News | Cardiovascular Surgery | August 26, 2016

FDA Calls for Zika Virus Testing for All Donated Blood in the United States

MRI brain scan of a 26-day-old neonate with Zika virus. It shows septation in the ventricle at the arrow. See more Zika radiology images at http://pubs.rsna.org/doi/full/10.1148/radiol.2016161584.

 

August 26, 2016 — As a further safety measure against the emerging Zika virus outbreak, the U.S. Food and Drug Administration issued a revised guidance recommending universal testing of donated Whole Blood and blood components for Zika virus in the U.S. and its territories.
“There is still much uncertainty regarding the nature and extent of Zika virus transmission,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “At this time, the recommendation for testing the entire blood supply will help ensure that safe blood is available for all individuals who might need transfusion.”

Read the article "Imaging Zika Virus — Radiologic Assessment and Tracking of the Disease."

The FDA first issued guidance on Feb. 16 recommending that only areas with active Zika virus transmission screen donated Whole Blood and blood components for Zika virus, use pathogen-reduction devices, or halt blood collection and obtain Whole Blood and blood components from areas of the U.S. without active virus transmission. All areas with active transmission in the U.S. are currently in compliance with this guidance. The revised guidance announced today recommends that all states and U.S. territories screen individual units of donated Whole Blood and blood components with a blood screening test authorized for use by the FDA under an investigational new drug (IND) application, or a licensed test when available. Alternatively, an FDA-approved pathogen-reduction device may be used for plasma and certain platelet products.

The FDA is updating its guidance after careful consideration of all available scientific evidence, consultation with other public health agencies, and taking into consideration the potential serious health consequences of Zika virus infection to pregnant women and children born to women exposed to Zika virus during pregnancy. Testing of donated blood is already underway in Florida and Puerto Rico, as well as in other areas, and it has shown to be beneficial in identifying donations infected with Zika virus. Expanded testing will continue to reduce the risk for transmission of Zika virus through the U.S. blood supply and will be in effect until the risk of transfusion transmission of Zika virus is reduced.

Zika virus is transmitted primarily by the Aedes mosquito. Zika virus can also be spread by sexual contact. Although 4 out of 5 people infected with Zika virus never develop symptoms, when symptoms do occur they may include fever, arthralgia (joint pain), maculopapular rash (red area with small bumps), and conjunctivitis (red, irritated eyes). In addition, Zika virus infection during pregnancy can cause serious birth defects and is associated with other adverse pregnancy outcomes.

“As new scientific and epidemiological information regarding Zika virus has become available, it’s clear that additional precautionary measures are necessary,” said Luciana Borio, M.D., the FDA’s acting chief scientist. “We are issuing revised guidance for immediate implementation in order to help maintain the safety of the U.S. blood supply.”

The first local or non-travel related transmission of Zika virus in the U.S. by mosquitoes was reported from Puerto Rico in December 2015; and soon thereafter, local transmission was reported in American Samoa and the U.S. Virgin Islands. In July 2016, the first cases of local or non-travel related transmission of Zika virus in the continental U.S. were reported in Miami-Dade County, Florida.

In addition to protecting the nation’s blood supply, the FDA works to protect the safety of our nation’s supply of human cells, tissues, and cellular and tissue-based products; supports the development and availability of diagnostic tests that may be useful for identifying the presence of or prior exposure to the Zika virus; works with commercial and government developers to advance the development of investigational vaccines and therapeutics; and monitors for fraudulent products and false product claims related the Zika virus.

For more information: www.cdc.gov/zika/intheus/what-to-do.html

 

Related Content

open-heart surgery, PCI, percutaneous coronary intervention, NOBLE trial, left main coronary artery disease, LMCAD, TCT 2016
News | Cardiovascular Surgery| November 03, 2016
Coronary artery bypass (CABG) surgery is the standard treatment for revascularization in patients with left main...
EXCEL Trial, TCT 2016, drug-eluting stents, CABG, surgery left main heart disease, LMCAD
Feature | Stents Drug Eluting| October 31, 2016
A major international study has found that drug-eluting stents, a less-invasive alternative to bypass surgery, is as...
CHOP, Children's Hospital of Philadelphia, prenatal heart surgery, tumor removal, intrapericardial teratoma

Tucker Roussin, 3, is the first survivor of fetal surgery for a life-threatening tumor connected to his heart. Fetal medicine experts at Children's Hospital of Philadelphia successfully removed this tumor. Credit: Children’s Hospital of Philadelphia.

News | Congenital Heart| October 28, 2016
For the first time, fetal medicine experts have performed prenatal heart surgery to remove a life-threatening tumor,...
medicare bundled cardiac payments, CMS cardiology payments
Feature | Business| October 24, 2016 | By John W. Meyer, MPH, FACHE
(Editor’s note: This is the second part of a two-part series on the proposed Medicare five-year demonstration for
CDC warning, LivaNova Stockert 3T heater-cooler devices, open-heart surgery patients
News | Cardiovascular Surgery| October 14, 2016
The Centers for Disease Control and Prevention (CDC) is warning healthcare providers and patients about the potential...
SentreHeart, Eclipse Surgical Device, left atrial appendage, LAA closure, first clinical use, Poland
News | Left Atrial Appendage (LAA) Occluders| October 13, 2016
SentreHeart Inc. announced this week it has treated the first patients using the Eclipse Surgical Device, which is...
3-D bioprinting, 3-D printing, printed organs, 3D bioprinting

3-D printed vessel made from living cells implanted in an animal to test feasibility of using such structures clinically. Blood vessels are a stepping stone to the creation of more complex 3-D printed organs made from biomaterials. Image from the South Carolina Project for Organ Biofabrication.

 

Feature | 3-D Printing| October 13, 2016 | Dave Fornell
The U.S. Food and Drug Administration (FDA) changed its rules concerning custom medical devices Oct.
Heartware HVAD, ventricular assist device, artificial heart, Medtronic
News | October 05, 2016
October 5, 2016 — Medtronic said two previously communicated global voluntary recalls related to the HeartWare Intern
bundled payments for cardiology, CMS cardiac reimbursements
Feature | Business| September 13, 2016 | John W. Meyer, MPH, FACHE
(Editor’s note: This is the first part of a two-part series on the proposed Medicare five-year demonstration for
Overlay Init