Medical devices help patients achieve certain functions, from mobility to controlling the heartbeat. They are very critical – an error can result in significant consequences, such as heart attacks, organ function loss, organ loss, permanent disabilities and death.
The U.S. Food and Drug Administration (FDA) receives thousands of medical device reports of suspected device-associated injuries and deaths. But why does this happen?
The following are three causes of medical device injuries.
Failure to properly test a device
Like any other instrument, medical devices should be tested before entering the market. Failure to do this or, at least, use quality standards for testing, users can suffer injuries.
Improper material selection
The materials used for medical devices should be top-notch. Manufacturers always look for robust materials with excellent biocompatibility. Using faulty materials or a wrong combination can lead to contamination or incompatibility and, in turn, toxic responses.
A medical device manufacturer should provide adequate information concerning how to use it. Not providing potential users with information on how they should wear a device to avoid pressuring it on the body or things to avoid can lead to injuries.
Who is liable for your injuries?
Is the device’s manufacturer or the physician who administered it liable for a patient’s injuries?
If your injury is due to a defect on the device, the manufacturer or designer may be held liable. However, if a medical provider’s mistake causes the injury, perhaps they failed to provide a warning or made false claims regarding the device, they may be liable.
Other parties that may be responsible are the device’s distributor and the facility that approved the device.
If you are injured by a medical device or you lose a loved one, you could get legal help to protect your/their rights.