FDA offers guidance to manufacturers of home use devices

The FDA has issued a draft guidance in the Federal Register containing design considerations for medical device manufacturers developing products intended for home use.

An aging population, technological advancements and a growing interest in the cost-saving ability of connected health have all contributed to a growing home healthcare market, according to the Dec. 12, 2012, statement. “Although home use devices provide significant benefits to patients and families, including quality of life improvements and cost savings, home use devices are also associated with unique risks. These risks result from interactions among the user, the use environment and the device, and can greatly impact user and patient safety.”

Home environments are less controlled than healthcare settings and manufacturers should take into consideration factors such as temperature, water supply, humidity, child-proofing and contaminant, according to the draft guidance. In addition, manufacturers should consider that patients with low health literacy may be using these devices without assistance from experienced healthcare providers. They should be designed for patients with a range of physical, cognitive and emotional capabilities.

“By taking into consideration the physical environment, the user, the device or systems, the labeling and by utilizing human factors, you can produce devices that suit the home use environment, and are thereby more likely to have reasonable assurance of their safety and effectiveness for their intended use,” the draft guidance concluded. “Designing your home device in the manner should result in a safer and easier-to-use device, minimize user error and reduce the likelihood that adverse events will occur--the  preferred outcomes of a well-designed medical device.”

Read the complete guidance on the FDA website.