Electrosurgical units play a vital role in operating rooms today. Their failures have the potential to harm both patients and surgeons. In this article, US Food and Drug Administration (FDA) postmarket safety reports involving electrosurgical units were examined to determine the most common failure categories of these devices. Based on this analysis, mechanical failure was the most prevalent failure experienced, primarily through part detachment, failing to articulate or movement/motion issues, or improper or poor cutting. When these issues are properly reported to FDA, FDA can work with manufacturers to improve these devices and ensure that these devices remain safe and effective.
Healthcare technology management professionals play an important role in reporting medical device adverse events to the Food and Drug Administration by helping to identify and report device concerns, providing critical context to medical device reports, and mitigating safety concerns. The expert opinions and insights shared by healthcare technology management professionals are beneficial to the Food and Drug Administration and help the agency mitigate device-related problems and improve patient safety. This article is a case study that discusses how a medical device report involving infusion pump controllers was submitted to the Food and Drug Administration's Medical Product Safety Network reporting program and contributed to a voluntary class I recall affecting more than 800,000 devices nationwide. The details and context provided in the medical device report by the reporting team helped inform the investigation into, and resolution of, a device safety concern.
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.
Medical device reporting is a federal regulation requiring manufacturers, importers, and user facilities (hospitals, nursing homes, etc) to report medical device-related adverse events (21 CFR Part 803). User facilities must report adverse events involving medical devices to 1 of 2 entities: the device manufacturer or the US Food and Drug Administration (FDA). Adverse events that result in serious injury or illness must be reported to the device manufacturer (or the FDA if the manufacturer is unknown), whereas adverse events that result in death must be reported to both the device manufacturer and FDA.
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