When Single-Use Means Something More

Originally Published MX March/April 2003

BUSINESS PLANNING & TECHNOLOGY DEVELOPMENT

When Single-Use Means Something More

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.