Importance of Microbiological Testing for Medical Devices
Microbiological testing of medical devices is an indispensable practice that underpins patient safety and healthcare quality. By subjecting devices to rigorous microbiological testing, we help identify potential contamination risks and ensure the devices' suitability for clinical use. This includes assessing the presence of harmful microorganisms on device surfaces, in packaging, and within the device itself, as well as validating cleaning and disinfection methods for reusable devices to guarantee microbial contamination can be eliminated between uses.
We also assess the antimicrobial surface properties of medical devices and healthcare materials, such as examination gloves, hospital textiles or other antimicrobial substrates, and offer bespoke assays for testing wound care products on representative organisms or biofilms.
Identifying and mitigating these microbial threats is essential to prevent infections, allergic reactions, and other adverse outcomes in patients. We provide manufacturers and healthcare professionals with crucial insights into their products’ safety, enabling informed decisions about device design, materials, and usage protocols. This proactive approach not only enhances patient well-being but also upholds the reputation and reliability of medical device manufacturers in the eyes of both regulators and the healthcare community.
Medical Device Validation Services
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Thorough Cleaning and Disinfection
We recognise that reusable medical devices demand uncompromised cleanliness. Whether assessing the elimination of bacteria, bloodborne viruses, or matrices of organic soils, we ensure the ability of your devices to be cleaned and disinfected. Through our rigorous process, we remove potential contaminants, safeguarding the integrity of your devices and enhancing user safety.
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Validation of Antimicrobial Membranes and Seals
We understand the critical role that antimicrobial membranes and seals play in preventing microbial ingress into your medical devices. Our comprehensive validation processes scrutinise every aspect of these components, confirming their effectiveness in maintaining a barrier against pathogens. With our expertise, your devices are fortified with the highest level of protection.
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Testing Antimicrobial Properties
Your medical gloves and treated materials must offer a robust defence against microbial threats. Our advanced testing methodologies evaluate the antimicrobial properties of treated materials, guaranteeing their ability to inhibit the growth of pathogens effectively. This validation empowers you to provide healthcare professionals with products that contribute to a safer environment.
With our dedicated support, we have successfully aided many reusable medical device manufacturers with their FDA product registrations by validating the cleaning of their products to industry standards. Our protocols are robust to ensure compliance with international standards while being flexible enough to be adapted to the specific application of your device.
Below is a non-exhaustive list of the services we offer to aid with qualification of medical devices and healthcare products. If there is a service you are interested in which is not listed here, please contact us to discuss.
Medical Devices and Healthcare Product Validation |
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Standard |
Test |
| ANSI/AAMI ST98:2022 | Medical device cleaning validation |
| ISO 14937 | Sterilisation of healthcare products and medical devices |
| ASTM D7907 | Antimicrobial medical gloves |
| AATCC TM100 | Antibacterial textiles |
| ISO 20743 | Antibacterial textiles |
| ISO 13629 | Antifungal textiles |
| ISO 18184 | Antiviral textiles |
| ASTM E3383 | Antimicrobial barrier properties of wound dressings |