WASHINGTON—A new report from the National Research Council recommends steps the Food and Drug Administration and other agencies and professional associations can take to ensure that the medical devices and health information technology used in home healthcare are easy and safe for laypeople to use and that caregivers, whether formal or informal, are well-trained.
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, 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.
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. 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.
