It is crucial that medical devices, from scalpels to stethoscopes, be kept clean both for patient safety and for device performance considerations
Following a 2017 review of the previous AAMI TIR30 standard which governed the requirements for the validation of cleaning methods of healthcare products, it was found that there was sufficient cause for the creation of a fully new standard that was published in late 2022.
What changed, and how can Lucideon help?
The new ST98 standard covers a broader set of requirements than previous standards, applying to all devices that require processing before clinical use, including single-use devices that must undergo processing prior to use.
The standard addresses an industry need to systematically define and categorise the underlying problems and challenges that cleaning processes, test soils, and test methods must overcome to achieve validation requirements as part of a cleaning method.
Lucideon is fully up to date with ANSI/AAMI ST98 requirements
We operate ‘Simulated Use’ methods that anticipate the toughest live use conditions through worst-case scenario testing.
We validate:
- Cleaning methods for reusable medical devices
- Cleaning methods for single-use medical devices
- Instructions for Use (IFUs)
- Test soil selection and composition
We tailor our approach to our clients and their working conditions to develop methods, specific to each device, that consider the hard-to-reach, high risk areas (hinges, crevices, knurled handles, etc.) and the most stubborn contaminants that the device will encounter.
Depending on device complexity, we ensure that methods are sufficient to fulfil cleaning validation after simulated use through six full processing cycles, mimicking the slow build-up of mechanical weaknesses and contamination.
As a tried and tested partner, with decades of experience working to FDA, CE, and UKCA requirements, our thorough approach satisfies ANSI/AAMI ST98 and provides clients with security and confidence that their working practises are of the highest quality.
For more information, visit our medical device cleaning, sterilisation and validation page, or contact us here or directly at query@lucideon.com
Dec 2023