Reporting medical device safety incidents to regulatory authorities : An analysis and classification of technology-induced errors

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http://hdl.handle.net/10138/318786

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Palojoki , S , Saranto , K & Lehtonen , L 2019 , ' Reporting medical device safety incidents to regulatory authorities : An analysis and classification of technology-induced errors ' , Health informatics journal. , vol. 25 , no. 3 , pp. 731–740 . https://doi.org/10.1177/1460458217720400

Title: Reporting medical device safety incidents to regulatory authorities : An analysis and classification of technology-induced errors
Author: Palojoki, Sari; Saranto, Kaija; Lehtonen, Lasse
Contributor: University of Helsinki, Clinicum
University of Helsinki, Clinicum
Date: 2019-09
Language: eng
Number of pages: 10
Belongs to series: Health informatics journal.
ISSN: 1460-4582
URI: http://hdl.handle.net/10138/318786
Abstract: The European Union Medical Device Directive 2007/47/EC1 defines software with a medical purpose as a medical device. The implementation of health information technology suffers from patient safety problems that require effective post-market surveillance. The purpose of this study was to review, classify and discuss the incident data submitted to a nationwide database of the Finnish National Competent Authority with other forms of data. We analysed incident reports submitted to the authority database by users of electronic health records from 2010 to 2015. We identified 138 valid reports. Adverse events associated with electronic health record vulnerabilities, clustered around certain error types, cause serious harm and occur in all types of healthcare settings. The low rate of reported incidents raises questions about not only the challenges associated with medical software oversight but also the obstacles for reporting.
Subject: 3141 Health care science
adverse event
electronic health record
medical software
oversight
patient safety
INFORMATION-TECHNOLOGY
HEALTH-CARE
AGREEMENT
HOSPITALS
OVERSIGHT
US
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