In an age when everything in medicine is now looked at though a cost vs. benefit analysis and U.S. government healthcare reform efforts focused on cutting costs, the U.S. Food and Drug Administration (FDA) has not introduced economic considerations into its product evaluations. The FDA currently has a formal evaluation process for medical devices looking at safety and efficacy prior to market clearance. But, in light of the economics that drives usage of these devices, the question is raised whether economic considerations should also be added as part of the FDA review.
The cost studies that have been undertaken so far have overstated the cost of the ablation therapy interventions. For a number of years, catheters have been reprocessed, resulting in savings to hospitals. In 2002, the FDA issued a directive relating to medical device reuse, requiring that devices be reprocessed by third parties. Reprocessing manufacturers had to be licensed by the FDA using the 510(k) premarket submission. The reprocessing of devices used in the electrophysiology (EP) lab reduces catheter costs by about 30 percent. A 2008 Government Accounting Office (GAO) report indicated that outcomes are the same as when original equipment is used.
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