| Date Posted |
Subject |
| Dec. 23, 2006 |
Original Article: Gregori L, et al. Reduction in infectivity of endogenous transmissible spongiform encephalopathies present in blood by adsorption to selective affinity resins. The Lancet 2006; 368:2226-2230. Also see Prion Filter Could Prevent VCJD Spread From Donated Blood (Medical News Today) |
| Dec. 22, 2006 |
Notice to Hospitals: Association of increased mortality and risk of serious adverse events when prophylactic low-dose heparin is abruptly discontinued in patients to be started on Xigris® [drotrecogin alfa (activated)] therapy for severe sepsis. (Health Canada) |
| Dec. 22, 2006 |
Clinical Investigation: Rogers MA, et al. Allogeneic blood transfusions explain increased mortality in women after coronary artery bypass graft surgery. Am Heart J. 2006 Dec;152(6):1028-34. |
| Dec. 22, 2006 |
Federal Register: Medical Device Regulations; Disqualification of a Clinical Investigator; Final Rule; Technical Amendment (FDA) |
| Dec. 16, 2006 |
FDA News: FDA Revises Labeling for Trasylol (Aprotinin Injection) to Strengthen Safety Warnings and Limit Usage of Drug to Specific Situations (FDA/CDER) |
| Dec. 14, 2006 |
FDA News: FDA Approves First Test to Screen Blood Donors for Chagas Disease (FDA/CBER) also see AABB Association Bulletin #06-08: Information Concerning Implementation of a Licensed Test for Antibodies to Trypanosoma cruzi (AABB Membership required to access) |
| Dec. 13, 2006 |
ASH Education Program Book: Triulzi, DJ. Transfusion-Related Acute Lung Injury: An Update. Hematology Am Soc Hematol Educ Program. 2006:497-501. |
| Dec. 13, 2006 |
FDA MedWatch: Erythropoiesis Stimulating Agents (ESA) Procrit, Epogen, and Aranesp: Information for Healthcare Professionals |
| Dec. 8, 2006 |
Recommendations & Reports: A Comprehensive Immunization Strategy to Eliminate Transmission of Hepatitis B Virus Infection in the United States: Recommendations of the Advisory Committee on Immunization Practices (ACIP) Part II: Immunization of Adults (CDC/MMWR, Dec. 8, 2006/55(RR16);1-25 |
| Dec. 3, 2006 |
CMS Releases Final Outpatient Rule and Payment Rates for Blood and Blood Products (AABB) Also see Hospital Outpatient Prospective Payment System (HOPPS) rule for calendar year 2007 (US DHHS/CMS) |
| Nov. 25, 2006 |
Communication: Clark P, et al. Imported Platelets Demonstrate Decreased pH and Glucose by Reagent Strip Testing when Compared to Locally Derived Platelets. Ann Clin Lab Sci 2006; 36:443-446. |
| Nov. 16, 2006 |
News Release: Blood transfusions should be used in moderation for acute coronary syndrome (Duke University Medical Center) |
| Nov. 16, 2006 |
News Release: The Leapfrog Group Issues Call for Hospitals to Commit to New Policy on Health Care "Never Events" |
| Nov. 10, 2006 |
Recall of Home Access and Home Access Express HIV-1 Test System (FDA/CBER) |
| Nov. 9, 2006 |
FDA News Release: FDA Announces Actions to Strengthen its Postmarket Program for Medical Devices. Effort Will Improve Management of Adverse Events, Enhancing Patient Safety. Also see: Medical Device Postmarket Transformation Initiative (FDA/CDRH) |
| Nov. 9, 2006 |
Original article: Moskowitz DM, et al. Use of the Hemobag for modified ultrafiltration in a Jehovah's Witness patient undergoing cardiac surgery. J Extra Corpor Technol. 2006 Sep;38(3):265-70. |
| Nov. 3, 2006 |
AABB Association Bulletin #06-07: Transfusion-Related Acute Lung Injury |
| Oct. 28, 2006 |
New Book: Hillyer CD, Silberstein LE, Ness PM, Anderson KC, Roback JD. Blood Banking and Transfusion Medicine, 2nd Edition - Basic Principles and Practice. Churchill Livingstone, Oct. 2006. ISBN 0443069816. |
