After increasing to a historic level in 2018, the amount of medical device recalls remained elevated in 2019. This is borne out by the statistics that quantify exactly how widespread the problem has become. The number of medical device recalls has increased for several reasons, and one of the primary causes is the increasing sophistication of the devices. This problem appears to be here to stay as the prevalence of recalls will likely remain high for some time as the FDA increases its oversight in this area. As always, if you or a loved one has been injured by a defective medical device, you may be entitled to financial compensation for the damages that you suffered.
The Number of Device Recalls Spiked in 2018 and Remained Higher than Average in 2019
In 2018, the amount of medical device recalls significantly increased. A total of 208 million medical devices were recalled in that quarter. There were 343 separate recalls in the first quarter of 2018. This total was greater than the sum of all of the medical device recalls in 2017. While there was a slight drop in the number of medical devices recalled in 2019, this was not necessarily because these devices were manufactured more safely.
In order to fully understand the trends behind medical device recalls, it is necessary to look behind the numbers. You need to loom at the types of recalls and the level of danger that is posed. In addition, it is also helpful to know the reasons for the recalls. Not every medical device recall is the same.
Malfunctioning Software is a Main Cause of Recall
One of the main drivers behind the spike in recalls is the fact that the software that drives these medical devices has grown more complex as the technology advances. Since these devices are becoming more complicated, there are more ways for them to malfunction. For example, pacemakers have seen numerous recalls in recent years because there have been circuit errors in the devices. For example, in the numbers for the first quarter of 2018, 78 of the 343 recalls occurred due to software failures. More and more devices now need software to function, opening them up for more possible issues. This is a change from the device recalls of the earlier part of the last decade when design defects were the primary reason for the recalls. This trend in recalls appears here to stay for the foreseeable future and will mean that the number of recalls remains elevated.
When the amount of device recalls exploded, the second leading cause of recalls was the mislabeling of products. Software malfunctions are arguably more serious than the mislabeling of products.
The Number of Recalls Is Significant
In order to gain an understanding of the scope of the problem, it is important to focus on the number of product recalls that have been issued as opposed to the total of products. For example, while the statistics could indicate that 200 million products were recalled during a quarter, this could mean that there was a large number of recalls of one device and it may not have even represented a serious problem. The key stat to watch is the number of different devices that were recalled. For example, a pacemaker recall may only mean that 10,000 units are recalled, but it could present a serious problem given the function that pacemakers perform. What is even more significant is that 343 different devices were recalled in a quarter.
An Increase in FDA Inspections Can Lead to More Recalls
In general, the FDA has increased the number of inspections that it performs. One of the major reasons that the number of recalls has spiked is that the government is regulating more than it had in the past. This better protects patients who depend on these products to live or to remain healthy. At the same time, the increased number of inspections could simply be a function of the increasing number of medical devices that are available on the market. Medicals devices are tested and inspected at some point and it could be that the percentage of devices that are being recalled may not even have increased that much. For example, the number of medical device inspections conducted by the FDA increased by 46 percent between 2007 and 2017. In addition, the FDA has dramatically raised the number of foreign inspections that it has carried out during that time period, more than doubling it.
One reason for the slight drop in recalls from 2018 to 2019 is that the federal government was shut down for approximately one month at the beginning of the year. This meant that FDA inspectors were furloughed from their duties and were unable to perform inspections during that time. Then, when they returned to the job, they had to spend months catching up on inspections, thereby cutting some of the recalls in 2019.
Further, in order to fully understand the severity of the problem, you must pay attention to the type of medical device recall that has been issued. Class I recalls are the most serious and represent issues that can possibly put the patient’s life in danger. Theoretically, there could be a spike in recalls, and if they are Class II recalls which are less serious, it may not pose as much danger. However, the amount of Class I recalls in recent years has skyrocketed.
The problem with the 2018 spike in recalls is that the bulk of the recalls were of the Class I variety. This means that the recalls were more severe and threatened to pose more harm to patients. As medical devices grow more complex, it is likely that the severity of the recalls will continue to remain high as software problems may affect the functioning of these devices. While there is no such thing as an insignificant medical device recall, there is certainly a severe recall that is aimed at preventing imminent harm.
The same factors that have caused recalls to spike in the past two years seem likely to persist into 2020.