Safety Isn’t Always First When the FDA Approves Medical Devices

By Diane Archer

Health News Review explains why FDA-approved medical devices may not be safe or effective in a tool-kit for reporters; its message is important for everyone to understand. In short, as with drugs, the FDA approves a medical device if the manufacturer can show a benefit of the device over a placebo. The manufacturer does not have to show that it is better than other devices on the market or free from harmful side effects.

Medical devices are non-drug products that are used to diagnose or treat a medical condition, from bandages to MRI machines. It appears that the FDA has approved tens of thousands of them without a lot of focus on patient safety. Even when the device is implanted in a person’s body, the level of safety evidence required for FDA approval is low.

What’s even scarier is that after these products go to market, there is no systematic review of their safety. So, reports of serious harm to patients may go unnoticed and unaddressed. The FDA oversight can be weak, and the FDA may not issue a recall or even a warning about patient safety. You can read here about a heater-cooler devices (HCDs) used during heart surgery that can cause life-threatening infections and here about how using morcellators to remove fibroids can cause cancer to spread.

StatNews has also reported on the patient safety problems with medical devices. It refers to a January 2016 Senate Democratic staff report on how ineffective oversight of medical device safety led to a major superbug outbreak that killed at least 20 people and harmed 350 others. In that case, the medical device was an Olympus duodenoscope that is widely used. And, though Olympus was aware of the design flaw that caused the superbug outbreak, it did not alert U.S. hospitals or the FDA. US hospitals are required to report patient safety issues to the FDA, but many hospitals who experienced superbug outbreaks failed to let the FDA know. The FDA’s oversight is “passive,” depending upon alerts from doctors, hospitals and device manufacturers.

To make matters worse, when patients are harmed, they generally have little recourse. The Supreme Court has ruled that FDA premarket approval for riskier devices generally protects the manufacturers. And, Public Citizen says that the 21st Century Cures Act, which is about speeding drugs and devices to market, may weaken FDA oversight even more. The law protects manufacturers from FDA regulatory burdens.

Originally published in on October 3, 2017.

Diane Archer

Diane Archer is founder and CEO of, a digital platform for baby boomers and carers. She began her career in health advocacy in 1989 as the founder and president of the Medicare Rights Center.

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