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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Wednesday, November 7, 2012

President Obama: Faulty Medical Devices

This is a joyous day!

President Obama has been re-elected.  

In his 2012 State of the Union Address President Obama indicated that he was aware of faulty implanted medical devices and that targeted regulation is necessary to strengthen the U.S. free market.  

“We've all paid the price for lenders who sold mortgages to people who couldn't afford them, and buyers who knew they couldn't afford them. That’s why we need smart regulations to prevent irresponsible behavior. Rules to prevent financial fraud, or toxic dumping, or faulty medical devices don't destroy the free market. They make the free market work better,” Obama said.

Removal of  conflicted regulators from decision-making and rescinding industry entitlements  heightens assurance to patients that implanted devices are safe and effective.  Patients with access to accurate post-market data from CMS and hospitals make informed decisions and patient harm is reduced.  Businesses that produce valued implants will thrive.  

Let's get to work!

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