Addressing the risks of home-use medical devices with a new safety standard
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The expansion of home-based healthcare delivery in the United States is transforming the context in which medical devices are used. Devices designed originally for controlled clinical environments and for operation by trained healthcare professionals are now deployed routinely in home settings and operated by layperson patients and caregivers. The home environment is inherently variable and lacks the infrastructure, oversight, and standardization of clinical settings, while layperson users represent a diverse population with varying levels of training, health literacy, and physical capabilities. This paper examines how the interaction between device design, layperson users, and home environments creates predictable and systematic hazards. Current safety evaluation frameworks address home-use devices only partially and in a fragmented manner. As a result, there is no unified mechanism for evaluating a device’s suitability for home use. To address this gap, this paper proposes the development of a voluntary safety standard for home-use medical devices to be implemented through an independent third-party certification process. Such a certification would provide clear signals to healthcare providers, patients, and caregivers, while incentivizing manufacturers to adapt products to real-world, non-clinical use conditions.
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This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivs 4.0 License.