Managing a tissue recall in a large academic hospital.

Abstract:

BACKGROUND:In October 2005, a recall of human tissue for implantation was initiated because one recovery center obtained tissues from donors who were not screened properly for infectious diseases. The Food and Drug Administration (FDA) and Centers for Disease Control (CDC) recommended notifying affected patients and offering access to infectious disease testing. STUDY DESIGN AND METHODS:A multidisciplinary team was established to provide a framework for responding to the recall. The plan was designed to meet six goals. Steps included patient identification, surgeon and patient notification, patient education and testing, communication of test results, and information for the public. RESULTS:The institution received 55 recalled tissues, of which 48 had been implanted into 30 patients undergoing neurosurgical, orthopedic, and general surgical procedures. Patients were identified and sent notification letters within 2 weeks of the FDA and CDC recommendations. Twenty-seven patients underwent testing, which was performed at the convenience of the patients at no cost to them. One patient had evidence of previous (but not current) hepatitis B infection. Overall, patients were appreciative of the processes used. Media coverage was positive. CONCLUSION:The response plan was generally successful in achieving the established goals. Potential improvements were identified in several areas, including initial patient notification and coordination of test result communication. It is critical to allow flexibility to meet each patient's needs. The plan may serve as a template for use in future tissue recalls by other hospital-based tissue banks.

journal_name

Transfusion

journal_title

Transfusion

authors

Steelman VM,Schlueter AJ

doi

10.1111/j.1537-2995.2007.01211.x

subject

Has Abstract

pub_date

2007-05-01 00:00:00

pages

927-34

issue

5

eissn

0041-1132

issn

1537-2995

pii

TRF01211

journal_volume

47

pub_type

杂志文章
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    abstract::Donor deferral rates in regional blood centers vary from 5 to 24 per cent, reducing by more than 1,250,000 the number of units of volunteer blood available for transfusion in the nation each year. Those criteria for donor deferral which are intended to exclude donors likely to suffer a "donor reaction" are based parti...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1046/j.1537-2995.1980.20581034503.x

    authors: Tomasulo PA,Anderson AJ,Paluso MB,Gutschenritter MA,Aster RH

    更新日期:1980-09-01 00:00:00

  • Absence of acute adverse in vitro effects on aged AS-1 red blood cells and thawed plasma after prolonged exposure to 13.56-MHz radio energy.

    abstract:BACKGROUND:There is growing interest in radio frequency identification (RFID) technology for tracking blood products to improve productivity and safety in the transfusion medicine supply chain. We conducted a limited study to assess the temperature and biologic effects after extreme exposure to 13.56-MHz RF radiation o...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1111/j.1537-2995.2011.03534.x

    authors: Davis R,Gottschall J,Gutierrez A,Hohberger C,Graminske S,Veeramani D,Holcombe J

    更新日期:2012-09-01 00:00:00

  • A randomized, double-blind comparison of donor tolerance of 400 mL, 200 mL, and sham red cell donation.

    abstract:BACKGROUND:Volume replacement could allow the safe collection of twice the normal amount of red cells in a standard donation. Studies in small numbers of donors have shown that a temporary decrease in red cell mass is well tolerated when donors give twice the usual amount (170-225 mL) of red cells in a standard 405- to...

    journal_title:Transfusion

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1046/j.1537-2995.1996.36896374369.x

    authors: Smith KJ,James DS,Hunt WC,McDonough W,Quintana R

    更新日期:1996-08-01 00:00:00

  • Evaluation of immunohematologic routine methods using the new erythrocyte-magnetized technology on the QWALYS 2 system.

    abstract:BACKGROUND:QWALYS 2 is a fully automated system for ABO/D grouping, Rh phenotyping, K typing, and antibody screening (ABS). Its new erythrocyte-magnetized technology (EMT) is based on the use of magnetic nanoparticles and avoids centrifugation and washing steps. STUDY DESIGN AND METHODS:Overall 499 blood samples were ...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1111/j.1537-2995.2009.02136.x

    authors: Schoenfeld H,Bulling K,von Heymann C,Neuner B,Kalus U,Kiesewetter H,Pruss A

