Medical device manufacturers are busy preparing for the about MDR and Class III device changes. As you work through your portfolio and sort your products into families, you’ll face many tough decisions. You need to be aware of some key changes to the regulations -
When planning a cleaning validation study for your medical device, a validated extraction method is one requirement.
The purpose of an extraction process is to recover any residual soils from the medical device or testing substrate and then quantify those residuals for specific test markers such as protein, hemoglobin or carbohydrates.
The process of cleaning medical devices, either in healthcare settings or at a third-party manufacturer, includes many operational steps and variables. To prove the robustness of process design and to validate that normal process variables do not impact a product’s acceptance criteria, a cleaning validation is executed.
To comply with the 2015 FDA Guidance on reprocessing of medical devices, the validation design for your product should prove the following:
After each use of a medical device, soil may accumulate at a microscopic or macroscopic level that could potentially impede the terminal disinfection or sterilization process.
Over the course of a medical device’s life cycle, it may be used from one to many hundreds of times. For a reusable or third-party reprocessed product, it may be contaminated, cleaned and disinfected/sterilized multiple times throughout its clinical use.