Skip to main content
Log in

Testing of Anesthesia Machines and Defibrillators in Healthcare Institutions

  • Systems-Level Quality Improvement
  • Published:
Journal of Medical Systems Aims and scope Submit manuscript

Abstract

To improve the quality of patient treatment by improving the functionality of medical devices in healthcare institutions. To present the results of the safety and performance inspection of patient-relevant output parameters of anesthesia machines and defibrillators defined by legal metrology. This study covered 130 anesthesia machines and 161 defibrillators used in public and private healthcare institutions, during a period of two years. Testing procedures were carried out according to international standards and legal metrology legislative procedures in Bosnia and Herzegovina. The results show that in 13.84% of tested anesthesia machine and 14.91% of defibrillators device performance is not in accordance with requirements and should either have its results be verified, or the device removed from use or scheduled for corrective maintenance. Research emphasizes importance of independent safety and performance inspections, and gives recommendations for the frequency of inspection based on measurements. Results offer implications for adequacy of preventive and corrective maintenance performed in healthcare institutions. Based on collected data, the first digital electronical database of anesthesia machines and defibrillators used in healthcare institutions in Bosnia and Herzegovina is created. This database is a useful tool for tracking each device’s performance over time.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3
Fig. 4
Fig. 5
Fig. 6

Similar content being viewed by others

References

  1. World Health Organization. (2009). WHO Guidelines for Safe Surgery, ISBN: 9789241598552

  2. Ministry of public Health Thailand. [online] Available at: http://eng.moph.go.th/ [Accessed February 2017].

  3. US Food and Drug Administration. (2016). [online] Available at: http://www.fda.gov [Accessed December 2016].

  4. Ronsmans, C., and Graham, W.J., Maternal mortality: Who, where, and why. Lancet. 368:1189–1200, 2006.

    Article  PubMed  Google Scholar 

  5. World Health Organization. (2012). WHO Size and distribution of the global volume of surgery in 2012. [online] Available at: http://www.who.int/bulletin/volumes/94/3/15-159293/en/ [Accessed November 2016].

  6. Wang, B., Furst, E., Cohen, T.K., Ridgway, O.R., Stiefel, M., and R., Medical equipment management strategies. Biomedical Instrumentation and Technology. 40(3):233–237, 2006.

    Article  PubMed  Google Scholar 

  7. Ziken International (2005). How to manage series for healthcare technology. - Guide 5, How to organize the maintenance of your healthcare technology. [online] Available at: http://www.cedglobal.org [Accessed November 2016].

  8. WHO (2011). Medical equipment maintenance programme overview. WHO medical devices technical series. ISBN 978 92 4 150153 8

  9. Analysis of the French health ministry’s. [online] Available at: https://goo.gl/rUHrx5 [Accessed November 2016].

  10. Check the Anesthesia Machine - Commentary by Daniel Saddawi-Konefka, MD, and Jeffrey B. Cooper, PhD. [online] Available at: https://psnet.ahrq.gov/webmm/case/312/check-the-anesthesia-machine [Accessed November 2016].

  11. The shocking truth about defibrillators. Available at: https://goo.gl/6EMrY8

  12. Iadanza, E., and Dyro, J. (2004). Clinical engineering handbook. Academic Press. ISBN: 9780122265709

  13. International Organization for Standardization (ISO). [online] Available at: www.iso.org [Accessed December 2016].

  14. International Electrotechnical Commission. [online] Available at: http://www.iec.ch/ [Accessed November 2016].

  15. Warning over faulty heart defibrillators. [online] Available at: https://goo.gl/wAKhSV [Accessed September 2016].

  16. Association for the Advancement of Medical Instrumentation. [online] Available at: https://Www.Aami.Org/ [Accessed December 2016].

  17. Feldman, M.D., Petersen, A.J., Karliner, L.S. et al. J GEN INTERN MED (2008) 23(Suppl 1): 57. doi:10.1007/s11606-007-0275-4

  18. Craig, J. and Wilson, M.E. (1983). Survey of Anaesthetic misadventures. Anaesthesia. 1981 Oct;36(10):933–6.

  19. Turner, M.J., Kam P.C., Baker A.B. (2004). Metrology in medicine. Department of anesthetics, University of Sydney. [online] Available at: https://goo.gl/0kJZw2 [Accessed September 2016].

  20. Lucatelli, M. V. et al. (2003). Clinical engineering and metrology in electro medical equipment. Metrology for life. Brazilian Society of Metrology (SBM)

  21. Ferreira, M. (2011). The role of metrology in the field of medical devices. 2nd international symposium on metrological infrastructure, Cavtat, Croatia

  22. American National Institute of Standards and Technology - NIST. (2011). Medical Device Interoperability [online] Available at: http://www.nist.gov/healthcare [Accessed September 2016].

  23. EURAMET - European Metrology Research Programme. [online] Available at: https://www.euramet.org/research-innovation/emrp/ [Accessed September 2016].

  24. Karaböce B, Gülmez Y, Akgöz M, Kaykısızlı H, Yalçınkaya B and Dorosinskiy L. Medical metrology studies at Tübitak UME, 17 international congress of metrology, published by EDP sciences, 2015

  25. Badnjevic, A., Gurbeta, L., Dzemic, Z., and Boskovic, D., Measurement in medicine – Past, present, future. Folia Medica Facultatis Medicinae Universitatis Saraeviensis Journal. 50(1):43–46, 2015.

