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HR 3148 106th Congress House Health Commerce Congress Congressional reporting requirements Government Operations and Politics Government paperwork Informed consent (Medical law) Labeling Law Licenses Medical records Medical supplies Product safety

Reprocessed Single Use Medical Device Patient Safety Act of 1999

Introduced: October 26, 1999 See on congress.gov
 Everywhere this bill has been 4 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Nov 5, 1999
Referred to the Subcommittee on Health and Environment.
Oct 26, 1999
Referred to the House Committee on Commerce.
Oct 26, 1999
Sponsor introductory remarks on measure. (CR E2184)
Oct 26, 1999
Introduced in House
 Plain-English summary Congressional Research Service
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 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.

What's happening now November 5, 1999

Referred to the Subcommittee on Health and Environment.

 Committees of jurisdiction 2