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Clinical Limits of Use Tools

Clinical Limits of Use Tools (CLOUT) for Medical Devices and Technology

This guide provides an overview of the systematic process to establish clinical limits of use tools (CLOUT) for medical devices and technology. The overarching goal of developing these tools is to improve the prescription and/or usage of the medical devices and technology by appropriately classifying the available features and limits of safe operation.

The recommendations put forth in this document have been derived from work conducted by the Human Engineering Research Laboratories in collaboration with the Human Factors Engineering Division at VA National Center for Patient Safety.

Clinical Limits of Use Tool (CLOUT) for Wheeled Mobility Devices

The Veterans Health Administration (VHA) within the Department of Veterans Affairs (VA) purchases medical devices and assistive technologies to maximize the health, function, quality of care and quality of life for Veterans. While safety is a primary consideration when coordinating and delivering patient care with incorporation of healthcare technologies, there is a paucity of scientific evidence on safe and effective use of medical devices, industry standard regulations have not been well developed and/or enforced, and the limits of use of these devices have not been sufficiently explored.

To support the VA to maximize the quality of service for Veterans while also ensuring that medical devices meet safety and performance expectations, an internally developed tool, with a focus on purchasing for safety, must be established. Development of this tool will provide a framework to identify device limits of use that will guide clinical care, shape VA expectations for purchasing, and guide procurement personnel to facilitate comprehensive evaluation of products against established specifications. Patient safety will be prioritized when all stakeholders - including Veterans, VA professionals and vendors - understand the recommended process for evaluating and determining limits of use for devices provided by VA.