The way in which we deliver healthcare is changing rapidly. Technology and rapid adoption is enabling device and tech manufacturers to develop products that move the delivery of care away from the clinical environment. Having the option to stay out of hospitals could be extremely important from both a financial standpoint as well as a health perspective, and could essentially help low-risk patients avoid exposure to viruses. Our experts today provide information regarding the regulatory requirements for home use devices and sterilization techniques.

Q: “I am developing a medical device that can be prescribed by a doctor and used in someone’s home. What can I expect from FDA?”

A: On August 5, 2014, FDA published design considerations for devices intended to be used in the home. This document calls to the medical device manufacturer’s attention areas that, due to the differences between use in a clinical environment and a home environment, should be considered in the design of the medical device. These considerations include environmental conditions, user considerations, user considerations, design considerations, human factors, labeling and post market considerations. Read more.

Q: “There is a lot of talk lately about the importance of avoiding healthcare contamination. We manufacture a product and just found out some hospitals are reusing it. What are the differences between disinfection and sterilization of medical devices?”

A: A device should be disinfected and/or sterilized depending on its intended use. The disinfection of reusable medical instruments is a frequently used practice. There is a significant difference between disinfection and sterilization. Sterilization is defined by ISO 17664 as a “process used to render a device free from all forms of viable microorganisms” whereas disinfection is defined in this standard as a “process used to reduce the number of viable microorganisms on a product to a level previously specified as appropriate for its further handling or use.” Because disinfection is faster and less expensive, some hospitals substitute high level disinfection for sterilization of medical instruments. An article highlighting a comparison of sterilization techniques can be downloaded by clicking here.