(link) The medical device industry does not "own up" to post-market failures.
Joint replacements are the #1 expenditure of Medicare.
IOM 7/29/11 stated that the FDA 510(k) should be scrapped.
No post-market independent registry.
No warranty on product.
Industry entitlement from state court justice.
Patient/consumer stakeholders restricted from voting in FDA advisory panels.
Direct-to-consumer misleading advertising.
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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