Medical Device Material Compatibility Testing
Medical devices are subjected to various chemical agents when they are put through cleaning, disinfection and sterilisation processes. Compatibility of these chemicals with the device materials needs to be assessed to ensure the the devices can safely be used.
Incompatibility of the processes outlined in a medical device IFU (instructions for use) can lead to physical degradation of the materials which result in performance failures. Chemical residues and build-up become a higher risk when devices have cracks and crevices caused by degradation, which would impact the biocompatibility of the device.
Manufacturers of disinfectants, cleaning agents and decontamination technologies, as well as medical device manufacturers, both need to understand how their products interact and whether they are compatible.
Through our Material Compatibility Testing service, we develop custom testing plans that simulate real-world exposure of chemicals to material surfaces and medical device products; this can be done by replicating the reprocessing instructions of a medical device or by assessing how disinfectants/cleaning agents impact samples of materials through repeated exposure. We measure the effects of your products on a wide variety of materials, helping you to determine the damages that can happen overtime.
Using our team’s expertise in material science, we developed a series of in-house tests based on industry standards to properly analyse test item materials at both sample and product level during the Initial and Final Assessments.
Results from these tests provide important qualitative and quantitative data for assessing potential structural and surface damage at a visual, physical, and chemical level.
Frequently Asked Questions
What is material compatibility testing and why is it important?
Material compatibility testing is used to determine whether the right materials are being used with the right chemicals. It allows disinfectant manufacturers understand what surfaces and materials their products are compatible with and avoid costly destruction of medical equipment. Material compatibility testing is also helpful to medical device manufacturers in selecting what materials to use for their devices and ensuring those materials can withstand the cleaning, disinfection and sterilisation processes. Material compatibility testing is important in ensuring healthcare products and medical devices are safe to use and funciton as intended.
Is medical device material compatibility a regulatory requirement?
Yes. Part of assessing the safety of a medical device is investigating the materials manufacturers use for their device are appropriate for its’ intended use, to ensure optimal functionality, efficiency, compatibility, and reliability. The information provided in a technical file needs to confirm compliance with the MDR and having data on how processes within medical device IFUs impact the materials means claims, such as device lifespan, can be supported. FDA labelling regulations also require manufacturers to state adequate information necessary for the protection of users and patients – part of that is ensuring processes and chemicals do not degrade device materials.
What are common indicators of incompatibility?
Physical degradation such as the appearance of cracks, scratches and crazes are common in plastic materials. Discolouration and corrosion are common changes observed with certain metals, that indicate chemicals are incompatible with the material.
What are the causes of incompatibility?
Failures can be caused by chemicals used with the devices and how they interact with the material surface, as well as other environmental stresses encountered when used in the real-world. Materials will be affected by temperature, humidity and pressure so these need to be considered when developing reprocessing instructions, as well as when thinking about transport/distribution and storage of devices post manufacturing.
Is visual analysis enough to prove material compatibility?
Visual assessments are required as a minimum in order to highlight physical degradation such as cracks or discolouration. Microscopic analysis is also useful when there are areas or devices that are smaller and require extra attention. Quantitative measurements provide extra data to support what can be observed visually and answer questions as to why those physical changes are occuring. Additionally, visual assessments do not provide useful information when assessing the impact on mechanical and chemical properties, for which quantitative or semi/quantitative tests are needed.