I've been thinking about incident reporting in healthcare, in terms of what we can learn about the design of medical devices, based on both what is theoretically possible and also what actual incident reports show us.
Incident reporting systems (e.g., NRLS) are a potential source of information about poor usability and poor utility of interactive medical devices. However, because the health care culture typically focuses on outcomes rather than processes, instances of sub-optimal use typically pass unremarked. There is growing concern that there is under-reporting of incidents, but little firm evidence on the scale of that under-reporting. One study that compared observed errors against reported incidents involving intravenous medications identified 55 rate deviation and medication errors in nine hours of observation; 48 such incidents had been reported through the hospital incident reporting system over the previous two years, suggesting a reporting rate of about 0.1%. Firth-Cozens et al investigated causes for low reporting rates, even when clinicians had identified errors or examples of poor care. All groups of participants “considered that minor, commonplace or unintentional mistakes, ‘genuine or honest’ errors, one-off errors, or ones for which a subordinate is ‘obviously sorry’ or has insight, need not be reported”. Examples reported by their participants included incidents involving infusion pumps: problems for which the design or protocols for use of the pumps were contributing factors. Even when incidents are reported, those reports might not deliver insights into what went wrong. In our recent study of incident reports involving home use of infusion pumps, we found that reports gave much greater insight into how people detected and recovered from the device not working than into what had caused the device not to work properly in the first place.
While incident reporting systems might be one source of information on poor design or use of interactive devices in healthcare, this is not a reliable route for identifying instances of poor design. Once an incident is reported it is important that the role of device design in contributing to the incident be properly considered, and not simply dismissed with the common response that the device “performed as designed” and that it was therefore a user error.
Incident reporting systems (e.g., NRLS) are a potential source of information about poor usability and poor utility of interactive medical devices. However, because the health care culture typically focuses on outcomes rather than processes, instances of sub-optimal use typically pass unremarked. There is growing concern that there is under-reporting of incidents, but little firm evidence on the scale of that under-reporting. One study that compared observed errors against reported incidents involving intravenous medications identified 55 rate deviation and medication errors in nine hours of observation; 48 such incidents had been reported through the hospital incident reporting system over the previous two years, suggesting a reporting rate of about 0.1%. Firth-Cozens et al investigated causes for low reporting rates, even when clinicians had identified errors or examples of poor care. All groups of participants “considered that minor, commonplace or unintentional mistakes, ‘genuine or honest’ errors, one-off errors, or ones for which a subordinate is ‘obviously sorry’ or has insight, need not be reported”. Examples reported by their participants included incidents involving infusion pumps: problems for which the design or protocols for use of the pumps were contributing factors. Even when incidents are reported, those reports might not deliver insights into what went wrong. In our recent study of incident reports involving home use of infusion pumps, we found that reports gave much greater insight into how people detected and recovered from the device not working than into what had caused the device not to work properly in the first place.
While incident reporting systems might be one source of information on poor design or use of interactive devices in healthcare, this is not a reliable route for identifying instances of poor design. Once an incident is reported it is important that the role of device design in contributing to the incident be properly considered, and not simply dismissed with the common response that the device “performed as designed” and that it was therefore a user error.
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