| Date Posted |
Subject |
| Dec. 29, 2007 |
Product Approval Information-
NDA: FDA
Approves Voluven to Treat Serious Blood Volume Loss following Surgery (FDA/CBER) |
| Dec. 27,
2007 |
MedWatch: Update
to the Cardinal Health’s worldwide voluntary recall for its
Alaris® Pump module (FDA) |
| Dec. 27,
2007 |
Review Article:
Rizzo JD, et al. Use
of epoetin and darbepoetin in patients with cancer: 2007 American Society
of Hematology/American Society of Clinical Oncology clinical practice
guideline update. Blood, 1 January 2008, Vol. 111, No. 1, pp. 25-41. |
| Dec. 21, 2007 |
First
Edition Paper: Wandall HH, et al. Galactosylation
does not prevent the rapid clearance of long-term 4°C stored platelets.
Blood. Prepublished online December 20, 2007 |
| Dec. 21, 2007 |
electronic
Medical Device Reporting (eMDR) (FDA/CDRH) |
| Dec. 18,
2007 |
Guidance for Industry
and FDA Review Staff: Collection
of Platelets by Automated Methods (FDA/CBER) |
| Dec. 14, 2007 |
Guidance for Industry
Withdrawn:Recommendations
for Management of Donors at Increased Risk for
Human Immunodeficiency Virus Type 1 (HIV-1) Group
O Infection was issued for immediate implementation
in accordance with 21 CFR 10.115(g)(4)(i). The
guidance is being withdrawn based upon comments
received. FDA may revise the guidance and issue
a draft guidance for public comment in the future (FDA/CBER) |
| Dec. 14, 2007 |
Notice
to Readers: Updated
Information Regarding Antiretroviral Agents Used
as HIV Postexposure Prophylaxis for Occupational
HIV Exposures (CDC MMWR. December 14, 2007 / 56(49);1291-1292) |
| Dec. 12, 2007 |
Recall: Tubing
Sets used with COBE Spectra Apheresis System, Trima and Trima Accel
Automated Blood Collection Systems (FDA/CBER) |
| Dec. 12, 2007 |
Important Notification: Blood
Grouping Reagent Anti-Lea BioClone 2.0 (FDA/CBER) |
| Nov. 29, 2007 |
Guidance
for Industry and FDA Staff: Class
II Special Controls Guidance Document: Automated Blood Cell Separator
Device Operating by Centrifugal or Filtration Separation Principle (FDA/CBER) |
| Nov. 29, 2007 |
AABB
Association Bulletin #07-03: Clarifications
to Recommendations to Reduce the Risk of TRALI (AABB
Membership required to access) |
| Nov. 29, 2007 |
California
Eliminates Need for Written Informed Consent for
HIV Testing (Associated
Content) See Chartered
Assembly Bill No. 682 (CA
Legislative Info) |
| Nov. 27, 2007 |
Guidance for Industry: Providing
Regulatory Submissions to the Center for Biologics Evaluation and
Research (CBER) in Electronic Format - Lot Release Protocols (FDA/CBER) |
| Nov. 23, 2007 |
Guidance for Industry: Adequate
and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis
B Surface Antigen (HBsAg) Assays Used to Test Donors of Whole Blood
and Blood Components, Including Source Plasma and Source Leukocytes (FDA/CBER) |
| Nov. 15, 2007 |
Organ
patients' spread of HIV probed: Organ
recipients unaware of risk- follow-up on story of Nov. 13 below (Chicago
Tribune) |
| Nov. 15, 2007 |
Murphy GJ, et al. Increased
Mortality, Postoperative Morbidity, and Cost After Red Blood Cell
Transfusion in Patients Having Cardiac Surgery. Circulation.
2007 Nov 12; [Epub ahead of print] |
| Nov. 15, 2007 |
AMA
Recommends Public Cord Blood Banks (AP) |
| Nov. 14, 2007 |
Concern
over menstrual blood bank: Experts have expressed concern over
the launch by a US company of a service for women
to store their own menstrual blood (BBC News) Also
see the company's
website offering women the chance to store their
own menstrual stem cells |
| Nov. 13, 2007 |
4
transplant recipients get HIV from donor: Donor's
infection is 1st such case in U.S. in 22 years (Chicago Tribune) |
| Nov. 8, 2007 |
Federal
Register: Requirements
for Human Blood and Blood Components Intended for
Transfusion or for Further Manufacturing Use; Proposed
Rule (FDA/CBER) |
| Nov. 8, 2007 |
Compliance
Program: Chapter 41 - Inspection of Tissue Establishments (FDA/CBER) |
| Nov. 8, 2007 |
Background
Information Regarding the ISBT Label (FDA/CBER) |
| Nov. 8, 2007 |
Laser
treatment 'could kill HIV': Lasers could be used to combat viruses and
infections like HIV and MRSA without side effects,
researchers say. (BBC News) Also see: Tsen KT, et al. Selective
inactivation of micro-organisms with near-infrared
femtosecond laser pulses. J. Phys.: Condens. Matter.
