With more of the elderly population in the United States choosing to live in their homes, rather than in formal medical facilities, there's a growing need for medical devices to be safe and easy for laypeople to use. A report from the National Research Council is recommending steps that the FDA, other agencies and professional groups can take to ensure that caregivers are well-trained--whether or not they are professionals.
Right now, according to the report, there are no standards or guidance for labels on medical devices meant for home use. The NRC is recommending that the FDA promote development of standards for labels and instructional material to ensure that nonprofessionals can understand how to work the device. Not only that, but the agency should make it easier to report problems if a gadget is not working properly.
The NRC also recommends that the FDA and the Office of the National Coordinator for Health Information Technology get together to make sure there's correct integration between devices and data--such as devices that monitor patients' blood pressure and provide results to patients and their doctors. The report also recommends better training for home caregivers.
- read the release from the National Academy of Sciences