WuXi AppTec is the partner medical device manufacturers look to for validation of reprocessing of their reusable device.
Hospital-acquired infection is a major concern for the healthcare community. This is why in 2015, when an outbreak of superbugs was linked to a contaminated duendoscope, industry and government agencies cast a wide net in looking for ways to prevent this from reoccurring.
Without a standard to define clean, the responsibility falls to device manufacturers to ensure their cleaning and disinfection directions within their Instructions for Use (IFU) are adequate and comprehensive. In addition, a device manufacturer must validate these instructions.
WuXi AppTec is the partner medical device manufacturers look to for validation of reprocessing of their reusable device. Our team of technical experts works in collaboration with clients, who we recognize are experts of their devices. The resulting study designs for efficacy or validation studies for cleaning and disinfection meet the 2015 FDA Guidance on Reprocessed Medical Devices and ensure that devices are tested to worst-case conditions.
What are worst-case conditions?
Each device is different and worst-case conditions do vary based on the device and IFU. Examples of worst-case conditions include:
- Proper test controls
- Use of relevant markers
- Simulated-use cycles representative of lifetime use of the product
- Evaluate cleaner or disinfectant residuals
- Recovery efficiency performed and within a level acceptable defined by the standards
- Cleaning and disinfectant studies are evaluated independently
Our studies, designed in such a way, address worst-case scenarios, and we will demonstrate reproducibility of the process during the validation. Our technical team has experience with more than 1500 unique products. We have completed our reprocessing validations with no known rejections from the regulatory agencies. We regularly re-do validations from other laboratories for device companies, because the validations are not tested to worst-case conditions.
We stand behind our work – from test plans through clearance – responding to questions or other regulatory requests as part of the submission process.
Contact us today to learn more about how we will collaborate with you for reprocessing studies, including efficacy and validations at email@example.com