ENSURE MEDICAL DEVICE SAFETY THROUGH BIOLOGICAL, CHEMICAL AND PHYSICAL TESTING
A medical device or material used in a medical device that comes in direct contact with a patient must be able to perform its intended function without inducing significant rejection or adverse reaction in a patient. The degradation or leaching of chemicals and other device materials may lead to deleterious effects on a patient, and potential adverse reactions can range from the rejection of the device by the body to longer term reproductive or developmental effects.
For these reasons, medical devices and materials are typically subject to a range of biological, physical and chemical tests to ensure that the benefits offered by the device exceed any potential risks to a patient as a result of the device itself or the materials used in the device.
Physical evaluations generally involve tests for the physical strength of a device (such as tensile strength and elongation) and physical performance characteristics (including force at break and resistance to leakage), as well as tests for product shelf-life.
Biological evaluations address a device’s bio-compatibility, and can also include biological performance tests such as resistance to bacteriophage, impermeability to microorganisms and bacterial filtration efficiency.
The chemical analysis of a medical device generally includes a wide range of tests and product evaluations. Testing can include tests for chemical compositions as well as tests to determine the potential for extractable or leachable materials or residues that are not intended to be part of the chemical composition but are present as a result of manufacturing processes. Additional chemical tests can include performance requirements, such as resistance to corrosion, permeation rates for chemicals, and anticipated shelf-life studies.