Reusable Medical Device Disinfection Validation: Everything You Need to Know
Article Summary
The importance of validating cleaning, disinfection, and sterilisation instructions for reusable medical devices and highlights of how ISO 17664 compliance protects patients and supports manufacturers in meeting regulatory requirements.Article Contents
Why is Disinfection Validation Essential for Reusable Medical Devices?
In every healthcare setting, several medical devices are utilised in the care, treatment, monitoring, and diagnosis of patients. These reusable medical devices may be used multiple times and for multiple patients. Ensuring they are appropriately cleaned and disinfected is paramount to preventing the spread of infectious organisms such as MRSA. Manufacturers of the reusable medical devices are required to determine an appropriate method of cleaning and disinfection for the end user to follow that successfully reduces the risk of infectious organisms remaining on the device. The method is provided in the Instructions for Use (IFU) and assures the user that, if followed correctly, the device will not pose an infection risk to their patients or themselves.Â
How Does Test Labs Validate Cleaning, Disinfection, and Sterilisation Processes?
At Test Labs, we have a lot of experience validating medical device cleaning, disinfection, and sterilisation instructions as detailed in the IFU. We have comparable equipment to NHS hospitals to enable methods to be followed identically by the likely end user, including specialised washer–disinfectors and autoclaves. Our trained staff use specific soils that mimic the likely contamination during use and employ aseptic techniques to prevent interference from outside variables while following the manufacturer’s instructions. We can provide guidance using extensive experience and advice regarding more advanced cleaning methods such as moist heat, low-temperature hydrogen peroxide, or other reprocessing technologies.Â
What Does ISO 17664 Require from Manufacturers?
These testing services ensure the disinfection, cleaning, and potential sterilisation instructions outlined in the Medical Device Instructions for Use (IFU) are fully validated, as required by ISO 17664. This international standard states that all medical device manufacturers are responsible for providing validated instructions for use when reprocessing of the medical device is intended. These instructions are required to be fully validated to ensure the safety of the device. At Test Labs, we have a wealth of experience with both manual and automated (washer-disinfector) processes to meet the stringent ISO 17664 standard.Â
How Do Manufacturers Demonstrate Compliance with Medical Device Regulations?
As a manufacturer you need to demonstrate that your medical device meets the requirements in the Medical Device Regulations by carrying out a conformity assessment. Each device has its own unique qualities, and the assessment route depends on the classification of the medical device. Our team are here from the start to discuss what applies to your device, what the specific needs of your device are to ensure effective cleaning and disinfection, and provide guidance on the most appropriate method.Â
How Should a Test Method Be Designed for Effective Risk Analysis?
A test method should follow good logic, planning, and start with a risk analysis. Once the failure modes and risks associated with a medical device have been identified, testing plans and protocols can be developed to quantify the magnitude of these risks. The goal of a test method and process is to provide evidence that the risks associated with a device are negligible or at least acceptable when compared to the benefits derived from use of the medical device. Furthermore, the setting of the device should be taken into account – domestic or industrial – as instructions that require the use of specialist equipment, such as autoclaves, would not be suitable for a device intended to be used in patients’ homes.Â
What Happens After the Validation Plan is Complete?
Once we have the validation plan put together, we can begin medical device testing. We are fully UKAS accredited to perform ISO 17664 validation of the instructions, so once completed, assuming the method passed, you can claim compliance for the device. In cases where instructions don’t perform as well as expected, we are here to support with advice and guidance to reach the intended outcome.Â
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