10% of people given fibrinogen have HCV

The Yomiuri Shimbun
About 10 percent of the 7,400 or so patients who were administered the blood product fibrinogen were infected with hepatitis C, a Health, Labor and Welfare Ministry study team announced Tuesday.
The team has been investigating patient records kept at medical institutions to which fibrinogen was shipped. The product was made by Green Cross Corp., a predecessor of Mitsubishi Tanabe Pharma Corp.
An estimated 10,000 people are thought to have been infected with the hepatitis C virus after the blood product fibrinogen was used in surgical operations involving about 280,000 people. However, the results of the investigation suggest this percentage of infection, 3.6 percent, could be lower than the true figure, medical sources said.
In its interim report, the study team found 99 people infected after being treated with fibrinogen have died from hepatitis-related diseases.
Fibrin glue, used as a surgical adhesive, was the most common use of fibrinogen among patients, making up about 40 percent of cases. Direct intravenous injection of fibrinogen as a hemostat agent in operations, including parturitions, accounted for 30 percent of treatments involving the product.
The survey results prompted the ministry to renew its call for people who have had surgery to have hepatitis checkups.
Out of 6,609 medical institutions to which Green Cross delivered the product, 644 institutions that kept individual patients' records of administration of fibrinogen were surveyed at the end of February. Of them, 475 institutions provided valid responses.
According to the survey, 7,406 patients were administered fibrinogen, and 741 of them were found to have been infected with HCV. Of them, 12 also had been infected with the hepatitis B virus, while 40 others had been infected with HBV alone.
Hospitals are unsure whether 4,908 of the 7,406 patients have hepatitis. The number of people found to have been infected likely will further rise as the investigation progresses, the medical sources said.
Of patients administered fibrinogen, 1,817, or 24.5 percent, have already died. Of them, 99 died from hepatitis-related diseases.

Entegrion achieve FDA approval

Entegrion, Inc., a privately owned life sciences product development company specializing in technologies for hemorrhage control, resuscitation, and tissue repair, announced that it has received 510(k) market approval from the U. S. Food and Drug Administration (FDA) for its hemostatic medical textile technology. The first application of the technology is Stasilon FR – hemostatic wound dressings for first responders. This market includes EMS workers, police officers, emergency personnel and fire fighters. The Stasilon FR – hemostatic wound dressing was approved by the FDA for use by medical professionals under prescription and “over-the-counter” by consumers to control bleeding resulting from “minor cuts and abrasions” as well as “lacerations, punctures and incisions.” Pending acceptance of an amendment to the FDA approval, a second version of the technology will be implemented as Stasilon OR – hemostatic surgical pads.
Entegrion 510K available HERE