FDA Releases Draft Guidance on Design of Medical Devices for Home Use
The U.S. Food and Drug Administration is urging manufacturers to take special care in designing and developing medical devices intended for home use, warning that failure to do so could lead to equipment malfunction, use error, and even the death or serious injury of patients.
The advice comes in the form of a draft guidance document, Design Considerations for Devices Intended for Home Use, released by the agency on Dec. 12, part of its Home Use Initiative, which was launched in 2010.
“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 FDA says in the document, addressing medical device manufacturers. In general, the agency says manufacturers must appreciate that lay people, often the users of medical devices at home, lack the formal training and education that hospital personnel possess. With more and more medical devices being used outside of formal healthcare facilities, “minimizing the risks posed by such devices can greatly improve the public health.”
The guidance document, which is open to public comment for 90 days, calls on manufacturers to utilize “design control requirements” and to develop a risk management plan that identifies potential hazards and how to control them. Noting the critical role that software plays in some medical devices, the guidance calls on manufacturers to broaden their “existing concept development and preliminary testing processes to account for the needs of home users.”
The FDA wants manufacturers to consider a wide array of factors, such as:
- Environmental considerations, including the physical locations of where the device will be used and whether the environment is sterile
- User considerations, including physical strength and cognitive skills
- Mechanical strength of the devices, understanding they may fall or move around a lot
- Calibration of the device. Key here, says the FDA, is the need to design a device that requires little, if any, calibration.
- Wireless technology, in particular making sure any wireless device is compatible with other wireless uses in the home
- Human factors, specifically understanding “how a device will be used by the users”
In their premarket submissions, manufacturers must include summaries of the “specific steps” they took to ensure a medical device is appropriate for home use. “This can help FDA determine whether applicable safety and effectiveness requirements have been met,” the agency says.
Home healthcare will be the focus of an Oct. 9-10, 2013 summit hosted by AAMI and the FDA. The summit will take place in Herndon, VA.
To read the FDA’s draft guidance, click here.
Posted: December 18, 2012