28 Nov 2007; 19:472201 |
| Nov. 6, 2007 |
Bayer
Withdraws Heart Surgery Drug (NY Times) Also see Press
Release:
Bayer
Temporarily Suspends Global Trasylol® Marketing (Bayer AG) |
| Nov. 6, 2007 |
Proposed
3rd edition of Standards for Cellular Therapy Product
Services: Public
comment solicited now through January
8, 2008 (AABB) |
| Nov. 6, 2007 |
West
Nile Virus Story: Deadly
virus finds new home in rural West (Boston Globe) |
| Nov. 3, 2007 |
System Review Series: Blood
Bank Information Systems (CAP Today) |
| Nov. 3, 2007 |
Feature Story: The
next step: bringing autoverification into the blood bank. (CAP
Today) |
| Nov. 1, 2007 |
Feature
Stories: Catching,
tracking, and tackling TRALI & TRALI
defined & All-male
plasma makes UK TRALI tumble (CAP Today,
October 2007) |
| Nov. 1, 2007 |
Did
HIV Arrive Earlier Than Thought? HIV May
Have Reached the U.S. 12 Years Before AIDS Recognition
(WedMD) Also
see: Gilbert TP, et al.
The
emergence of HIV/AIDS in the Americas and beyond.
Proc. Natl. Acad. Sci. 1 Nov 2007. Published early
online. |
| Nov. 1, 2007 |
First
Edition Paper: Guillot
PV, et al. Intrauterine
transplantation of human fetal mesenchymal stem cells from first trimester
blood repairs bone and reduces fractures in osteogenesis
imperfecta mice. Blood. Prepublished online October
29, 2007 |
| Oct. 27, 2007 |
Draft
Guidance for Industry:Blood
Establishment Computer System Validation in the
User’s Facility (FDA/CBER) |
| Oct. 27, 2007 |
Outbreak
Notice: New
Malaria Cases in Kingston, Jamaica. Reinstatement of
recommendation that US travelers to Kingston, Jamaica,
take malaria preventive medication (CDC) |
| Oct. 27, 2007 |
Early
Communication about an Ongoing Safety Review
Aprotinin Injection (marketed as Trasylol) (FDA/CDER) |
| Oct. 24, 2007 |
Hughes JD, et al. Warm
storage of whole blood for 72 hours. Transfusion. 2007 Nov;47(11):2050-56. |
| Oct. 22, 2007 |
Biological
Product Deviation Reporting (BPDR) Product Deviation
Codes UPDATED (FDA/CBER) |
| Oct. 22, 2007 |
Vamvakas
EC, Blajchman MA. Transfusion-related
immunomodulation (TRIM): An update. Blood Rev. 2007 Nov;21(6):327-48. |
| Oct. 22, 2007 |
Bilgin YM, et al. Is
increased mortality associated with post-operative
infections after leukocytes containing red blood cell transfusions
in cardiac surgery? An extended analysis. Transfus
Med. 2007 Aug;17(4):304-11. |
| Oct. 22, 2007 |
Chapman
WC, et al. A
phase 3, randomized, double-blind comparative study of the efficacy
and safety of topical recombinant human thrombin and bovine thrombin
in surgical hemostasis. J Am Coll Surg. 2007 Aug;205(2):256-65. |
| Oct. 22, 2007 |
Colwell
CW Jr, et al. Randomized
Study of Aprotinin Effect on Transfusions and Blood Loss in Primary
THA. Clin Orthop Relat Res. 2007 Aug 30; (Epub ahead of print) |
| Oct. 16,
2007 |
Article:
Brooks JP, Ferrell JE. Legal
and Ethical Considerations in the Transfusion of Infected or Untested
Autologous Blood. Am J Clin Pathol. 2007 Jul;128(1):135-42. |
| Oct. 15, 2007 |
First
Edition Paper: Chang
J, et al. Intravenous
immunoglobulins reverse acute vaso-occlusive crises
in sickle cell mice through rapid inhibition of neutrophil
adhesion.
Blood. Prepublished online October 11, 2007. |
| Oct. 11, 2007 |
Banked
Blood Loses Ability to Deliver Oxygen to Tissues (DukeMedNews)
Also see: Studies:
Stored blood lacks nitric oxide (SanLuisObispo.com)
and Why
Banked Blood Goes Bad (Time) Also note e-Network
Forum discussion |
| Oct. 11, 2007 |
Experts
Worried About Irradiation Machines: Replacement
Urged to Thwart Terrorists (Washington Post) Also note: Reactivated
e-Network Forum discussion |
| Sept. 28, 2007 |
Northfield
to seek quick review for PolyHeme (Chicago Tribune) |
| Sept 25, 2007 |
Recall
Updated: Class
1 Recall: Baxter Upgraded Colleague CX Single Channel Volumetric
Infusion Pumps (FDA/CDRH) |
| Sept 24, 2007 |
Warning
on vCJD blood screening:
An expert in the human form of "mad cow disease", variant
CJD, has warned it could become endemic in the UK
unless blood screening is developed quickly ALSO
SEE Audio
Interview (BBC News). Recent Meeting: Prion
2007 and Abstracts |
| Sept 24, 2007 |
First
Edition Paper: Raza
A, et al. Phase
II study of lenalidomide in transfusion-dependent, low- and intermediate-1-risk
myelodysplastic syndromes with karyotypes other than deletion 5q. Blood. Prepublished
online Sept 24, 2007 |
| Sept 24, 2007 |
Federal
Register:Revisions
to the Requirements Applicable to Blood, Blood
Components and Source Plasma; Correction and
Companion Document to Direct Final Rule; Proposed Rule;Correction (FDA/CBER) |
| Sept 23, 2007 |
Research
Article: Zilberberg
MD, et al. Red
blood cell transfusions and the risk of acute respiratory
distress syndrome among the critically ill: a cohort
study. Crit Care. 2007 Jun 6;11(3):R63. |
| Sept 23, 2007 |
Original
Article: Whitson
BA, et al. Bloodless
Cardiac Surgery is Associated With Decreased Morbidity and Mortality. J Card Surg.
