Einstein's Tea Leaves Inspire New Blood Separation Technique
Scientists at Monash University in Australia have developed a process for rapidly and efficiently separating blood plasma at the microscopic level without any moving parts, potentially allowing doctors to do blood tests without sending samples to a laboratory.

Chinese Scientists at the Tianjin Blood Center Have Discovered a Gene that is Crucial in Matching Organ Transplants
The World Health Organization has named it HLA-B-9518 and publicized the discovery to the world.

Potential for Adult Stem Cells to Repair Hearts Damaged by Severe Coronary Artery Disease Investigated by Rush Cardiologists
Rush University Medical Center is one of the first medical centers in the country, and currently the only site in Illinois, participating in a novel clinical trial to determine if a subject’s own stem cells can treat a form of severe coronary artery disease.

Rheologics, Inc. Announces Phase I Clinical Study On Blood Viscosity And Peripheral Vascular Disease
Rheologics, Inc. has announced the initiation of a Phase I study to explore the effect of lowering blood viscosity in patients with critical limb ischemia and end-stage peripheral vascular disease. The study is taking place at the Seoul Veterans Hospital in Seoul, South Korea utilizing the Rheolog(R) blood viscometer.

BTI Biotechnology Institute Laboratory (Vitoria-Gasteiz) Develops New Therapy for Degenerative Articular Diseases (Arthrosis)
Articular infiltration with Platelet Rich Growth Factor plasma (PRGF), provides a new therapeutic approach, minimally invasive for joint diseases (arthrosis); and which is effective over various stages or degrees of the disease.

Nephros Receives Conditional Approval from the FDA of Investigational Device Exemption Application
Nephros, Inc. has reported that the Company received conditional approval for its Investigational Device Exemption (IDE) application from the Food and Drug Administration (FDA) to begin a human clinical trial of the Company's OLpur(TM) H2H(TM) Hemodiafiltration Module and OLpur(TM) MD 220 Hemodiafilter.

Roche Diagnostics Submits West Nile Virus Blood Screening Test To FDA
Roche Diagnostics announced today that it has submitted its Biological License application for the cobas TaqScreen WNV Test to United States Food & Drug Administration (FDA).

Thermogenesis Responds to FDA Request
ThermoGenesis Corp. announced today that the Company has responded to the U.S. Food and Drug Administration’s (FDA) questions on ThermoGenesis’ pre-market approval (PMA) application for its CryoSeal Fibrin Sealant(FS) System as an adjunct to hemostasis in liver resection surgeries. The CryoSeal FS System is an automated device and companion sterile blood processing disposable used to prepare surgical fibrin sealants from a patient’s own plasma in about an hour.

FDA Approves Orthovita’s PMA Supplement for the CELLPAKER(R) Plasma Collection System Used in Conjunction with the VITAGEL(R) Surgical Hemostat
The new approval permits Orthovita to sell CELLPAKER product that is manufactured at its subcontractor’s facility.

GenesisBPS Announces the North American Distribution and FDA 510K Clearance of the SEPAX Cell Separation System for Cord Blood Processing
GenesisBPS has announced that the SEPAX Cell Separation System, developed and manufactured by Biosafe SA has received 510(k) marketing clearance from the U.S. Food and Drug Administration's Center for Biologics Evaluation & Research (CBER) for use as a cord blood-processing device.

Cerus’ INTERCEPT Blood System Receives First Approval in Germany
Cerus Corporation has announced that the Paul-Ehrlich-Institut (PEI), the agency that regulates blood components in Germany, has approved the sale of platelets treated with the INTERCEPT Blood System by a German blood center located in the University Hospital Schleswig-Holstein, Campus Lubeck.

Cerus Announces French Regulatory Approval of the INTERCEPT Blood System for Plasma
Cerus Corporation has announced that the French regulatory agency for medical products, the Agence Francaise de Securite Sanitaire des Produits de Sante, has granted regulatory approval in France for use of plasma treated with the INTERCEPT Blood System, subject to official journal publication.

