Review of Reported Clinical Information System Adverse Events in US Food and Drug Administration Databases

Abstract

Summary Background The US FDA has been collecting information on medical devices involved in significant adverse advents since 1984. These reports have been used by researchers to advise clinicians on potential risks and complications of using these devices. Objective Research adverse events related to the use of Clinical Information Systems (CIS) as reported in FDA databases. Methods Three large, national, adverse event medical device databases were examined for reports pertaining to CIS. Results One hundred and twenty unique reports (from over 1.4 million reports) were found, representing 32 manufacturers. The manifestations of these adverse events included: missing or incorrect data, data displayed for the wrong patient, chaos during system downtime and system unavailable for use. Analysis of these reports illustrated events associated with system design, implementation, use, and support. Conclusion The identified causes can be used by manufacturers to improve their products and by clinical facilities and providers to adjust their workflow and implementation processes appropriately. The small number of reports found indicates a need to raise awareness regarding publicly available tools for documenting problems with CIS and for additional reporting and dialog between manufacturers, organizations, and users.

An analysis of electronic health record–related patient safety incidents

“…Previous research shows that new technology increases the number of technology-related errors. [6][7][8][9][10]40 Second, hospital districts in Finland devote institutional resources to incident reporting procedures, obtain feedback and share reports. Consequently, the staff are also encouraged to report HIT incidents, because managers consider them as important as clinical bedside events.…”

“…5 However, new technology may also pose novel risks to patient safety by disrupting established, traditional working norms and creating new risks in practices related to HIT design, implementation and use. [6][7][8][9][10] Despite this, current evidence concerning HIT safety is relatively limited, 11,12 and the few studies on the subject suggest that HIT contributes to less than 1 per cent of total errors in healthcare systems. 2,13 The establishment of a voluntary patient safety incident reporting system is a core method for receiving and processing patient safety-related information and creating a more accurate understanding of patient safety risks.…”

Using FDA reports to inform a classification for health information technology safety problems

“…1 While the MAUDE database has been used previously to examine the safety of medical devices such as infusion pumps 21 22 and pacemakers, 23 there has been limited exploration of its utility for understanding HIT problems. 24 In this study, we set out to systematically search and analyze the events submitted to MAUDE, aiming to better understand the nature of these problems and to expand our HIT safety classification.…”

“…24 However, this yielded only 120 reports from 1984 onwards. For this study, we in contrast elected to first download all reports without filtering, and then to search across the report set using our own methods rather than the FDA interface.…”

Rights and responsibilities of users of electronic health records

“…35,36 Clinicians have the right to expect that all errors related to electronic health records will be reported, investigated and resolved in a timely manner. 37 Vendors and health care organizations responsible for maintaining the electronic health records should make these reports, along with their responses, publicly available so that others can learn from them.…”