| Oct. 27, 2006 |
Guidance for Industry: Implementation of Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Donors of Blood and Blood Components (FDA/CBER) |
| Oct. 27, 2006 |
SABM News: New book available! Perioperative Blood Management: A Physician's Handbook, edited by Jonathan Waters, MD |
| Oct. 25, 2006 |
Original article: Boodhwania M, et al. Ultrafiltration reduces blood transfusions following cardiac surgery: a meta-analysis. Eur J Cardiothorac Surg. 2006 Oct 12; (Epub ahead of print) |
| Oct. 25, 2006 |
Recall of Dupaco Blood/Fluid Warming Set (FDA/CBER) |
| Oct. 18, 2006 |
Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments (FDA/CBER) |
| Oct. 18, 2006 |
Guidance for Industry: Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components (FDA/CBER) |
| Oct. 13, 2006 |
Report: Mathiason CK, et al. Infectious Prions in the Saliva and Blood of Deer with Chronic Wasting Disease. Science. 2006 Oct 6;314(5796):133-6. |
| Oct. 11, 2006 |
Cover Story: Paxton, A. Critical thinking on critical values. CAP Today, September 2006 |
| Oct. 11, 2006 |
Editorials and Perspectives: Bryan CF, et al. Implications of ABO Error Rates in Proficiency Testing for Solid Organ Transplantation. Transplantation. 2006 Sep 27;82(6):733-736. |
| Oct. 9, 2006 |
Advisory Committee on Blood Safety and Availability: Presentations - August 2006 (US DHHS) |
| Oct. 5, 2006 |
Guidance for Industry: Bar Code Label Requirements - Questions and Answers (FDA/CBER) |
| Oct. 4, 2006 |
Original Article: Khan SY, et al. Soluble CD40 ligand accumulates in stored blood components, primes neutrophils through CD40, and is a potential cofactor in the development of transfusion-related acute lung injury. Blood, 1 October 2006, Vol. 108, No. 7, pp. 2455-2462. Also see Commentary: Stroncek, DF. Hot on the trail of TRALI. Blood, 1 October 2006, Vol. 108, No. 7, pp. 2136-2137. |
| Oct. 4, 2006 |
News Release: Baxter Announces Sale of Transfusion Therapies Business to Texas Pacific Group |
| Oct. 1, 2006 |
Senate Bill 246 approved by the Governor and filed with Secretary of State 9/26/06, an act to add Section 1648 to the Health and Safety Code, relating to human milk. |
| Sept. 22, 2006 |
Original Article: van de Watering L, et al. Effects of storage time of red blood cell transfusions on the prognosis of coronary artery bypass graft patients Transfusion 2006 46(10):1712. |
| Sept. 22, 2006 |
Guidance for Industry: Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels (FDA/CBER) Also see: United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128 (ICCBBA, Nov. 2005, Version 2.0.0) and Guidance for Industry: Bar Code Label Requirements - Questions and Answers (FDA/CBER, Oct. 6) |
| Sept. 21, 2006 |
Original Article: Figueroa, PI et al. Nearly Two Decades Using the Check-Type to Prevent ABO Incompatible Transfusions: One Institution's Experience. Am J Clin Pathol. 2006 Sep;126(3):422-6. Also see e-Network Forum discussion: Should pre-transfusion ABO/Rh testing be performed twice, and if so, on different samples or by different personnel? |
| Sept. 18, 2006 |
Locally Acquired Mosquito-Transmitted Malaria: A Guide for Investigations in the United States. CDC MMWR Recommendations and Reports, 55(RR13);1-9. |
| Sept. 12, 2006 |
STOP Trials Demonstrated Value of Chronic Blood Transfusion to Prevent Stroke in Children With Sickle Cell Disease: Presented at SCD (Doctor's Guide) |
| Sept. 8, 2006 |
