03305nas a2200397   4500008004100000022004200041245008600083210006900169250001000238300001200248490000600260520215300266653002702419653004802446653001502494653001002509653000902519653002202528653001002550653002102560653003702581653002502618653001102643653001102654653002002665653001602685653001702701653004602718653002202764653001802786100001202804700001702816700001202833700001302845856004902858       2007                        eng d  a1389-9333 (Print) 1389-9333 (Linking)00aInfections and human tissue transplants: review of FDA MedWatch reports 2001-20040 aInfections and human tissue transplants review of FDA MedWatch r  a39119  a211 - 90 v83 aBACKGROUND: 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%). CONCLUSION: 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.10a*Infection / mortality10a*United States Food and Drug Administration10aAdolescent10aAdult10aAged10aAged, 80 and over10aChild10aChild, Preschool10aCommunicable Diseases / etiology10aDisease Notification10aHumans10aInfant10aInfant, Newborn10aMiddle Aged10aTime Factors10aTissue Transplantation / *adverse effects10aTreatment Outcome10aUnited States1 aWang, S1 aZinderman, C1 aWise, R1 aBraun, M  uhttps://www.notifylibrary.org/reference/1604