2007 Sep-Oct;22(5):373-8. |
| Sept 21, 2007 |
Outbreak
Notice Update: Malaria in Kingston, Jamaica: Recommendations
Removed |
| Sept 19, 2007 |
FDA News: FDA Clears for Marketing
First Rapid Test to Screen for Bacterial Contamination
in Blood Platelets |
| Sept 17, 2007 |
Panel:
Aprotinin Should Remain on Market (AP) |
| Sept 12, 2007 |
Blood
banks loosen tattoo rules (Billings Gazette) |
| Sept 10, 2007 |
Research
Article: Zilberberg
MD, Shorr AF. Effect
of a restrictive transfusion strategy on transfusion-attributable
severe acute complications and costs in the US ICUs:
a model simulation.
BMC Health Serv Res. 2007 Aug 31;7(1):138. |
| Sept. 4, 2007 |
Kopko P, et al. AABB
survey of transfusion-related acute lung injury policies and practices
in the United States. Transfusion. 2007 Sep;47(9):1679-85. |
| Sept. 4, 2007 |
First Edition Paper:
Ward FJ, et al. Clonal
regulatory T cells specific for a red blood cell
autoantigen in human autoimmune hemolytic anemia. Blood. Prepublished
online Aug. 30, 2007 |
| Sept. 4, 2007 |
First
Edition Paper: Irei
T, et al. The
persistent elimination of B cells responding to blood
group A carbohydrates by synthetic group A carbohydrates
and B-1 cell differentiation blockade: novel concept
in preventing antibody-mediated rejection in ABO-incompatible
transplantation.
Blood. Prepublished online Aug. 31, 2007 |
| Sept. 3, 2007 |
Blood
shortage grows serious:
Many factors threaten to turn Southern California's
typical seasonal lack of reserves into a permanent
problem (LA Times, free registration may be required) |
| Aug. 31, 2007 |
Original
Article:The SAFE
Study Investigators. Saline
or Albumin for Fluid Resuscitation in Patients
with Traumatic Brain Injury. N Engl J Med. 2007
Aug 30;357(9):874-84. |
| Aug. 28, 2007 |
Outbreak
Notice:
Malaria
in the Bahamas: Recommendations for Travelers -Malaria Chemoprophylaxis,
Donor Deferral Recommended for
Travelers to Great Exuma(CDC) |
| Aug. 28, 2007 |
FDA News: FDA Approves Human
Thrombin for Topical Use in Surgery |
| Aug. 26, 2007 |
FEDERAL
REGISTER: Current
Good Manufacturing Practice for Blood and Blood Components;
Notification of Consignees and Transfusion Recipients
Receiving Blood and Blood Components at Increased
Risk of Transmitting Hepatitis C Virus Infection
("Lookback");
Final Rule AND Guidance for Industry: “Lookback” for
Hepatitis C Virus (HCV):Product Quarantine, Consignee
Notification, Further Testing, Product Disposition,
and Notification of Transfusion Recipients Based
on Donor Test Results Indicating Infection with HCV (FDA/CBER) |
| Aug. 15, 2007 |
FEDERAL
REGISTER: Revisions
to the Requirements Applicable to Blood, Blood Components
and Source Plasma; Direct Final Rule and Companion
Document to Direct Final Rule (FDA/CBER) |
| Aug. 15, 2007 |
FDA Preliminary Public Health Notification: Repair,
Service, or Testing May Not Have Been Performed on Certain Baxter
COLLEAGUE and FLO-GARD Infusion Pumps (FDA/CDRH) |
| Aug. 14, 2007 |
Safety
Information: Reports
of Progressive Multifocal Leukoencephalopathy (PML)
following RITUXAN use in Systemic Lupus Erythematosus
and Vasculitis (off-label use) Also see related Public
Communication (Health Canada) |
| Aug. 10, 2007 |
Perspective:
Tefferi A, et al. Proposals
and rationale for revision of the World Health Organization diagnostic
criteria for polycythemia vera, essential thrombocythemia, and primary
myelofibrosis: recommendations from an ad hoc international expert
panel. Blood. 2007 Aug 15;110(4):1092-7. |
| Aug. 7, 2007 |
Guidance for Industry: Adequate
and Appropriate Donor Screening Tests for Hepatitis
B; Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Donors
of Whole Blood and Blood Components, Including Source Plasma and
Source Leukocytes (FDA/CBER) |
| Aug. 7, 2007 |
ASFA has
published a 4th Special Issue of the Journal of Clinical Apheresis.
