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Apheresis News Volume 2.02

Apheresis News facilitates the exchange of information and resources between members of the global apheresis community by providing a website portal and free, monthly e-newsletter dedicated to the latest information affecting apheresis.
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March 07, 2007  // Volume 2.02
TOP STORY

FDA Preliminary Public Health Notification: Unpredictable Events in Medical Equipment Due to New Daylight Savings Time Change

Researchers Develop Resin Beads That Capture Mad Cow Disease Agent From Blood
For the first time, experimental results indicate that it is possible to use a resin filter to remove harmful prion proteins from the blood of an infected animal, a finding that has major implications for the removal of infectious prion proteins – the agents associated with variant Creutzfeldt-Jakob disease, mad cow disease, scrapie and other prion diseases in animals – during blood transfusions.

Fenwal Launched as Independent Corporation Following Completion of Divestiture From Baxter Healthcare Corporation
Fenwal Inc. has announced its launch as an independent company. The new corporation is formed upon Baxter Healthcare Corporation completing the sale of its Transfusion Therapies business to Texas Pacific Group and Maverick Capital, Ltd.

Haemonetics Launches Next Generation Mobile Blood Donation System
Haemonetics Corporation has announced FDA clearance and U.S. launch of the Cymbal system, the Company's innovative blood collection system. The Cymbal system is highly portable and designed for ease-of-use and donor comfort while collecting two units of red blood cells from one blood donor in a single donation.

SCIENCE

Body Glue Cuts Recovery Time
A new process concentrates elements of the blood to enhance the growth and healing ability of the body.

Sifting Out Cure For HIV: Special Ceramic Membranes Could Filter Virus From Blood
HIV may one day be able to be filtered from human blood saving the lives of millions of people, thanks to a world-first innovation by Queensland University of Technology scientists.

Bloodbot Helps Keep Canadian Blood Clean
The robot does the tedious work of separating the components of the blood samples, registering them according to a barcode reading, and then preparing them to be frozen until researchers can analyze them.

Equivalent Results from Umbilical Cord Blood and Related Donor Stem Cell Transplants
Researchers from Japan have reported that the outcomes of patients with hematologic malignancies treated with umbilical cord blood transplants produces similar outcomes to patients receiving HLA matched related transplants.

Old Age is No Longer a Barrier to Stem Cell Transplant
The conventional wisdom has been that people in their 50s and 60s or older are not good candidates for stem cell transplant (SCT), but research presented here shows that the technique can be as successful in the elderly as it is in younger people.

Ortho Biotech in Discussions with FDA Regarding Prescribing Information for Erythropoiesis-Stimulating Agents
Ortho Biotech Products, L.P. has announced that the company is in discussions with the U.S. Food and Drug Administration (FDA) regarding a safety update to the prescribing information of all erythropoiesis-stimulating agents (ESA), including PROCRIT(R) (Epoetin alfa), based on reports from several investigational studies evaluating ESAs. These data may have an impact on labeling in other parts of the world for EPREX(R) (Epoetin alfa), which is marketed by Janssen-Cilag.

ThermoGenesis Corp. Submits 510(k) Application to FDA for AutoXpress Cord Blood Processing System
ThermoGenesis Corp. announced today that the Company has submitted a 510(k) pre-market notification application to the U.S. Food and Drug Administration (FDA) requesting regulatory clearance for its AutoXpress System (AXP(TM)).

FDA Clears Baxter's Modified Infusion Pump
This pump was the subject of recalls and seizure actions in 2005.

FDA Approves Gen-Probe's TIGRIS(R) Instrument to Screen Donated Blood for West Nile Virus
Gen-Probe Incorporated announced today that the U.S. Food and Drug Administration (FDA) has approved the Company's PROCLEIX(R) TIGRIS(R) System, the first fully automated molecular diagnostics instrument, to screen donated blood, organs and tissues for West Nile virus (WNV) using the PROCLEIX WNV Assay.

Cerus Reports on Post-Market Surveillance Studies for the INTERCEPT Blood System at 9th European Haemovigilance Seminar
Laurence M. Corash, M.D., Chief Medical Officer of Cerus Corporation presented information regarding the study methodology and data from ongoing INTERCEPT Blood System haemovigilance studies during the European Haemovigilance Seminar held February 27 and 28 in Dublin, Ireland.

