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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Thursday, September 29, 2011

Private innovation to provide implanted medical device registry!

"Mining" adverse event information - two new businesses!  link here

How will you as a consumer stakeholder benefit?

Orthopedic joint implants are now the #1 expenditure of Medicare.  There is a void of information on the failure rate because the U.S. has no registry.  (Currently:  Consumers receive more information on automobiles prior to purchase.  There is no warranty on product.  Device failures do not prompt industry "innovation". )

The FDA and implanted medical device manufacturers are going to be eclipsed by these new post-market database start-ups.

I was blown away (at Health 2.0 SF convention) by Clarimed's (Nora Illuri) presentation that displayed public & mined data in a design-smart, useable, understandable  format.

The British Registry identified the 37,000 Johnson & Johnson DePuy ASR metal-on-metal failed hips.  

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