Within this new edition is a comprehensive Fact Sheet that summarizes
available medical literature pertaining to the treatment of a disease
by apheresis and is available through the ASFA
website |
| Aug. 2, 2007 |
Premarket
Approval Information:
ThermoGenesis
CryoSeal® FS System - FDA approves device for preparation of
autologous fibrin
sealant - BUT The device must be used in a blood
establishment and not an
operating room (FDA/CBER) |
| Aug. 2, 2007 |
News Opinion: Seize
the Cesium- an editorial noting that Cesium-137 may be a favored
isotope for a radiological terrorist attack (NY
Times, registration may be required) Also see related
e-Network Forum discussion |
| July 30, 2007 |
Class 1 Recall: Baxter
Healthcare Corp. COLLEAGUE® and FLO-GARD® Volumetric Infusion
Pumps (FDA/CDRH) Also see Baxter
News Release |
| July 27, 2007 |
Transfusion Complications
Article: Benjamin RJ & Wagner SJ. The
residual risk of sepsis: modeling the effect of
concentration on bacterial detection in two-bottle
culture systems and an estimation of false-negative
culture rates.
Transfusion. 2007 Aug. 47(8):1381–89. |
| July 25, 2007 |
Recall
of Level 1 Normothermic IV Fluid Administration and Irrigation Sets-
Smiths Medical ASD, Inc.(FDA/CBER) |
| July 25, 2007 |
Outbreak Notice Update: Malaria
in Kingston, Jamaica: Recommendations for Travelers: risk
of infection still exists and the preventive measures
as outlined in this notice continue to be recommended (CDC) |
| July 25, 2007 |
First Edition Paper:
Emilia G, et al. H.
pylori infection and chronic immune thrombocytopenic purpura:
long-term results of bacterium eradication and association with bacterium
virulence profiles. Blood. Pre-published online July 24, 2007 |
| July 20, 2007 |
Class
1 Recall: Baxter
Healthcare Corp. Upgraded COLLEAGUE® Triple Channel Volumetric
Infusion Pumps (FDA/CDRH) |
| July 17, 2007 |
Full
Text Article: Bihl F,
et al. Transfusion-transmitted
infections. J Transl Med. 2007 Jun 6;5:25. |
| July 17, 2007 |
Institute of Medicine
(IOM)Committee Report: HIV
and the Blood Supply: An Analysis of Crisis Decisionmaking (National
Academies Press) An important retrospective to remind
us not to repeat the failures of the past |
| July 16, 2007 |
Recall
of Fenwal CS3000 Apheresis Kits (FDA/CBER) |
| July 11, 2007 |
First Edition Paper:
Liu Z, et al. A
potent erythropoietin mimic human antibody interacts through a novel
binding site. Blood. Pre-published online July 9, 2007 |
| July 5, 2007 |
Early
Online Publication:
Jones M, et al. In
vitro amplification and detection of variant Creutzfeldt-Jakob
disease PrPSc J Pathol. 2007 Jul 5. Also see Hopes
for better vCJD diagnosis (BBC News) |
| July 5,
2007 |
CDC
Health Information for International Travel 2008
now available online |
| July 5, 2007 |
First Edition
Paper: Bernaudin F, et al. Long-term
results of related, myeloablative stem cell transplantation to cure
sickle cell disease.
Blood. Pre-published online July 2, 2007. |
| July 1, 2007 |
Lee E, et al. Do patients
with autoantibodies or clinically insignificant alloantibodies
require an indirect antiglobulin test crossmatch? Transfusion.
2007 Jul;47(7):1290-5. |
| July 1, 2007 |
Gombotz H, et al. Blood
use in elective surgery: the Austrian benchmark study. Transfusion.
