New instruction for Medical Device Reusage by FDA

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The U.S. Food and Drug Administration announced steps to help reduce the risk of exposure to improperly reprocessed devices that can lead to the transmission of disease.

Medical devices intended for repeated use are commonplace in health care settings. They are typically made of durable substances that can withstand reprocessing, a multistep process which includes cleaning, disinfecting, or sterilization to remove debris and biologic materials that may transmit infection between patients. While successful reprocessing of reusable devices occurs routinely in health care settings, there are some devices which present particular challenges to reprocessing.

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NEW BIOMEDICAL INITIATIVES GETTING FUNDING AROUND THE WORLD……..

Artificial heart maker gets $7.5 million grant

SynCardia Systems, 1992 E. Silverlake Road, manufacturer of the world’s only FDA-approved total artificial heart, has received a five-year, $7.5 million grant from the National Institutes of Health.

The grant was awarded to three of its researchers to optimize the design of cardiovascular devices.

The principal investigator on the project is Danny Bluestein, professor of Biomedical Engineering at Stony Brook University in New York. His collaborators are Shmuel Einav, also of Stony Brook College, and Dr. Marvin Slepian, professor of cardiology and biomedical engineering medicine at the University of Arizona,

Local company gains biomedical funding

Medical technology company Glenveigh Medical in Chattanooga is getting nearly half a million dollars in federal grants to pay for research that officials expect will boost America‘s role in biomedical research.

The federal “therapeutic discovery” grants and tax credits, awarded under national health care reform legislation and announced this month, provide more than $6.7 million to Tennessee recipients whose projects show “significant potential to produce new and cost-saving therapies, support good jobs and increase U.S. competitiveness,” according to the U.S. Department of Health and Human Services.

The only Chattanooga-based company awarded the grant this year was Glenveigh, which specializes in maternal-fetal medicine products. The company moved from Research Triangle Park in Raleigh-Durham, N.C., to Chattanooga in 2007.

About $81,000 in grants will help Glenveigh create a device for measuring cervical dilation during labor, and an additional $156,000 will help the company develop treatment for pre-eclampsia, a dangerous condition for pregnant women.

The company also received $244,479 for a device that can slow blood loss in women hemorrhaging after giving birth, said the company’s founders.

The “Ebb” device, developed by Salt Lake City-based maternal-fetal medicine specialists and licensed by Glenveigh, can reduce post-partum blood loss and prevent a hysterectomy or even death, said Richard Proctor, president and CEO of Glenveigh.

“This device is going to save lives,” he said.

Federal Grants Advance Local Biomedical Research

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