Medical Devices May Pose Usability Challenges for Home Users, Risking Misuse and Patient Harm

January 29, 2024 | Evaluations & Guidance


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Healthcare provided in the home is becoming increasingly common, spurred by the aging of the US population and a shift in care practices toward shorter hospital stays. With this trend comes increased use of medical devices in the home—this includes devices intended for home use, as well as those originally intended for use in a clinical environment, such as infusion pumps, ventilators, and wound care technologies.

Advantages of home-based care include greater comfort and convenience for the patient, as well as potential cost savings. But the use of medical devices in the home is not without risk: Devices often are not designed with the home user in mind, and patients and lay caregivers may lack the expertise needed for proper device operation. Severe harm can result if patients or their caregivers do...

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