FDA blood bank

Purpose: Genomic alterations in blood-derived circulating tumor DNA (ctDNA) from patients with non-small cell lung adenocarcinoma (NSCLC) were ascertained and correlated with clinical characteristics and therapeutic outcomes. Experimental Design: Comprehensive plasma ctDNA testing was performed in 88 consecutive patients; 34 also had tissue next-generation sequencing; 29, other forms of genotyping; and 25 (28.4%) had no tissue molecular tests because of inadequate tissue or biopsy contraindications. Results: Seventy-two patients (82%) had ≥1 ctDNA alteration(s); among these, 75% carried alteration(s) potentially actionable by FDA-approved (61...

Analysis of cell-free DNA using next-generation sequencing (NGS) is a powerful tool for the detection/monitoring of alterations present in circulating tumor DNA (ctDNA). Plasma extracted from 171 patients with a variety of cancers was analyzed for ctDNA (54 genes and copy number variants (CNVs) in three genes (EGFR, ERBB2 and MET)). The most represented cancers were lung (23%), breast (23%), and glioblastoma (19%). Ninety-nine patients (58%) had at least one detectable alteration. The most frequent alterations were TP53 (29...

BACKGROUND: Chronic blood transfusion is the standard of care in the management of overt stroke due to sickle cell anemia (SS) to prevent recurrence of stroke. The problem arises when children are transitioned to adult care where blood transfusion may be discontinued. The purpose of this study was to report the outcome of 22 patients with SS and overt stroke who were transitioned to our adult program between 1993 and 2009. STUDY DESIGN AND METHODS: Transitioned patients were kept on chronic blood transfusion they had as children...

The field of transfusion medicine is on the threshold of a paradigm shift, as the technology for genotyping of red blood cell antigens, including US FDA-approved arrays, is now moving into standard practice. Access to cost-efficient, high-resolution genotyping has the potential to increase the quality of care by decreasing the risk for alloimmunization and incompatible transfusions in individuals on long-term blood transfusion protocols, including patient groups with hemoglobinopathies and other chronic diseases...

In Japan, biologics have been described as special sorts of medicines in the Pharmaceutical Affairs Law and are regulated by the Ministry of Health, Labour and Welfare (MHLW). In contrast, in the United States, some of the regulatory laws for biologics are different from other medicines and the relevant regulatory agencies have been changed historically. We reviewed the histories of the laws and changes in regulatory agencies for biologics, especially focusing plasma fractionation products in the United States, which may give suggestions and advice for the regulation of biologics in Japan...

Legal issues play a vital role in providing a framework for the Indian blood transfusion service (BTS), while ethical issues pave the way for quality. Despite licensing of all blood banks, failure to revamp the Drugs and Cosmetic Act (D and C Act) is impeding quality. Newer techniques like chemiluminescence or nucleic acid testing (NAT) find no mention in the D and C Act. Specialised products like pooled platelet concentrates or modified whole blood, therapeutic procedures like erythropheresis, plasma exchange, stem cell collection and processing technologies like leukoreduction and irradiation are not a part of the D and C Act...

Critical Care Case Report Posters IIISESSION TYPE: Affiliate Case Report PosterPRESENTED ON: Tuesday, October 28, 2014 at 01:30 PM - 02:30 PMINTRODUCTION: Cryopreserved hematopoietic stem cell transfusions are sometimes associated with transient and benign reactions like nausea, flushing and bradycardia. We present a patient who developed ventricular bigeminy during the infusion of peripheral blood stem cell transplant (PBSCT).CASE PRESENTATION: A 69-year-old man with a history of multiple myeloma, peripheral neuropathy and intermittent palpitations presented for autologous PBSCT after receiving two days of melphalan conditioning...

BACKGROUND: The blood recall process is intended to remove from use products that may be harmful, but characteristics of recalls nationally have not been reported. STUDY DESIGN AND METHODS: We analyzed recalls of all blood products for 2010 and categorized the reason for the recall, the organizations producing the recalled products, and the Food and Drug Administration (FDA) district in which the blood was collected. RESULTS: During 2010, there were 2468 recalls involving 8278 blood products...

BACKGROUND: Pretransfusion washing of red blood cells (RBCs) stored for a longer duration may have theoretical advantages but few data exist to support this practice. In many hospital settings, use of a point-of-care cell washer could conceivably be used to quickly wash allogeneic RBCs before transfusion. The purpose of this preliminary study was to compare a point-of-care device with a common blood bank device for washing longer-stored RBCs. STUDY DESIGN AND METHODS: Forty RBC units stored for 40 to 42 days were randomized to washing with the COBE 2991 device (Terumo BCT; FDA-cleared for washing stored RBCs) or the Cell Saver Elite (Haemonetics; FDA-cleared point-of-care device for processing and washing fresh autologous shed whole blood)...

BACKGROUND: Transfusion of bacterially contaminated platelet concentrates (PCs) can result in serious health consequences for the affected patient. Before being released from blood banking facilities, PCs are routinely screened for bacterial contamination by culture-based tests. However, culture-based PC screening methods require extended holding and incubation periods and are prone to false-negative results due to sampling error. Screening PCs closer to the time of transfusion using rapid point-of-issue tests represents an alternative approach; however, FDA-approved assays generally suffer from a lack of sensitivity...

