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FDA blamed for oversights with defective medical device

Advocates in the health care industry have raised concerns that the Food and Drug Administration has failed consumers in California by allowing dangerous medical devices onto the market. Many advocates and victims alike are confused as to how a defective medical device can so easily reach so many patients, causing serious injuries and infections. Currently, it is believed that the FDA's approach to defective devices and dangerous drugs is wildly inadequate.

This is not the first time that advocacy groups have raised concerns over the FDA's ability to protect patients. Back in 1990, federal auditors criticized the FDA for its seriously lacking oversight of medical devices. In more recent times, a senator created a report that exposed how the FDA failed to prevent the nationwide spread of infections that were resistant to antibiotics, which was linked to defective scopes and last discussed on Feb. 26, 2015 ("Spread Of Bacteria Linked To Alleged Defective Medical Device").

A new system to monitor medical devices has been proposed, but it is not without opposition. It is estimated that implementing a new system to track medical devices would cost approximately $250 million for its initial five years in use. While cost is certainly a concern that must be addressed, the financial implications should not be placed above patient's lives.

The FDA already tracks and analyzes medications and claims as part of a joint initiative with Congress that was first implemented 10 years ago. However, the effectiveness of that program has apparently not trickled over into preventing patients in California from being harmed by a defective medical device. Until the FDA establishes better policies and procedures to approve and track new technology in health care, patients across the United States will still be at risk for irreversible harm.

Source: CNN, "How will the government regulate potentially dangerous medical devices?", Chad Terhune, Feb. 3, 2016

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