HR 3148 · 106th Congress · Health

Reprocessed Single Use Medical Device Patient Safety Act of 1999

Introduced 1999-10-26· Sponsored by Rep. Eshoo, Anna G. [D-CA-14]· House

Bill Progress

Introduced
2
Committee
3
House Vote
4
Senate
5
Enacted
Latest: Referred to the Subcommittee on Health and Environment.(1999-11-05)

Plain Language Summary

[AI summary unavailable — showing source text] Reprocessed Single Use Medical Device Patient Safety Act of 1999 - Amends the Federal Food, Drug, and Cosmetic Act to require every person or establishment (entity) engaged in the reprocessing of a medical device labeled for single use shall: (1) upon first engaging in such reprocessing and for each year in which such entity continues to so engage, register with the Secretary of Health and Human Services and provide all required information; and (2) for each such year, submit to the Secretary a list of devices labeled for single use that the entity is reprocessing, including names of original manufacturers and specific models. Requires each such entity to: (1) provide such information to each person or establishment that uses such device; and (2) demonstrate the device's safety and effectiveness. 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 t…

Summarized by Claude AI · Non-partisan · For informational purposes only

Cosponsors (5)

4 Democrats1 Republican