Blood Center to Collect DNA of Donors
For the first time, the Puget Sound Blood Center will begin collecting, testing and storing the DNA of blood donors.The purpose of the Blood Center study is to help develop new DNA-based tests to record more sophisticated profiles of blood donations, beyond the usual A, B, O and Rh factor designations.

Eclipsys at US FDA Door With Software
Eclipsys India is awaiting approval from the USFDA 510(K) for a software product developed for blood banks.

Siemens Ready to Tag Blood Supplies
Siemens says its latest RFID-based technology can make blood transfusions safer by assisting in the comprehensive monitoring of blood donations.

ABSTRACTS, REVIEWS AND SPECIAL REPORTS

Ultrafiltration Versus Intravenous Diuretics for Patients Hospitalized for Acute Decompensated Heart Failure
This study compares the safety and efficacy of veno-venous ultrafiltration and standard intravenous diuretic therapy for hypervolemic heart failure (HF) patients.

A Systematic Review of Randomized Controlled Trials for Plasma Exchange in the Treatment of Thrombotic Thrombocytopenic Purpura
The mainstay of treatment for thrombotic thrombocytopenic purpura (TTP) is plasma exchange (PE). A systematic review was undertaken to summarize the randomized controlled trial (RCT) evidence, to date, on PE as treatment for TTP.

New Transfusion Therapies Company to Be Named ‘Fenwal’
Texas Pacific Group (TPG) and Maverick Capital, Ltd. announced today that the transfusion therapies business being acquired from Baxter International Inc. will be named Fenwal, Inc. when the transaction closes later this quarter.

Haemonetics Acquires IDM Medical Software Company
Haemonetics Corporation has announced that it acquired the assets of Information Data Management, Inc. ("IDM"). IDM's software applications for blood collection, blood laboratory operations, and services complement Haemonetics' 5D suite of software products and services.

Rheologics Acquires Cardiodyne Electronics
Rheologics Technologies, has announced the acquisition of Cardiodyne Electronics, Inc., a basic research firm in the biomedical field. As part of the transaction, Rheologics acquired the following technologies: finger-stick blood viscometer, blood volume analyzer, and two blood filtration technologies in the apheresis class.

RITA Medical Merger Waiting Period Over
The antitrust waiting period for the sale of RITA Medical Systems Inc. to AngioDynamics Inc. has expired.

Cepheid, BioMerieux Sign Test Pact
Genetic analysis systems maker Cepheid and France-based medical test maker bioMerieux said Wednesday they will collaborate on a line of tests designed to check for blood and tissue infections.

Fresenius Medical Care Becomes the Leading Dialysis Provider in Asia
The Company has announced the acquisition of a 51% equity interest in Jiate Excelsior Co. Ltd. in Taiwan.

Aethlon Medical Announces Government Research Collaborations
Aethlon Medical, Inc. has announced that research related to the Aethlon Hemopurifier(R) as a potential treatment for Ebola Hemorrhagic Fever (EHF) has been initiated at The Centers for Disease Control and Prevention (CDC).

NxStage Medical Signs Long-Term Supply Contracts for Its System One(TM) Portable Home Hemodialysis System
NxStage Medical, Inc. has that the company has signed long-term agreements with two existing suppliers as part of a broad strategy to secure supply to meet the growing demand for its NxStage(R) System One(TM) portable kidney dialysis system.

Lixte Biotechnology to Obtain High-Quality Tissue and Blood Samples from German University
Lixte Biotechnology Holdings, Inc. announced today that its wholly owned subsidiary, Lixte Biotechnology, Inc., entered into an agreement with the Institute of Pathology at the University of Regensburg in Germany to obtain a supply of high quality, accurately annotated tissue and blood samples for cancers other than brain cancers.

University of Massachusetts Memorial Revives Cord Blood Program for Stem Cell Transplants
UMass Memorial was contacted by Cryobanks International Inc. of Altamonte Springs, Florida, to explore setting up a new voluntary donation site.

