Originally Published MX March/April 2003
BUSINESS PLANNING & TECHNOLOGY DEVELOPMENT
When Single-Use Means Something More|
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Title 21 of the U.S. Code, Section 321 (the Federal Food, Drug, and Cosmetic Act) includes the following definitions pertinent to the issues of single-use and the reprocessing of medical devices.
Critical reprocessed single-use device. A reprocessed single-use device that is intended to contact normally sterile tissue or body spaces during use.
Original device. A new, unused single-use device.
Reprocessed. With respect to a single-use device, . . . an original device that has previously been used on a patient and has been subjected to additional processing and manufacturing for the purpose of an additional single use on a patient. 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. A single-use device that meets this definition shall be considered a reprocessed device without regard to any description of the device used by the manufacturer of the device or other persons, including a description that uses the term recycled rather than the term reprocessed.
Semicritical reprocessed single-use device. A reprocessed single-use device that is intended to contact intact mucous membranes and not penetrate normally sterile areas of the body.
Single-use device. A device that is intended for one use, or [for use] on a single patient during a single procedure.
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