An Analysis of FDA Adverse Event Reporting Data for Trends in Medical Device Use Error

Abstract

Humans can contribute to error at all stages of the medical device product life-cycle. Use error associated with medical devices can result in catastrophic consequences for end users and inefficient use of healthcare system resources. Industry-wide statistics about medical device use error has the potential to aid in identifying opportunities for human factors intervention, however publicly available statistics are sparse. The Food and Drug Administration (FDA) requires medical device manufactures, importers, and device user facilities to track and report adverse events for post-market surveillance through medical device reports (MDRs). This data is available in an online database: Manufacturer and User Facility Experience (MAUDE). This study provides a comprehensive evaluation of use error adverse events in MAUDE (2010-2018) based on device class, device operator, and event outcome, to address the lack of industry-wide statistics on medical device use error. Results indicate that use error is significantly represented in adverse event reporting, constituting 28.1% of reports labeled with device problem codes. Events associated with patient device operators were predominately associated with diabetes-related medical devices, while provider operators were associated with a wider array of devices. Additionally, it was found that most use error reports were attributed to issues with device output; using the device in accordance with manufacturer expectations; and physically activating, positioning, or separating device components. This work demonstrates the viability of using MAUDE to attain industry wide statistics on medical device use error for later integration in industry-wide or device-specific risk mitigation strategies.

The effects of alarm fatigue on the tendency to make medical errors in nurses working in intensive care units

“…It was observed in this study that an increase in alarm fatigue in the participants increased their tendency to make errors in patient follow‐up and material safety, which are among the dimensions of METSN (Table 3). Knisely et al 37 reported that checking the expiration dates of the consumables used checking the devices before use would be effective in preventing errors related to the use of materials and devices. Kahraman 21 stated that the use of devices without checking their details by nurses causes medical errors because it delays the treatment process.…”

Simulation-based research for digital health pathologies: A multi-site mixed-methods study

“… 1 – 3 Currently, a great deal of research into digital health harms focuses on the role of manufacturers and regulatory agencies in improving device oversight, however these interventions can be slow to implement, and need to be paired with changes on the floor of clinical practice. 21 – 28 Given that research has demonstrated that 96.6% of reports on regulatory platforms such as FDA MAUDE database are made by manufacturers (as opposed to treating clinicians), it is perhaps unsurprising that a clinical perspective has been lacking when designing a response to these events. 23 In our research we utilise simulation methods in order to centre the clinician–patient interaction during digital events, and examine the gaps in knowledge, training and resources that impede effective medical care during these scenarios.…”

Simulation based research for digital health pathologies: a multi-site mixed-methods study

“…Currently, a great deal of research into digital health harms focuses on the role of manufacturers and regulatory agencies in improving device oversight, however these interventions can be slow to implement, and need to be paired with changes on the floor of clinical practice (21)(22)(23)(24)(25)(26)(27)(28). Given that research has demonstrated that 96.6% reports on regulatory platforms such as FDA MAUDE database are made by manufacturers (as opposed to treating clinicians), it is perhaps unsurprising that a clinical perspective has been lacking when designing a response to these events (23).…”