Presentation
Mitigating Risks in the Use of Medical Devices in the Home Setting/Environment
SessionThursday Poster Session
DescriptionMedical devices can be used in a variety of settings, ranging from surgical suites and hospitals to within a patient’s home. In 2004, the National Association for Home Care & Hospice reported that more than 7 million people in the United States receive home health care annually. Since then, both the number of medical devices available to be used at home and the complexity of those home use medical devices have increased. The U.S. FDA also launched a Home as a Health Care Hub in 2024 to help advance innovation of medical device technologies that are designed to be safe and effective when used in the home.
Since the intended user and intended use environment can affect the safety and efficacy of a medical device, human factors engineering is an important consideration in identifying and mitigating associated risks. Due to the increasing prevalence of home use devices, the need for minimizing the risks they pose is essential. The wide variability in home use environments and/or intended user(s)’ knowledge base can result in use errors or misuse scenarios with potentially hazardous consequences. Failure to consider such scenarios during the design of home use devices can have injurious consequences to patients.
Since the intended user and intended use environment can affect the safety and efficacy of a medical device, human factors engineering is an important consideration in identifying and mitigating associated risks. Due to the increasing prevalence of home use devices, the need for minimizing the risks they pose is essential. The wide variability in home use environments and/or intended user(s)’ knowledge base can result in use errors or misuse scenarios with potentially hazardous consequences. Failure to consider such scenarios during the design of home use devices can have injurious consequences to patients.
Event Type
Poster
TimeThursday, October 22nd5:30pm - 6:30pm PDT
Location