Application the Risk-Based Maintenance for Optimizing the Overall Medical Devices Safety

Khelood A. Mkalaf; Peter  Gibson

doi:10.51173/jt.v4i4.615

Authors

Khelood A. Mkalaf Technical Institute for Administration, Middle Technical University, Baghdad, Iraq https://orcid.org/0000-0001-9260-9865
Peter Gibson Faculty of Engineering and Information Science, University of Wollongong, NSW, 2522, Australia

DOI:

https://doi.org/10.51173/jt.v4i4.615

Keywords:

Overall Medical Device, Risk-Based Maintenance, Patient Safety, Reliability, Ventilator

Abstract

The purpose of this study was to identify risks to patients as a result of sudden device failure during the delivery of medical treatment services. Which, can affect the reputation of hospitals following the exposure of patients' lives to various risks like death, injury, and misdiagnosis. Furthermore, a sudden failure will lead to increased economic losses as a result of increased maintenance costs. Of (20) medical devices, (6) high-risk devices were selected, such as a ventilator, diathermy, anesthesia, BiPAP, oxygen concentrator, and electrosurgical devices. A quantitative statistical analysis based on risk-based maintenance is used to evaluate the effectiveness of the reliability of the medical device and its risks to patient lives. The results show that the reliability of the chosen medical device has declined, with higher maintenance costs due to excessive maintenance or the type of maintenance policy used. Therefore, this study provides evidence that hospitals must adopt a risk-based maintenance approach to prevent sudden failure while in service. In addition, these medical devices have various complex parts that must adopt a combination of maintenance schedules. Based on Risk-Based Maintenance's experience in improving patient safety in public hospitals in the 20 most successful OECD countries.

Downloads

Download data is not yet available.

Author Biography

Khelood A. Mkalaf, Technical Institute for Administration, Middle Technical University, Baghdad, Iraq

Dr. Khelood A. Mkalaf works with Middle Technical University. Iraq since 1989.
1. Head of Department of Materials Management Techniques. Technical Institute For Administration: Baghdad, Baghdad, IQ.
2. Member of the editorial board of the journal Technical. Middle Technical University. Iraq.
3. A Reviewer in the Journal "Materials Science Forum", 2020.
4. Member of the Technical Program Committee member of ICITM 2020. University of Oxford, United Kingdom.
5. Member of the Technical Program Committee member of ICEIT2020 and 2022. University of Oxford, United Kingdom.
6. Members of the Technical Committee and reviewers in the ICITM 2019 and ICITM 2021. University of Cambridge, United Kingdom.
7. Reviewer in the 2nd international conference on materials, Engineering, and science (IConMEAS 2019).

8. Reviewer in the 3rd international conference on materials, Engineering, and science (IConMEAS 2021).

References

Pazart, Lionel, Sylvia Pelayo, T. Chevallier, Gabriel Gruionu, Philippe Mabo, Yves Bayon, Frédéric Barbot et al. "Threats and Opportunities for the Clinical Investigation of High-risk Medical Devices in the Context of the New European Regulations." In Biodevices, 2021. pp. 274-284.

Tarricone, Rosanna, Oriana Ciani, Aleksandra Torbica, Werner Brouwer, Georges Chaloutsos, Michael F. Drummond, Nicolas Martelli, et al. "Lifecycle evidence requirements for high-risk implantable medical devices: a European perspective." Expert Review of Medical Devices 17, no. 10, 2020, pp. 993-1006.

Singh, Karnika, and Praveen Selvam. "Medical device risk management." Trends in Development of Medical Devices, 2020, pp. 65-76.

Górny, Adam, "Application of the FMEA method for the assessment of technical safety levels." In IOP Conference Series: Materials Science and Engineering, vol. 564, no. 1, 2019, p. 012091. IOP Publishing.

Mkalaf, Khelood A., Peter Gibson, and John Flanagan. "A Study of Current Maintenance Strategies and the Reliability of Critical Medical Equipment in Hospitals in Relation to Patient Outcomes." International Journal of Health and Medical Engineering Vol. (7). No. 10, 2013, pp. 2655-2662.

Badnjević, Almir, and Lejla Gurbeta Pokvić. "Medical devices maintenance." In Clinical Engineering Handbook, pp. 520-526. Academic Press, 2020.

Song, Wenyan, Jing Li, Hao Li, and Xinguo Ming. "Human factors risk assessment: An integrated method for improving safety in the clinical use of medical devices." Applied Soft Computing, Vol. (86), 2020, p.105918.

Sezdi, Mana. "Two different maintenance strategies in the hospital environment: preventive maintenance for older technology devices and predictive maintenance for newer high-tech devices." Journal of healthcare engineering, 2016.

Wang, B., E. Furst, T. Cohen, O. R. Keil, M. Ridgway, and R. Stiefel, "Medical equipment management strategies", Biomedical Instrumentation & Technology, Vol. (40), No. (3), 2006, pp. 233-237.