    更新日期:2009-07-01 00:00:00

  • Influence of a 12-hour, 22 degrees C holding period for buffy coats on the preparation of platelet concentrates stored in plasma.

    abstract:BACKGROUND:The preparation of platelet concentrates (PCs) from buffy coats (BCs) stored at room temperature is controversial, because of the strong metabolic activity of cells in BCs and the possible detrimental effect of neutrophil enzymes on platelets when the holding time before separation is prolonged. Despite good...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1046/j.1537-2995.1994.341095026974.x

    authors: Boeri N,Saleun S,Pelissier E,Saleun JP,Aiach M,Rendu F

    更新日期:1994-10-01 00:00:00

  • A novel A allele with 664G>A mutation identified in a family with the Am phenotype.

    abstract:BACKGROUND:The Am phenotype has been characterized as a weak expression of the A antigen on red blood cells but the presence of a normal quantity of the A antigen in saliva. This study describes a molecular genetic analysis of members of an Am family. STUDY DESIGN AND METHODS:The eight exon regions of the ABO genes of...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1111/j.1537-2995.2005.04132.x

    authors: Lin M,Hou MJ,Twu YC,Yu LC

    更新日期:2005-01-01 00:00:00

  • Glucose-6-phosphate dehydrogenase activity decreases during storage of leukoreduced red blood cells.

    abstract:BACKGROUND:During storage, the activity of the red blood cell (RBC) antioxidant system decreases. Glucose-6-phosphate dehydrogenase (G6PD) is essential for protection against oxidative stress by producing NADPH. G6PD function of RBC transfusion products is reported to remain stable during storage, but activity was meas...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1111/trf.13378

    authors: Peters AL,van Bruggen R,de Korte D,Van Noorden CJ,Vlaar AP

    更新日期:2016-02-01 00:00:00

  • Chemokines in stored platelet concentrates.

    abstract:BACKGROUND:Platelets contain several mediators, belonging to a family of proinflammatory cytokines named chemokines, that are stored in the organelles. Release and accumulation of these chemokines during storage of platelet concentrates (PCs) might be responsible for nonhemolytic transfusion reactions. STUDY DESIGN AN...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1046/j.1537-2995.1996.36596282589.x

    authors: Bubel S,Wilhelm D,Entelmann M,Kirchner H,Klüter H

    更新日期:1996-05-01 00:00:00

  • Comparison of the recovery and half-life of a high-purity factor IX concentrate with those of a factor IX complex concentrate. Factor IX Study Group.

    abstract:BACKGROUND:Recovery and half-life estimations were carried out to compare a high-purity factor IX concentrate with an established factor IX complex concentrate. STUDY DESIGN AND METHODS:Two high-purity factor IX concentrates, which are identical except for the presence or absence of heparin (Immuninehep-plus and Immun...

    journal_title:Transfusion

    pub_type: 临床试验,杂志文章

    doi:10.1046/j.1537-2995.1995.35495216081.x

    authors: Poon MC,Aledort LM,Anderle K,Kunschak M,Morfini M

    更新日期:1995-04-01 00:00:00

  • Metagenomics analysis of red blood cell and fresh-frozen plasma units.

    abstract:BACKGROUND:Although the risk of transmitting infectious agents by blood transfusion is dramatically reduced after donor selection, leukoreduction, and laboratory testing, some could still be present in donor's blood. A description of metagenomes in blood products eligible for transfusion represents relevant information...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1111/trf.14148

    authors: Lau P,Cordey S,Brito F,Tirefort D,Petty TJ,Turin L,Guichebaron A,Docquier M,Zdobnov EM,Waldvogel-Abramowski S,Lecompte T,Kaiser L,Preynat-Seauve O

    更新日期:2017-07-01 00:00:00

  • Human platelets target dendritic cell differentiation and production of proinflammatory cytokines.

