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Apheresis News Volume 2.04

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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May 02, 2007  // Volume 2.04
TOP STORY

Nut Allergy Passed in Blood Transfusion
A woman suffered a life-threatening reaction after being given blood from another patient with a peanut allergy. It is believed to be the first time a severe food allergy has passed from one person to another through donated blood.

Transfusion Expert Urges Wider Use of Filtered Blood
Filtering white cells from donor blood before a transfusion is much safer for patients and long overdue as a national standard for all surgical procedures, according to University of Rochester researchers.

SCIENCE

Another Option for Dialysis
The need to undergo dialysis may, for the first time, no longer hamper kidney patients' freedom of mobility. An automated wearable device, a prototype, is being developed by an international team of doctors, lecturers and researchers.

Cellerant Therapeutics Reversed Autoimmune Disease in Lupus Mice with Transplant of Purified Donor Blood Stem Cells
Cellerant Therapeutics has announced the publication of data suggesting that established autoimmune disease can be reversed or stabilized by the transplantation of purified allogeneic hematopoietic stem cells in a mouse study of Systemic Lupus Erythematosus.

Newest Adult Stem Therapy Treats Diabetes
In yet another advance in adult stem cell therapy, the Journal of the American Medical Association (JAMA) released a study in which 14 of 15 Juvenile Diabetes patients demonstrated significant improvement as a result of an adult stem cell treatment.

Clarifying the Issues Surrounding Dendreon's Provenge
This article is a response to a letter published in The Cancer Letter which warned the FDA about flaws in the Provenge (Sipuleucel-T) trial data.

Eclipsys PowerBANK(TM) Enterprise Edition Receives 510K Clearance from the Food and Drug Administration
PowerBANK Enterprise Edition is Eclipsys' solution for automating the functions of a hospital's blood bank and is a component of Eclipsys Sunrise Laboratory, a laboratory information solution (LIS) that helps increase productivity and decrease costs, providing efficient workflow and data management.

FDA Expands Use for Anti-Bleeding Drug
The Food and Drug Administration has approved Humate-P for the prevention of excessive bleeding during and after surgery in certain patients with mild to moderate and severe von Willebrand disease. Humate-P, a product made from human plasma, is manufactured by CSL Behring GmbH, Marburg, Germany.

Opposites Still a Match
A husband has donated a kidney to his wife, despite their different blood types.

RFID Tracks Hospital's Devices
The Heart Hospital Baylor Plano is one of about a dozen hospitals around the country and the first in Dallas-Fort Worth that's implemented a radio frequency identification network.

China Breaks 'Blood-selling Ring'
Six people involved in a blood-selling scheme are reported to have been detained in southern China, as officials crack down on the illegal practice that helped spread AIDS in the country.

Man Sent to Prison for Trying to Pass Off Tainted Blood as Clean
A Lake County judge has sentenced an East Chicago man to two years in prison for concealing that he was HIV positive when he gave blood to a Hammond plasma center.

ABSTRACTS, REVIEWS AND SPECIAL REPORTS

Autologous Nonmyeloablative Hematopoietic Stem Cell Transplantation in Newly Diagnosed Type 1 Diabetes Mellitus
In this study, high-dose immunosuppression and nonmyeloablative hematopoietic stem cell transplantations (AHST) were performed with acceptable toxicity in a small number of patients with newly diagnosed type 1 diabetes mellitus. With AHST, beta cell function was increased in all but 1 patient and induced prolonged insulin independence in the majority of the patients.

Characterization of Mononuclear Cells Remaining in the Leukoreduction System Chambers of Apheresis Instruments After Routine Platelet Collection: A New Source of Viable Human Blood Cells
The study showed that the residual cell content of Trima Accel LRS chambers recovered after platelet collection is a good source of viable monocytes and lymphocytes.

Evaluation of a New Apheresis System for the Collection of Leukoreduced Single-donor Platelets
This study suggests that the new Fresenius COM.TEC system offers a significantly and importantly improved collection efficiency in plateletpheresis procedures in comparison to the Fresenius AS.TEC system.

BUSINESS

Haemonetics to Restructure European Unit
Haemonetics Corp. has disclosed that it plans to consolidate its European business over the next nine months at a cost of $4 million to $5 million.

Baxter Moves From Drips to Stem Cell Research
Baxter International Inc. is quietly entering the complex, but promising field of stem cell research.

Fresenius to Buy Kyorin Blood Business
Germany's Fresenius has said that it would buy the blood volume replacement business of Japanese pharmaceutical company Kyorin Pharmaceutical Co for an undisclosed price.

Nipro Releases Artificial Kidney Dialysis Machine in Overseas Markets
Nipro, in conjunction with Nikkiso, recently announced the release of its artificial kidney dialyzer for overseas.