Aksys to Shut Down Operations
Medical device manufacturer Aksys Ltd. will be shutting down after the company could not get the third-party financing it needed to continue operations, according to a regulatory filing.

Baxter Goes Full Speed Ahead on R&D
"This is not your father's Baxter." That's how Baxter International Chairman Robert L. Parkinson Jr. said he hopes Wall Street will begin to view the company's heightened focus on research and development.

CHF Solutions Promotes David B. Springer to President and Chief Executive Officer, and Ronald M. Nelson to Chief Financial Officer
CHF Solutions, Inc., a privately held medical device manufacturer, has promoted David B. Springer to president and chief executive officer. Springer joined CHF Solutions in March 2006 as president and chief operating officer. John L. Erb, who has served as chief executive officer and a member of the CHF Solutions board of directors since November 2001, has been elected chairman of the board.

U.S. Patent Office to Grant Human BioSystems its Fifth Patent, "Compositions, Methods and Apparatuses for Preserving Platelets"
Human BioSystems has announced that the U.S. Patent Office has allowed HBS' patent application for platelet preservation entitled "Compositions, Methods and Apparatuses for Preserving Platelets."

Notice of Expansion of NINR Definition of Underrepresented Applicant (NOT-NR-07-001)

NHLBI Career Transition Award (K22) (PAR-07-317)

Funding Opportunities for Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Grant Programs for 2007 (NOT-OD-07-036)

PHS 2007-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44])

PHS 2007-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42]) (PA-07-281)

NIH Leads Effort to Help Women in Science and Medicine Fulfill Potential
NIH Director Dr. Elias A. Zerhouni has created the Working Group on Women in Biomedical Careers to examine issues raised in the recent National Academies report, "Beyond Bias and Barriers, Fulfilling the Potential of Women in Academic Science and Engineering," and to respond to the challenges issued to government funding agencies to maximize the potential of women scientists and engineers.

NIH Center for Scientific Review to Host Open House Workshops to Improve the Review of NIH Grant Applications
Starting in March 2007, the Center for Scientific Review (CSR) at the National Institutes of Health (NIH) will convene the first of six one-day Open House Workshops in 2007 to solicit input from leaders of the scientific community and other stakeholders. This input will be critical to realigning and reinventing CSR’s application review groups so the $20+ billion NIH invests in biomedical research grants each year advances the most promising research.

California Senate Bill 102 Introduced by Senator Carole Migden on Jan. 17, 2007
This is an act to amend Section 1645 of the Health and Safety Code, relating to blood transfusions.

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

States Get Federal Backing to Build More Efficient, High Quality Medicaid Systems
HHS Secretary Mike Leavitt today awarded $103 million to 27 states across the nation to fund implementation of new ways to improve Medicaid efficiency, economy and quality of care.

Bush Seeks Big Medicare and Medicaid Saving
President Bush will ask Congress in his budget next week to squeeze more than $70 billion of savings from Medicare and Medicaid over the next five years.

Medicare Physician Fee Schedule Fact Sheet

Changes to the 2007 Medicare Physician Fee Schedule Database

CMS Manual Instruction For Changes to 2007 Medicare Physician Fee Schedule Database

Physician Fee Schedule National Payment Amount Files

FOOD AND DRUG ADMINISTRATION (United States of America)

Guidance for Industry - 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
This guidance is for immediate implementation.

Guidance for Industry
Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies

Donor Screening Tests for Testing HCT/P Donors - Updated

Variances for Collection of Blood and Blood Products from Patients with Hemochromatosis - Update

Guidance for Industry: Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry and Food and Drug Administration Staff on Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle

Electronic Biological Product Deviation Reporting (eBPDR) Latest System Changes

Substantially Equivalent 510(k) Device - TANGO Automated Blood Bank Analyzer System, Version 3.0 Service Pack 4 - Biotest AG

Devices Regulated by CBER - Updated

FDA Approves New Product to Treat Von Willebrand Disease

Medical Devices 101: An Educational Forum
FDA's medical device requirements for entrepreneurs, startup companies, and small businesses.

