Journal of the Institute of Electronics and Information Engineers (전자공학회논문지)

The Institute of Electronics and Information Engineers (대한전자공학회)
권호 표지
DOI QR코드

DOI QR Code

Design for a Medical Devices Safety Information Reporting System for the Hospitals

의료기기 안전성 정보 원내 보고 시스템 설계

  • Jang, Hye Jung (Department of Clinical Trials for Medical Devices, Yonsei University Health System Severance Hospital) ;
  • Choi, Young Deuk (Department of Urology, College of Medicine, Yonsei University) ;
  • Kim, Nam Hyun (Department of Medical Engineering, College of Medicine, Yonsei University)
  • 장혜정 (연세대학교 의료원 임상시험센터 의료기기임상시험부) ;
  • 최영득 (연세대학교 의과대학 비뇨기과학교실) ;
  • 김남현 (연세대학교 의과대학 의학공학교실)
  • Received : 2014.10.10
  • Accepted : 2015.01.02
  • Published : 2015.01.25
Download PDF
⟨ Previous Next ⟩

Abstract

In this study, medical devices safety information reporting system was designed to manage medical devices for the efficient management of in-hospital adverse events. The current management of medical device adverse event reporting regulations and the legal status of the system and procedures for identifying the system were reviewed. MSF/CD(Microsoft Solution Framework/Component Design) was applied to the system design. Through this study, we can understand medical devices management including the notice provisions of the Ministry of Food and Drug Safety for medical devices safety information reporting. We also expect this study will help to improve patient safety and the effective management of medical equipment, and contribute to activating medical devices safety information reporting.

본 연구는 의료기기법이 시행된 이래 의료기기 부작용등 안전성 정보관리를 위한 의료기기 안전성 정보 원내 보고 시스템 설계에 대한 연구이다. 본 연구는 현행 의료기기 부작용등 안전성정보 보고 관리에 대한 법적 규정 및 시스템에 대한 절차와 현황을 파악하고, MSF/CD(Microsoft Solution Framework/Component Design)설계방법론을 적용한 시스템 설계 방법을 적용하여 의료기기 안전성 정보 원내 보고 시스템 구축을 위한 설계를 하였다. 본 연구를 통해 우리나라의 부작용 등 안전성 정보 보고에 대한 식품의약품안전처 고시 규정을 포함한 의료기기 관리 제도를 파악하고, 좀 더 환자의 안전과 의료기기의 위험관리를 효과적으로 할 수 있는 의료기기 안전성 정보 원내 보고 시스템을 설계 및 구축함으로써 의료기기 부작용 등 안전성 정보 보고의 활성화에 이바지 할 수 있기를 기대한다.

Keywords

References

  1. Korea Health Industry Development Institute. Medical Devices Industry Report. 41-100. 2013.
  2. Espicom. Worldwide Medical Market Forecasts to 2018. 2013.
  3. Y. Huh, "IT convergence medical devices technology", Journal of IEIE, Vol 37, no.6, pp.60-68, 2010.
  4. K. M. Lee,.N. K. Baek,.J. H. Seo, "A study on the system improvement policy according to the status analysis of medical device control system in Korea", Korea Safety Management & Science, Vol. 12, no. 3, pp. 37-52, 2010.
  5. M. S. Kim, J. S. Kim, I. S. Jung, Y. H. Kim, & H. J. Kim, "The effectiveness of the error reporting promoting program on the nursing error incidence rate in Korean operating rooms", Journal of Korean Academy of Nursing, 37: 185-191. 2007. https://doi.org/10.4040/jkan.2007.37.2.185
  6. Weingart, S. N., Callanan, L. D., & Aronson, M. D. "A physician-based voluntary reporting system for adverse event and medical errors". Journal of General Internal Medicine, 16: 809-814. 2001. https://doi.org/10.1046/j.1525-1497.2001.10231.x
  7. Barker, K. N., & McConnell, W. E. "The problems of detecting medication error in hospitals", Am J Hosp Pharma, 19 ; 360-369. 1962.
  8. Cohen, H. "Shrinking medication errors down to size". Nurs manag, 32(10) : 25-30. 2001. https://doi.org/10.1097/00006247-200110000-00014
  9. Leape, L. L "Why should we report adverse incidents?", J Eval Clin Pract, 5 : 1-4. 1999. https://doi.org/10.1046/j.1365-2753.1999.00162.x
  10. Vincent, C., Stanhope, N., & Crowley-Murphy, M. "Reasons for not reporting adverse incidents: an empirical study". J Eval Clin Pract, 5 : 13-21. 1998.
  11. Baker, H. "Rule outside the rules for administration of medication : A study in New South Wales", Australia, J of Nurs Scholarsh, 29(2) : 155-58. 1997.
  12. Hart, G. K., Baldwin, I., Gutteridge, G., & Ford, J. "Adverse incident reporting in intensive care". Anaesthesia, 50 : 846-849. 1994.
  13. Jayasuriya, J. P., & Anandaciva, S. "Compliance with an incident report scheme in anaesthesia". Anaesthesia, 50 : 846-849. 1995. https://doi.org/10.1111/j.1365-2044.1995.tb05848.x
  14. MFDS Notification No 2005-20 as of 16 April, 2005.
  15. Medical devices act chapter V, article 30, (1). 29 July, 2014.
  16. MFDS Notification No 2014-91 as of 12 February, 2014.
  17. J. M. Son, K. B. Kim, "Microsoft Solution Framework/Component Design", Information Publishing Group, 2004.