    abstract:BACKGROUND:Dendritic cells (DCs) are the most potent antigen-presenting cells that initiate and regulate immune responses. They are unique in their feature to produce bioactive interleukin (IL)-12, a major proinflammatory cytokine connecting innate and adaptive immunity. Platelets (PLTs) are highly reactive components ...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1111/j.1537-2995.2006.00802.x

    authors: Kissel K,Berber S,Nockher A,Santoso S,Bein G,Hackstein H

    更新日期:2006-05-01 00:00:00

  • Pathogen safety of a pasteurized four-factor human prothrombin complex concentrate preparation using serial 20N virus filtration.

    abstract:BACKGROUND:Beriplex P/N/Kcentra/Coaplex/Confidex is a four-factor human prothrombin complex concentrate (PCC). Here, we describe the pathogen safety profile and biochemical characteristics of an improved manufacturing process that further enhances the virus safety of Beriplex P/N. STUDY DESIGN AND METHODS:Samples of p...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1111/trf.14010

    authors: Nowak T,Popp B,Gröner A,Schäfer W,Kalina U,Enssle K,Roth NJ

    更新日期:2017-05-01 00:00:00

  • Multiple hemolytic transfusion reactions misinterpreted as severe vaso-occlusive crisis in a patient with sickle cell disease.

    abstract:BACKGROUND:Hemolytic transfusion reactions are a rare, yet serious complication of red blood cell (RBC) transfusion. Patients with sickle cell disease (SCD) are at an increased risk for such reactions, because they are prone to make alloantibodies against transfused RBCs, complicating this integral part of their diseas...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1111/trf.15010

    authors: Dean CL,Maier CL,Roback JD,Stowell SR

    更新日期:2019-02-01 00:00:00

  • Sequence analysis of two variable cytomegalovirus genes for distinction between transfusion- and breast milk-transmitted infections in a very-low-birthweight infant.

    abstract:BACKGROUND:Cytomegalovirus (CMV) infections in very-low-birthweight infants can lead to serious clinical consequences. When CMV-related symptoms occur after transfusion, CMV transmission is often attributed to the transfusion products rather than to breast milk. However, it is sometimes difficult to distinguish between...

    journal_title:Transfusion

    pub_type:

    doi:10.1111/trf.13547

    authors: Yamagishi N,Furui Y,Koshinami S,Ichijo K,Shimizu Y,Hoshi Y,Gotanda Y,Miyakawa K,Uchida S,Tadokoro K,Nagai T,Satake M

    更新日期:2016-06-01 00:00:00

  • Association of ABO blood group with P-selectin levels in Chinese Han healthy volunteers.

    abstract:BACKGROUND:Recent genome-wide association studies in Caucasians suggested that an association exists between the ABO gene locus and soluble levels of P-selectin (sP-selectin). However, it is unclear if the relationship corresponds to the phenotypic expression of ABO groups or is present in different ethnic groups. The ...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1111/trf.13212

    authors: Chen Y,Zhuo X,Lin Y,Huang W,Xiao J,Zeng J,Jiang L,Chen C,Lin H,Dettke M

    更新日期:2015-11-01 00:00:00

  • NAT screening of blood donors for severe acute respiratory syndrome coronavirus can potentially prevent transfusion associated transmissions.

    abstract:BACKGROUND:The severe acute respiratory syndrome (SARS) was first described in February 2003. Close contact with symptomatic patients appears to be the main route of transmission, whereas blood transfusion transmission could not be ruled out. STUDY DESIGN AND METHODS:A SARS coronavirus (SARS-CoV) detection kit develop...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1111/j.1537-2995.2004.03269.x

    authors: Schmidt M,Brixner V,Ruster B,Hourfar MK,Drosten C,Preiser W,Seifried E,Roth WK

    更新日期:2004-04-01 00:00:00

  • Preparation of white cell-depleted red cells for 42-day storage using an integral in-line filter.