Update: Delayed Onset Pseudomonas fluorescens Bloodstream Infections After Exposure to Contaminated Heparin Flush -- Michigan and South Dakota, 2005-2006. MMWR Weekly 55(35);961-963 |
| Sept. 8, 2006 |
Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research (FDA/CBER) announcing plans to re-examine rule allowing emergency research involving an exception to informed consent requirements |
| Sept. 6, 2006 |
Original Article: Breimer ME, et al. Blood Group A and B Antigen Expression in Human Kidneys Correlated to A1/A2/B, Lewis, and Secretor Status. Transplantation. 82(4):479-485, August 27, 2006. |
| Sept. 1, 2006 |
FDA Forms Task Force on Human Tissue Safety (FDA News) and (FDA Public Health Notification: Donor Referral Services (FDA/CBER) |
| Aug. 31, 2006 |
AABB Association Bulletin #06-05: Monitoring and Preventing the Occurrence of Deviations and Near-Miss Events in Pretransfusion Testing: Mislabeling/Wrong Blood in Tube (AABB Membership required to access) |
| Aug. 31, 2006 |
Original Article: Weisbach V, et al. Comparison of the performance of microtube column systems and solid-phase systems and the tube low-ionic-strength solution additive indirect antiglobulin test in the detection of red cell alloantibodies. Transfusion Medicine 16 (4), 276-284. |
| Aug. 28, 2006 |
FDA News: United States Marshals Seize Defective Infusion Pumps Made by Alaris Products: Pumps Can Deliver Excess Medication and Harm Patients |
| Aug. 18, 2006 |
Full Text Article: Implementation of a Redistribution System for Near-Outdate Red Blood Cell Units. Arch Pathol Lab Med. 2006 Aug;130(8):1178-83. |
| Aug. 8, 2006 |
Guidance for Industry: Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin G (IgG) Antibodies (FDA/CBER) |
| Aug. 3, 2006 |
First Edition Paper: Tsai, AG et al. Dissociation of local nitric oxide concentration and vasoconstriction in the presence of cell-free hemoglobin oxygen carriers. Blood, prepublished online July 20, 2006 |
| Aug. 3, 2006 |
Abstract: Holland LL, Brooks JP. Toward rational fresh frozen plasma transfusion: The effect of plasma transfusion on coagulation test results. Am J Clin Pathol. 2006 Jul;126(1):133-9. |
| Aug. 3, 2006 |
Chagas Disease After Organ Transplantation - Los Angeles, California, 2006 (MMWR Weekly, 55(29);798-800) |
| July 26, 2006 |
Important Drug Information: Antihemophilic Factor (Human), Koate DVI - Talecris Biotherapeutics: Notice A | Notice B (FDA/CBER) |
| July 26, 2006 |
Important Customer Notification: Vironostika HIV-1 - bioMerieux, Inc. (FDA/CBER) |
| July 21, 2006 |
Recall: RAD-SURE Blood Irradiation Indicators-International Specialty Products / Kent Adhesive Products Company (FDA/CBER) |
| July 21, 2006 |
Product Approval Info-Licensing Action: Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal IgM) and Antibody to Hepatitis B Surface Antigen (Human) (ABBOTT PRISM HBsAg and ABBOTT PRISM HBsAg Confirmatory) - Abbott Laboratories (FDA/CBER) |
| July 21, 2006 |
Press Release: Governor Schwarzenegger Takes Executive Action to Strengthen Stem Cell Research in California (CA Office of the Governor) |
| July 14, 2006 |
First Edition Paper: Ogawa M, et al. Hematopoietic origin of fibroblasts/myofibroblasts: its patho-physiological implications. Blood, prepublished online July 13, 2006 |
| July 12, 2006 |
Article: Basran S et al, The association between duration of storage of transfused red blood cells and morbidity and mortality after reoperative cardiac surgery. Anesth Analg. 2006 Jul;103(1):15-20. |
| June 30, 2006 |
Statement of AABB Before the Subcommittee on Africa, Global Human Rights, and International Operations - Making Safe Blood Available in Africa (AABB) |
