According to the United States Food and Drug Administration (FDA), there were almost 70 medical devices recalled over the past two years. In 2016, there have already been over 20 devices recalled, indicating that the epidemic of medical technology recalls is not slowing down. There are several reasons why medtech recalls seem to be an epidemic over the past few years.
Reasons for a Medical Device Recall
Lack of Testing
In an effort to get devices to market as soon as possible, some manufacturers may skip important testing. Many devices that have recently been recalled received FDA clearance through what is known as 510(k) or pre-market notification. In this process, a manufacturer must only show that a device is “substantially equivalent” to another device already on the market. One example of recently recalled devices that were approved through this process were hip and knee replacements. Because the replacements were “similar” to those already approved, the manufacturer did not have to submit it to clinical trials. What was discovered after the replacements were used in patients is that some types, such as metal-on-metal hip replacements, had additional issues that those made of other materials did not. This included fragments of metal entering the bloodstream causing major illnesses and increased failure of the replacement.
Another issue with the 501(k) process is that, although a device might be basically the same as another device, software plays an increasingly important role in how some medical devices work. With medical technology using computerized mechanisms more often, the software used to operate those devices grows in importance. The FDA regulation does not address software updates or failure, leading to additional recalls of devices. In fact, according to the FDA, software failures are responsible for as much as 24 percent of all device recalls. One example of a device recalled due to software issue is insulin pumps. Because the pumps use computerized software to operate, demonstrations have shown that some pumps could be accessed remotely, delivering a fatal dose of insulin to a patient. Although it is unlikely someone would attempt to do so purposely, two people with the same pump could inadvertently inject the wrong amount of insulin if they used the pumps at the same time.
Lack of Follow-Up Safety Studies
Once a product is released on the market, the FDA has limited authority to require manufacturers to conduct follow-up safety studies. Unfortunately, even with clinical trials, an issue with a device may not be recognized in a small test group, but when the device is used on a much larger scale, problems may become more evident. Recently, over 100,000 defibrillators were recalled when it was learned that a short-circuit could cause the device to fail without warning. This meant that when the defibrillator was supposed to send an automatic electric shock to the heart to correct possibly lethal irregular heartbeats, it did not do so and could lead to the patient’s death.
Lack of Knowledge
Many times, a medical device recall is not issued because consumers are unaware that they are able to report problems to the FDA. Too often, people believe that only doctors are able to report medical device failures or malfunctions. This occurred when orthodontic headgear injured children in their sleep when they came loose. Parents, and even some doctors, were unaware that they could report the incidents to the FDA who could investigate the cause of the injuries.
Although it would be impossible to never have a medical device recall, it is possible that the FDA could minimize the increasing number of recalls simply by requiring more testing, better evaluation, follow-up and education of consumers regarding what they can do when a device malfunctions.
Learn more about a Medical Device Recall.