Healthc Inform Res.  2017 Apr;23(2):94-100. 10.4258/hir.2017.23.2.94.

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

• Jang HJ
• Choi YD
• Kim NH

• KMID: 2378517
• DOI: http://doi.org/10.4258/hir.2017.23.2.94

Abstract

OBJECTIVES
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.
METHODS
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.
RESULTS
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 benefits all exceeded 4 points, each receiving 4.20, 4.20, and 4.13, respectively. Among the variables, time-consuming and decision-making had the lowest mean values, each receiving 3.53. Satisfaction was found to be high for system quality and user satisfaction, but relatively low for time-consuming and decision-making.
CONCLUSIONS
We were able to verify that effective reporting and monitoring of adverse incidents and the safety of medical devices can be implemented through the establishment of an in-hospital medical device safety information reporting system that can enhance patient safety and medical device risk management.

Keyword

Hospital Information Systems; Patient Safety; Safety Management; Risk Management

MeSH Terms

Electronic Health Records*
Equipment Safety*
Hospital Information Systems
Korea
Patient Safety
Risk Management
Safety Management

Figure

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  Figure 1 System architecture.

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  Figure 2 Medical device safety information reporting view.

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  Figure 3 Status view of medical device safety information reporting.

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