    Google Scholar 

  26. Badnjevic, A. and Gurbeta, L. Development and perspectives of biomedical engineering in south east European countries, 39th IEEE international convention on information and communication technology, electronics and microelectronics (MIPRO), Opatija, Croatia

  27. Boskovic, D. and Badnjevic, A. (2015). Opportunities and Challenges in Biomedical Engineering Education for Growing Economies, 4th IEEE Mediterranean Conference on Embedded Computing (MECO), pp: 407–410, Budva, Montenegro

  28. Badnjevic, A., Gurbeta, L., Jimenez-Ruiz, E., and Iadanza, E., Testing of mechanical ventilators and infant incubators in healthcare institutions. Technology and health care. 25(2):237–250, 2017.

    Article  PubMed  Google Scholar 

  29. Gurbeta, L. and Badnjevic, A. (2016) Inspection process of medical devices in healthcare institutions: Software solution. Health Technol. (2017) 7: 109–117.

  30. Gurbeta, L. Badnjevic, A. Dzemic, Z. Jimenez-Ruiz, E. Jakupovic, A. (2016). Testing of therapeutic ultrasound in healthcare institutions in Bosnia and Herzegovina, 2nd EAI international conference on future access enablers of ubiquitous and intelligent infrastructures, Belgrade, Serbia

  31. Gurbeta L., Alic B., Dzemic Z., Badnjevic A. (2017) Testing of infusion pumps in healthcare institutions in Bosnia and Herzegovina. In: Eskola H., Väisänen O., Viik J., Hyttinen J. (eds) EMBEC & NBC 2017. EMBEC 2017, NBC 2017. IFMBE proceedings, vol 65. Springer, Singapore

  32. Gurbeta L., Alic B., Dzemic Z., Badnjevic A. (2017) Testing of dialysis machines in healthcare institutions in Bosnia and Herzegovina. In: Eskola H., Väisänen O., Viik J., Hyttinen J. (eds) EMBEC & NBC 2017. EMBEC 2017, NBC 2017. IFMBE proceedings, vol 65. Springer, Singapore

  33. Rules on metrological and technical requirements for these medical devices published in Official Gazette of Bosnia and Herzegovina (BH) No. 75/1

  34. Campbell, R.S., and Davis, B.R., Pressure-controlled versus volume-controlled ventilation: Does it matter? Respiratio Care. 47(4):416–426, 2002.

    Google Scholar 

  35. Fluke Biomedical Electrical Safety Analyzer. [online] Available at: www.flukebiomedical.com [Accessed September 2016].

  36. IMT Flow Analyzer. [online] Available at: www.imt.com [Accessed September 2016].

  37. Fluke Biomedical Impulse 7000DP Defibrillator analyzer. [online] Available at: www.flukebiomedical.com [Accessed September 2016].

  38. Zhao Wei, Shao Haiming, Lin Feipeng, Liang Bo and Ding Jiandong, "Energy calibration technique of defibrillator analyzer," 2015 12th IEEE International Conference on Electronic Measurement & Instruments (ICEMI), Qingdao, 2015, pp. 392–396. doi: 10.1109/ICEMI.2015.7494217

  39. Yang, S., and Yan, A.Y.K., Calibration of defibrillator analyzers. The Journal of Measurement Science. 10(4):50–55, 2015.

    Google Scholar 

  40. Tavakoli Golpaygani, A., Movahedi, M.M., and Reza, M., A study on performance and safety tests of defibrillator equipment. J Biomed Phys Eng:318–324, 2016.

  41. Mann, H.B., and Whitney, D.R., On a test of whether one of two random variables is stochastically larger than the other. Annals of Mathematical Statistics. 18(1):50–60, 1947.

    Article  Google Scholar 

  42. Mehta, S.P., Eisenkraft, J.B., Posner, K.L., and Domino, K.B., Patient injuries from anesthesia gas delivery equipment: A closed claims update. Anesthesiology. 119:788–795, 2013.

    Article  CAS  PubMed  Google Scholar 

  43. Cassidy, C.J., Smith, A., and Arnot-Smith, J., Critical incident reports concerning anaesthetic equipment: Analysis of the UK National Reporting and learning system (NRLS) data from 2006-2008. Anaesthesia. 66:879–888, 2011.

    Article  CAS  PubMed  Google Scholar 

  44. Quinn, C., Boult, M., and Hughes, G., An infusion of safety. Health Care Risk Report (UK). 10(2):12–15, 2004.

    Google Scholar 

  45. Squara, P., Imhoff, M., and Cecconi, M., Metrology in medicine: From measurements to decision, with specific reference to anesthesia and intensive care. Anesthesia and Analgesia. 120(1):66–75, 2015. doi:10.1213/ANE.0000000000000477.

    Article  CAS  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Almir Badnjevic.

Ethics declarations

Conflict of Interests

The authors hereby declare that they have no conflicts of interest.

Source of Funding Statement

No founding is received by any of the authors.

Additional information

This article is part of the Topical Collection on Systems-Level Quality Improvement

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Gurbeta, L., Dzemic, Z., Bego, T. et al. Testing of Anesthesia Machines and Defibrillators in Healthcare Institutions. J Med Syst 41, 133 (2017). https://doi.org/10.1007/s10916-017-0783-7

Download citation

  • Received:

  • Accepted:

  • Published:

  • DOI: https://doi.org/10.1007/s10916-017-0783-7

Keywords

Navigation