| Date Posted |
Subject |
| Dec. 26, 2008 |
Class 1 Recall: Stryker Leibinger USA., Stryker Custom Cranial Implant Kits (FDA/CDRH) |
| Dec. 26, 2008 |
Bioreactors might solve blood-platelet supply problems (EurekAlert) |
| Dec. 22, 2008 |
Electronic Biological Product Deviation Reporting (eBPDR): Latest System Changes and Instructions for Using the eBPDR System (FDA/CBER) |
| Dec. 7, 2008 |
New CDC Recommendations: Revised Surveillance Case Definitions for HIV Infection Among Adults, Adolescents, and Children Aged <18 Months and for HIV Infection and AIDS Among Children Aged 18 Months to <13 Years - United States, 2008. Dec. 5, 2008 / 57(RR10);1-8. |
| Dec. 7, 2008 |
Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics (FDA/CBER) |
| Dec. 4, 2008 |
Press Release: ACP Recommends Routine HIV Screening for All Patients Also see: Qaseem A, et al. Screening for HIV in Health Care Settings: A Guidance Statement From the American College of Physicians and HIV Medicine Association. Ann Intern Med. 20 Jan 2009; 150(2). |
| Nov. 25, 2008 |
Article: Atzil, S, et al. Blood Transfusion Promotes Cancer Progression: A Critical Role for Aged Erythrocytes. Anesthesiology. Dec 2008. 109(6):989-997. |
| Nov. 25, 2008 |
Urgent Medical Device Removal - updated for additional lot numbers: Thermogenesis AXP Processing Bagset (FDA/CBER) |
| Nov. 23, 2008 |
First Edition Paper: Zhang W, et al. Role of molecular mimickry of hepatitis C-virus (HCV) protein with platelet GPIIIa in hepatitis C-related immunologic thrombocytopenia. Blood. Prepublished online November 20, 2008; DOI 10.1182/blood-2008-09-181073. |
| Nov. 18, 2008 |
Draft Guidance for Industry on Process Validation: General Principles and Practice (FDA/CBER) |
| Nov. 16, 2008 |
Annual Summary for Fiscal Year 2007: Fatalities Reported to FDA Following Blood Collection and Transfusion (FDA/CBER) |
| Nov. 11, 2008 |
Article: Katz LD, et al. Performance of an algorithm for the reentry of volunteer blood donors deferred due to false-positive test results for antibody to hepatitis B core antigen. Transfusion. 2008 Jul 17; 48(11):2315-22. |
| Nov. 11, 2008 |
Importance of Influenza Vaccination for Health Care Personnel (FDA/CBER) |
| Oct. 30, 2008 |
News Release: Northfield Laboratories Inc. Announces Submission of BLA for PolyHeme(R) - Requests Priority Review |
| Oct. 29, 2008 |
'Old blood' linked to infection: Current blood storage length debated (EurekAlert!) |
| Oct. 24, 2008 |
First Edition Paper: Stasi R, et al. Effects of eradication of Helicobacter pylori infection in patients with immune thrombocytopenic purpura. A systematic review.
Blood. prepublished online October 22, 2008; DOI 10.1182/blood-2008-07-167155. |
| Oct. 22, 2008 |
Ohio joining trend of color-coded wristbands to reduce hospital errors (Cleveland.com) |
| Oct. 22, 2008 |
First Edition Paper: Bruce LJ, et al. The monovalent cation leak in over-hydrated stomatocytic red blood cells results from amino acid substitutions in the Rh associated glycoprotein (RhAG). Blood. prepublished online October 17, 2008; DOI 10.1182/blood-2008-07-171140. |
| Oct. 14, 2008 |
REDS-II RFP: Call for Refinement and Evaluation of HIV-1 Blood Donor Screening Tests |
| Oct. 12, 2008 |
Standards Improvement Initiative: Proposed Revisions to the Transplant Safety (TS) chapter for the Laboratory (LAB) program (The Joint Commission) |
| Oct. 12, 2008 |
Letter: Shulman, IA. The pursuit of happyness, transfusions, and blood donation on the screen. Transfusion. 2008 Oct. 48(10);2267. |
| Oct. 12, 2008 |
Full Text Article: Wagar EA, et al. Specimen Labeling Errors: A Q-Probes Analysis of 147 Clinical Laboratories. Arch Pathol Lab Med. 2008 Oct;132(10):1617-22. |
| Oct. 12, 2008 |
FDA News: FDA Licenses Drug to Prevent Joint Damage in Children with Hemophilia A Also see: Product Approval Information (FDA/CBER) |
| Oct. 10, 2008 |
Changing name to LifeStream reflects blood bank's larger mission (Press-Enterprise) |
| Oct. 10, 2008 |
Medical Device Notification (PSN-08-09): Sunquest Laboratory Blood Bank and Blood Donor Modules (FDA/CBER) |
| Oct. 10, 2008 |
Human Cell, Tissues and Cellular and Tissue-Based Products (HCT/P)-
