Effects and Satisfaction of Medical Device Safety Information Reporting System Using Electronic Medical Record

Healthcare Informatics Research
Hye Jung JangNam Hyun Kim

Abstract

This paper describes an evaluation study on the effectiveness of developing an in-hospital medical device safety information reporting system for managing safety information, including adverse incident data related to medical devices, following the enactment of the Medical Device Act in Korea. Medical device safety information reports were analyzed for 190 cases that took place prior to the application of a medical device safety information reporting system and during a period when the reporting system was used. Also, questionnaires were used to measure the effectiveness of the medical device safety information reporting system. The analysis was based on the questionnaire responses of 15 reporters who submitted reports in both the pre- and post-reporting system periods. Sixty-two reports were submitted in paper form, but after the system was set up, this number more than doubled to 128 reports in electronic form. In terms of itemized reporting, a total of 45 items were reported. Before the system was used, 23 items had been reported, but this increased to 32 items after the system was put to use. All survey variables of satisfaction received a mean of over 3 points, while positive attitude, potential benefits, and positive bene...Continue Reading

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Citations

Jan 3, 2019·Journal of Radiological Protection : Official Journal of the Society for Radiological Protection·Bon-Yeoul Koo, Hyoun-Joong Kong

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Software Mentioned

ComponentOne
NET Framework
Visual Studio
Windows Server

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