ROCKVILLE, Md. -- The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has approved the sale and distribution of the Disintegrator PRO for clinical use. The Disintegrator PRO is a small electrical device that, with the push of a button, creates a controlled plasma arc that disintegrates an inserted hypodermic needle, leaving a harmless, blunted end.
"The healthcare industry generates hundreds of millions of used needles each year," says Joe Adkins, president of Safeguard Medical Devices, Inc. (d.b.a.: Disintegrator Products), manufacturers of The Disintegrator PRO. "FDA approval of The Disintegrator PRO paves the way for a safer workplace for our nations approximately 900,000 healthcare workers, while potentially saving the healthcare industry, and ultimately the American public, more than half a billion dollars annually."
The American Nursing Association has estimated that 1 million accidental needlesticks occur in the United States healthcare industry alone. In total, several billion used syringes end up in the solid waste system. Used needles can transmit numerous bloodborne pathogens, including HIV, hepatitis B and C, as well as other infections.
But, in less than three seconds, The Disintegrator PRO heats the used needle to 1,700 degrees centigrade (3,000 degrees Fahrenheit), effectively destroying the needle while eliminating any viruses or potentially harmful bacteria from the blunted end.
FDA approval of The Disintegrator PRO follows recent FDA approval of
The Disintegrator Plus, a similar device designed for home use by diabetic patients and others who utilize needles and lancets in the course of treating their medical conditions. Together, the Disintegrator units have received 28 patent claims in the U.S. and abroad, and represent a technological leap over traditional methods of disposing of used needles, such as storing in sharps containers or even coffee cans and pop bottles before placement in trash bins.
The Centers for Disease Control and Prevention estimates 62 to 88 percent of sharps injuries can potentially be prevented by use of safer medical devices.
The Disintegrator units are manufactured by Safeguard Medical Devices,
Inc. (d.b.a.: Disintegrator Products) of Cleveland, Ohio and distributed by Perfecta Products, Inc. of Berlin Center, Ohio.
Source: Safeguard Medical Devices, Inc.