Material and device compatibility is vital to ensure that your disinfection method and medical device work harmoniously together. Incompatibility can cause chemical damage which can vary from cosmetic only such as discoloration, to tactile changes such as tackiness, to material deterioration which can affect the device functionality and, most importantly, patient safety.
When choosing your cleaning and disinfection method, compatibility should be front of mind.
What is it?
Material compatibility is the medical device individual material’s ability to withstand exposure to disinfectants without compromising functionality.
Device compatibility is the medical device’s ability withstand exposure to disinfectants without compromising functionality. One device can be made up of multiple materials.
Both are tested by applying a disinfectant repeatedly to a surface material or finished medical device, it may replicate the real-life use of the product or represent a worst-case scenario.
The testing methodology for material compatibility depends on:
- How the disinfectant is used.
- The number of test cycles to be performed.
- The medical device manufacturer requirements on the condition of the device after testing.
Methods will typically include:
Immersion studies: involve having the device or material immersed in the test solution for a long period of time. This method is generally accepted as the golden standard, however it is always not always the most appropriate.
Wiping studies: replicate the real-life use of wipe disinfectant and allows for an evaluation of both material compatibility and effect of the mechanical action of wiping.
Wrapping studies or wet-patch testing: performed by wrapping a material sample or device in a wipe impregnated with the chemistry. This method is effective for chemistries that are either in wipe format or that are applied by wiping when it is not feasible to perform a wiping study. This can be due to the high number of disinfection cycles that must be completed.
The testing methodology for device compatibility is:
- Performed by simulated-use testing.
- Regulated by ISO EN 17664:2021 “Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices”.
Simulate-use testing methodology aims to replicate a real-life disinfection cycle. So, a medical device is inoculated with a representative microorganism and representative organic soiling, before the decontamination cycle is performed. The device is then checked against certain markers, like residual protein for a cleaning efficacy validation or residual contamination of microorganisms.
Some regulations will have set the parameters for the test. If no uniform specifications or standards are available, parameters for a reasonable validation of the reprocessing process must be defined. In doing so the:
- Field of application of the medical device should be considered.
- Actual mode of application of the disinfectant onto a real medical device should be considered as well.
- Selection of the areas to be soiled should take place considering design-specific peculiarities of the medical device, including worst-case or challenging areas like ridges.
All chemistries will affect materials in one way or another. Compatibility depends primarily on the chemical composition of a material and the mode of action of the disinfectant. If both are in tune with each other, the material remains stable. Some materials are sensitive to alcohols, some to oxidizers, whereas others are relatively chemically resistant to most disinfectants.
The Power of Chlorine Dioxide
Tristel’s proprietary chlorine dioxide is generated by reacting sodium chlorite with citric acid, effective against pathogens at low concentrations. Additionally, has an oxidation potential which is lower than that of peracetic acid, hydrogen peroxide and aqueous chorine – making ClO2 less corrosive. Resulting in good compatibility with most plastics, many rubbers and adhesives found in materials of medical devices.
Unsure if your medical device is compatible with Tristel products? Use our device compatibility tracker! Simply enter the make and model to find out.
