Contributing Factors to the Increase in Recalls of Medical Devices

Medical Device Recalls Are Increasing in the United States

In the past decade, medical device quality problems were responsible for 83,000 patient deaths, and by the close of the second quarter of 2019, the FDA recall of medical devices had shot up more than 70% since the beginning of 2016. There are various reasons for these alarming statistics, but they verify that more people are at risk of suffering injuries from defective medical devices. A personal injury lawyer can help people who have been harmed in this way.

Medical Devices Are More Technologically Advanced

As technology progresses, these devices become more complicated, and the software involved grows more intricate. The more complex the software, the greater the chance that something can go wrong. Previously, the most common cause of medical device recalls was design defects, but that has now been surpassed by software issues. Software failures have been the leading cause of medical device recalls in every quarter for the past three years.

For example, when dealing with pacemakers, the circuit can fail, necessitating a recall to either repair or replace the device. Software problems can cause the battery to drain, and there have been injuries and deaths associated with this. Another example is a robotic surgery system that was recalled because the software incorrectly positioned the robotic arm. Since these recalls are due to technology which is continuously being upgraded, it is likely that the number of medical device recalls will remain elevated in the near future.

More Inspections may mean an FDA Recall Increase

Many times, the medical device recall comes as the result of a U.S. Food and Drug Administration review that turns up evidence of a problem. Due to funding constraints, the FDA has been limited in the number of inspections it could undertake. However, the FDA has recently had an increase in funding, and the agency has accordingly increased the number of inspections it makes. Now that the FDA is looking at more medical devices, there is a higher likelihood that they will find something wrong that would trigger a recall.

There Are More Medical Devices

While the number of medical device recalls may seem alarming, there is a counterargument to be made that the problem really is not as bad as it seems. Statistically speaking, there are more medical devices on the market than there have been in the past. Consequently, there are more devices that could possibly be recalled. This means that the overall number of recalls is not necessarily indicative of more negligence. Nevertheless, every recall of a medical device is a serious situation for those who rely on it.

Pay Attention to the Kind of FDA Recall

Just because there has been a medical device recall does not necessarily mean there is a dangerous condition that can cause major injury. There are several different types of possible recalls. A Class I recall is the most significant. It indicates that the medical device can pose a danger to the life of the patient with a strong possibility of injury. Class II and III recalls are less serious and do not pose as much danger.

However, more of the recent recalls have been in Class I, signifying that the problems are more severe. Usually, technological issues in this category are quite serious because people rely on the medical devices involved for critical needs. The malfunctioning of these devices does pose a serious threat. The risk to the population as a whole will probably be far greater from the Class I recall of a thousand devices of some kind than from a Class III recall of a million others.

If you or a loved one has been injured by a defective medical device, a personal injury lawyer can help you obtain financial compensation. Contact our attorneys today at Rebenack, Aronow & Mascolo, LLP – RAM Law in New Brunswick by calling (732) 247-3600 or in Somerville by calling (908) 448-2560. If you’d prefer, you can email us at [email protected]. We’d be happy to arrange a free initial consultation.