| June 22, 2006 |
Rapid HIV Test Distribution -- United States, 2003-2005 (MMWR, 55(24);673-676) |
| June 22, 2006 |
Methicillin-Resistant Staphylococcus aureus Skin Infections Among Tattoo Recipients - Ohio, Kentucky, and Vermont, 2004-2005 (MMWR, 55(24);677-679) |
| June 2, 2006 |
Reports: Twenty-Five Years of HIV/AIDS - United States, 1981-2006 (CDC/MMWR. Vol. 55, No. 21) |
| June 2, 2006 |
Go-ahead for 'pharmed' goat drug: The first medicine produced from a genetically modified animal [anti-thrombin] has been recommended for use in Europe. (BBC News) Also see: GTC Biotherapeutics Press Release |
| June 2, 2006 |
Guidance for Industry: Chronic Cutaneous Ulcer and Burn Wounds - Developing Products for Treatment (FDA/CBER) |
| May 25, 2006 |
Brief Report: Investigation into Recalled Human Tissue for Transplantation - United States, 2005-2006 (CDC/MMWR) |
| May 24, 2006 |
First Edition Paper: Stead RB et al. Evaluation of the safety and pharmacodynamics of Hematide™, a novel erythropoietic agent, in a phase 1, double-blind, placebo-controlled, dose escalation study in healthy volunteers. Blood, prepublished online May 23, 2006 |
| May 21, 2006 |
Looney, MR et al. Neutrophils and their Fcγ receptors are essential in a mouse model of transfusion-related acute lung injury. J Clin Invest.
Published online 2006 May 18. |
| May 21, 2006 |
Research: Ironside, James W et al. Variant Creutzfeldt-Jakob disease: prion protein genotype analysis of positive appendix tissue samples from a retrospective prevalence study. BMJ 2006;332:1186-1188 Also see: Editorial: A new human genotype prone to variant Creutzfeldt-Jakob disease - New evidence may rekindle fears of a larger epidemic and greater risk of iatrogenic spread. BMJ 2006;332:1164-1165 |
| May 21, 2006 |
City health agencies move to streamline HIV testing: San Francisco drops counseling requirement (San Francisco Chronicle) |
| May 16, 2006 |
Medical Device Recall: Ranger High Flow Blood / Fluid Warming Disposable Sets (FDA/CBER) |
| May 13, 2006 |
News Release: Figueroa bill to help newborn mothers allows them to store own breast milk at a hospital - bill passes first senate committee |
| May 12, 2006 |
Screening for Chronic Hepatitis B Among Asian/Pacific Islander Populations - New York City, 2005, MMWR Weekly May 12, 2006. 55(18);505-509. |
| Apr. 26, 2006 |
Brief report: Kiefel V et al. Antigen-positive platelet transfusion in neonatal alloimmune thrombocytopenia (NAIT). Blood, 1 May 2006, Vol. 107, No. 9, pp. 3761-3763. Also see Comment on Kiefel et al, by James B. Bussel When are platelets just platelets? Blood, 1 May 2006, Vol. 107, No. 9, pp. 3426-3427. |
| Apr. 24, 2006 |
FDA News: FDA Announces Convictions in Illegal Blood Diversion Scheme |
| Apr. 24, 2006 |
Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff: Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable (FDA/CDRH & CBER) |
| Apr. 11, 2006 |
First Edition Paper: Lee MT et al, Stroke Prevention Trial in Sickle Cell Anemia (STOP): Extended Follow-up and Final Results. Blood, Epub ahead of print 6 Apr 2006 |
| Apr. 7, 2006 |
Medical Device Notification: Misys Laboratory Blood Bank Module, Version 6.1 (FDA/CBER) |
| Apr. 4, 2006 |
FDA Approves Humanitarian Device Exemption for Treatment of Fetuses With Twin-To-Twin Transfusion Syndrome (FDA/CBER) |
| Apr. 3, 2006 |
'Bloodless' surgical program attracts new patients to AGH. North Side hospital one of only 120 nationwide to offer option (Pittsburgh Business Times) |
| Apr. 2, 2006 |
