The U.S. Food and Drug Administration (FDA) recently announced the recall of the CareFusion AVEA Ventilator from the market. The AVEA ventilator is used in hospitals and healthcare centers for the continuous breathing support for infants, children, and adults.
CareFusion issued a field safety notice this past May to healthcare facilities alerting affected facilities that the device has a risk of failure due to a faulty part. The AVEA ventilator has a fuse that is prone to failure, which can cause the device to lose power. The company asked for the faulty devices to be promptly returned to prevent any adverse events.
Defective ventilators can be deadly for patients who rely on the devices to provide them with oxygen. Within minutes of a ventilator losing power, patients can suffer severe and permanent brain damage and even death.
Recognizing the threat these defective devices pose to patients, last week, the FDA issued a Class I recall, its most serious type of recall.
The recall comes at a pivotal time for medical devices. The FDA just announced a reduction in fees for new medical device applications. The reduction is intended to inspire new medical device manufacturers to produce more life-saving medical devices.
In addition to the reduction of fees, the FDA is floating a draft guidance regarding 3D printed medical devices. The FDA is asking for comments from experts in both the 3D printing and medical device industries to perfect regulations before they are set in stone.
The AVEA ventilator is not the only device that has been shown to be dangerous to patients. The FDA has twice warned of the risks of device failure for Inferior Vena Cava filters (IVC filters) after hundreds of reports of adverse events. Devices like Essure contraception and power morcellators have received FDA black box warnings after nearly ten years on the market.
The rising number of defective devices leaves many critics wondering why the FDA is focusing on increasing the number of new medical devices rather than policing devices that are already on the market.