Seenthis
•
 
Identifiants personnels
  • [mot de passe oublié ?]

 

Kassem

@kassem
//
RSS: Kassem
tous les messages de Kassem
  • @kassem
    Kassem @kassem CC BY-NC-SA 12/03/2019
    4
    @monolecte
    @simplicissimus
    @7h36
    @biggrizzly
    4

    Hidden #FDA Reports Detail Harm Caused by Medical Devices
    ▻https://www.medscape.com/viewarticle/910150

    https://img.medscape.com/thumbnail_library/dt_190311_operating_room_interior_800x450.jpg

    La FDA permet à de nombreuses entreprises de fabrication d’appareils médicaux de ne pas rendre public les dysfonctionnements de leurs créations en attendant leur ré-évaluation (puis souvent retrait du marché).

    The growing cadre of #exceptions to the injury- and death-reporting rules strikes Dr. Michael Carome, director of the Public Citizen Health Research Group, as a retreat by the FDA from making crucial #information available for researchers and #patients.

    “It’s just another example of a flawed oversight system,” he said, “bent toward making it easier for industry rather than making protection of public health the primary goal.”

    #santé #etats-unis #délétère

    Kassem @kassem CC BY-NC-SA
    • @monolecte
      M😷N😷LECTE 🤬 @monolecte CC BY-NC-SA 13/03/2019

      #paywall #corruption

      M😷N😷LECTE 🤬 @monolecte CC BY-NC-SA
    • @kassem
      Kassem @kassem CC BY-NC-SA 4/12/2019

      Medical Device Failures Brought To Light Now Bolster Lawsuits And Research | Kaiser Health News
      ▻https://khn.org/news/medical-device-failures-brought-to-light-now-bolster-lawsuits-and-research

      https://khn.org/wp-content/uploads/sites/2/2019/11/medical-devices-7_1350.jpg

      For almost 20 years, malfunctions and injuries linked to 108 medical devices, including dental implants and pacemaker leads, were funneled into an FDA database that few patients, doctors or even FDA officials knew existed.

      In 2016, for example, Covidien reported 84 injuries or malfunctions in the public database known as MAUDE, while nearly 10,000 incidents flowed into the hidden database, KHN reported in March. A few MAUDE reports mentioned the existence of an “alternative summary reporting” program, but until this summer, the FDA made that internal data available only through the Freedom of Information process, which can take up to two years.

      KHN’s investigation prompted then-FDA commissioner Scott Gottlieb to pledge in a tweet to open the hidden data to the public. The agency released all 5.7 million records in June.

      Kassem @kassem CC BY-NC-SA
    Écrire un commentaire

thèmes

  • #délétère
  • #etats-unis
  • #exceptions
  • #FDA
  • #information
  • #patients
  • #santé
À propos de Seenthis Propriété intellectuelle Recommandations API