outcomes and interventions, infectious organism(s), time from transplant to infection and reporter characteristics.
  
  
  RESULTS
  We identified 83 reports of infections following allograft transplantations. Median patient age was 40 years (range: 1 month-87 years). The allografts included heart valves (42%), tendons (33%), bones (8%), blood vessels (6%), ocular tissues (5%), and skin (4%). Commonly reported outcomes and interventions were hospitalization (72%), antibiotic therapy (46%) and graft removal (42%). Nine of 11 patients who expired had received heart valves. In 65 reports that identified suspected organisms, bacteria were most common (42), followed by fungi (25) and prions (1). The median time from transplant to infection was 5.5 weeks (range: 3 days-52 weeks). Tissue manufacturers submitted 26% of reports. Among the remaining 74%, the reporters were quality assurance staff, infection control or risk management personnel (45%); physicians (15%); consumers (15%); nurses (13%); and surgical staff (12%).
  
  
  CONCLUSIONS
  This is the first review of reports to FDA for infections following allograft tissue transplantations. Infections led to serious outcomes and involved many tissue types. Although we were unable to confirm that reported infections were caused by the suspected tissue product, required reporting by tissue establishments and improvements in adverse event investigation will help to improve tissue safety surveillance.
authors.affiliation: U.S. Food and Drug Administration/Center for Biologics Evaluation and Research/Office of Biostatistics and Epidemiology, 1401 Rockville Pike, Rockville, MD 20852, USA.
authors.forename: Su
authors.initials: S
authors.lastname: Wang
authors.forename: Craig
authors.initials: C
authors.lastname: Zinderman
authors.forename: Robert
authors.initials: R
authors.lastname: Wise
authors.forename: Miles
authors.initials: M
authors.lastname: Braun
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D003141:Communicable Diseases / Q000209:etiology; D018563:Disease Notification; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007239:Infections / Q000401:mortality; D008875:Middle Aged; D013997:Time Factors; D016378:Tissue Transplantation / Q000009:adverse effects*; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration