According to the FDA (Food and Drug Administration), a medical device is “an instrument apparatus, machine, contrivance, implant, in vitro reagent, or other similar or related articles” that are intended for use in diagnosing and treating diseases and other conditions. Because medical devices are used on people who may be physically vulnerable, it's imperative that they're properly tested. Click To Tweet
Medical Device Testing
Medical device testing is an important step in the development of all medical devices, and the FDA is responsible for ensuring the safety, quality, and effectiveness of the device. Not only do these devices need to be technically dependent, but the FDA takes biological factors into consideration, as well. Here are a few reasons medical device testing is so important, as well as a few of the tests performed before a device can be used.
The Functionality of the Device
Medical devices range from tongue depressors all the way through general purpose lab equipment to antibody technology. Functionality testing determines that the product does what it claims. This prevents faulty devices from being put on the market and possibly causing harm or unneeded expenditure.
Bioburden testing is needed in order to stay compliant with the FDA’s regulations of medical devices. Bioburden testing detects the number of viable microorganisms such as bacteria, yeasts, and molds, that are on a medical device prior to sterilization. Bioburden testing is required and comes prior to sterilization tests.
Sterility Testing & Validation
Sterility testing and validation are required steps for all medical devices. There are a variety of sterility tests, such as direct transfer testing, product flush sterility, USP sterility tests, among others. Many times, viable microorganisms might remain on the medical device, where there is an ideal environment to grow and flourish. It is important to have these tests performed in order to keep from infectious diseases from spreading.
While environmental monitoring is not necessarily performed directly on medical devices, it is a large part of eliminating contamination factors. Without a proper clean room, devices are more apt to airborne contamination and thus, spread disease and illness. Environmental monitoring helps eliminate these contaminants which are generated by people, processes, and the facility. These need to be continuously removed from the air and is done so through air sampling, surface sampling, humidity and temperature control, microorganism identification, as well as other methods.
Medical Device Safety
Medical devices safety is crucial to stopping issues with the spread of infectious disease and illness. The FDA monitors and reports adverse reactions and other problems medical devices and then alerts medical professionals, as well as the public. Proper medical device testing is vital to health professionals and those they use them on.
To learn more about why it is important to have your medical devices tested, and how to get started, Contact Us.