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
Thursday, May 17, 2012
BMJ article: Regulatory failure MoM hips
Labels:
adverse events,
BMJ,
British Medical Journal,
Consumers Union,
Deborah Cohen,
FDA,
joint replacement,
MDUFA,
medical devices,
patient safety,
post-market data,
product recall,
revision surgery,
TMIT
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