    abstract::A new blood pack system for the preparation of white cell-depleted red cells was studied. The system is a modified additive-solution quadruple-unit blood pack that incorporates a cellulose-acetate fiber depth filter in-line between the AS-3 additive bag and the CP2D collection bag. Mean +/- SD white cell removal from ...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1046/j.1537-2995.1989.29689318446.x

    authors: Davey RJ,Carmen RA,Simon TL,Nelson EJ,Leng BS,Chong C,Garcez RB,Sohmer PR

    更新日期:1989-07-01 00:00:00

  • Transfusion-associated Serratia marcescens infection: studies of the mechanism of action.

    abstract::The growth of two strains of Serratia marcescens in blood components was tested in this study. One of the strains had been implicated in the epidemic of transfusion-associated sepsis experienced in Denmark and Sweden in 1991. In whole blood with a final concentration of 100 colony-forming units per mL of S. marcescens...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1046/j.1537-2995.1993.331094054615.x

    authors: Gong J,Högman CF,Hambraeus A,Johansson CS,Eriksson L

    更新日期:1993-10-01 00:00:00

  • Impact of cytomegalovirus (CMV) antibody reflex testing in the transfusion service on management of CMV-seronegative blood inventory.

    abstract:BACKGROUND:Our goal is to minimize unnecessary cytomegalovirus (CMV)-seronegative blood transfusion to preserve the CMV-seronegative blood inventory for patients who are identified as CMV seronegative. STUDY DESIGN AND METHODS:We implemented a CMV antibody reflex testing protocol for patients who require CMV-compatibl...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1111/j.1537-2995.2010.02643.x

    authors: Fontaine MJ,Jurado C,Miller E,Viele M,Goodnough LT

    更新日期:2010-08-01 00:00:00

  • Major transfusions remain frequent despite the generalized use of tranexamic acid: an audit of 3322 patients undergoing cardiac surgery.

    abstract:BACKGROUND:Aprotinin has been reapproved for use in Europe and in Canada. We sought to determine if its reintroduction was still pertinent given the widespread administration of tranexamic acid, another antifibrinolytic shown to reduce bleeding and transfusions. STUDY DESIGN AND METHODS:After institutional review boar...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1111/trf.13615

    authors: Stevens LM,Noiseux N,Prieto I,Hardy JF

    更新日期:2016-07-01 00:00:00

  • Center error reduction by recheck of blood type.

    abstract::Our computer system currently stores donor blood types for seven years and checks typing of all repeat donors against these files. In a recent three-month period (42,500 units), five discrepancies were found--two representing current error. Retrospective analysis of 18 errors made over the last three years showed that...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1046/j.1537-2995.1981.21281178157.x

    authors: Grindon AJ,Liles BA

    更新日期:1981-03-01 00:00:00

  • Addressing gaps in international blood availability and transfusion safety in low- and middle-income countries: a NHLBI workshop.

    abstract::In April 2017, a workshop sponsored by the National Heart, Lung, and Blood Institute, Division of Blood Diseases and Resources, and the Center for Translation Research and Implementation Science was held to discuss blood availability and transfusion safety in low- and middle-income countries (LMICs). The purpose of th...

    journal_title:Transfusion

    pub_type: 杂志文章,评审

    doi:10.1111/trf.14598

    authors: Custer B,Zou S,Glynn SA,Makani J,Tayou Tagny C,El Ekiaby M,Sabino EC,Choudhury N,Teo D,Nelson K,Peprah E,Price L,Engelgau MM

    更新日期:2018-05-01 00:00:00

  • Quality of red blood cells washed using the ACP 215 cell processor: assessment of optimal pre- and postwash storage times and conditions.

    abstract:BACKGROUND:Washing of red blood cell concentrates (RCCs) is required for potassium-sensitive transfusion recipients, including neonates in need of large-volume transfusions. When open, nonsterile washing systems are used, postwash outdate time is limited to 24 hours, often leading to problems providing the component to...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1111/trf.12170

    authors: Hansen A,Yi QL,Acker JP

    更新日期:2013-08-01 00:00:00

  • Anti-Dob implicated as the cause of a delayed hemolytic transfusion reaction.

