In order for a medical device to exist in today’s medical and pharmaceutical market, it must be approved by the FDA. The process of approval is referred to as the FDA 510k clearance process. This can be carried out by the FDA themselves, or by an accredited third party person such as http://www.fdathirdpartyreview.com.
Achieving approval for a medical device via an Accredited Person is a lot less time consuming and often proven to be the more efficient and effective route. This is because once your submission has been forward to the FDA by a third party review program, the FDA will finalise the results within a strict deadline of within 30 days. But just how safe are modern day medical devices?
Is the FDA Always right?
It is up to the FDA to ensure that approved medical devices are deemed both safe and effective. However, sometimes this can go horribly wrong. According to Healthable, this occurred when the FDA approved the use of a permanent birth control device for women. It passed the initial test and was approved by the FDA but following its release, the device was actually held responsible for a range of associated health problems. Once this was discovered, the FDA gave the device a black box warning. This is when the FDA deems a product completely unsafe to use. It is worth taking into consideration the fact that instances such as this are incredibly rare.
What Medical Devices Are Unsafe?
There are a few common types of medical devices that often fail in their safety claims. Nurses from around the world often report problems with certain medical devices to the FDA, who are then required to investigate the problem. Such devices that have led to the user experiencing adverse events include the likes of hip and knee implants and even catheters.
Importance of Patient Safety
Sometimes, although a medical device has been approved by the FDA, problems and danger to patients has occurred. This is usually due to the fact that certain dosage’s and side effects have been overlooked during the approval process. A well-known example of such an occurrence revolves around the marketing of certain antidepressants to young people. It has been proved that such drugs can be harmful to their health, even increasing depression and provoking unsettling thoughts that could encourage dangerous actions such as suicide. It is important to carry out research and seek medical advice from your doctor before engaging with certain medical devices and drugs. It is also important to report any worries you may have regarding particular devices that you may encounter in the future.