Defective Medical Devices – FAQs

Q. Who regulates medical devices?

In the United States, the Center for Devices and Radiological Health (CDRH), which is part of the Food and Drug Administration (FDA), is in charge of regulating and overseeing medical devices.

Q. What are defective medical devices?

Defective medical devices are devices that fail in the course of normal use and cause personal injury or even death. Defective medical devices can be categorized into three groups: defects in design, manufacturing and implantation. Design relates to actual failure of the device in normal use, for example, due to lack of testing. Manufacturing relates to defects when the product is manufactured, such as assembly problems and contamination. Implantation relates to the actual surgery, in which devices are used inappropriately, improperly implanted or allergic reactions to the device by the patient occur.

Q. How are defective medical devices pinpointed?

In many cases, patients directly contact the FDA to report problems with medical devices. Also, manufacturers, hospitals and healthcare providers are legally bound to report any problems with medical devices directly to the FDA. In fact, 82 per cent of all defective medical devices are discovered by healthcare professionals.