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IPC in Practice<\/span><\/span><\/a><\/div>In this article you’ll learn When selecting reprocessing solutions for your medical device, it is important to choose products that are both compatible and effective.<\/p>\n Material compatibility ensures that the disinfectant and the device work safely together. If a disinfectant is not compatible with the device materials, it can cause damage ranging from cosmetic changes, such as discolouration, to surface alterations like stickiness, or even material degradation that may impact device performance and patient safety.<\/p>\n Cosmetic changes<\/p> such as discolouration<\/p><\/div> Surface alterations<\/p> like stickiness<\/p><\/div> Material degradation<\/p> that may impact device performance and patient safety<\/p><\/div><\/div><\/div>\n At the same time, it is essential to use products that provide the required level of cleaning and disinfection for the intended application, ensuring the device is safe for patient use.<\/p>\n Let’s look at these two requirements in more detail.<\/p> Material compatibility refers to how different materials interact with specific chemicals. Depending primarily on the composition and physical properties of the material, other factors include the mode of action, concentration and exposure conditions of the disinfectant.<\/p> Overall, material compatibility needs to reflect a medical device’s individual material’s ability to withstand exposure to cleaning agents and disinfectants without compromising its functionality.<\/p><\/div> Good to know<\/p> This study involves submerging the device or material in the test solution for an extended period. The approach is often considered the gold standard, as it represents a worst-case exposure scenario. However, it may not always reflect actual clinical use conditions and is therefore not always the most appropriate method.<\/p><\/div><\/details> This study is designed to replicate real-life use of disinfectant wipes. They allow for the evaluation of both material compatibility and the impact of the mechanical action involved in wiping.<\/p><\/div><\/details> This study involves wrapping a material sample or device in a wipe impregnated with the disinfectant chemistry. It is particularly useful for wipe-based products or when application by wiping is intended but performing a full wiping study is not practical.<\/p><\/div><\/details><\/div>\n<\/span> Efficacy validation refers to the evidence demonstrating that a reusable medical device can be safely reprocessed using specific products, which include cleaning agents and\/or disinfectants, resulting in the device being ready for safe use.<\/p>\n Disinfectant manufacturers are responsible for performing testing in accordance with relevant standards.<\/p> Testing needs to demonstrate both the efficacy of their products and their material compatibility to support any microbiological claims.<\/p><\/div> Medical device manufacturers are also responsible for conducting efficacy validation on their specific devices.<\/p> This includes verifying that selected reprocessing products and methods are effective for the device, as well as providing clear, validated instructions to end users to ensure safe use for subsequent patients.<\/p><\/div><\/div><\/div>\n Efficacy validation testing is governed by ISO 17664:2021, \u201cProcessing of health care products \u2014 Information to be provided by the medical device manufacturer for the processing of medical devices.\u201d<\/p> This standard specifies that medical device manufacturers are responsible for validating at least one automated and one manual reprocessing method for their reusable devices.<\/p><\/div><\/div>\n These validations are typically performed through simulated-use testing. The validated processes are then defined as the recommended reprocessing methods and included in the device’s instructions for use.<\/p>\n This testing method is designed to replicate a real-life reprocessing cycle.<\/p> In some cases, regulatory standards define the test parameters. Where no harmonised specifications or standards exist, appropriate parameters must be established to ensure a scientifically sound validation of the reprocessing process.<\/p> All disinfectant chemistries interact with materials to some extent. When the properties of the material and the disinfectant are well aligned, the material will remain stable over repeated reprocessing cycles.<\/p> However, incompatibility can arise when certain chemistries react adversely with the material. For example:<\/p>\n Some polymers<\/span>+<\/span>Alcohols<\/span><\/p> Some polymers may be sensitive to alcohols, leading to stress cracking or embrittlement<\/strong>.<\/p><\/div> Low-grade metals<\/span>+<\/span>Oxidising agents<\/span><\/p> Low-grade metals may be susceptible to oxidising agents, which can cause discolouration or corrosion<\/strong>.<\/p><\/div><\/div> Other factors that can influence compatibility include contact time, temperature, frequency of exposure and the method of application.<\/p><\/div>\n For this reason, material compatibility must be assessed and validated under realistic use conditions to ensure that the medical device maintains its functional performance, structural integrity and safety throughout its intended lifetime.<\/p>\n<\/span> Tristel’s proprietary chlorine dioxide (ClO2<\/sub>) is generated through the reaction of sodium chlorite with citric acid and is effective against a broad range of pathogens at low concentrations. ClO2<\/sub> has a lower oxidation potential compared to other commonly used disinfectants such as peracetic acid, hydrogen peroxide and aqueous chlorine, making it less aggressive toward materials.<\/p>\n Lower<\/p> ClO2<\/sub><\/p> Chlorine dioxide<\/p><\/div> Higher<\/p> As a result, chlorine dioxide generally demonstrates good compatibility with a wide range of materials, including many plastics, rubbers and adhesives commonly used in medical devices.<\/p>\n![\"\"](\"https:\/\/tristel.com\/wp-content\/uploads\/2026\/09\/Tristel-Academy-Linkedin-Post-Templates-105-x-105-mm-1.png\")
<\/span><\/p>What is material compatibility?<\/h2>\n
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<\/figure><\/div>\nThe testing methodology for material compatibility depends on:<\/h3>
Typical methods include:<\/h3>
1<\/span>Immersion studies<\/span>+<\/span><\/summary>
2<\/span>Wiping studies<\/span>+<\/span><\/summary>
3<\/span>Wrapping (wet-patch) studies<\/span>+<\/span><\/summary>
What is efficacy validation?<\/h2>\n
Disinfectant manufacturers<\/h3>
Medical device manufacturers<\/h3>
![\"Healthcare](\"https:\/\/tristel.com\/wp-content\/uploads\/2026\/06\/Untitled-design-2.png\")
<\/figure>\nISO 17664:2021<\/h3>
Simulated-use testing<\/h3>
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<\/figure>\nWhen defining these parameters, the following aspects should be considered:<\/h3>
What makes chemistry compatible with a medical device?<\/h2>\n
The power of chlorine dioxide<\/h2>\n
Oxidation potential<\/h3>