Poly Medicure in Marketing Tie-up With US Company
This gives the medical disposable devices company its first step into exports to the US market after its acquisition of US Safety Syringes in March last year.

U.S. Renal Care Inc. Opens Five Dialysis Facilities in Texas
U.S. Renal Care Inc. has opened two outpatient dialysis facilities in North Texas in the cities of Fort Worth and Weatherford and in the Central Texas towns of Boerne and the South Texas town of Elsa.

Strategic Healthcare Group LLC Signs Agreement With the American Red Cross to Provide Blood Management Consulting Services
Strategic Healthcare Group LLC has announced an agreement with the American Red Cross to provide blood management consultation at two client hospitals.

NeoStem Receives Licenses from New York State to Begin Operations
NeoStem, Inc. has announced that the New York State Department of Health has issued two provisional licenses to allow the Company to begin commercializing its next generation stem cell collection services in New York.

Olympus and MSoft in Blood Tracking System Dispute
Trafford NHS Trust has found itself in the midst of a dispute between Olympus and MSoft over the web-based blood tracking solution it installed at its hospital.

American Red Cross Appoints New President and CEO
The American Red Cross Board of Governors has unanimously approved Mark W. Everson, currently serving as Commissioner of Internal Revenue, to become the next president and CEO of the Red Cross, effective May 29, 2007.

U.S. Renal Care Names New President, COO
U.S. Renal Care Inc. has announced that it has hired Stephen Pirri as president and chief operating officer of the company.

Aethlon Medical Discloses Notice of Allowance for Broad-Spectrum Virus Patent
Aethlon Medical, Inc. has announced that the United States Patent and Trademark Office has issued a Notice of Allowance for its patent application entitled, "Method for Removal of Viruses from Blood by Lectin Affinity Hemodialysis."

FUNDING & PROGRAMS

Baxter Announces 2007 Renal Discoveries Grant Program To Advance Science And Care For Kidney Disease Patients
Baxter Healthcare Corporation announced 2007 funding and application deadlines for its Renal Discoveries Extramural Grant Program (EGP), which is focused on patient-oriented research in academic nephrology training centers around the world. Four grants will be awarded and funded in 2007 - one each in Asia/Pacific, Latin America, North America and Europe/Middle East/Africa/Russia.

Notice of Intent to Publish a Request for Applications to Support Research on Interventions in Chronic Illness (NOT-NR-07-004)

Career Enhancement Award for Stem Cell Research (K18) (PA-07-359)

REGULATORY

Kennedy-Dingell Bill Would Provide Health IT Incentives
A major health reform bill introduced April 25 by two chairmen of congressional health committees would provide incentives for nationwide adoption of e-health records and clinical decision support systems.


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

Medicare Payment Formula Results In Some For-Profit Dialysis Chains Giving Higher Doses Of Anemia Drug Than Not-For-Profit Centers
For-profit dialysis centers administer higher and more doses of the anemia medication Epogen, manufactured by Amgen, to kidney disease patients than non-for-profit centers, according to a study published recently in the Journal of the American Medical Association.

CMS Offers Free Online Training in Health IT Implementation
CMS launched this week Doctors’ Office Quality IT University with initial modules on office workflow redesign, culture change and communication for implementing health IT; methods of implementing care management; and ways to incorporate patient self-management into clinical care.

April 2007 Update of the Hospital Outpatient Prospective Payment System (OPPS): Summary of Payment Policy Changes

Guidance on Compliance with the HIPAA National Provider Identifier (NPI) Rule

Medicare Announces Measure Specifications for the Physician Quality Reporting Initiative

Proposed Decision Memo for Clinical Trial Policy (CAG-00071R)

Medicare Physician Guide: A Resource for Residents, Practicing Physicians, and Other Health Care Professionals

Facilitator’s Guide – Companion to Medicare Physician Guide: A Resource for Residents, Practicing Physicians, and Other Health Care Professionals


FOOD AND DRUG ADMINISTRATION (United States of America)

FDA Makes Recommendations for Reauthorizing Device User Fees
The FDA has proposed recommendations to Congress for reauthorizing the Medical Device User Fee and Modernization Act. If adopted, the recommendations would help ensure that safe and effective medical devices get quickly to patients. Under the user fee program, industry covers a portion of the costs of FDA's review process for medical devices.

FDA Provides Web Access to Information on Post-Approval Device Studies
The U.S. Food and Drug Administration has unveiled a new Web page that will keep the public informed about the status of post-approval patient studies for certain recently approved medical devices.

FDA Raids Union Maker of Medical Devices Over Safety Risks
The Food and Drug Administration have seized all of the medical devices from a New Jersey company, pediatric heart valves and tube-like devices for blood flow, because of a concern the products pose a serious safety risk.