[Pre-published online 7 June 2007] |
| July 1, 2007 |
Ouattara A, et al. Impact
of aspirin with or without clopidogrel on postoperative
bleeding and blood transfusion in coronary surgical
patients treated prophylactically with a low-dose
of aprotinin. Eur Heart J. 2007 Apr;28(8):1025-32. |
| July 1, 2007 |
Wass CT, et al. Changes
in red blood cell transfusion practice during the
past two decades: a retrospective analysis, with the Mayo
database, of adult patients undergoing major spine
surgery. Transfusion. 2007 Jun;47(6):1022-7. |
| June 28, 2007 |
Doudier B, et al. Autochthonous Malaria from Marseille to Minneapolis. Emerg Infect Dis. 2007 Aug; [Epub ahead of print] |
| June 26, 2007 |
Press Release: First Use Of Cord Blood To Alter Course Of Type 1 Diabetes (ADA) Also see: Umbilical cord blood may cut diabetes’ severity- Kids had lower glucose levels after getting their own vital fluids, study finds (MSNBC) |
| June 26, 2007 |
News Release: The Joint Commission Announces 2008 National Patient Safety Goals |
| June 26, 2007 |
First Edition Paper: Hendrickson JE, et al. Inflammation enhances consumption and presentation of transfused RBC antigens by dendritic cells. Blood. Pre-published online June 25, 2007 |
| June 20, 2007 |
Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs (FDA/CBER) |
| June 20, 2007 |
Draft Guidance for Industry: "Computer Crossmatch" (Electronic Based Testing for the Compatibility between the Donor’s Cell Type and the Recipient’s Serum or Plasma Type) (FDA/CBER) |
| June 20, 2007 |
Press Release: Immucor's ECHO cleared by FDA for Marketing in US |
| June 18, 2007 |
Doc suspected in hepatitis C cases; testing urged for 4,500 (CNN) |
| June 18, 2007 |
Wu WC, et al. Preoperative Hematocrit Levels and Postoperative Outcomes in Older Patients Undergoing Noncardiac Surgery. JAMA. 2007;297(22):2481-8. Also see: Farjah F et al. Hematocrit Level and Postsurgical Outcome: Powers of Observation. JAMA 2007;297(22):2525-6. and Red Blood Cell Count Before Surgery May Affect Postsurgery Risk After Age 65 (WebMD) |
| June 18, 2007 |
First Edition Paper: Zimring JC, et al. Non-hemolytic antigen-loss from RBCs requires cooperative binding of multiple antibodies recognizing different epitopes. Blood. prepublished online June 14, 2007 |
| June 18, 2007 |
New initiative to improve mothers' access to safe blood: Data released on blood safety and donation in 172 countries (WHO) |
| June 12, 2007 |
2007 Report of the Human Tissue Task Force (FDA/CBER) |
| June 8, 2007 |
Fung MK, et al. Transfusion of platelets containing ABO-incompatible plasma: a survey of 3156 North American laboratories. Arch Pathol Lab Med. 2007 Jun;131(6):909-16. |
| June 8, 2007 |
Westin SN, et al. Incidence of symptomatic deep venous thrombosis with epoetin alfa or darbepoetin alfa treatment of anemia in patients with ovarian or primary peritoneal cancer. Gynecol Oncol. 2007 May;105(2):414-7. |
| June 8, 2007 |
Croce MA, et al. Emergent pelvic fixation in patients with exsanguinating pelvic fractures. J Am Coll Surg. 2007 May;204(5):935-9; discussion 940-2. |
| June 7, 2007 |
Report From the STS Workforce on Evidence Based Surgery: Ferraris VA, et al. Perioperative Blood Transfusion and Blood Conservation in Cardiac Surgery: The Society of Thoracic Surgeons and The Society of Cardiovascular Anesthesiologists Clinical Practice Guideline. Ann Thorac Surg 2007;83:27-86. |
| June 4, 2007 |
DRAFT Guidance for Industry: Providing Regulatory Submissions in Electronic Format - Receipt Date (FDA/CBER) |
| June 1, 2007 |
Federal Register Notices (Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request): Docket No. 2006N-0475. Human Tissue Intended for Transplantation and Docket No. 2007N-0018 Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing; Form Food and Drug Administration 3356; Eligibility Determination for Donors; and Current Good Tissue Practice. |
| May 31, 2007 |
Page Updated: Potential Risk of Variant Creutzfeldt-Jakob Disease (vCJD) From Plasma-Derived Products which includes Potential Variant Creutzfeldt-Jakob Disease (vCJD) Risk From US Licensed Plasma-Derived Factor VIII (PdFVIII, Antihemophilic Factor) Products (FDA/CBER) |
| May 31, 2007 |
Safety Information Notice to Hospitals: Complications Associated with the Use of Bone Cements in Vertebroplasty and Kyphoplasty Procedures (Health Canada) |
| May 29, 2007 |
Full Text Article: Bryant BJ, Klein HG. Pathogen Inactivation: The Definitive Safeguard for the Blood Supply. Arch Pathol Lab Med. 2007 May;131(5):719-33. |
| May 25, 2007 |
Ahrens N, et al. Coexistence of autoantibodies and alloantibodies to red blood cells due to blood transfusion. 2007 May. Transfusion 47 (5), 813–16. |
| May 25, 2007 |
