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논문 기본 정보

자료유형
학술저널
저자정보
저널정보
대한의료정보학회 Healthcare Informatics Research Healthcare Informatics Research 제23권 제2호
발행연도
2017.1
수록면
94 - 100 (7page)

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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.
#Hospital Information Systems #Patient Safety #Safety Management #Risk Management

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참고문헌 (19)

참고문헌 신청
/ 2005 / Regulation on the management of safety information as medical device side effect report google schola / 2014 / Medical Devices Act, Chapter V, Article 31, Law No. 12392 google schola / 2014 / Regulation on the management of safety information as medical device side effect report google schola Baker HM / 1997 / Rules outside the rules for administration of medication: a study in New South Wales, Australia / Image J Nurs Sch 29 (2) : 155 ~ 158 google schola Baker KN / 1962 / The problems of detecting medication errors in hospitals / Am J Hosp Pharm 19 : 360 ~ 369 google schola

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