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.

Analysis of Medical Device Reports Involving Ventilator-Related Incidents in a Clinical Setting

“…These MDRs were excluded owing to the lack of information surrounding the adverse event linked to the use of ventilator-related devices. Describing the most frequent ventilator-related device problems (malfunction, serious injury, and death) since 2019 may serve as a valuable resource to the clinical community to decide how to implement safety measures to help limit the recurrence of similar adverse events 8 . The specific device problems and number of associated observations greater than 1 are outlined in Table 1.…”

Reporting Medical Device Events

“…FDA has previously published articles discussing voluntary reportable event case studies that have ranged from patient falls from beds, electronic thermometer inaccuracies, and a variety of home-use device failures. 1,5,6 Each of these articles further expands on ways for HTM professionals to take preventative measures to mitigate risk with these devices, best practices for reporting events, and the resulting outcomes that improved patient safety. The more feedback FDA receives on how medical devices are performing in the real world, the more rapidly and effectively the Agency can work with manufacturers to improve products and address patient safety concerns.…”

“…Examples of voluntary reportable events include unclear or vague product labeling, compromised sterile packaging, missing components, interoperability or cybersecurity concerns, and usability issues, all of which have not caused or contributed to a serious adverse event. FDA has previously published articles discussing voluntary reportable event case studies that have ranged from patient falls from beds, electronic thermometer inaccuracies, and a variety of home-use device failures 1,5,6 . Each of these articles further expands on ways for HTM professionals to take preventative measures to mitigate risk with these devices, best practices for reporting events, and the resulting outcomes that improved patient safety.…”