Isbister JP. Clinicians as gatekeepers: what is the best route to optimal blood use? Dev Biol (Basel). 2007;127:9-14. |
| May 25, 2007 |
Gonzalez AM, et al. Effects of fresh versus banked blood transfusions on microcirculatory hemodynamics and tissue oxygenation in the rat cremaster model. Surgery. 2007 May;141(5):630-9. |
| May 25, 2007 |
Tissue harvesting targeted: Bill to be reintroduced calling for tougher regulation of industry (Rochester Democrat and Chronicle) |
| May 24, 2007 |
FDA Policy on Blood Donations from Men Who Have Sex with Other Men (FDA/CBER) |
| May 24, 2007 |
Press Release: Northfield Laboratories Reports Results of Pivotal Phase III Trauma Study Results reported of Phase III trauma trial with PolyHeme(R) (Northfield Laboratories) |
| May 22, 2007 |
MedWatch Product Safety Alert: Exjade (deferasorix) Tablets For Oral Suspension Also see Novartis Letter to Healthcare Professionals |
| May 21, 2007 |
No Cancer Risk From Blood Transfusion: Receiving Blood From a Precancerous Donor Doesn't Raise Cancer Risk (WebMD) Also see articles by Edgren G, et al: Risk of cancer after blood transfusion from donors with subclinical cancer: a retrospective cohort study. Lancet 2007; 369:1724-1730 and A population-based binational register for monitoring long-term outcome and possible disease concordance among blood donors and recipients. Vox Sang 91(4), 316–323. |
| May 18, 2007 |
FDA News: FDA Approves Expanded Use for Surgical Sealant |
| May 18, 2007 |
Full Text Article: Goodnough LT, Shander A. Blood Management. Arch Pathol Lab Med. 2007 May;131(5):695-701. |
| May 18, 2007 |
First Edition Paper: Cserti CM, Dzik WH. The ABO blood group system and plasmodium falciparum malaria. Blood. Prepublished online May 14, 2007. |
| May 18, 2007 |
Full Text Article: Osby MA, et al. Safe Handling and Administration of Blood Components: Review of Practical Concepts Arch Pathol Lab Med. 2007 May;131(5):690-4. |
| May 16, 2007 |
First Edition Paper: Jozsi M, et al. Anti-factor H autoantibodies block C-terminal recognition function of factor H in hemolytic uremic syndrome. Blood. prepublished online May 10, 2007 |
| May 13, 2007 |
Scientists create 'plastic' blood: Scientists have developed an artificial plastic blood which could act as a substitute in emergencies. (BBC News) |
| May 13, 2007 |
Original Article: Giordano TP, et al. Risk of Non-Hodgkin Lymphoma and Lymphoproliferative Precursor Diseases in US Veterans With Hepatitis C Virus. JAMA. 2007;297:2010-2017. |
| May 8, 2007 |
New CDC document In a Moment’s Notice: Surge Capacity for Terrorist Bombings - Challenges and Proposed Solutions. Includes comments on blood banks' plans for response (CDC) |
| May 8, 2007 |
Information on radiofrequency identification (RFID) (FDA/CDRH) |
| May 2, 2007 |
Original Article: Murphy MF, et al. Prevention of bedside errors in transfusion medicine (PROBE-TM) study: a cluster-randomized, matched-paired clinical areas trial of a simple intervention to reduce errors in the pretransfusion bedside check. Transfusion. 2007 May; 47(5):771–80. |
| May 1, 2007 |
Toy to Receive 2007 International Woman in Transfusion Award (UCSF Today) |
| Apr. 27, 2007 |
Documents for April 26-27 Meeting of Blood Products Advisory Committee (FDA/CBER) |
| Apr. 25, 2007 |
First Edition Paper: Kjaersgaard M, et al. Epitope specificity and isotype of monoclonal anti-D antibodies dictate their ability to inhibit phagocytosis of opsonized platelets. Blood. prepublished online April 24, 2007. |
| Apr. 24, 2007 |
Sale of tainted blood nets HIV-positive man 2 years (Chicago Post-Tribune) |
| Apr. 21, 2007 |
Public Communication: Important Safety Information and New Prescribing Information for the Erythropoiesis-Stimulating Agents, Aranesp® (darbepoetin alfa) and EPREX* (epoetin alfa) AND Information for Healthcare Professionals (Health Canada) |
| Apr. 21, 2007 |
Adverse Tissue Reaction Policies (The Joint Commission) |
| Apr. 21, 2007 |
Original Article: Lacroix J, et al. Transfusion Strategies for Patients in Pediatric Intensive Care Units N Engl J Med. 2007 Apr 19;356(16):1609-19. Also see Editorial: Corwin HL, Carson JL. Blood Transfusion — When Is More Really Less? N Engl J Med. 2007 Apr 19;356(16):1667-69. |
| Apr. 14, 2007 |
First Edition Paper: Kjeldsen-Kragh J, et al. A screening and intervention program aimed to reduce mortality and serious morbidity associated with severe neonatal alloimmune thrombocytopenia. Blood. Prepublished online April 11, 2007. |
| Apr. 7, 2007 |
Original Article: Lundy D, et al. Seven hundred and fifty-nine (759) chances to learn: a 3-year pilot project to analyse transfusion-related near-miss events in the Republic of Ireland. Vox Sang. 2007 Mar;92(3):233-41. |