Obituary: Professor Robin Coombs. Developer of Coombs test passed away January 25 at age 85 (The Guardian-UK) |
| Apr. 1, 2006 |
Blood Center's High-tech Help For US's Blood Shortage (Medical News Today) |
| Apr. 1, 2006 |
Meeting Minutes: FDA Workshop on Behavior-Based Donor Deferrals in the NAT Era - 3/8/2006 (FDA/CBER) |
| Mar. 23, 2006 |
ISBT Labels that Need to be Submitted by Licensed Blood Establishments for Prior Approval (FDA/CBER) |
| Mar. 23, 2006 |
Mad Cow Disease shows sharp drop over past three years, UN agency reports (UN News Centre) |
| Mar. 23, 2006 |
First Edition Paper: Arnold DM, Julian JA, Walker IR, Mortality rates and causes of death among all HIV-positive individuals with hemophilia in Canada over twenty-one years of follow up. Blood, Epub ahead of print 21 Mar 2006 |
| Mar. 17, 2006 |
Primary and Secondary Syphilis: United States, 2003-2004 MMWR, 55(10);269-273 |
| Mar. 17, 2006 |
Methamphetamine Use and HIV Risk Behaviors Among Heterosexual Men - Preliminary Results from Five Northern California Counties, December 2001-November 2003, MMWR, 55(10);273-277 |
| Mar. 10, 2006 |
"A Patient's Guide to Blood Management" Brochure. Developed by the SABM Education Committee to educate the public about blood management, transfusion options, and strategies to minimize blood loss, the brochure can be viewed and is available for purchase on SABM's website. |
| Mar. 10, 2006 |
Blood Products Advisory Committee Meeting March 9-10, 2006: Briefing Information, Slides (FDA/CBER) |
| Mar. 10, 2006 |
Press Release: Neoteric announces agreement with Angelantoni, manufacturer of the Hemosafe® Blood Bank refrigerator |
| Mar. 9, 2006 |
First Edition Paper: Neufeld EJ, Oral chelators deferasirox and deferiprone for transfusional iron overload in thalassemia major: new data, new questions, Blood, Epub ahead of print 7 Mar 2006 |
| Mar. 7, 2006 |
Medication Safety Alert - Drug Name Confusion: Near Sight/Sound Dead Hit - Amicar and Omacor (ISMP) |
| Mar. 4, 2006 |
Device Correction: Operator’s Manual for Baxter Fenwal Amicus Separator (FDA/CBER) |
| Mar. 2, 2006 |
FDA Public Health Notification: Update of Information about BioMedical Tissue Services (FDA/CBER) |
| Feb. 27, 2006 |
A New Product (VariZIG™) for Postexposure Prophylaxis of Varicella Available Under an Investigational New Drug Application Expanded Access Protocol (CDC, MMWR) |
| Feb. 25, 2006 |
Tibor J. Greenwalt Memorial Service scheduled for April 7, 2006 (Hoxworth Blood Center) |
| Feb. 17, 2006 |
Book Release: Perioperative Transfusion Medicine 2nd Edition, Spiess BD, Spence RK, Shander A, Lippincott Williams & Wilkins, Dec. 2005 |
| Feb. 16, 2006 |
Book Release: Mollison's Blood Transfusion in Clinical Medicine, 11th Edition. Klein H, Anstee D. Blackwell Publishing, Jan. 2006. |
| Feb. 13, 2006 |
Corporate Press Release: Cerus Obtains Exclusive Rights to INTERCEPT Blood System from Baxter |
| Feb. 10, 2006 |
Original Article: Fujimi S et al, Platelet depletion in mice increases mortality after thermal injury, Blood First Edition Paper, prepublished online Feb 7, 2006 |
| Feb. 9, 2006 |
Third vCJD 'blood case' diagnosed: A third case of vCJD linked to a blood transfusion has been diagnosed (BBC News) Also see: The UK Spongiform Ecephalopathy Advisory Committee epidemiology subgroup position statement on the vCJD epidemic: discusses possibility of secondary epidemic from iatrogenic exposures (self-sustaining epidemic, points 19-24) |
| Feb. 9, 2006 |
Varicella Zoster Immune Globulin (VZIG) – Anticipated Short Supply and Alternate Product Availability under an Investigational New Drug Application Expanded Access Protocol (FDA/CBER) |
