Page:United States Statutes at Large Volume 116 Part 2.djvu/838

 116 STAT. 1620 PUBLIC LAW 107-250—OCT. 26, 2002 "(2)(A) The term 'reprocessed', with respect to a single-use device, means 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. "(B) A single-use device that meets the definition under clause (A) 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'. "(3) The term 'original device' means a new, unused singleuse device. "(mm)(l) 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. "(2) 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.". SEC. 303. MEDWATCH. Deadline. Not later than 6 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall modify the MedWatch mandatory and voluntary forms to facilitate the reporting of information by user facilities or distributors as appropriate relating to reprocessed single-use devices, including the name of the reprocessor and whether the device has been reused. Approved October 26, 2002. LEGISLATIVE HISTORY—H.R. 5651: CONGRESSIONAL RECORD, Vol. 148 (2002): Oct. 16, considered and passed House. Oct. 17, considered and passed Senate. WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 38 (2002): Oct. 26, 28, Presidential remarks and statement.

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