| Apr. 4, 2007 |
AABB Association Bulletin 07-02: West Nile Virus - Recommendations for Triggering Individual Donation Nucleic Acid Testing and Developing a Communication Plan (Access limited to members) |
| Apr, 4, 2007 |
Full Text Article: Saxena S et al. Ensuring Timely Completion of Type and Screen Testing and the Verification of ABO/Rh Status for Elective Surgical Patients. Arch Pathol Lab Med. 2007 Apr; 131(4):576-11. |
| Apr. 2, 2007 |
FDA Approves Rhophylac(R) for the Treatment of Immune Thrombocytopenic Purpura (ITP) (PRNewswire) |
| Apr. 2, 2007 |
Article: Liu QP, et al. Bacterial glycosidases for the production of universal red blood cells. Nature Biotechnology 4 April 2007. 25;454-64. Also see: Blood groups 'can be converted' Scientists have developed a way of converting one blood group into another (BBC News) |
| Apr. 2, 2007 |
Notice to Hospitals: Association of Trasylol® (aprotinin) with hypersensitivity reactions and renal dysfunction (Health Canada) |
| Mar. 27, 2007 |
Verax Biomedical Submits 510(k) Application To FDA For Platelet PGD Test (Medical News Today) Also see: Verax Biomedical Press Release and Abbott Press Release: Abbott Signs Exclusive Worldwide Distribution Agreement with Verax Biomedical for Rapid Platelet Bacteria Test |
| Mar. 25, 2007 |
Article: Mason KD, et al. Programmed Anuclear Cell Death Delimits Platelet Life Span Cell, Vol. 128, 1173-1186, 23 Mar. 2007 Also see News Report: New lease on shelf life for blood |
| Mar. 22, 2007 |
Original Article: Licker M, et al. Cardioprotective effects of acute normovolemic hemodilution in patients with severe aortic stenosis undergoing valve replacement. Transfusion Feb 2007;47(2):341–350. |
| Mar. 22, 2007 |
General Article: Waters JH, et al. Modification of Suction-Induced Hemolysis During Cell Salvage. Anesth Analg 2007;104:684-687. |
| Mar. 19, 2007 |
Safety Information: Acute renal failure associated with EXJADE* (deferasirox) & Reports of cytopenias with EXJADE* (deferasirox) (Health Canada) |
| Mar. 17, 2007 |
Blood Donor History Questionnaire Version 1.2 February 2007 (AABB) |
| Mar. 17, 2007 |
Recall of Medical Devices: Biomet Biologics (FDA/CBER) |
| Mar. 17, 2007 |
Important Notification: Fast Flow Fluid Warmers by Smith Medical - additional warning issued to users (FDA/CBER) |
| Mar. 17, 2007 |
Wasley A, et al. Surveillance for Acute Viral Hepatitis: United States, 2005. MMWR Surveillance Summaries, Mar. 16, 2007. 56(SS03);1-24. |
| Mar. 15, 2007 |
Manual of Standard Operating Procedures and Policies: Administrative Processing of Biologics License Applications (BLA); SOPP 8401; Version #5; March 12, 2007 (FDA/CBER) |
| Mar. 10, 2007 |
FDA News: FDA Strengthens Safety Information for Erythropoiesis-Stimulating Agents (ESAs) |
| Mar. 9, 2007 |
Doctors take recycling to heart: Device recycles patient's blood during surgery (Statesman Journal) |
| Mar. 9, 2007 |
Report: Racial/Ethnic Disparities in Diagnoses of HIV/AIDS: 33 States, 2001-2005. CDC MMWR March 9, 2007 / 56(09);189-193. |
| Mar. 5, 2007 |
Press Release: Fenwal Launched as Independent Corporation Following Completion of Divestiture from Baxter Healthcare Corporation |
| Mar. 2, 2007 |
FDA Preliminary Public Health Notification: Unpredictable Events in Medical Equipment due to New Daylight Savings Time Change (FDA/CDRH) |
| Mar. 1, 2007 |
Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (FDA/CBER) |
| Mar. 1, 2007 |
Paper: Bereket-Yücel, S. Risk of Hepatitis B Infections in Olympic Wrestling. Br J Sports Med. Published Online First: 1 March 2007. Also see Sport fears over sweat virus risk: virus could be spread in sweat during contact sports, say Turkish researchers (BBC News) |
| Mar. 1, 2007 |
FDA Clears Baxter's Modified Infusion Pump: Pump was subject of recalls and seizure actions in 2005 (FDA/CBER) Also see Baxter gets OK for fixing pumps (Chicago Tribune, registration may be required to access) |
| Feb. 24, 2007 |
Cinical Review: Scott JD, Gretch DR. Molecular Diagnostics of Hepatitis C Virus Infection, A Systematic Review, JAMA 2007; 297(7):724-732. |
| Feb. 24, 2007 |
JAMA Patient Page: Zeller JL, at al. Hepatitis C. JAMA 2007; 297(7):768. |
| Feb. 22, 2007 |
Biologic Product Withdrawal of Carimune® NF Immune Globulin Intravenous -ZLB Behring (FDA/CBER) |
| Feb. 19, 2007 |
The Joint Commission Launches New Brand Identity: Organization Name, Logo, Website & Tagline |
| Feb. 19, 2007 |
Original Article: Young C, et al. Transfusion-acquired Trypanosoma cruzi infection. Transfusion (OnlineEarly Articles). doi:10.1111/j.1537-2995.2006.01147.x |
| Feb. 19, 2007 |
Original Article: Sanders RP, et al. A revised classification scheme for acute transfusion reactions. Transfusion (OnlineEarly Articles). doi:10.1111/j.1537-2995.2007.01163.x |
