FDA Finalizes Guidance For Home-Use Medical Devices
By Nick Otto
The FDA recently released guidance for manufacturers on design considerations for medical devices intended for use at home to address the unique risks associated with the domestic environment.
Device-makers making medical products for home use are advised to develop a risk-management plan that describes the process for identifying hazards, evaluating and controlling known risks, and monitoring how well the controls are working, according to the finalized guidance released recently.
This risk-management plan should “strive for the highest level of risk mitigation possible by designing risk out of the system to the greatest extent possible,” the guidance states. Additionally, the FDA noted that putting risks in product labeling is not sufficient for the home environment because users may ignore or not understand safety precautions.
The guidance continues, noting that labeling alone won’t provide the sufficient risk control for the home-use environment because warning labels, especially lengthy ones, “can be ignored by or confusing to the user.”
The agency suggests manufacturers pay special attention to environmental considerations when designing home-use products. These include the potential for electromagnetic interference, contaminants such as pets and tobacco smoke, and variations in temperature, air flow, and humidity. Portability and tamper-resistance should also be considered.
The agency also recommends devices be designed with minimal need for calibration and enough mechanical strength to survive falling on hard surfaces. If a device uses wireless technology, coexistence with other wireless devices deserves careful consideration, the guidance notes.
Additionally, the FDA says distractions inside or outside the home could interfere with the user’s ability to hear an alarm. Devices should be designed to be heard in environments “typically found around the home.”
Lastly, the guidance points to hazards typically associated with home-use devices, and suggests having an “accurate and complete understanding of how devices will be used.” Therefore, it’s recommended that device-makers conduct human factor “usability” testing as early in the design process as possible, along with several other tests as the device evolves.
The draft was originally released in December 2012 as part of the agency’s “Home Use Initiative,” the Regulatory Affairs Professional Society (RAPS) notes.
Significant changes from the draft RAPS points out include the revised definition of “home use” to include “outdoor environments, office environments, schools, vehicles, emergency shelters, and independent living retirement homes.”
Another change is the elimination of the childproof requirements, which was replaced with a cautionary note that children may interact with the device.