Reporting adverse events related to medical devices: A single center experience from a tertiary academic hospital

Autoři: Fahad Alsohime aff001;  Mohamad-Hani Temsah aff001;  Gamal Hasan aff002;  Ayman Al-Eyadhy aff001;  Sanaa Gulman aff002;  Haytam Issa aff002;  Omar Alsohime aff005
Působiště autorů: Pediatric Department, College of Medicine, King Saud University, Riyadh, Saudi Arabia aff001;  Pediatric Intensive Care Unit, King Saud University Medical City, Riyadh, Saudi Arabia aff002;  Prince Abdullah Ben Khalid Celiac Disease Research Chair, King Saud University, Riyadh, Saudi Arabia aff003;  Department of Pediatrics, Assiut Faculty of Medicine, Assiut University, Egypt aff004;  Standards and Guidelines Department, Medical Devices Sector, Saudi Food and Drug Authority, Riyadh, Saudi Arabia aff005
Vyšlo v časopise: PLoS ONE 14(10)
Kategorie: Research Article
doi: 10.1371/journal.pone.0224233


Intensive care units (ICU) rely on multiple technical resources with extensive use of different medical devices, such as ventilators, vital sign monitors, infusion, and injection pumps. This study explored how ICU nurses approach adverse events related to medical devices in a single tertiary center and identify their level of awareness of the national reporting system for adverse events related to medical devices beside their source for risk information updates. Totally, 297 nurses working in the ICU at King Saud University Medical City completed a survey on medical devices and adverse events reporting and 198 reported experiencing an adverse event related to equipment failure. However, 195 nurses were unaware of an official national reporting system for reporting such events. It is important to develop a framework of safe operation of medical devices based on international standards. This reporting system should include the national patients’ safety authorities, and should be anonymous, confidential, and non-punitive.

Klíčová slova:

Adverse events – Equipment – Intensive care units – Medical devices and equipment – Nurses – Questionnaires – Surveys – Pediatric critical care


1. Medical electrical equipment—Part 1–6: General requirements for basic safety and essential performance—Collateral standard: Usability. IEC 60601-1-6:2010. Accessed July 6, 2019.

2. Deutsch E, Lippert HD, Ratzel R, Tag B, Gassner UM. Verordnung über das Errichten, Betreiben und Anwenden von Medizinprodukten (Medizinprodukte-Betreiberverordnung—MPBetreibV). Berlin, Heidelberg: Springer Berlin Heidelberg. Kommentar zum Medizinproduktegesetz (MPG). 2018;373–402.

3. Saudi Food and Drug Authority. Medical Device National Registry.

4. Al-Surimi K, Househ M, Almohandis E, Alshagathrh F. Establishing a National Medical Device Registry in Saudi Arabia: Lessons Learned and Future Work. Stud Health Technol Inform. 2015;213:23–6. 26152943

5. Communities TCOTE. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices 1993. Available from:

6. Medizinproduktegesetz in der Fassung der Bekanntmachung vom 7. August 2002 (BGBl. I S. 3146), das zuletzt durch Artikel 7 des Gesetzes vom 18. Juli 2017 (BGBl. I S. 2757) geändert worden ist. Bundesgesetz über Medizinprodukte (Medizinproduktegesetz—MPG) MPG. 2013; 1–31. Accessed July 6, 2019.

7. Part 803—Medical device reporting: Subpart A—General Provisions. Electronic Code of Federal Regulations 52–68. 2018. Available from:

8. Teow N and Siegel SJ. FDA Regulation of Medical Devices and Medical Device Reporting. Pharmaceut Reg Affairs. 2013;2:110.

9. Geissler N, Byrnes T, Lauer W, Radermacher K, Kotzsch S, Korb W, Hölscher UM. Patient safety related to the use of medical devices: a review and investigation of the current status in the medical device industry. Biomed Tech (Berl). 2013;58(1):67–78.

10. Mattox E. Medical devices and patient safety. Crit Care Nurse. 2012;32(4):60–8. doi: 10.4037/ccn2012925 22855080

11. Rich S. How human factors lead to medical device adverse events. Nursing. 2008 Jun;38(6):62–3. doi: 10.1097/01.NURSE.0000320363.32444.d8 18497666

12. Aziz N, Zain Z, Mafuzi RMZR, Mustapa AM, Najib NHM, Lah NFN. Relative importance index (RII) in ranking of procrastination factors among university students. AIP Conference Proceedings 1761, 020022;2016.

13. National Hospital Standards, Third Edition.: Saudi Central Board for Accreditation of Healthcare Institutions (CBAHI); 2015.

14. National Center for Medical Devices Reporting NCMDR. Medical Devices Sector, SFDA.May 15, 2019. Available from:

15. (Mds—IR7) Implementing rule on post-marketing surveilance. Medical Devices Sector, SFDA, 1–16.2010.

16. Andersen HB. Experience from the Danish reporting system. Paper presented at the 1st Nordic Patient Safety Conference, Stockholm, May 20th– 21st 2010.

17. Engleman D, Rich S, Powell T, Flack M. Medical Product Safety Network (MedSun) Collaborates with Medical Product Users to Create Specialty Subnetworks. In: K H, JB B, MA K, al. e, editors. Advances in Patient Safety: New Directions and Alternative Approaches (Vol 1: Assessment)2008.

18. Illingworth J. Protection or prosecution? Learning from Denmark. The Health Foundation [Internet]. 2013. Available from:

19. Geissler N, Byrnes T, Lauer W, Radermacher K, Kotzsch S, Korb W, et al. Patient safety related to the use of medical devices: a review and investigation of the current status in the medical device industry. Biomed Tech (Berl). 2013;58(1):67–78.

20. (ISO) IOfS. IEC 62366:2007 Medical devices: Application of usability engineering to medical devices. IEC [Internet]. 2015. Available from:

21. Vincent CJ, Blandford A. Usability standards meet scenario-based design: challenges and opportunities. J Biomed Inform. 2015;53:243–50. doi: 10.1016/j.jbi.2014.11.008 25460202

22. Altayyar SS. Medical devices and patient safety. J Anal Pharm Res. 2016;2(5).

23. (MHRA) MaHPRA. Report on devices adverse incidents in 2010. Device Bulletin DB2011 (02), Department of Health, London, UK [Internet]. 2011. Available from:

Článek vyšel v časopise


2019 Číslo 10