| Feb. 13, 2007 |
Review: Dzik WH. New technology for transfusion safety. Br J Haematol. 2007 Jan;136(2):181-90. |
| Feb. 13, 2007 |
Recall of Ortho Clinical Diagnostics FETALSCREEN -initiated 1/9/07 (FDA/CBER) |
| Feb. 11, 2007 |
Comments: Barone J, et al. Blood doping in the surgical intensive care unit: evidence-based surgical rebuttal. Surgery. 2007 Jan;141(1):7-8. |
| Feb. 11, 2007 |
CE Article: Gould S, et al. Packed Red Blood Cell Transfusion in the Intensive Care Unit: Limitations and Consequences. Am J Crit Care. 2007 Jan;16(1):39-48; quiz 49. |
| Feb. 9, 2007 |
FDA News: Cardinal Health 303, Inc. Signs Consent Decree with FDA; Agrees to Correct Manufacturing Deficiencies |
| Feb. 9, 2007 |
MedWatch: Heparin Sodium Injection 10,000 units/mL, and HEP-LOCK U/P 10 units/mL Medication Errors |
| Feb. 7, 2007 |
'Low' vCJD death toll from blood: There are likely to be relatively few deaths from the human form of mad cow disease, vCJD, as a result of infected blood, scientists have suggested (BBC News) |
| Feb. 6, 2007 |
Review: Bokemeyer C, et al. EORTC guidelines for the use of erythropoietic proteins in anaemic patients with cancer: 2006 update. Eur J Cancer. 2007 Jan;43(2):258-70. |
| Feb. 3, 2007 |
FDA News: FDA Approves New Product to Treat Von Willebrand Disease |
| Feb. 1, 2007 |
Guidance for Industry: Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container (FDA/CBER) |
| Feb. 1, 2007 |
Full Text Article: Bunn, HF. New agents that stimulate erythropoiesis. Blood, 1 February 2007, Vol. 109, No. 3, pp. 868-873. |
| Feb. 1, 2007 |
Abstract: Blaustein DA, et al. Recent experience with high-dose intravenous iron administration. Kidney Int Suppl. 2006 Dec;(104):S26-9. |
| Feb. 1, 2007 |
Full Text Article: Chant C, et al. Anemia, transfusion, and phlebotomy practices in critically ill patients with prolonged ICU length of stay: a cohort study. Crit Care. 2006;10(5):R140. |
| Jan. 29, 2007 |
Medicare Coverage Decision Summary: CMS determines extracorporeal photopheresis reasonable and necessary for cGVHD and acute cardiac allograft rejection (CMS) |
| Jan. 29, 2007 |
News Release: Bayer Discontinues Trasylol® Clinical Trial Program in non-CABG Indications (Bayer Pharmaceuticals Corp) |
| Jan. 27, 2007 |
CBER Presentation: Celia M.Witten, PhD, MD. Cell Therapy in Multiple Sclerosis: FDA Regulatory Issues |
| Jan. 27, 2007 |
Electronic Biological Product Deviation Reporting (eBPDR) Latest System Changes. Version 4.0.0 Release Information- several important enhancements added (FDA/CBER) |
| Jan. 23, 2007 |
Guidance for Industry for immediate implementation: Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered From Donors Who Were Tested For Communicable Diseases Using Pooled Specimens or Diagnostic Tests (FDA/CBER) |
| Jan. 16, 2007 |
Draft Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies (FDA/CBER) |
| Jan. 13, 2007 |
Book Review: "The Transfusion Committee: Putting Patient Safety First" Reviewed by James P. AuBuchon, MD (Book may be purchased from AABB HERE) |
| Jan. 10, 2007 |
New rules may shrink ranks of blood donors (Pittsburgh Post-Gazette) |
| Jan. 10, 2007 |
Original Article: Bhandal N, Russell R. Intravenous versus oral iron therapy for postpartum anaemia. BJOG. 2006 Nov;113(11):1248-52. |
| Jan. 10, 2007 |
Blood First Edition Paper: Posthouwer D, et al. Progression to end-stage liver disease in patients with inherited bleeding disorders and hepatitis C: an international, multicenter cohort-study. Prepublished online January 9, 2007. |
| Jan. 9, 2007 |
JCAHO Potential 2008 National Patient Safety Goals. Plans include goals for patient identification technology and prevention of catheter and tubing misconnections. |
| Jan. 9, 2007 |
Recall of Vironostika HIV-1 Microelisa System (FDA/CBER) |
| Jan. 4, 2007 |
Draft Guidance for Industry and FDA Staff - Radio-Frequency Wireless Technology in Medical Devices (FDA/CDRH) |
| Jan. 4, 2007 |
Original Article: Singh AK, et al. Correction of anemia with epoetin alfa in chronic kidney disease. N Engl J Med. 2006 Nov 16;355(20):2085-98. |
| Jan. 4, 2007 |
Original Article: Drüeke TB, et al. Normalization of Hemoglobin Level in Patients with Chronic Kidney Disease and Anemia. N Engl J Med. 2006 Nov 16;355(20):2071-84. |
| Jan. 1, 2007 |
Press Release: First Prion-Free Cows Reported in Nature Biotechnology (Hematech) Also see Scientists Announce Mad Cow Breakthrough: Genetic Engineering Creates Cattle Without Protein That Causes Disease (Washington Post, free registration required to access) |
| Jan 1, 2007 |
Mediware Delivers Integration Between HCLL™ Blood Bank And McKesson's Horizon Lab™ (Medical News Today) |
