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.
Please share what you have learned!
Twitter: @JjrkCh

Sunday, September 11, 2011

Evaluating medical device safety with 'horse and buggy' regulation

(Link here) LA Times Story - tests are lacking on medical devices

"Between 1983 and 1997, one in four medical devices used software.  Today, the figure is more than half. Software problems are now the third leading cause for recalls of medical devices."

Public policy change will be driven by your involvement.  Contact your U.S. Congresspersons and demand that the FDA charter be changed to include patient/consumers as full voting stakeholders.  Independent registries that are transparent and available for university study.
Warranty on product as a percentage of device life.  Access to justice (compensation) for victims of failed "innovation".

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