Alphabetical List of Registered Establishments, updated Oct. 6, 2008 (FDA/CBER) |
| Oct. 3, 2008 |
US Consensus Standard DRAFT - The United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components using ISBT 128, Version 3, DRAFT C is now available for public comment until December 1st. (ICCBBA) Also see related e-Network Forum discussion |
| Oct. 2, 2008 |
HIV Prevalence Estimates - United States, 2006. MMWR. Oct 3, 2008 / 57(39); 1073-6. |
| Oct. 2, 2008 |
Letter: Dengue Hemorrhagic Fever Transmitted by Blood Transfusion. N Engl J Med. 2008 Oct 359:1526-7. |
| Sept. 30, 2008 |
Research Paper: Rachel JM, et al. Monoclonal B-cell lymphocytosis in blood donors. Br J Haematol. 2007 Dec;139(5):832-6. |
| Sept. 30, 2008 |
Verax Biomedical granted CE mark for Platelet PGD test (Pharmaceutical Business Review) |
| Sept. 27, 2008 |
Early Communication about an Ongoing Safety Review, Epoetin alfa (FDA/CDER) |
| Sept. 27, 2008 |
First Edition Paper: An, X et al. Adhesive activity of Lu glycoproteins is regulated by interaction with spectrin. Blood. prepublished online September 26, 2008; DOI 10.1182/blood-2008-03-146068. |
| Sept. 19, 2008 |
Subpopulation Estimates from the HIV Incidence Surveillance System - United States, 2006. MMWR. Sept. 12, 2008 / 57(36);985-9. |
| Sept. 16, 2008 |
Related Articles of Interest:
• Johnson V, et al. Emergency transfusion of incompatible red blood cells [letter]. Arch Pathol Lab Med 2007;131:1514–15.
• Ong MG, et al. Emergency Transfusion of Incompatible Red Blood Cells [letter]. Arch Pathol Lab Med 2008;132:1386-86.
• Johnson V, et al. In Reply [letter]. Arch Pathol Lab Med 2008;132:1386-86.
|
| Sept. 16, 2008 |
Progressive Multifocal Leukoencephalopathy with use of Rituxan in patient with rheumatoid arthritis (FDA/MedWatch) |
| Aug. 27, 2008 |
Blood Transfusion, Anesthesia, and Surgery Linked to NHL Risk (RM Global Health). Also see: Cerhan JR, et al. Blood transfusion, anesthesia, surgery and risk of non-Hodgkin lymphoma in a population-based case-control study. Int J Cancer 2008;123:888-894. |
| Aug. 26, 2008 |
Time is start-up's precious product:A U of M spinoff aims to use its drug therapy to extend the "golden hour" for people who have life-threatening injuries (Star Tribune) |
| Aug. 25, 2008 |
FDA News: FDA Approves First Bone Marrow Stimulator to Treat Immune-Related Low Platelet Counts Also See: Press Release: FDA Approves Nplate(TM) for Long-Term Treatment of Adult Chronic ITP (Amgen) |
| Aug. 25, 2008 |
First Edition Paper: Kurtzberg J, et al. Results of the Cord Blood Transplantation Study (COBLT): Clinical outcomes of unrelated donor umbilical cord blood transplantation in pediatric patients with hematologic malignancies. Blood. Prepublished online August 21, 2008. DOI 10.1182/blood-2007-06-098020. |
| Aug. 21, 2008 |
Recall: Antihemophilic Factor, Human: CSL Behring L.L.C. Monoclate-P®, 1000 Unit Vials (FDA/CBER) |
| Aug. 15, 2008 |
Guidance for Industry - Medical Device Tracking; Guidance for Industry and FDA Staff (FDA/CDRH) |
| Aug. 8, 2008 |
Patient Safety News: Preventing Medical Errors - Danger Giving Topical Thrombin Intravascularly (FDA/CDRH) |
| Aug. 8, 2008 |
Persons Tested for HIV - United States, 2006. MMWR. August 8, 2008. 57(31);845-849 |
| Aug. 8, 2008 |
First Edition Paper: Ghiran I, et al. Ligation of erythrocyte CR1 induces its clustering in complex with scaffolding protein FAP-1. Blood. Pre-published online Aug 6, 2008 |
| Aug. 5, 2008 |
Class 1 Recall: Levitronix CentriMag Extracorporeal Blood Pumping System: CentriMag Primary Console (with v200 Application Software) (FDA/MedWatch) |
| July 31, 2008 |
Follow Up to the January 3, 2008 Communication About an Ongoing Safety Review Erythropoiesis-Stimulating Agents (ESAs) Epoetin alfa (marketed as Procrit, Epogen) Darbepoetin alfa (marketed as Aranesp) (FDA/CDER) |
| July 31, 2008 |
At baby shower, a medical pitch: Storage of cord blood for fee urged (Boston Globe) |
| July 26, 2008 |
Peer Review and Staff Privileges - text of the opinion Smith v. Selma Community Hospital |
| July 26, 2008 |
Brief Report: Lymphocytic
Choriomeningitis Virus Transmitted Through Solid
Organ Transplantation - Massachusetts, 2008.
