If you or a loved one have an implanted joint replacement, please go to the link above and fill in the survey.
Consumers Union is actively advocating for patients with implanted medical devices. Today, CU Safe Patient Project, Senior Director, Lisa McGiffert participated by Brookings Institute webinar with FDA Jay Carney and NWHN Kate Ryan in a discussion on implementing UDI's. Unique device identifiers are the first step in providing patients with accurate and timely information about the composition, origin and producer of their implant. This information will be uniform and shared in the electronic health record, with the insurer and the FDA. This will allow researchers to analyze which devices are safe and effective and provide the patient with a portal to determine which devices have been recalled. The federal government is still working on implementation, so Consumers Union is providing this survey as a preliminary "registry" for patients until the national program is fully instituted.
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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