Home Use Medical Devices

Abstract

More than 7 million people in the United States each year receive healthcare in the home setting from a wide variety of devices, from relatively simple devices such as urine collector bags to complex infusion pumps. As more patients require the use of home use medical devices, the devices being used in the home are also increasing in complexity, creating a greater opportunity for adverse events. In addition, the uncontrolled, often unsupervised environment of home use medical devices comes with its own safety considerations. Clinical engineers and healthcare technology managers play an important role in identifying problems with home use medical devices, particularly when patients bring their devices from the home to the hospital with them that can be reported to the device manufacturer and US Food and Drug Administration (FDA). Detecting and reporting these problems will allow the hospital, FDA, and device manufacturer to work together to address device problems. The following analysis of MedSun reports involving home healthcare devices determines the most common home use medical devices that are reported on, as well as the most common types of failure modes for these devices and implications of such failures. When these failures are assessed and reported to the FDA, the FDA can work with the clinical community and device manufacturers to promote the safety and effectiveness of home use medical devices and the patients they serve.