MMWR July 25, 2008 / 57(29);799-801. |
| July 21, 2008 |
The Joint Commission is requesting stakeholder review and public comment of Blood Management Performance Measures (Joint Commission) |
| July 19, 2008 |
News Release: Statement from The Joint Commission Regarding Application for Hospital Deeming Authority (Joint Commission) |
| July 18, 2008 |
Medical Device Notification (PSN-08-05) Sunquest Laboratory Blood Bank and Blood Donor Modules -Updated (FDA/CBER) |
| July 17, 2008 |
Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency (FDA/CBER) |
| July 16, 2008 |
Feature Story: For RBCs, out with the old, in with the new? (CAP Today) |
| July 16, 2008 |
Full Text Article: Scott BH, et al. Blood transfusion is associated with increased resource utilisation, morbidity and mortality in cardiac surgery. Ann Card Anaesth 2008;11:15-19. |
| July 16, 2008 |
Important Drug Warning: Microangiopathic Hemolytic Anemia (MAHA) in Patients
treated with Avastin® (bevacizumab) and sunitinib malate: Genentech, Inc. (FDA/Medwatch) |
| July 3, 2008 |
Public Health Notification: Life-threatening Complications Associated with Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion (FDA/CDRH) |
| June 26, 2008 |
Report: Trends in HIV/AIDS Diagnoses Among Men Who Have Sex with Men — 33 States, 2001-2006. MMWR Weekly. June 27, 2008 / 57(25);681-6. |
| June 25, 2008 |
Hausfater P et al. Cutaneous Infrared Thermometry for
Detecting Febrile Patients. Emerg Infect Dis. 2008 Aug;
[Epub ahead of print] |
| June 20, 2008 |
Lung injuries from transfusions have doctors stumped (Cleveland Plain Dealer) |
| June 12, 2008 |
Ahead of Print Article: Lockhart PB, et al. Bacteremia Associated With Toothbrushing and Dental Extraction. Circulation. 2008 Jun 9. [Epub ahead of print] |
| June 11, 2008 |
First Edition Paper: Higgins JM, Sloan SR. Stochastic modeling of human RBC alloimmunization: evidence for a distinct population of immunologic responders. Blood. Prepublished online June 5, 2008 |
| June 11, 2008 |
FDA Medical Device Safety Tips & Articles: How Human Factors Lead to Medical Device Adverse Events (FDA/CDRH, reprinted from June Nursing2008, Vol. 38, No. 6, pp. 62-63) |
| May 30, 2008 |
Public Workshop:Safety of Hemoglobin-Based Oxygen Carriers (HBOCs) April 29-30, 2008 Transcripts (FDA/CBER) |
| May 30, 2008 |
Biological Product Deviation Reports: Annual Summary for Fiscal Year 2007 (FDA/CBER) |
| May 23, 2008 |
FDA Launches Sentinel Initiative: a national, integrated, electronic system for monitoring medical product safety (FDA) |
| May 23, 2008 |
Blood Banks Target High School Donors (NPR) |
| May 21, 2008 |
Draft Guidance for Industry: Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc) (FDA/CBER) |
| May 21, 2008 |
Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Plasmodium Species Antigen Detection Assays (FDA/CDRH) |
| May 21, 2008 |
First Edition Paper: Singleton BK, et al. Mutations in EKLF/KLF1 form the molecular basis of the rare blood group In(Lu) phenotype. Blood. Prepublished online May 16, 2008. |
| May 16, 2008 |
Bayer pulls Trasylol supplies after study (MSNBC) Also see full text NEJM article: Fergusson DA, et al. A Comparison of Aprotinin and Lysine Analogues in High-Risk Cardiac Surgery. 1: N Engl J Med. 2008 May 14. [Epub ahead of print] |
| May 16, 2008 |
Medical Device Recall: Thermogenesis BioArchive Vapor Bypass Assembly (FDA/CBER) |
| May 16, 2008 |