| Feb. 8, 2006 |
Letter: Violative Advertising and Promotional Labeling Letter: Rho(D) Immune Globulin Intravenous (Human) Rhophylac (FDA/CBER) |
| Feb. 8, 2006 |
FDA Issues Public Health Advisory for Trasylol (aprotinin injection) (FDA/CBER) |
| Feb. 6, 2006 |
FDA News Release: FDA Orders Biomedical Tissue Services, Ltd., to Cease Manufacturing and to Retain Existing Inventories of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) |
| Feb. 3, 2006 |
DRAFT Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (FDA/CBER) |
| Feb. 1, 2006 |
Federal Register, Proposed Rule: Distribution of Blood Derivatives by Registered Blood Establishments that Qualify as Health Care Entities; Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements and Administrative Procedures |
| Feb. 1, 2006 |
Original Article: Heyns AD et al. Prevalence of HIV-1 in Blood Donations Following Implementation of a Structured Blood Safety Policy in South Africa, JAMA 2006;295(5):519-26. Also see: Editorial: Bekker L, Wood R. Blood Safety—At What Cost? JAMA. 2006;295(5):557-8. |
| Jan. 26, 2006 |
Original Article: Mangano DP et al, The Risk Associated with Aprotinin in Cardiac Surgery, NEJM 26 Jan 2006, 354(4):353-65. Also see: Blood-loss drug a risk to kidneys, study says (Seattle Times) |
| Jan. 25, 2006 |
Brief Report: Sachs UJH et al, Antibody-induced neutrophil activation as a trigger for transfusion-related acute lung injury in an ex vivo rat lung model, Blood, 1 Feb 2006, 107(3):1217-19. |
| Jan. 25, 2006 |
Clinical Trials and Observations: Zhang M et al, Correlates of spontaneous clearance of hepatitis C virus among people with hemophilia, Blood, 1 Feb 2006, 107(3):892-7. |
| Jan. 25, 2006 |
Technical Report: Zhang CC et al, Angiopoietin-like proteins stimulate ex vivo expansion of hematopoietic stem cells, Nature Medicine, Published online: 22 Jan 2006 Also see: Lab finds way to grow type of adult stem cell and Biologists cite way to multiply blood stem cells Cambridge research may aid bone marrow transplants (Boston Globe, free registration required to access full articles) |
| Jan. 24, 2006 |
New Product Information: Blood Track Courier Automated System for Managing Blood Product Movement Also see: FDA 510(k) clearance letter |
| Jan. 19, 2006 |
FDA Announces New Prescription Drug Information Format to Improve Patient Safety. Scroll down to bottom of page for additional important links to Final Guidances for Industry: Content and Format of Labeling for Human Prescription Drug and Biological Products and Draft Guidances for Industry: Content and Format of Labeling for Human Prescription Drug and Biological Products and Final Rule: Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products (3 pdf files) |
| Jan. 19, 2006 |
Medical Device Reporting : Contact information for reporting public health emergencies has changed |
| Jan. 13, 2006 |
Class 1 Recall: Ortho-Clinical Diagnostics VITROS® Immunodiagnostic HBsAg Confirmatory Kit (FDA/CBER) |
| Jan. 13, 2006 |
Original Article: Mintz PD et al, Photochemically treated fresh frozen plasma for transfusion of patients with acquired coagulopathy of liver disease, Blood First Edition Paper, prepublished online Jan 12, 2006 |
| Jan. 9, 2006 |
FDA MedWatch Safety Alert: WinRho SDF (Rho(D) Immune Globulin Intravenous [Human]) |
| Jan. 9, 2006 |
Substantially Equivalent 510(k) Device Information - BacT/ALERT BPN Culture Bottle & BacT/ALERT BPA Culture Bottle (FDA/CBER) |
| Jan. 6, 2006 |
Feature Story: Not so fast—relaxing transfusion triggers (CAP Today) |
