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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Friday, February 17, 2012

Implanted Medical Device Guinea Pigs no more: Consumers Union on Capitol Hill

LINK HERE:   MDUFA reauthorization must include patient safety

  • Improve review of devices before they enter the market
  • improve monitoring of devices after they enter the market
  • Retain current conflict of interest standards for federal advisory committees

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