    abstract::A 27-year-old, gravida 3, para 2 woman experienced a delayed hemolytic transfusion reaction. She had anti-Dob in both serum and eluate 8 days after infusion of 6 units of Do(b+) red cells. No antibody had been detected prior to transfusion. By the 15th day after transfusion, there was no evidence of survival of red ce...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1046/j.1537-2995.1985.25185116501.x

    authors: Moheng MC,McCarthy P,Pierce SR

    更新日期:1985-01-01 00:00:00

  • Prevalence of transfusion-transmissible viral infections in first-time US blood donors by donation site.

    abstract:BACKGROUND:Understanding the donor base, infectious disease prevalence, and donation loss at various blood donation sites will help maximize blood collection efforts and blood availability. STUDY DESIGN AND METHODS:Using donation data collected at five US blood centers, the prevalence of HIV, HTLV, HBsAg, and HCV in f...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1046/j.1537-2995.2003.00399.x

    authors: Wang B,Schreiber GB,Glynn SA,Nass CC,Smith JW,Higgins MJ,Hutching ST,Wright DJ,McEntire RL,Murphy EL,Retrovirus Epidemiology Donor Study.

    更新日期:2003-06-01 00:00:00

  • Safety of blood donation by individuals over age 70 and their contribution to the blood supply in five developed countries: a BEST Collaborative group study.

    abstract:BACKGROUND:Some countries impose an upper age limit on whole blood and double RBC donation while others do not. We evaluated the safety of blood donation in older individuals (≥71 years), and their contribution to the blood supply of five countries. STUDY DESIGN AND METHODS:Twelve blood center members of the Biomedica...

    journal_title:Transfusion

    pub_type: 杂志文章,多中心研究

    doi:10.1111/trf.15132

    authors: Goldman M,Germain M,Grégoire Y,Vassallo RR,Kamel H,Bravo M,Irving DO,Di Angelantonio E,Steele WR,O'Brien SF,Biomedical Excellence for Safer Transfusion Collaborative (BEST) Investigators.

    更新日期:2019-04-01 00:00:00

  • Vancomycin-induced red cell aggregation.

    abstract::Vancomycin, an antibiotic similar in structure to ristocetin, is used to treat staphylococcal infections. However, vancomycin-induced hemagglutination complicated red cell (RBC) serologic testing in the blood bank. At concentrations greater than 3.0 mg per ml, vancomycin caused spontaneous macroscopic red cell (RBC) a...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1046/j.1537-2995.1989.29189101158.x

    authors: Williams L,Domen RE

    更新日期:1989-01-01 00:00:00

  • Mixed-type autoimmune hemolytic anemia: differential diagnosis and a critical review of reported cases.

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    journal_title:Transfusion

    pub_type: 杂志文章,评审

    doi:10.1111/j.1537-2995.2008.01805.x

    authors: Mayer B,Yürek S,Kiesewetter H,Salama A

    更新日期:2008-10-01 00:00:00

  • Extended blood grouping of blood donors with automatable PCR-ELISA genotyping.

    abstract:BACKGROUND:In the past 10 years, PCR-based methods have been described to allow the detection of gene polymorphisms responsible for many blood group antigens. These methods are routinely used to test samples of fetal origin and to resolve serologic discrepancies. Another interesting application of blood group genotypin...

    journal_title:Transfusion

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1046/j.1537-2995.2003.00474.x

    authors: St-Louis M,Perreault J,Lemieux R

    更新日期:2003-08-01 00:00:00

  • Mobilization, collection, and immunomagnetic selection of peripheral blood CD34 cells in recovered aplastic anemia patients.

    abstract:BACKGROUND:Most patients with severe aplastic anemia (sAA) respond to immunosuppression, but a significant number relapse or develop clonal abnormalities such as paroxysmal nocturnal hemoglobinuria, myelodysplasia, or leukemia. In principle, patients without matched sibling donors and older patients might benefit from ...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1111/j.1537-2995.2007.01258.x

    authors: Sloand EM,Read EJ,Scheinberg P,Tang Y,More K,Leitman SF,Maciejewski J,Young NS

    更新日期:2007-07-01 00:00:00