Kawasumi America Receives FDA 510(k) Clearance on Needle Safety Device
TAMPA, Fla. -- Kawasumi Laboratories America, Inc. has received FDA 510(k) clearance to market a needle safety device to protect oncology clinicians from Huber needlestick injuries incurred while removing needles from subcutaneous ports. OSHA estimates that an alarming 600,000 to 800,000 healthcare workers are injured each year from needle stick injuries and many of them are exposed to bloodborne diseases like hepatitis and HIV/AIDS.
Kawasumi America's new plastic protection device known as K-Shield not only offers oncology nurses and staff protection from needlesticks, but provides a convenient means for disposing the Huber needle after removal from patients. Compared to other types of Huber needle safety devices currently on the market, K-Shield does not discomfort the patient at any time, nor does it present any needle movement during the time of infusion.
The trade name K-Shield represents a family of needle safety devices for oncology and other clinical applications such as infusion and blood collection, and prostate brachytherapy. The K-Shield Huber needle safety device represents the first phase in product applications to be available for sale. Additional K-Shield applications for the infusion and blood collection product line will soon be submitted for FDA 510(k) clearance to market in the U.S.
"Kawasumi is pleased to provide clinicians with a cost effective mechanism for needle stick safety," said Ron Lamb, president of Kawasumi Laboratories America. "This is especially important right now -- at a time when OSHA is tightening the squeeze on health care facilities to comply with their requirements for needle stick prevention."
Scott Horowitz, marketing manager for Kawasumi added, "K-Shield was very well received during our clinical trials and continues to be highly accepted with a great deal of confidence in field demonstrations at oncology clinics nationwide."
Founded in 1954, Kawasumi Laboratories, Inc. is a leading manufacturer of medical devices and pharmaceuticals. Headquartered in Tokyo, Japan, the company is listed on the Second Section of the Tokyo Stock Exchange. Kawasumi Laboratories America, Inc., based in Tampa, Fla. since 1991, is a wholly owned subsidiary of Kawasumi Laboratories, Inc.
Source: PRNewswire
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