Medical devices can be defective for a wide variety of reasons. Any one of these reasons can be enough to put the patient who has received the medical device in danger as there are thousands of fatalities each year from defective devices. Unfortunately, medical device recalls are all too common, whether they are due to a defective design or a manufacturing problem. Broadly speaking, medical device recalls occur when the manufacturer has to pull the product from the market either to take corrective action or to remove it entirely. Here are some reasons why medical devices can be recalled.
Dangerous or Defective Design
Products must not be unreasonably dangerous for their intended purpose. However, the design that is chosen by manufacturers may necessitate a recall for many different reasons. Sometimes, what manufacturers try to do just simply does not work in theory and is not possible to accomplish with the design that they have chosen. Other times, the way that the product is designed heightens the risk that the patient will experience a certain critical side effect.
The defective design recalls are not as easily addressed as other types of medical device recalls. It is difficult to change the device once it has been designed and sold to the general public. This is more than a basic fix and design defect recalls often mean that the medical device is taken out of circulation completely. An example of this occurred in transvaginal mesh, which is considered a medical device since it was implanted in the body. This mesh had a tendency to shrink and migrate out of place. Eventually, this led to product recalls and the FDA ordering the product off of the market. Given the design, it simply was not possible to manufacture this device safely.
Another example of this is metal hip implants. The design of these products caused there to be metal-on-metal which led to toxins being released into the bloodstream. The use of the metal in this design caused the injury, and subsequent versions of this product have taken the metal out of the implant.
Not all design defects place the patient’s life and health at risk, Some design defects simply make it more difficult to operate the device and must be fixed for the patient to realize the full benefit of the device. However, most design defect recalls affect the health and safety of the patient.
Some medical devices are properly designed, but still fail to work anyway. This is because of a problem in the manufacturing process that causes a defect that harms consumers. In some cases, the defect comes from the fact that someone has made an error in the factory. An example of this could be an impurity or toxicity being introduced into the product when it is being made. Manufacturing errors are not just limited to the assembly. These could also occur when the product is being shipped or at any time prior to the device being implanted or used by the customer.
Sometimes, manufacturing defects can involve contamination of the product. An impurity may have been introduced during the manufacturing process that either degrades the function of the medical device or causes it to be unsterile. The manufacturer is responsible for everything that happens to its product on the assembly line and until it is used by the patient.
Defective in Operation
One of the major areas of problems for medical devices is the fact that the software does not work. Many medical devices are technologically advanced and run on an operating system that is necessary for the device to properly do its job. However, sometimes the software is not functioning or the device cannot obtain the full connectivity that is required, impairing the operation of the device. In fact, in 2017, software problems were the cause of approximately one-quarter of medical device recalls. In many instances, these defects are fixable with either reprogramming or a patch to the program that corrects the error.
Other medical devices require a power source to continuously operate. This is true for medical devices such as a pacemaker that must continuously be at the ready to send an electric charge when necessary. Since implanted medical devices cannot be plugged in, they run on battery power in order to keep operating. However, sometimes the battery malfunctions and does not power the device. For example, some pacemakers have had a problem where the battery power drained more quickly than expected. In some cases, this caused fatalities. As a result, pacemakers required a recall to fix this battery-related issue. Other medical devices are prone to developing a leakage that can also either drain the power or pose other dangers for the patient.
Medical devices are recalled when they do not work in their entirety. Sometimes, components of the medical devices malfunction, necessitating a recall to fix the part. Any aspect of the device that does not work can mean the recall of the entire medical device.
Sometimes, the medical device works perfectly fine on its own. However, there are several different aspects of a properly functioning medical device. One of these is the packaging of the device. This includes the instructions for how to operate and use the device. When the manufacturer has given incorrect information that causes patients to use the device improperly in a manner that puts them at risk, it is considered a product defect that necessitates a product recall. This can put users in danger the same as any other medical device malfunction. Labeling errors can still subject a medical device manufacturer to liability in a lawsuit if a user is injured as a result. The good news for manufacturers is that these defects are relatively easy to address in a medical device recall.
If you or a loved one have used a medical device that has been recalled and suffered injury, you may be entitled to financial compensation for your harm. Contact the attorneys at Sadaka Associates to set up a free consultation to discuss your legal rights.