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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Saturday, April 14, 2012

Consumers Union Letter in New York Times

(FiDA Blog bolding added.)

Safety of Medical Implants
Published: April 13, 2012  New York Times
To the Editor:
Your article about malfunctioning heart defibrillators (“Troubling Flaws in Heart Device Shake Industry,” front page, April 7) is just the latest example of how medical implants can become ticking time bombs because of weak federal oversight.
We need a comprehensive post-market surveillance system so safety problems can be detected sooner and patients can be notified when devices turn out to be defective or dangerous.
Congress required a unique device identifier system five years ago, but we still don’t have this essential element for monitoring the safety of implants and other devices. When safety concerns arise, the Food and Drug Administration should have full authority to order companies to do studies and enforce prompt compliance.
This year, Congress should give the F.D.A. the tools it needs to assess devices more carefully and track what happens to patients once these devices are on the market. It’s time to bring some common sense to medical device oversight.
Consumer Reports

Yonkers, April 10, 2012

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