Medical devices are modern-day miracles. There is so much innovation that allows you to live a healthy life, even if you have a disability or disease. Not only are there treatments and medications being developed every year to address serious illnesses, but devices are also being built and tested to assist the sick to live normal lives. Assistive medical devices need to be tested to ensure that they meet quality control standards and that they are safe to use. Here are three reasons medical devices should be tested before going on the market.
Medical device testing is a way to perform a risk assessment
Medical device testing allows inventors to learn if their device poses risks when being used. Materials used to make the device may break down with regular use or even pose the threat of triggering a common allergic reaction. Medical device testing reveals the probable problems that could pop up with general use of the device. This allows the inventor to make important changes for safety and usability purposes before putting their invention on the market. Medical device testing can also save the inventor a lot of money in the long run, especially if lawsuits were to pop up in relation to safety risks with the medical device after it goes on the market.
Endotoxin testing reveals if there are biological safety concerns.
Medical devices are used in close conjunction with the body. Someone who is already sick probably does not have the most robust immune system. Therefore, it is important to test for endotoxins that can trigger fever, septic shock, or toxic shock syndrome. Tests are carried out in a microbiology lab like the ones at Nelson Laboratories to surmise if there are endotoxic bacteria, which often originates in the gastrointestinal tract, that can trigger such harmful reactions when using the medical device. This helps the device to meet strict Food and Drug Administration standards.
Sterility testing shows how easy it is for consumers to clean the device.
Many medical devices need to be cleaned regularly in order for them to be safe to use, especially because they are used so close to the body of a sick person. Medical device testing shows how easy it is to sterilize a medical device in a home setting. Sterilizing medical devices lowers the risk of infectious bacteria colonizing on the medical device. Since medical devices come in a variety of shapes and sizes, there is no "one-size fits all" method for sterilization; however, testing shows if the device is easy and safe to clean at home