A very significant portion of these new medical devices are completely reliant on inbuilt sophisticated software to control the mechanical, electrical and electronic components.
Validation of processes used to sterilize drug products and equipment are the most critical validation activities undertaken.
Reusable medical devices must be designed to function safely and effectively following sterilization in a health-care setting.
By definition, they must be designed to withstand multiple exposures to sterilants or disinfectants without losing their ability to function effectively.
In particular, the government’s concern is a growing class of mechanical devices with embedded software that runs to hundreds of thousands of lines of code.
The FDA is the primary body that is responsible for the approval to use therapeutic goods in the general US population.
Today’s designs are complex and sophisticated, and the process of cleaning, disinfecting, and sterilizing reusable devices can be complex.