The FDA Enforcement Report

Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications

Medical Devices; Technical Amendment

Donor Screening Tests for Testing HCT/P Donors - CMV Table Updated


THE JOINT COMMISSION (United States of America)

Adverse Tissue Reaction Policies


HEALTH CANADA (Canada)

Health Canada Endorsed Important Safety Information on Erythropoiesis-Stimulating Agents (ESAs): Aranesp(R) (darbepoetin alfa) and EPREX (epoetin alfa)


MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (United Kingdom)

Device Bulletin - Reporting Adverse Incidents and Disseminating Medical Device Alerts


NATIONAL HEALTH SERVICE (United Kingdom)

Contaminated Blood Inquiry Begins
An independent public inquiry into the supply of contaminated NHS blood to haemophilia patients is set to hear evidence from those affected.

Contaminated Blood Warning Went Unheeded, Claims Inquiry Witness
The government failed to withdraw US plasma supplies given to haemophilia patients despite a warning from the Public Health Laboratory Service in 1983 that they may be contaminated with the AIDS virus.

Welsh Hospital Trust First NHS Organisation to Remotely Authorise Blood Transfusions
The hospital has implemented the Blood Audit Release System (BARS), saving money in labour costs and logistics.


IRISH BLOOD TRANSFUSION SERVICE (Ireland)

Haemochromatosis Patients to Give Blood
Haemochromatosis patients will be able to donate blood from this June as part of a pilot project being run by the Irish Blood Transfusion Service.


THE BLOOD SERVICE (New Zealand)

Book Blood Donations Online
New Zealand's 140,000 blood donors will be able to go online to book times to give blood by the end of the year.


AUSTRALIA NEW ZEALAND THERAPEUTIC PRODUCTS AUTHORITY (Australia and New Zealand)

Draft Order: Medical Device Standards for Risk Management

Draft Order: Medical Device Standards for Clinical Evidence


WORLD HEALTH ORGANIZATION (International)

Chagas Spread to U.S. and Europe Via Blood Banks
Chagas has spread from Latin America to the United States and Europe due to inadequate blood screening, the World Health Organisation has said.

WHO Proposes Global Agenda on Transplantation
At the second Global Consultation on Transplantation, the World Health Organization presented countries and other stakeholders with a blueprint for updated global guiding principles on cell, tissue and organ donation and transplantation.

ASFA

Order Your Copy of the Revised ASFA Therapeutic Apheresis Indication Categories

The American Society for Apheresis is pleased to announce the publication of the Fourth Special Issue of the Journal of Clinical Apheresis: Clinical Applications of Therapeutic Apheresis.

A working group of the Apheresis Applications Committee developed the Fourth Special Issue, building upon the previously published Special Issues of 1986, 1993, and 2000. The key change in the 2007 edition from previous Special Issues is the introduction of the comprehensive Fact Sheet format designed to summarize and condense the available medical literature pertaining to the treatment of a disease by apheresis into a succinct review focusing on practical issues for the apheresis practitioner.

Each fact sheet serves as a quick reference and includes such information as assigned ASFA category, disease incidence, number of patients reported to have been treated, types of reports appearing in the medical literature, level of evidence for therapeutic apheresis use, general disease description and treatment, rationale for apheresis, recommended apheresis regimen, and parameters for discontinuatation.

“This is the first time that each disease is presented as a Fact Sheet which summarizes the evidence for the use of therapeutic apheresis”, said Committee Chair, Zbigniew M. Szczepiorkowski, MD, PhD, FCAP, adding, “We have attemted to incorporate evidence based medicine into the well defined and widely accepted ASFA Categories.”

"ASFA wishes to thank Gambro BCT for their unrestricted support of this publication," said Beth H. Shaz, Co-chair of the Committee. "With the use of the ASFA website and the Journal of Clinical Apheresis, our goal is to continually update and add new fact sheets. Through the Apheresis Application Committee our goal is to publish the next Special Issue in 2010. We plan to invite other medical professional societies that utilize therapeutic apheresis to work with ASFA on the next issue."

Order your copy today through the ASFA website at http://www.apheresis.org/educational_materials/index.cfm.

JOB OPPORTUNITIES
Registered Nurse
Seattle Cancer Care Alliance
FEATURED EVENT
International Society for Experimental Hematology Annual Meeting
Event Date: September 28-30, 2007
Event Location: Hamburg, Germany
ANNOUNCEMENTS

Apheresis News and American Society for Apheresis Offer Recruiters Comprehensive Job Posting Solution

Are you interested in recruiting for an apheresis-related position for your company or institution?

Apheresis News and ASFA invite you to post your job opportunities. Career submissions are posted on the Apheresis News website and a link to your career posting will be including in the Apheresis News e-newsletter. Careers submissions are also posted online on the ASFA website for a period of 30 days.

This recruiting opportunity is available for only $500 per career posting.

Email info@apheresisnews.com for more information, and to submit your job posting.

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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