To amend the Federal Food, Drug, and Cosmetic Act to require any person who reprocesses a medical device to comply with certain safety requirements, and for other purposes.
Requires every person or establishment that uses a class II or III reprocessed medical device, or a critical class I reprocessed medical device, for the provision of medical care to individuals to seek informed patient consent for such use, and to include a record of such use in the individual's medical record.
Requires a report from the Secretary to specified congressional committees on the safety and efficacy of the reprocessing of devices labeled for single use.
Requires the Secretary to modify the MEDWATCH forms to facilitate the reporting of such information.
Introduced in House
Introduced in House
Sponsor introductory remarks on measure. (CR E2184)
Referred to the House Committee on Commerce.
Referred to the Subcommittee on Health and Environment.
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