H.R. 3148106th CongressHouse Bill

Reprocessed Single Use Medical Device Patient Safety Act of 1999

Introduced in the HouseDead

This bill died when its Congress ended.

Bills don't carry over between Congresses. Without re-introduction in a new session, it cannot advance.

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.

Introduced Oct 26, 1999
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Introduced

Filed in the House

2
Passed House
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Passed Senate
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Became Law

This house bill has been filed and is working its way through Congress. It will need to pass both the House and the Senate, then be signed by the President to become law.

Who introduced this

AE

Anna Eshoo

Democrat

U.S. Representative · CA-14

5 cosponsors — mostly Democrats

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