Reusable device testing for medical devices

Reusable medical devices such as surgical instruments, endoscopes and respiratory devices play a critical role in patient care. However, their repeated use introduces the potential for contamination and for infection. This creates a crucial challenge in maintaining their consistent safety and performance. Addressing this concern requires that experts from a trusted third-party body such as TÜV SÜD perform an in-depth evaluation, known as reusable device testing. 

Reusable device testing is the process of testing and validating reusable medical devices to ensure their safety, effectiveness and performance. This includes, among other things, the validation of instructions for use (IFU) in terms of cleaning, disinfection and sterilisation. Repeated cycling of the reprocessing instructions is also considered to address the lifecycle of the medical device. 

Testing for reusable devices is required from a regulatory point of view. In addition to that, there are several other benefits such as enhanced patient safety, adherence to regulations, and overall efficiency in the medical sector. Here are the benefits in detail: 

1. Ensuring patient safety – Reusable medical device validation helps ensure that devices are safe for patients to use, reducing the risk of harm or injury. 

2. Improving infection control – Proper cleaning and sterilisation of reusable devices is critical to prevent the spread of infections in healthcare settings. Reusable device testing helps ensure that devices can be effectively cleaned and sterilised between uses. 

3. Meeting regulatory requirements – In most regulatory markets, reusable device testing is a mandatory requirement to comply with the local regulations (e.g. MDR). 

4. Enhancing device performance – Reusable device testing may help identify any issues with device performance related to reprocessing. This allows manufacturers to make improvements and enhance device functionality. 

5. Cost-effectiveness – Reusable medical devices are often more cost-effective than single-use devices. By conducting proper testing and cleaning validation for medical devices, we allow these devices to be safely and effectively used multiple times, reducing overall costs. 

6. Sustainability – Reusable medical devices are also more sustainable than single-use devices, as they generate less waste. Proper testing and validation can help ensure that these devices are safe and effective for repeated use, promoting sustainability. 

TÜV SÜD is globally recognised for its quality and safety as a third-party one-stop testing provider. We are a trusted provider of reusable medical device testing services, offering a comprehensive range of solutions required by relevant regulatory frameworks worldwide. With state-of-the-art laboratories, our complete reusable device testing panel ensures high standards of data and quality reporting to meet the testing needs of manufacturers of all sizes. 

Our team of medical doctors, engineers, and toxicologists are recognised as experts in their fields. They possess the technical, clinical, and regulatory expertise required to thoroughly evaluate reusable device test results of medical devices for suitability across global markets. Their collective expertise makes TÜV SÜD a trusted partner of choice for medical device manufacturers. 

We provide assistance with efficient use of resources, while ensuring that project timelines are met with predictability and diligence, so that you can have confidence in the safety and efficacy of your products. 

We offer a suite of reusable medical device testing services and help manufacturers and suppliers independently meet global regulatory standards. Beyond cleaning validation for reusable medical devices, you can also engage us for sterility assurance testing and biocompatibility testing for medical devices.

Our reusable medical device testing services help manufacturers meet requirements of the International Organisation for Standardization (ISO), U.S. Food and Drug Administration (FDA), Association for the Advancement of Medical Instrumentation (AAMI), and American Society for Testing and Materials (ASTM). 

The list of standards that TÜV SÜD tests against includes: 

• ISO 17664-1 
• ISO 15883 series 
• ISO 11607 
• EN 285 
• AAMI TIR12 
• AAMI ST77 
• AAMI ST79 
• AAMI ST98 
• ASTM F3208 
• The FDA Guidance for Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling 

A typical process of performing reusable device testing is as follows. 

First, manufacturers of reusable devices provide detailed instructions for use (IFU) that include information on the recommended cleaning and sterilisation procedures. The IFU must be clear, comprehensible and concise. It must be available in the languages accepted in the Member States where the device is expected to be sold. 

Following that, reusable device testing involves a range of validation procedures, including cleaning, disinfection and/or sterilisation validation, mechanical testing, and biocompatibility testing. Manufacturers must follow the appropriate standards and regional guidance requiring suitable instructions for use on the medical device label that has been thoroughly validated. 

These tests can vary depending on the type of medical device being manufactured and its intended use. Some of the common tests included in reusable device testing are: 

• Cleaning validation – Ensures that the device can be adequately cleaned between uses to prevent the buildup of contaminants. 
• Disinfection validation – Ensures that the device can be adequately disinfected between uses to reduce the defined number of viable organisms. 
• Sterilisation and drying validation – Ensures that the device can be effectively sterilised between uses to render the device free from microorganisms. 
• Life-cycle testing – Subjects the device to the number of processing cycles it can be subjected to and remain safe and functional for its intended use. 
• Functionality testing – Ensures that the device meets the specified performance requirements after repeated reprocessing of the device. 
• Human factors testing – Ensures that the device label and instructions for use are consistently adhered to during each use. 
• Biocompatibility testing – Ensures that the device materials and any remaining residues from the reusable medical device reprocessing validation are not toxic or harmful to the human body. Considers the device's life cycle to ensure that the device materials are safe after repeated reprocessing.