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Apheresis News Volume 1.01

Apheresis News facilitates the exchange of information and resources between members of the global apheresis community by providing a website portal and a free, monthly e-newsletter dedicated to the latest information affecting apheresis.
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November 01, 2006  // Volume 1.01
TOP STORY

Implementation of Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Donors of Blood and Blood Components
This guidance provides blood establishments that collect blood and blood components intended for transfusion or for further manufacture with advice on reporting to the Food and Drug Administration (FDA) a manufacturing change consisting of the implementation of a standardized full-length donor history questionnaire and accompanying materials.

SCIENCE

Anormed Completes Enrollment in Phase III Trial for Mozobil on Schedule
AnorMED Inc. has announced that it has completed enrollment in the second pivotal Phase III clinical trial evaluating its proprietary product MOZOBIL in cancer patients, and that the Company is on track to meet its schedule of releasing top-line data from both Phase III trials in the first half of 2007.

Patient's Own Blood Cells Treat Tennis Elbow
Using patients' own platelets, doctors report they were able to successfully treat tennis elbow.

Multi-Center Study Concludes Nephros Mid-Dilution Hemodiafiltration Therapy Achieves Higher Clearance of Low Molecular Weight Proteins
Nephros, Inc. has announced that the results of a randomized, multi-site scientific study indicate that the Company’s Mid-Dilution Hemodiafiltration (Mid-HDF) therapy, using its OLpur MD 190 filter, offers the advantages of both pre- and post-HDF, and is "the most efficient dialysis procedure for Low-Molecular Weight Protein removal."

Early Catheter Replacement Better Than Delayed Replacement in Hemodialysis Patients With Catheter-Related Infection
Catheters can be removed early on with no additional risk of infection in dialysis patients who have had catheter-related infection (CRI), according to results of a small randomized study presented at the 44th annual meeting of the Infectious Diseases Society of America (IDSA).

New Device Utilizes Beam of Light to Test Blood Cheaply, Quickly 
A scientist and a doctor have collaborated on the development of a new device that tests blood for diseases quickly by shining a beam of light into a sample of blood, said to be cheaper and easier than standard diagnostic tests and to eliminate the need to send samples to a lab.

Code Scanning Boosts Safety
A hand-held computer prevents potentially fatal accidents by matching patients to blood products before allowing transfusions to start and has been proven a complete success during pilot trials at the John Radcliffe in Headington.

Hydromer, Inc. Announces a Non-Leaching Anti-Thrombogenic Coating for Evaluation
The surface bonding capabilities of the F202 polymer, which maintains long-term non-leaching properties, are outstanding on a wide variety of medical materials such as cardiovascular devices and stents, hemodialysis equipment and intravenous catheters.

Study Shows Nearly One In Five People Plan To Donate Blood In The Next Year
Donating the most needed component(s)," such as red blood cells and platelets, was the primary reason mentioned by more than 50 percent of respondents who intended to make their next donation on an automated collection system.

Demand for Platelets up 50% in 5 Years
The demand for platelets - vital components of blood used in the treatment of cancer - has increased by 50% over the last five years, the Irish Cancer Society (ICS) has said.

Irish Blood Bank Considers New vCJD Blood Filter Trial
The Blood Bank has said it may consider proceeding with its own clinical trial of a new filter to remove the infectious agent believed to carry vCJD in blood, following the halting of an unrelated earlier trial.

Blood Transfusions May Have Contained HIV, Hepatitis Due to Faulty Testing Kits
West Bengalese patients who received blood transfusions from donation centers that used Monozyme India Private Ltd.'s faulty diagnostic device may have been exposed to HIV and hepatitis B and C viruses.

Korean Women May Have Been Exposed to Acitretin in Blood Transfusions
The Korean National Red Cross has told approximately 400 Korean woman who received blood transfusions to avoid pregnancy for at least two years because they may have been exposed to Acitretin, which can cause birth defects.

A Reminder of Darker Days
The events surrounding the blood scandal of the mid-1990s have re-emerged this week following the news that Crumlin Children's Hospital is recalling around 70 former patients who who were given blood products between 1991 and 1994 which were not adequately screened for Hepatitis C.

