A new report from the National Research Council recommends steps the Food and Drug Administration, and agencies such as the Office of the National Coordinator, can take to ensure medical devices and health IT for home healthcare are easy and safe to use.
These steps include developing new labeling standards, easier reporting of adverse events, improved training and methods to regulate, certify and monitor the devices.
For many reasons – including the rising cost of healthcare, the aging of the U.S. population and patients’ desire to remain in their homes – healthcare is increasingly moving from formal medical facilities into homes. A wide range of procedures, therapies and monitoring tasks are now carried out far from any hospital or clinic, often with no healthcare professional on-site.
So far, however, experts caution that little attention has been paid to ensuring that this transition of care into the home happens safely and effectively.
The report recommends that FDA promote the development of new standards for labels on medical devices intended for use in the home, as well as for the accompanying instructional materials, to ensure that they are understandable to nonprofessionals. Standards and guidance for labeling these devices are currently lacking, the report notes.
FDA also should make it easier for people to report problems with medical devices they use in the home; its current systems for reporting adverse events are not easy for laypeople to use, the report finds. In addition to making these systems user-friendly, the agency should collect more data that could help identify the root causes of adverse events involving devices and should develop and promote a more convenient way for lay users and professionals to report problems.
In addition, FDA and the ONC should work together to regulate, certify and monitor applications that integrate medical devices and health information technologies – for example, devices that monitor patients’ blood pressure and provide results to patients and their doctors. The ONC for Health Information Technology should also work with other agencies to establish guidelines and standards for making consumer health information technologies usable and accessible.
The way home caregivers are trained needs to be improved, the report adds. Professional practice and advocacy groups should develop certification, credentialing, and training standards that will prepare formal caregivers to practice in the home. They should develop informational and training materials for informal caregivers as well.
The report recommends that the U.S. Department of Health and Human Services, Centers for Medicare and Medicaid Services and other federal agencies collaborate to facilitate adequate access to health- and safety-related home modifications, especially for those who cannot afford them, enabling people whose homes contain safety hazards or obstacles that limit self-care to obtain the modifications they need.
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