Are medical devices safe?
In general, medical devices are safe if they meet all the following conditions:
- Approved by the FDA (when required by law)
- Manufactured following all safety-related rules, regulations, and best practices
- Used properly in accordance with their directions
Unfortunately, some products make it onto the market without meeting the proper conditions. Manufacturers may make mistakes during production, or they may deceive regulators and consumers about the safety of their devices. In addition, inaccurate directions, warnings, or other label information may be printed on the device, causing individuals to use it incorrectly or in an unsafe manner.
In the best cases, defective and dangerous devices will be recalled and either removed from the marketplace or replaced with safe versions of the device. However, sometimes unsafe devices can sometimes lead to injuries or even death. In such cases, consumers may have legal rights that they can pursue to receive compensation for the injuries caused to them or their loved ones.
How can I report an unsafe medical device?
The FDA requires manufacturers, importers, and device user facilities (such as hospitals and nursing homes) to report malfunctions of medical devices, whether or not they cause injury or death. This sort of postmarket surveillance allows the FDA to become aware of potential problems with devices and possibly issue a recall if it becomes apparent that the device model has a serious defect.
Individuals may also report unsafe medical devices to the FDA through the MedWatch Online Voluntary Reporting Form by submitting a Medical Device Report (MDR). Anyone can report an unsafe medical device, including patients, caregivers, healthcare professionals, and general consumers.
What if I’ve been injured by a medical device?
If you or a loved one has been hurt while using a medical device, or experienced a severe side effect from an implanted medical device, you may be able to seek compensation to help pay for treatments and other costs related to your injury. For more information, see the Legal section of our website.