Design considerations for medical device manufacturers.

As technology advances, so does the complexity of reusable medical devices. This creates greater challenges for cleaning, disinfecting, and sterilizing devices between patient uses. There is increasing concern from the U.S. Food and Drug Administration (FDA) and the reusable device industry that inadequately reprocessed devices are contributing to infections acquired in hospitals and other healthcare facilities. This concern has led to a recently published draft guidance document for reusable device manufacturers, as well as meetings held by the FDA and AAMI in 2011, to address perspectives on these industry issues. The FDA has encouraged reusable device manufacturers to consider design features that allow for simple and more effective reprocessing procedures. This is a challenge for engineers whose primary focus is to design devices that can meet demands for increased sophistication and functionality. However, intensified regulatory scrutiny of reprocessing validations requires design innovation.