Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Twitter: @JjrkCh

Friday, September 9, 2011

The medical device industry is unfettered by clinical trials, the justice system, etc.

(Link here ) New York Times editorial on damage from brain stents.

This will continue until the public demands that

  • patient/consumer stakeholders be given voting rights on the FDA medical device advisory panels
  • a web-published independent registry of all implant devices is established for transparency & academic study
  • the current pre-emption from state court is revoked for the device industry
  • no device is cleared by the FDA without a percentage of the life expectancy of the device being warranted.

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