Product Approval Information: Novo Nordisk - NovoSevenRT Coagulation Factor VIIa (Recombinant) (FDA/CBER) Also see: FDA News Item |
| May 2, 2008 |
Viscosity Enhancers Curb Bleeding Complications:
Loss of 40% or more of blood can be life-threatening (US News & World Report) |
| Apr. 26, 2008 |
FDA News: FDA Clears Glove Made from New Type of Latex |
| Apr. 25, 2008 |
Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion and Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (FDA/CBER) |
| Apr. 24, 2008 |
AABB Association Bulletin #08-03: West Nile Virus – Revised Recommendations for Triggering Individual Donation Nucleic Acid Testing and Use of Communication Plans (AABB membership required to access) |
| Apr. 22, 2008 |
Recall: Rho(D) Immune Globulin (Human)
Hyper RHO S/D, Mini-Dose Talecris Biotherapeutics, Inc. (FDA/CBER) |
| Apr. 22, 2008 |
Outbreak Notice: Reinstatement of Malaria Recommendations for Great Exuma, Bahamas (CDC) |
| Apr. 17, 2008 |
Product Safety Information: Fatal Iatrogenic Hypoglycemia: Falsely Elevated Blood Glucose Readings with a Point-of-Care Meter Due to a Maltose-Containing Intravenous Immune Globulin Product (FDA/CBER) |
| Apr. 15, 2008 |
Approval History, Letters, Reviews and Related Documents: ARTISS [Fibrin Sealant (Human)] (FDA/CBER) |
| Apr. 15, 2008 |
Multiple simultaneous kidney transplants: Chicago Hospital Performs Rare, Four-Way Kidney Transplant (ABC News) |
| Apr. 9, 2008 |
Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) (FDA/CBER) |
| Apr. 8, 2008 |
First Edition Paper: Takayama N, et al. Generation of functional platelets from human embryonic stem cells in vitro via ES-sacs, VEGF-promoted structures that concentrate hematopoietic progenitors. Blood. Prepublished online April 3, 2008. |
| Apr. 1, 2008 |
Research: Mbulaiteye SM, et al. Seroprevalence
and Risk Factors for Human Herpesvirus 8 Infection,
Rural Egypt. Emerg Infect Dis. 14(4). April
2008. |
| Mar. 28, 2008 |
Variances for Collection of Blood and Blood Products from Patients with Hemochromatosis: list of establishments granted approval for a variance to 21CFR640.3(d) and 21CFR640.3(f) (FDA/CBER) |
| Mar. 28, 2008 |
DNA test as close as your local drugstore: home paternity kit now available (Pittsburg Post-Gazette) |
| Mar. 28, 2008 |
Manual of Standard Operating Procedures and Policies:
Regulatory - Compliance: Procedures for Handling Adverse Reaction Reports Related to "361" Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), SOPP 8508,
Version #2, Mar. 26, 2008 (FDA/CBER) |
| Mar. 22, 2008 |
Recall-Firm Press
Release: B.
Braun’s Supplier Recall of Heparin API Prompts Voluntary Recall
of Heparin Solutions (FDA/CBER) |
| Mar. 22, 2008 |
Original Article:
Koch CG, et al. Duration
of red-cell storage and complications after cardiac surgery. N
Engl J Med. 2008 Mar 20; 358(12):1229-39. |
| Mar. 22, 2008 |
Approval History, Letters, Reviews and Related Documents: XYNTHA™
Antihemophilic Factor (Recombinant), Plasma/Albumin Free, Wyeth Pharmaceuticals,
Inc (FDA/CBER) |
| Mar. 22, 2008 |
Surveillance Summaries: Wasley
A, et al. Surveillance
for Acute Viral Hepatitis - United States, 2006.
MMWR March 21, 2008. 57(SS02);1-24. |
| Mar. 17, 2008 |
CAP Transfusion
Medicine Topic Center New Items: RhIG Dose Calculator (Zip
MS Excel File)
and Disclaimer (MS
Word File) |
| Mar. 17, 2008 |
Page
Updated: Donor
Screening Assays for Infectious Agents and HIV Diagnostic Assays (FDA/CBER) |
| Mar. 14, 2008 |
F.D.A.
