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Revolutions Medical Receives 510K FDA Clearance to Market Rev Vac Safety Syringe

March 25, 2009
Rev Vac
Safety Syringe
Needle
by Regina Geok-Ling Tan, special to DOTmed News
According to a NIOSH report published in November 1999, an estimated 600,000 to 800,000 health care workers have needlestick and other percutaneous injuries each year. Revolutions Medical Corporation is one of the companies that has created an automatic retracting syringe to prevent needlestick injuries -- the Rev Vac Safety Syringe. New Medical Technology, Inc., Retractable Technologies, Inc., and Safety First Medical also manufacture automatic retracting syringes.

The FDA-approved Rev Vac Safety Syringe uses patented technology to draw the needle back into the syringe chamber after use. It is made for one-handed use, which may reduce the number of accidental needlestick injuries. There are no clamps, sheaths, or other mechanized safety features that require two-handed use. It is also a single-use disposable syringe, which may help eliminate the transmission of blood-borne diseases, such as HIV, hepatitis, syphilis, malaria, TB, and herpes, among others.

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The Rev Vac Safety Syringe needle is retracted directly from the patient into the barrel of the syringe, according to the Revolutions Medical website. Also, the hands and fingers of the healthcare professional stay behind the front of the syringe. The potential cost-effectiveness of the Rev Vac Safety Syringe comes from its reduced cost (estimated to be 20% - 50% lower than the current market price); the decreased waste, e.g., one discarded piece vs. two discarded pieces; and the potentially reduced cost of health care from a decreased occurrence of needlestick injuries.

Due to these reasons, "We feel that our Rev Vac Safety Syringe will be the alternative to all the uses for a regular disposable syringe," Revolutions Medical CEO and chairman Ron Wheet told DOTmed News.

Syringe 101

There are currently four general types of safety syringes in the market: sheathing tube syringes, sliding needle cover syringes, hinged needle cover syringes, and spring retractable syringes. The main producers of these syringes are Becton Dickinson, Kendall Healthcare, Medi-Hut Co., Inc., New Medical Technology, Inc., Retractable Technologies, Inc., Safety Medical Supply International, SIMS Portex, Inc., Sterimatic Medical Corporation, and Univec, Inc. Becton Dickinson has an estimated 54% market share, Kendall Healthcare has an estimated 37% of market share, and the other companies comprise 7% of market share. There is also needle-free injection technology available, according to the CDC website.

For Revolutions Medical Corporation, its three major competitors are Becton Dickinson, Kendall Healthcare, and Terumo, according to Mr. Wheet. "Since the beginning of 2009, our [RM's] stock has moved from around $0.20 per share to around $0.50 per share," Mr. Wheet said.