Any type of medical device used with a patient has to be developed, manufactured and tested extensively to ensure it is completely safe. This includes requiring the complete cleaning of the device after the manufacturing process to remove even trace amounts of potentially harmful chemicals or contaminants that may be required during production.
Medical device cleaning validation is a part of the development process. All components have to meet specific standards as found in the United States Food and Drug Administration Quality System Regulations (QSR) Part 820. This clearly outlines the steps that have to occur to validate the cleaning process to ensure that the medical device is free from both particulate matter as well as chemical residue.
The Steps
There are several steps or aspects of medical device cleaning validation that have to be completed and recorded. There will be variations in the specifics for each device, but overall the steps themselves will be identical.
- Understanding the manufacturing process – the first step identifies all chemicals and particulate matter that will come in contact with the device. This includes understanding the exact manufacturing method as well as any materials included in the production from third-party vendors and suppliers.
- Limits – once all chemicals and potential contaminants used in the manufacturing process are known it will be essential to determine safe limits for each. Information on limits for each type of chemical can be found on Material Safety Data Sheets from the different suppliers of the products. Different devices, based on their use and if they are internal or external, will have different limits.
- Testing – developing the most effective testing methods for medical device cleaning validation will be critical. The easier the testing method used on the device, the lower the risk of errors or inaccurate measurements. Test strips are a highly effective option for many chemical residues, and they are easy to read and very accurate.
- Validating the test – whatever testing method is used, the test itself has to be validated. Using testing strips or materials developed using top testing labs will simplify this process as the test has already been approved. Additionally, the testing method itself has to be validated. This is typically complete by the manufacturer, ensuring the test is correctly used and that the cleaning method selected is effective.
This process can be lengthy and take several weeks to months to complete. The more chemicals and contaminants that are present, the more complicated the cleaning validation process becomes.
