The presence of 3D printed single-use devices that require processing (cleaning and disinfection or sterilization) at the healthcare facility prior to clinical use has increased over the years. While the cleaning validations for these devices are within scope of reprocessing standards and guidance documents, such as ANSI/AAMI ST98:2022, Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices, and the FDA’s Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, they do present unique challenges compared to other single-use devices. These challenges include selecting the appropriate test soil, soiling methods, cleaning methods, and endpoints.
The intent of this open discussion is to discuss these challenges and their potential solutions.
Topics discussed:
- Test soil selection and soiling methods
- Removing the test soil during cleaning can be difficult due to the materials of the device. Including certain cleaning steps can help improve the process
- Selecting the appropriate endpoints to evaluate