Spurred by thousands of American women who were being injured due to faulty IUDs, President Gerald Ford signed the Medical Device Amendments of 1976 into law, granting the Food and Drug Administration (FDA) greater regulatory oversight regarding the safety and effectiveness of medical devices intended for widespread distribution. It was a historic consumer protection law intended to preserve public health and safety — but the legislation was also riddled with regulatory loopholes, particularly with respect to products that were already out in the market. Now, almost forty years later, Americans are still feeling the impact of the incomplete legislation as they encounter a multitude of common medical devices, including lethal products, that haven’t undergone adequate testing.
As The Atlantic reports, the medical device regulation bill contained lax provisions for classifying the safety of devices that are similar to products already available on the market, meaning that many contemporary devices do not have to undergo thorough testing simply because they were considered safe enough back in 1976:
The legislation created varying safety standards for devices that the FDA would deem as low, medium, and high risk. Medium-risk products, like surgical stitches, could be sold without first being tested on people under most circumstances, provided the device was “substantially equivalent” to one already on the market. For high-risk devices, like artificial hearts, companies were generally required to test their products in people and demonstrate to FDA that the products were safe and effective.
The law applied immediately to new types of devices and directed the FDA to retroactively classify existing ones, with one caveat: Products that were already on the market when the law passed would effectively be regulated as medium-risk until FDA officially classified them. The unfortunate result has been that some high-risk devices have won approval without being tested in people.
This interim solution was not supposed to last 37 years. Yet nearly four decades since Congress passed the Medical Device Amendments, the FDA still has not classified some of the temporarily “grandfathered” devices. As a result, potentially high-risk devices are continuing to reach the market without ever being tested in people.
The contemporary high-risk products that still have not undergone human testing due to the loophole include aortic balloons for heart surgeries and automated external defibrillators (AEDs). After thousands of faulty hip replacements caused a public health outcry over the last several years, Congress finally took action in 2012 to give the FDA more authority to re-classify the so-called “grandfathered” products. But while the FDA has taken action to re-label hip replacements, “19 grandfathered device types remain unclassified.”
Unfortunately, congressional procrastination on public health and safety measures is depressingly standard, as the FDA’s regulatory powers consistently lag behind until a crisis erupts to force lawmakers to make a change. Last year’s deadly deadly meningitis outbreak stemming from lax standards at a Massachusetts-area compounding pharmacy illustrates the trend perfectly. Lawmakers eventually responded to that crisis by introducing legislation to give the FDA more power to oversee the largely unregulated compounding pharmacy industry — but only after the outbreak resulted in the deaths of over 30 Americans, and the FDA director Margaret Hamburg begged a Senate health committee to give the agency more oversight.