Heparin Maker Urges Caution on Dosages
Baxter Healthcare Corporation, maker of the heparin drug and bottle that led to the overdose deaths of three infants at Methodist Hospital last fall, has issued a letter warning healthcare workers to read carefully labels on its blood thinners to avoid future errors.

Doctors Urge Public Cord Blood Banking
Parents should donate umbilical cord blood to public cord blood banks, not bank it privately, a pediatricians' group said in New York.

Study Says Blood Donations May Help Donors' Health
Blood donations may help keep the body's circulatory system healthy by reducing stores of iron, but the effect may not work for older people, a U.S. study suggested on Tuesday.

'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.

'Tagging' Improves Patient Safety
Hospital patients are used to wearing wristbands. But now those bands have gone high-tech.

ABSTRACTS, REVIEWS AND SPECIAL REPORTS

Avoiding Calcineurin Inhibitors in the Early Post-operative Course in High-risk Liver Transplant Recipients: The Role of Extracorporeal Photopheresis
The aim of this work is to report on the results of a single-center, prospective study on the feasibility of calcineurin-inhibitor (CNI)-staggered immunosuppression by use of extracorporeal photopheresis (ECP) in liver transplant (LT) recipients at risk of renal and neurological complications.

Instant Insight: A Sound Idea
Thomas Laurell, Lund University, Sweden, explains how ultrasound can be used to separate and move cells and particles in microfluidic devices.

BUSINESS

StemCell Technologies Signs Worldwide Distribution Agreement for ALDECOUNT with Aldagen
StemCell Technologies, Inc., a Vancouver-based life sciences company, announced today that it has signed a worldwide distribution agreement with Aldagen, Inc., a Durham, NC-based regenerative medicine company, whereby StemCell will distribute Aldagen’s ALDECOUNT(R) product. StemCell Technologies is also the worldwide distributor for Aldagen’s ALDEFLUOR(R) product. 

Reliance Life Sciences Acquires Genemedix PLC, UK
Reliance Life Sciences Private Limited, India, has acquired GeneMedix plc, a UK-based biotechnology company with London and Singapore Stock Exchange listings.

Datascope Announces Sale of Proguide Chronic Dialysis Catheter
Datascope Corp. announced that it has completed the sale of its ProGuide chronic dialysis catheter and the associated assets to Merit Medical Systems, Inc. of South Jordan, Utah for $3 million plus a royalty on future sales of the ProGuide catheter.

NxStage(R) Medical and DaVita Announce Agreement for Home Hemodialysis Using the NxStage System One(TM)
NxStage Medical, Inc. has announced a multi-year, national agreement with certain market rights, under which the two companies will collaborate on expanding availability of home hemodialysis to patients across the continental United States.

Talecris Adds Illinois Plasma Collection Center to Roster
The new facility is the first Talecris collection center to open since the company purchased International BioResources - and its 58 existing plasma collection centers - for an undisclosed amount in December.

BioLife Solutions Inc. Appoints Funakoshi Co. as Exclusive Distributor in Japan
This decision supports the Company's strategic plan to capture a significant share of the worldwide market for preservation media.

American Renal Associates Acquires a New Facility in St. Louis, Missouri
American Renal Associates Inc. announced the acquisition of Metro St. Louis Dialysis-Florissant LLC, an outpatient facility located in St. Louis, MO. This is the 1st facility acquired by ARA in 2007 and is ARA's first facility in the State of Missouri.

ThermoGenesis Announces Higher Production Volumes for AutoXpress(TM) (AXP(TM)) Cord Blood Stem Cell Processing Bags
ThermoGenesis Corp. has announced that its contract manufacturing organizations for the disposable cord blood stem cell processing bag sets for its AXP System have increased weekly production to more than 2,000 sets.

Pay-for-plasma Operation Sees Increase in Business
Carrie Ginn, assistant manager at BioLife Plasma Services in Athens, said the number of plasma donors at BioLife has almost doubled over the past year. BioLife pays donors $25 dollars for the first visit in a seven-day period and $35 for the second.

Blood Unit Faces Phased Closure
Transfusion chiefs have decided to shut an Edinburgh plant which manufactured blood products.

