Doctors, nurses and other medical professionals frequently use medical devices to improve the lives of their patients. They may perform lifesaving surgery to insert a stent, or they simply may be using a device to check a patient’s vital signs.
Therefore, it’s extremely important that these medical devices are regularly monitored, and quickly repaired or recalled if problems do arise.
How the FDA Protects Americans from Defective Medical Devices
When a medical device needs to be corrected or removed from the market, the U.S. Food and Drug Administration (FDA) has established a protocol under 21 CFR 806 (Medical Device Correction and Removals) to define and guide what happens when a manufacturer needs to correct or remove a defective medical device.
Depending the severity of the problem there are a few different actions that the manufacturer can take to correct or remove a defective medical device from the market.
Recalls
First, there are recalls. A recall happens when a device needs to be corrected or removed because it is in violation of the laws that the FDA administers. A recall is usually voluntary. A recalled medical device may pose a risk of injury or even death. Recalls must be reported to and monitored by the FDA.
Withdrawals
When a company removes or corrects a medical device for a very minor violation that’s not subject to legal action by the FDA or when there was no violation, it is considered market withdrawal. Examples of market withdrawal are routine maintenance, minor adjustments or repairs or stock rotation. Medical devices that are subject to market withdrawals pose no risk to a person’s health.
Recovery
Stock recovery happens when the medical device that needs to be corrected or removed has not yet been marketed or left control of the device manufacturer.
The FDA tries to ensure that the consumer is protected from defective medical devices. Unfortunately, there are still defective medical devices out there.
If you or a loved one has been harmed by a defective medical device, contact the compassionate and experienced personal injury attorneys at Gilreath & Associates.