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The term "critical reprocessed single-use device" means a reprocessed single-use device that is intended to contact normally sterile tissue or body spaces during use.
There's only so far you can push a single-use device.
The term "original device" means a new, unused single-use device.
The term "semi-critical reprocessed single-use device" means a reprocessed single-use device that is intended to contact intact mucous membranes and not penetrate normally sterile areas of the body.
The subsequent processing and manufacture of a reprocessed single-use device shall result in a device that is reprocessed within the meaning of this definition.
The term "single-use device" means a device that is intended for one use, or on a single patient during a single procedure.
Similar(37)
In health facilities management, reprocessing refers to the rendering of used devices (multiple-use or single-use devices) or unused opened devices to be patient ready.
Boston Scientific, one of the major manufacturers of single-use devices, had sales of nearly $3 billion in 1999.
Today, more than half the country's hospitals send at least some of their single-use devices to reprocessors, said Daniel J. Vukelich, president of the Association of Medical Device Reprocessors.
Some single-use devices can be reused after reprocessing, but a decade ago there was great consternation that inadequately decontaminated products might cause infections.
Hospitals have cleaned and reused disposable devices for about 20 years, said Larry Spears, an enforcement official with the Center for Devices and Radiological Health at the F.D.A. Companies specializing in the cleaning and repackaging of single-use devices first appeared about a decade ago.
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