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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Timeline

1. 5 August 1999

   Introduced

   Read twice and referred to the Committee on HELP.

   Source: IntroReferral

2. 5 August 1999

   Introduced

   Introduced in Senate

   Source: IntroReferral

Votes

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Versions

• Introduced in Senate · 5 August 1999 · Download file

Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 5 August 1999

  ViewDownloadOpen at official source

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 5 August 1999

  ViewDownloadOpen at official source

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• Introduced in Senate

  summary · EN · 5 August 1999

  Open at official source

  Leesvertaling

  Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.

  Vertaal naarNL · DutchDE · GermanFR · FrenchES · SpanishIT · ItalianPL · PolishPT · PortugueseSV · SwedishDA · DanishFI · FinnishEL · GreekCS · CzechHU · HungarianRO · RomanianBG · BulgarianHR · CroatianSK · SlovakSL · SlovenianLT · LithuanianLV · LatvianET · EstonianGA · IrishMT · Maltese

  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

Sponsors

• Sen. Durbin, Richard J. [D-IL] · D · Sponsor
• · sshr00 · Standing

Related records

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