Gharahasanlou, Ali Nouri, Mohammad Ataei, Reza Khalokakaie, Abbas Barabadi, and Vahid Einian, "Risk-based maintenance strategy: a quantitative approach based on time-to-failure model."International Journal of System Assurance Engineering and Management, Vol (8), No. (3), pp. 602-611, 2017.

Wu, H. and G. Liu Building the quality control system for medical equipment in hospital, International Conference on Management and Service Science (MASS), 24-26 Aug. 2010, Wuhan, IEEE, 2010, pp. 1-4.

Khalaf, A. B., Y. Hamam, Y. Alayli and K. Djouani, "The effect of maintenance on the survival of medical equipment", Journal of Engineering, Design and Technology, Vol. (11), No. (2), pp. 142-157, 2013.

Khan, F. I. and M. M. Haddara, "Risk-based maintenance (RBM): A quantitative approach for maintenance/inspection scheduling and planning", Journal of Loss Prevention in the Process Industries, Vol. (16), No. (6), pp. 561-573, 2003.

Avendaño, G., P. Fuentes, V. Castillo, C. Garcia, and N. Dominguez, Reliability and safety of medical equipment by use of calibration and certification instruments, In Test Workshop (LATW), In the 11th Latin American, 28-31 March 2010 Pule del Este, IEEE, pp. 1-4, 2010.

Segal, B., D. Davis, C. Trueman, and T. Pavlasek, Risk of patient injury due to electromagnetic-interference malfunctions: Estimation and minimization, IEEE International Symposium on Electromagnetic Compatibility, 13 -17 Aug. 2001, Montreal, Que., IEEE, Vol. (2), 2001, pp. 1308-1312.

Ratnayake, R. M. C., and T. Markeset, "Technical integrity management: measuring HSE awareness using AHP in selecting a maintenance strategy", Journal of Quality in Maintenance Engineering, Vol. (16), No. (1), 2010, pp. 44-63.

Amuasi, J. and J. Crawley, Twinning over the internet: Medical equipment repair, Appropriate Medical Technology for Developing Countries, (Ref. No 002/057), IEE Seminar on, The Institution of Electrical Engineers, IET, pp. 12/11- 12/12, 2002.

Chompu-inwai, R., S. Tipgunta and A. Sunawan, Implementation of total productive maintenance in healthcare: A pilot study, International Conference on Service Systems and Service Management, Melbourne, VIC, IEEE, pp. 1-6, 2008.

Khalaf, A., K. Djouani, Y. Hamam and Y. Alayli, Evidence-based mathematical maintenance model for medical equipment, International Conference on Electronic Devices, Systems and Applications (ICEDSA), 11-14 April 2010, Kuala Lumpur, IEEE, pp. 222-226, (2010).

Mkalaf, K.A., Total Productive Maintenance: A Safety Approach to Optimize the Anesthesia Device Outcomes. In 2020 9th International Conference on Industrial Technology and Management (ICITM) IEEE. pp. 122-126, February 2020.

Wang, B. and A. Levenson, "Equipment inclusion criteria: a new interpretation of JCAHO's medical equipment management standard", JCE, Vol. (25), No (1), 2000, pp. 26-35.

Mitchell, R.J., Williamson, A. and Molesworth, B., Use of a human factors classification framework to identify causal factors for medication and medical device-related adverse clinical incidents. Safety Science, 79, pp.163-174, 2015.

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(4), pp.788-795, 2013.

Schulz, C.M., Burden, A., Posner, K.L., Mincer, S.L., Steadman, R., Wagner, K.J. and Domino, K.B., Frequency and type of situational awareness errors contributing to death and brain damage: a closed claims analysis. Anesthesiology, Vol. (127), No. (2), 2017, pp.326-337.

Gong, Y., Cao, X., Mei, W., Wang, J., Shen, L., Wang, S., Lu, Z., Yu, C., Che, L., Xu, X. and Tan, J., Anesthesia considerations and infection precautions for trauma and acute care cases during the Coronavirus Disease 2019 pandemic: recommendations from a task force of the Chinese Society of Anesthesiology. Anesthesia and analgesia, 2020.

Galar, D., Thaduri, A., Catelani, M. and Ciani, L., Context-awareness for maintenance decision making: A diagnosis and prognosis approach. Measurement, 67, pp.137-150, 2015.

Lee, J., Ni, J., Singh, J., Jiang, B., Azamfar, M., and Feng, J., Intelligent Maintenance Systems and Predictive Manufacturing. Journal of Manufacturing Science and Engineering, 142(11), p.110805, 2020.

Thomas, A.N. and MacDonald, J.J., A review of patient safety incidents reported as ‘severe or ‘death from critical care units in England and Wales between 2004 and 2014. Anaesthesia, 71(9), 2016, pp.1013-1023.