Post-market data will help reduce risk to patients
Congratulations to Lana Keeton and Truth in Medicine (blog cited on right column) for tenacity and diligence leading to federal public policy changes that will elevate safety and effectiveness of U.S. medical devices and will make jobs in that industry more stable and respected.
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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