Panel Votes to Continue Use of Anemia Drugs - but
does vote for additional restrictions on the use of anemia drugs
by cancer patients (New York Times) |
| Mar. 14, 2008 |
MedWatch Information: Amgen
and FDA notify healthcare professionals of changes to the Boxed Warnings
for increased mortality and/or tumor progression section of the Aranesp
and Epogen/Procrit labeling (FDA/CDER) |
| Mar. 12, 2008 |
Immucor
acquires BioArray Solutions (Atlanta Business Chronicle) |
| Mar. 9, 2008 |
Page Updated: Notification
Process for Transfusion Related Fatalities and Donation Related Deaths (FDA/CBER) |
| Mar. 5, 2008 |
Important Safety Information: Dosing and Administration of Immune Globulin (Human), GamaSTAN™ S/D Packaged in 2-ml Syringes (FDA/CBER) |
| Mar. 4, 2008 |
Medical Device Notification: Haemonetics Filtered Red Cell Disposable Kits (FDA/CBER) |
| Feb. 29, 2008 |
Recall: Thymoglobulin. Genzyme Corporation (FDA/CBER) |
| Feb. 29, 2008 |
Updated: Offices and Divisions (FDA/CBER) |
| Feb. 22, 2008 |
Recall: ThermoGenesis AXP Bag Sets 8-5101 (FDA/CBER) |
| Feb. 22, 2008 |
Federal Register: Risk Communication Advisory Committee; Notice of Meeting (FDA, HHS) |
| Feb. 19, 2008 |
Survey: Patients harmed by anemia drug policy-but CMS is skeptical of the poll and is sticking by its Medicare coverage decision (AMA News) |
| Feb. 13, 2008 |
FDA News: Baxter's Multiple-dose Vial Heparin Linked to Severe Allergic Reactions Also see Baxter Updated News Release |
| Feb. 13, 2008 |
Clinical Trials & Observations: The prognostic significance of a positive direct antiglobulin test in chronic lymphocytic leukemia: a beneficial effect of the combination of fludarabine and cyclophosphamide on the incidence of hemolytic anemia. Blood, 15 February 2008, Vol. 111, No. 4, pp. 1820-1826. |
| Feb. 10, 2008 |
Article: Webert
KE, et al. Proceedings
of a consensus conference: pathogen inactivation-making
decisions about new technologies. Transfus Med Rev.
2008 Jan;22(1):1-34. |
| Feb. 10, 2008 |
Federal
Register: Revisions
to the Requirements Applicable to Blood, Blood
Components and Source Plasma; Confirmation of Effective
Date and
Technical Amendment (FDA/CBER) |
| Feb. 10, 2008 |
First
Edition Paper: Goerge
T, et al. Inflammation
induces hemorrhage in thrombocytopenia.
Blood. Prepublished online February 6, 2008; DOI
10.1182/blood-2007-11-123620. |
| Feb. 10, 2008 |
Early
Release: Acute
Allergic-Type Reactions Among Patients Undergoing
Hemodialysis - Multiple States, 2007-2008. MMWR. February 1,
2008 / 57 (Early Release);1-2. |
| Feb. 6, 2008 |
Article: Leiss W, et al. Men having sex with men donor deferral risk assessment: an analysis using risk management principles. Transfus Med Rev. 2008 Jan;22(1):35-57. |
| Feb. 1, 2008 |
Press
Release: Gambro
BCT and Fenwal Suspend PASSPORT Post-Market Surveillance
Study for 7-Day Platelets (Gambro BCT) Also
see: Letter
from AABB Bacterial Contamination Standard Task
Force to Gambro BCT and Fenwal in Response to the
Discontinuation of the Passport Study - 1/31/08 (AABB) |
| Jan. 30, 2008 |
ASH 50th
Anniversary Review:
Kaushansky K. Historical
review: megakaryopoiesis and thrombopoiesis.
Blood, 1 February 2008, Vol. 111, No. 3, pp. 981-986. |
| Jan. 28, 2008 |
FDA News: FDA
Warns Public of Contaminated Syringes |
| Jan. 26, 2008 |
California Paul Gann Blood
Safety Act amended |
| Jan. 19, 2008 |
Product Recall: Heparin Sodium Injection (FDA/MedWatch) |
| Jan. 18, 2008 |
Product Approval Information-
Licensing Action: Abbott
PRISM® HTLV-I/HTLV-II (FDA/CBER) |
| Jan. 17, 2008 |
Article: McCullough J. Pathogen
Inactivation: A New Paradigm for Preventing Transfusion-Transmitted
Infections. Am J Clin Pathol. 2007 Dec;128(6):945-55. |
