Reusable Device Testing for Medical Devices

UPHOLD PATIENT SAFETY WITH REUSABLE DEVICE

In the healthcare sector, a variety of medical devices are indispensable in providing quality patient care. Among these, reusable medical devices stand out for their sustainability and cost-efficiency, making them vital in numerous medical procedures. However, their repeated use introduces a crucial challenge – maintaining consistent safety and performance. Addressing this concern requires an in-depth evaluation process, known as reusable device testing.

WHAT IS REUSABLE DEVICE TESTING FOR MEDICAL DEVICES?

Reusable device testing refers to the process of testing and validating reusable medical devices to ensure their safety, effectiveness, and performance. It 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.

IMPORTANCE OF REUSABLE DEVICE TESTING 

Reusable medical devices play a critical role in patient care, providing cost-effective and sustainable solutions for healthcare providers. Examples of reusable devices include surgical instruments, endoscopes, and respiratory devices.

However, given the potential for contamination and the risk of infection, reusable devices must undergo rigorous testing and validation to ensure their safety and effectiveness. By implementing reusable medical device testing and validation, manufacturers can ensure regulatory compliance, mitigate patient harm, and maintain their reputation in the industry.

HOW IS REUSABLE DEVICE TESTING PERFORMED FOR MEDICAL DEVICES

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

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 that are included in reusable device testing include:

1. Cleaning validation: Ensures that the device can be adequately cleaned between uses to prevent the buildup of contaminants.
2. Disinfection validation: Ensures that the device can be adequately disinfected between uses to reduce the defined number of viable organisms.
3. Sterilisation and drying validation: Ensure that the device can be effectively sterilised between uses to render the device free from microorganisms.
4. Life-cycle testing: Subjecting the device to the number of processing cycles that the device can be subjected to and still remain safe and functional for its intended use.
5. Functionality testing: Ensures that the device meets the specified performance requirements after repeated reprocessing of the device.
6. Human factors testing: Ensures that the device label and instructions for use are consistently adhered to during each use.
7. 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. Takes into consideration the life cycle of the device to ensure that the device materials are safe after repeated reprocessing.

BENEFITS OF REUSABLE DEVICE TESTING

Not only that testing for reusable devices is required from regulatory point of view, this also offers of several benefits, including enhanced patient safety, adherence to regulations, and overall efficiency in the medical sector. Take a look at the advantages in detail below: 

1. Ensuring patient safety: Reusable medical device validation helps to 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 for preventing the spread of infections in healthcare settings. Reusable device testing helps to 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 to identify any issues with device performance related to reprocessing, allowing 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, it becomes possible that these devices can 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 to ensure that these devices are safe and effective for repeated use, promoting sustainability.

HOW CAN WE HELP YOU?

TÜV SÜD is a trusted provider of reusable device testing services for medical devices, 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 possess the technical, clinical, and regulatory expertise required to thoroughly evaluate reusable device test results of medical devices for suitability across global markets. We provide end-to-end assistance with efficient use of resources, while ensuring project timelines are met with predictability and diligence, so you can have confidence in the safety and efficacy of your products.

Contact us for reusable device testing services

OUR SERVICES AT A GLANCE

TÜV SÜD provides the following reusable device testing services for medical devices to help manufacturers meet requirements of the International Organisation for Standardisation (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

• FDA Guidance

why choose us 

TÜV SÜD is globally recognised for its quality and safety as a third party one-stop testing provider. We offer a suite of testing services required for medical devices 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. 

At TÜV SÜD, our global network of medical health and services professionals worldwide is recognised as authorities in their fields. Their collective expertise makes TÜV SÜD a trusted partner of choice for manufacturers seeking accreditations in line with medical device regulations.