(link) Minneapolis Star Tribune Editorial ignores patient safety issues.
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This editorial in the Minneapolis Star Tribune gushes over innovation and bipartisanship, but misses the point: jobs and profit do not trump patient safety.
It is critical that the medical industry listen to citizens and patients-we support our doctors and innovation that proves to be safer and more effective, but joint replacement is now the #1 expenditure of Medicare. Elders do not need an expensive and questionably functional hip/knee/stent/pacemaker at age 65 that may bankrupt the Medicare program.
Medical devices are proliferating and the medical device industry refuses to respond to overwhelming information that nearly 20% of their products fail placing patients in medical and legal purgatory. The independent IOM (Institute of Medicine) reported on 7/29/11 that the FDA clears most implanted medical devices without any pre-market clinical testing. Further, there is no post-market data registry, making it nearly impossible for patients and their trusted clinicians to make intelligent decisions about which device would enhance their lives. When devices fail, the cash-strapped FDA is not usually the entity that informs the public: registries in other countries caught 37,000 DePuy Johnson & Johnson hip failures. There is no warranty on product.
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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