ABSTRACTS, REVIEWS AND SPECIAL REPORTS

Cytapheresis in the Treatment of Cell-affected Blood Disorders and Abnormalities
The report presents the researchers' experience with cytaphereses performed in treatment of 476 patients.

Overnight Storage of Autologous Stem Cell Apheresis Products Before Cryopreservation Does Not Adversely Impact Early or Long-term Engraftment Following Transplantation
The results of the study suggest that overnight storage of the autograft before cryopreservation does not adversely affect graft viability or influence long-term disease status, and support the continued use of overnight storage of stem cells before cryopreservation as a convenient, cost reduction measure.

BUSINESS

Texas Pacific Group and Maverick Name Ron K. Labrum to Lead Transfusion Therapies Business Following Acquisition
Texas Pacific Group and Maverick Capital, Ltd. today announced that Ron K. Labrum will lead the Transfusion Therapies business that the firms are acquiring from Baxter International, Inc. Labrum will become CEO of the new company upon completion of the sale.

Haemonetics Announces Change to Board of Directors
Haemonetics Corporation has announced the decision by Ronald A. Matricaria, Chairman of the Board, to retire from Haemonetics at the end of the calendar year. 

OccuLogix and Asahi Kasei Sign Rheo Deal
OccuLogix Inc. and Asahi Kasei Medical Co. of Japan have signed a distribution agreement covering a second-generation filter for the Rheo treatment system for a common form of age-related blindness.

Abbott Signs Exclusive Worldwide Distribution Agreement with Verax Biomedical for Rapid Platelet Bacteria Test
Abbott Laboratories (ABT) signed an exclusive worldwide agreement to market Verax Biomedical Inc.'s Verax Platelet PGD test that is designed to detect bacterial contamination in blood and tissues.

Blood Systems Laboratories Selects ABBOTT PRISM(R) System and Assays for Automated Blood Screening
Abbott announced it has signed an agreement with Blood Systems Laboratories to supply ABBOTT PRISM(R) System fully automated blood screening instruments and assays for use at its U.S. blood donor testing sites.

LifeShare Blood Centers Select Sysmex America Hematology Analyzers
Sysmex America, Inc. today announced that LifeShare Blood Centers has selected the Sysmex XE-2100D automated hematology analyzers for use in its Shreveport and Lake Charles Louisiana blood centers.

Daxor Announces UMDNJ of Newark, NJ Acquires Blood Volume Analyzer BVA-100
Daxor Corporation has announced the receipt of a signed trial agreement from the University of Medicine and Dentistry of New Jersey (UMDNJ) of Newark, New Jersey.

Fresenius Medical Care Announces New Sourcing and Supply Agreement with Amgen
Fresenius Medical Care AG & Co. KGaA today announced that its subsidiary, Fresenius Medical Care Holdings Inc. has entered into a new sourcing and supply agreement with Amgen USA, Inc. under which Amgen will supply FMC-NA’s commercial requirements in the United States and Puerto Rico for erythropoiesis stimulating proteins for dialysis patients, inclusive of EPOGEN (Epoetin alfa) and Aranesp (Darbepoetin alfa).

Fresenius to Buy Nabi Unit
German health-care company Fresenius Medical Care AG said Wednesday it will buy a business from Nabi Biopharmaceuticals Inc. for up to $85 million in cash to acquire a new treatment for patients with kidney failure.

New Program Lets Soldiers Donate Blood on the Battlefield
The Department of National Defence and Canadian Blood Services are working together on new system that will allow Canadian troops to donate blood to wounded colleagues in the battlefield.

National Institutes of Health Awards Grant for New Bacterial Test
Immunetics, Inc. has received a $2.5 million grant from the National Heart, Lung and Blood Institute to support clinical trials for its BacTx(TM) test for bacterial contamination of platelet units.

FUNDING & PROGRAMS

Announcing Electronic Grant Submission Training Opportunity (NOT-OD-07-009)
As NIH continues to transition paper applications to electronic submission using the SF424 (R&R) forms, a training event has been scheduled. The event will include a plenary presentation on December 5 combined with “hands-on” computer labs offered December 4 – 6, 2006.