Collaborative Scientific Training Program

CBER Presentation: Celia M.Witten, PhD, MD. Cell Therapy in Multiple Sclerosis: FDA Regulatory Issues

FDA Reviews Comments on Device-ID System
The U.S. Food and Drug Administration (FDA) is making progress on its efforts to determine whether it will require companies to use a unique device identification (UDI) system to track and trace medical devices they manufacture and supply.

US DEPARTMENT OF HEALTH AND HUMAN SERVICES (United States of America)

Health Information Technology Initiative Major Accomplishments: 2004-2006

MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (United Kingdom)

Reporting Adverse Incidents and Disseminating Medical Device Alerts

Committee on the Safety of Devices Meeting

Medical Device Alert - Intensive Care Continuous Renal Replacement System: Gambro Prismaflex Model Number 6023014700 - All serial numbers

WORLD HEALTH ORGANIZATION (International)

Screened Blood Still Not Guaranteed
Pakistan’s blood transfusion system is fragmented and there is a need for a centralised blood transfusion authority to ensure patients’ safety, said Dr Hassan Abbas Zaheer, the World Health Organisation (WHO) Blood Safety Programme national coordinator.

ASFA 2007 Annual Meeting

Invitation from the Conference Chair

On behalf of the ASFA 2007 Annual Meeting Organizing Committee and the ASFA Board of Directors, I am pleased to invite you to attend ASFA’s 28th Annual Meeting, scheduled to occur from April 18-21, 2007 at the Gaylord Opryland Resort and Convention Center, in Nashville, Tennessee. This beautiful venue, with its many activities and spectacular indoor gardens, will offer something for everyone. This year, the scope and theme for our conference will be ‘Evidenced-based Apheresis Medicine: Why We Do What We Do’. With the newly revised and soon to be published 2007 Special Edition of the Journal of Clinical Apheresis, we find ourselves once again looking back at what we have done, and establishing new guidelines for the future direction of apheresis medicine.

Many of the topics selected for presentations in the scientific and education programs during the course of our annual congress will highlight various aspects of this theme. In this conference, we have incorporated some new types of sessions designed to engage the audience in active participation. In addition, we have introduced a session specifically focused on welcoming, educating, and encouraging our new members to become involved in both the Society and the annual meeting. The Apheresis Operations session is intended to address concerns and challenges faced by our apheresis leaders and managers in efficiently running their programs. The remaining sessions offer other topics of interest to both newcomers and experienced practitioners. Cutting-edge abstract presentations and vendor educational sessions complement the scheduled offerings.

We invite all members as well as non-member colleagues interested in any aspect of donor and therapeutic hemapheresis to join us in this, our major educational and scientific event for 2007. The Annual Meeting Organizing Committee and the ASFA Board of Directors and I hope to see you all in Nashville. Please visit the ASFA website at www.apheresis.org to view the Preliminary Program and register for the meeting.

Christine Fernandez-Roig, RN, BSN
President-Elect, ASFA
Chair, ASFA 2007 Annual Meeting Organizing Committee


Register to Attend the ASFA 2007 Annual Meeting - Early registration deadline: Monday, March 5, 2007

Make Your Hotel Reservation - Special rate deadline: Thursday, March 15, 2007

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

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

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!

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

Nephrology Nursing Journal
“The Nephrology Nursing Journal is a refereed clinical and scientific resource that provides current information on wide variety of subjects to facilitate the practice of professional nephrology nursing. Its purpose is to disseminate information on the latest advances in research, practice, and education to nephrology nurses to positively influence the quality of care they provide. ”
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Hemodialysis International
“Originally published annually, since 2003 Hemodialysis International has published quarterly issues containing original papers on clinical and experimental topics related to dialysis, in addition to the Annual Dialysis Conference Proceedings. This journal is a must-have for nephrologists, nurses and technicians worldwide.”