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, June 22, 2012

No concern about patient harm: single-minded and self-dealing.

Published on Jun 20, 2012 by ‪reperikpaulsen
Rep. Erik Paulsen (MN-03) took to the House floor in support the a package of FDA reforms. Reforms in this package will make the device approval process more transparent, more consistent, and more predictable. Specifically a provision proposed by Rep. Paulsen to streamline the third party review process will free up valuable resources at the FDA.
Comment by ‪explanthis 6/22/12   (FiDA blog)
Patients are harmed and placed in medical and legal purgatory because Congress has directed the FDA to approve implanted medical devices without clinical testing 510(k) with no warranty or post-market independent data or UDI so that consumers can select a safe device.  Representative Paulsen has personal financial investments in medical device companies and is a cheerleader for the industry. He is not impartial and he is aware of FDA Adverse Event #5009052.

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