BioLife Biometric System First Step to "Paperless" Plasma Collection
Innovative technology now launching in Baxter’s BioLife Plasma Services blood plasma collection centers makes the donor-screening process as easy as lifting a finger. Called the Electronic Donor Questionnaire (eDQ), the new system is the initial step in BioLife’s effort to create paperless plasma centers.

Loyalty Program With New Desktop Marketing Communication Proves More Successful Than Outdated Programs That Utilize E-mail
Mississippi Valley Regional Blood Center (MVRBC) recently launched an innovative Loyalty Program and integrated scheduling system for blood donors. The program is designed to increase blood donations, donor frequency and retention, while at the same time lower marketing and communication costs for reaching whole blood, platelet apheresis and double-red cell donors.

Clarient Gets Cancer Cell Tech Patent
Clarient Inc., a maker of cancer detection equipment, said recently that it received a patent for a technology to detect rare cancer cells in blood and blood marrow.

NeoStem, Inc. Appoints Wayne A. Marasco, M.D., Ph.D., to Chair Company's Scientific Advisory Board
NeoStem, Inc. has announced that Wayne A. Marasco, M.D., Ph.D., has agreed to serve as Chairman of the Company's Scientific Advisory Board.

FUNDING & PROGRAMS

NLM Grants for Scholarly Works in Biomedicine and Health (G13) (PAR-07-237)

Notice of Intent to Publish a Request for Applications for the NIH Director’s New Innovator Awards (NOT-OD-07-047)

Implementation of NIH Fiscal Policy for Non-Competing Grant Awards – FY 2007 (NOT-OD-07-049)

Notice of Legislative Mandates in Effect for FY 2007 (NOT-OD-07-050)

Salary Limitation on Grants, Cooperative Agreements, and Contracts (NOT-OD-07-051)

Ruth L. Kirschstein National Research Service Award (NRSA) Stipend and Other Budgetary Levels Effective for Fiscal Year 2007 (NOT-OD-07-052)

NHLBI Creates A New Clinical Research Guide (NOT-HL-07-002)

Notice of a FAQ Website for RFA-HL-07-009, NHLBI Ancillary Studies in Clinical Trials (R01) (NOT-HL-07-007)

REGULATORY

Organ Donation Gets Easier
Idaho is the first state to pass a law aimed at making it easier for people to donate their organs and could be joined in coming weeks by about 20 other states considering similar legislation.

CENTERS FOR MEDICARE AND MEDICAID SERVICES (United States of America)

Medicare to Provide Beneficiaries With Information on Physician Performance as Part of Value-driven Health Care Initiative

CMS Recognizes Joint Commission Accreditation for Clinical Laboratories

MedCAC Solicitation for New Members (deadline March 12, 2007)

April Update to the 2007 Medicare Physician Fee Schedule Database (MPFSDB)

Medicare Evidence Development & Coverage Advisory Committee - Clinical Trial Policy, Posted Transcript and Minutes from December 13 Meeting


FOOD AND DRUG ADMINISTRATION (United States of America)

Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

FDA Enforcement Report

Agency Information Collection Activities: Submission for Office of Management and Budget Review; Comment Request; Export of Medical Devices-Foreign Letters of Approval

Biologic Product Withdrawal of Carimune(R) NF Immune Globulin Intravenous

Recall of Ortho Clinical Diagnostics FETALSCREEN

Cardinal Health 303, Inc. Signs Consent Decree with FDA Agrees to Correct Manufacturing Deficiencies

Substantially Equivalent 510(k) Device - ALYX Component Collection System: ALYX 2RBC-NLR Kit - Baxter Healthcare Corp

Substantially Equivalent 510(k) Device - Bd.id Patient Identification System for Transfusion Management V7.00 - Becton, Dickinson & Co

The Essentials of Food and Drug Administration Medical Device Regulations: A Primer for Manufacturers and Suppliers; Public Seminar

FDA Workshop on Immune Globulins for Primary Immune Deficiency Diseases: Antibody Specificity, Potency and Testing


THERAPEUTIC GOODS ADMINISTRATION (Australia)

Reasons for Rejection of Applications for Medical Devices


NATIONAL BLOOD AUTHORITY (Australia)

National Blood Authority Undergoes IT Transfusion
More than three years after its establishment as a statutory authority independent from the Department of Health and Ageing's IT infrastructure, the National Blood Authority in Canberra is undertaking a complete refresh of its IT infrastructure including a new data management system to improve its data management capability.


MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (United Kingdom)

Field Safety Notice: Infusion & Transfusion: Administration Set - Baxter Healthcare Ltd - Continu-Flo Solution Sets with Check Valve - Updated

Field Safety Notice: Dialysis, haemodialysis: Machine Haemodialysis - Gambro Lundia AB - Machine haemodialysis - PrismaFlex - Updated


DEPARTMENT OF HEALTH (United Kingdom)

Coding for Success: Simple Technology for Safer Patient Care

Scan and Save - NHS to Save £ millions and Improve Patient Safety with Bar Codes
The NHS, patients and industry will benefit from bar coding technology, which will increase patient safety, improve efficiency and save the NHS £millions in extra bed days.


NATIONAL HEALTH SERVICE (Scotland)

Transfusion Bosses Order NHS Staff to Bin Millions of Pounds of Life-saving Plasma
NHS workers have been ordered to destroy millions of pounds worth of blood - despite a nationwide shortage of donors.

ASFA

ASFA 2007 Annual Meeting

Register to Attend the ASFA 2007 Annual Meeting by clicking here.

Make Your Hotel Reservation by clicking here.  

Attend the HP/AT Certification Exam Review Session

The HP/AT Certification Exam Review Session, developed and administered by ASFA, will take place on Wednesday, April 18, 2007, from 8am to 5pm, at the Gaylord Opryland.

Please register for the HP Certification Exam Review Session on the Meeting Registration Form. The registration fee for this session, detailed on the Registration Form, include session materials, coffee breaks, and lunch.

This session provides an overview of numerous topics that are tested during the HP Certification Exam. The topics of the presentations correspond to the content outline provided by the ASCP for the HP Certification Exam. Experts in the field will provide a broad overview of each of the topics. Participants will have an opportunity to work with sample test questions and some case studies.


Attend Corporate Symposia and Social Evening

Several corporate symposia will be held in conjunction with the ASFA 2007 Annual Meeting at the Gaylord Opryland. Please register for these symposia directly with the associated vendor.

Wednesday, April 18, 2007
8am - 12pm Baxter Healthcare Corporate Symposium
12pm - 4pm Gambro BCT Corporate Symposium

Friday, April 20, 2007
5:30pm – 7:30pm Fresenius HemoCare Corporate Symposium

All attendees are also invited to attend a Social Evening, hosted by Therakos, on Thursday, April 19, 2007 at 7pm.


Attend the FACT Collection Inspector Training Workshop

The Foundation for the Accreditation of Cellular Therapy (FACT) will be holding a collection inspector training workshop in conjunction with the ASFA Annual Meeting on Tuesday, April 17, 2007 from 12pm to 5pm at the Gaylord Orpyland.

This training course is designed to educate progenitor cell collection facility inspectors on inspection requirements, provide feedback regarding the inspection and accreditation process, and to stimulate discussion about effective and ineffective inspection practices and techniques.

Please visit the FACT website, www.factwebsite.org, to register for this workshop.

Please contact the ASFA Head Office at asfa@apheresis.org with any questions that you may have.

We look forward to seeing you in Nashville!

JOB OPPORTUNITIES

Transfusion Medicine/Blood Banking Physician
University of North Carolina at Chapel Hill Department of Pathology and Laboratory Medicine

Apheresis RN in Pathology-Transfusion Medicine
Virginia Commonwealth University Health System

FEATURED EVENT
FDA Workshop on Immune Globulins for Primary Immune Deficiency Diseases: Antibody Specificity, Potency and Testing
April 25-26, 2007
Bethesda, Maryland
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.

ASSOCIATIONS

European Society for Artificial Organs (ESAO)
“The European Society for Artificial Organs (ESAO) is worldwide society to encourage and publish progress made in the field of artificial organs and allied spheres.“

International Society of Nephrology (ISN)
“Founded in 1960, the International Society of Nephrology is a not-for-profit society whose mission is the global advancement of nephrology. ISN promotes research and education to prevent and treat kidney disease throughout the world.”

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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