Reprocessed Single Use Medical Device Patient Safety Amendments of 1999

Summary

Reprocessed Single Use Medical Device Patient Safety Amendments 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 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.

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3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 5 August 1999

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• Introduced in Senate (PDF)

  Introduced in Senate · EN · 5 August 1999

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• Introduced in Senate

  summary · EN · 5 August 1999

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