As part of the Orthomanufacture 2021 conference, Lise Vanderkelen will share some interesting benefits of family grouping medical devices when dealing with the validations for cleaing and disinfection instructions. The webinar will be accessible through the Orthomanufacture website; register below.
Validating cleaning and sterilization processes is an important and necessary step in ensuring patient safety and minimizing healthcare-acquired infections, corrective actions and recalls. The instructions for cleaning and disinfecting reusable devices are therefore of crucial importance. Also, the process of validating these instructions is a time-consuming and costly task for manufacturers, surely if every medical device procedure must be qualified on its own. This is where family grouping or selecting the worst-case device can make a large difference, allowing the manufacturer to group similar medical devices and perform the same validations for these products. Only if the device is unique and specialized an individual validation procedure should be considered.
In this presentation, three main approaches for grouping reusable medical devices for validation procedures are specified: device use, material type and device design. Depending on the category used for determining the different ‘family groups’, different reusable medical devices can be grouped together and receive the same cleaning validations. Additional to these considerations with regards to the devices themselves, reprocessing instructions must also be evaluated and allocated only to devices that undergo the same reprocessing procedures.
Family grouping for steam sterilization validations requires different considerations as compared to family grouping for cleaning. Additionally, whereas family grouping for cleaning validations will mostly consider worst-case devices, family grouping for steam sterilization may include the selection of a worst-case tray configuration (if appropriate).