Great moments in government regulation, or 3 cheers for the FDA
The current regime is so dedicated to public safety. Recently , FDA approved the marketing of a home water purification device to be used by patients with end stage renal (kidney) disease (ESRD) who do their own dialysis at home. Because Medicare covers patients with ESRD, it pays for such items.
CMS , the federal agency that handles Medicare, states that the device that FDA approved does not have the ports needed for the patient to test the water and the dialysis fluid. Testing of both the water and the dialysate is necessary for patient safety and required by law.
Because FDA had previously approved other dialysis testing devices, it compared the new product to them rather than treating it as a new device. Someone must have forgotten about the published standards for water purity and testing of medical equipment. According to CMS, FDA stated that it only regulates the manufacturer and the marketing; patient safety is left to CMS.
Aren't you glad the FDA is looking out for us?
CMS , the federal agency that handles Medicare, states that the device that FDA approved does not have the ports needed for the patient to test the water and the dialysis fluid. Testing of both the water and the dialysate is necessary for patient safety and required by law.
Because FDA had previously approved other dialysis testing devices, it compared the new product to them rather than treating it as a new device. Someone must have forgotten about the published standards for water purity and testing of medical equipment. According to CMS, FDA stated that it only regulates the manufacturer and the marketing; patient safety is left to CMS.
Aren't you glad the FDA is looking out for us?
posted by McMircle at 1:18 PM
2 Comments:
What is CMS?
-Steve G.
CMS is the Centers for Medicare and Medicaid Services. It's the federal agency that handles Medicare. CMS has state agencies inspect hospitals, clinics and dialysis treatment centers to make sure they comply with regulations intended to protect Medicare patients.
Hope that helps.
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