International Woman in Transfusion Award
AABB, the BBTS and ISBT have established this unique award to honor women for lifetime achievements in transfusion medicine and science.

American Society for Apheresis Best Abstract Award
Ten awards valued at $1500 each will be awarded to ASFA members and non-members.

REGULATORY

FOOD AND DRUG ADMINISTRATION (United States of America)

Donor Screening Tests for Testing HCT/P Donors - Updates

Notice: FDA Form 3356 Annual Tissue Establishment Registration - December 2006 

Recall of Dupaco Blood/Fluid Warming Set

Substantially Equivalent 510(k) Device Information - GenesisCS Component Concentrating System - Perfusion Partners & Associates, Inc

2006 Biological Approvals - Update

Draft Guidance for Industry and Food and Drug Administration Staff; Annual Reports for Approved Premarket Approval Applications; Availability

Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
The FDA will hold a public meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee Dec. 7 and 8. The committee will discuss and make recommendations regarding issues related to stent thrombosis (blood clotting) in coronary drug-eluting stents.

Global Harmonization Task Force, Study Groups 1, 2, 4, and 5; New Proposed and Final Documents; Availability

FDA and Industry Differ on Safety of Medical Device Reprocessing
The FDA regulates reprocessing of single-use medical devices, a burgeoning $100 million industry, and says reprocessed devices are safe and effective. Device manufacturers worry that complete cleaning and sterilization is not possible because of some complex device designs, however, and they contend patient safety is threatened.

MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (United Kingdom)

MedicalDeviceAlert - Blood Administration Set: Volumed Blood Set, Manufactured by Sendal SA and Distributed by Arcomedical Infusion Ltd.

Field Safety Notice - Intravenous Cannulae, Cordis Neurovascular Inc, Pre-shaped PROWLER and Pre-shaped PROWLER SELECT Infusion Catheters

Field Safety Notice - Dialysis, Haemodialysis: Machine Haemodialysis - Aksys Ltd - Aksys PHD Personal Hemodialysis System for Daily Home Hemodialysis; an Automated High Permeability Hemodialysis System, Water Purification System for Hemodialysis; Model 1M101

Device Bulletins - Single-use Medical Devices: Implications and Consequences of Reuse

THERAPEUTIC GOODS ADMINISTRATION (Australia)

Important Advice Regarding Listed and Registered Devices

Update on the Regulation of the Re-manufacture of Single Use Medical Devices

Definitions Relating to the Regulation of the Re-manufacture of Single Use Medical Devices

ASFA

ASFA ANNUAL MEETING CALL FOR ABSTRACTS

The American Society for Apheresis (ASFA) invites apheresis professionals to submit abstracts for presentation at the ASFA 2007 Annual Meeting to be held at the Gaylord Opryland Resort and Convention Center, Nashville, TN from April 18-21, 2007.

Click here to submit your abstract today.


AMERICAN SOCIETY FOR APHERESIS EDUCATIONAL WEBINAR SERIES

November 29, 2006 - Understanding the Regulatory and Accreditation Programs for Apheresis Donor, Stem Cell, and Therapeutic Activities

December 6, 2006 - FDA Regulatory Oversight, Inspections, and Enforcement for Apheresis Stem Cell Activities

Register now by clicking here.  

JOB OPPORTUNITIES

Cascade Regional Blood Services
Apheresis Coordinator

Bonfils Blood Center
Various Openings

FEATURED EVENT

American Society of Nephrology Renal Week
November 14-19, 2006
San Diego, California

For further event information, click here.

WEBSITE PREVIEW

The Apheresis News website features information on apheresis events, publications, regulatory bodies, associations, jobs, and products. Please visit www.apheresisnews.com to access these resources.

JOURNALS

Transfusion & Apheresis Science
“Transfusion and Apheresis Science brings comprehensive and up-to-date information to physicians and health care professionals involved in the rapidly changing fields of transfusion medicine and apheresis."

Dialysis & Transplantation
“Dialysis & Transplantation is the oldest renal care journal in the world. It also has the largest-circulation (24,000-plus)."

This newsletter is intended to be a useful and timely reference for those working or interested in apheresis. Because of the constantly changing nature of the Internet, some of the website links included herein may change without notice.
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