BACKGROUND: Testing of platelets (PLTs) for bacterial contamination is required by the AABB Standards but is not fully standardized. On January 31, 2011, a new AABB Standard, 5.1.5.1.1, specified that bacterial detection methods for PLT components shall use assays either approved by the Food and Drug Administration (FDA) or validated to provide sensitivity equivalent to these FDA-approved methods. METHODS: An Internet-based survey of AABB member institutions was conducted from May to June 2012, to document current practices used in 2011 for bacterial detection in different PLT products and to assess the impact of the new standard...

The Food and Drug Administration (FDA) is revising the labeling requirements for blood and blood components intended for use in transfusion or for further manufacture by combining, simplifying, and updating specific regulations applicable to labeling and circulars of information. These requirements will facilitate the use of a labeling system using machine-readable information that would be acceptable as a replacement for the ``ABC Codabar'' system for the labeling of blood and blood components. FDA is taking this action as a part of its efforts to comprehensively review and, as necessary, revise its regulations, policies, guidances, and procedures related to the regulation of blood and blood components...

ISO/IEC 18000-3 mode 1 standard 13.56 MHz RFID tags have been accepted by the International Society for Blood Transfusion (ISBT) and the United States Food and Drug Administration (FDA) as data carriers to integrate with and augment ISBT 128 barcode data carried on blood products. The use of 13.56 MHz RFID carrying ISBT 128 data structures allows the global deployment and use of RFID, supporting both international transfer of blood and international disaster relief. The deployment in process at the BloodCenter of Wisconsin and testing at the University of Iowa Health Center is the first FDA-permitted implementation of RFID throughout in all phases of blood banking, donation through transfusion...

BACKGROUND: The Trima Accel displays a "verify WBCs" message if the plateletpheresis product (PLT) may not be leukoreduced (LR). Most blood banks require sensitive white blood cell (WBC) testing of these PLTs by flow or Nageotte. We evaluated how often these PLTs were non-LR by European or US Food and Drug Administration (FDA) criteria and whether sensitive WBC testing is necessary. STUDY DESIGN AND METHODS: Phase 1 reviewed the frequency of this message with various procedure types and the flow WBC results for PLTs with or without the message...

BACKGROUND: As early as 2001, the Food and Drug Administration (FDA) required blood centers and hospital transfusion services to report events associated with testing, storage, or distribution of blood products that deviated from current good manufacturing practices or affected the safety, purity, or potency of the product. Between 2004 and 2009, an average of only 8.6% of hospitals reported blood product deviations. STUDY DESIGN AND METHODS: Case scenarios designed to evaluate knowledge of FDA reportable deviations were developed and sent for evaluation to the Center for Biologics Evaluation and Research (CBER) and FDA division directors for FDA reportable deviations...

PURPOSE: To facilitate development of innovative immunotherapy approaches, especially for treatment concepts exploiting the potential benefits of personalized therapy, there is a need to develop and validate tools to identify patients who can benefit from immunotherapy. Despite substantial effort, we do not yet know which parameters of antitumor immunity to measure and which assays are optimal for those measurements. EXPERIMENTAL DESIGN: The iSBTc-SITC (International Society for Biological Therapy of Cancer-Society for Immunotherapy of Cancer), FDA (Food and Drug Administration), and NCI (National Cancer Institute) partnered to address these issues for immunotherapy of cancer...

The use of blood donor history and state-of-the-art FDA-licensed serological and nucleic acid testing (NAT) assays have greatly reduced the "infectious window" for several transfusion-transmitted pathogens. Currently transmission of human immunodeficiency virus (HIV), Human T-cell Lymphotropic Virus (HTLV), hepatitis viruses and West Nile Virus are rare events. The seroprevalence of cytomegalovirus in the donor population is high and cytomegalovirus infection can cause significant complications for immunocompromised recipients of blood transfusion...

No abstract text is available yet for this article.

BACKGROUND: The ACP 215 was a functional closed system for preparing glycerolized and deglycerolized RBCs, CSBT had approved the technique of long term storage glycerolized rare blood lower than -65°C, and then deglycerolized by this machine. From the manual method to use ACP 215, Chinese blood banks chose 9% sodium chloride and 0.9% sodium chloride in deglycerolization process, while the AABB guideline prescribed that 12% sodium chloride and 0.9% sodium chloride-0.2% glucose were acceptable in washing step of ACP 215...

In the US, blood donors face a variety of restrictions that leave many people excluded entirely from the donor pool. This paper explores the specific circumstances and meanings surrounding the donor ban on Men-who-have-Sex-with-Men (MSM). The ban on MSM is one of the few existing donor guidelines to receive considerable criticism on grounds that it effectively prohibits any sexually active gay man from donating blood and thus discriminates against gays. Due in part to these questions of fairness, the Blood Products Advisory Committee (BPAC) of the Food and Drug Administration (FDA) met to reconsider the decades-old policy, first in 1997 and again in 2000...