Assessing Medical Device Risks in Radiology Departments: A Critical Review

Authors

  • Ritesh Kumar Associate Professor, Department of Pharmaceutics,Sharda School of Pharmacy, Sharda University Agra, India
  • Dharmesh Sisodiya Assistance Professor, Department of Pharmacy, Indira Gandhi National tribal University, India
  • Anuj Kumar Sharma Professor & Deputy Dean, IIMT College of Medical Science, IIMT University, India
  • Vichitra Kaushik Principal, Shanti Niketan College of Pharmacy, India
  • Jashanjit Singh Associate Professor, Gurukul Institute of Pharmaceutical Sciences, Badesh Kalan, Khamanon, Fatehgarh Sahib, Punjab
  • Rupali Bhimrao Patil Assistant Professor, Shri Prakash Chand Jain College of Pharmacy Palaskheda, Jamner, Tal. Jamner, Dist. Jalgaon (Maharatra)
  • Ruchi Gupta Assistant Professor, Faculty of Life Sciences, Mandsaur University, Mandsaur, Madhya Pradesh
  • Durgesh kumari Gupta Assistant Professor, Rajiv Gandhi Institute of Pharmacy, Faculty of Pharmaceutical Science & Technology, AKS University, Sherganj Panna Road, Satna M.P

DOI:

https://doi.org/10.63278/10.63278/mme.v31.1

Keywords:

Risk Management, Medical Devices, Radiologists, Saudi Arabia.

Abstract

Background: This study explores radiologists’ perceptions of risks associated with medical devices in radiology departments within hospitals in Saudi Arabia. Given the increasing use of advanced medical technologies and devices in the healthcare sector, it is important to understand how healthcare professionals, particularly radiologists, perceive and manage these risks.

Methods: A total of 257 radiologists from hospitals across Saudi Arabia participated in the study. Data were collected through a self-administered online questionnaire designed to assess their perceptions of risk management practices and the effectiveness of current risk control measures in radiology departments. The data collected were analyzed using the Statistical Package for the Social Sciences (SPSS) to identify key trends and insights regarding the management of risks associated with medical devices in radiology.

Results: The results indicate that while most radiologists perceive their department's risk management systems to be effective, several areas need improvement. Many participants reported that formal risk management systems and committees are in place to oversee the control of medical device risks, but there are challenges in terms of policy clarity and the overall effectiveness of MoH regulations. Furthermore, predictive risk models were found to be used more frequently for electrical and overwork risks, while radiation dose risks were addressed less frequently.

Conclusion: The study reveals a generally positive perception of risk management practices among radiologists in Saudi Arabia, but gaps remain in policy clarity, risk prediction practices, and implementation. The results suggest that improving communication, improving the effectiveness of risk management policies, and increasing training and awareness of healthcare professionals could help mitigate risks associated with medical devices in radiology departments. These improvements could lead to safer healthcare environments and better patient outcomes.

References

Aljamali, N. M., Kadhium, A. J., & Al-Jelehawy, A. H. J. (2021). Review in protection of laboratory and electrical equipment in laboratories and institutions. Journal of Controller and Converters, 6(1), 24-30.‏

Al-Mazroua, S., & Al-Otaiby, N. (2020). Assessment of Radiation Exposure and Staff Dose in Interventional Radiology Procedures: A Prospective Study. Journal of Radiation Protection Dosimetry, 185(2), 112-125.

Almomani, H., & Aldaihani, A. H. (2021). Using Computerized Maintenance Management System (CMMS) in Roads Maintenance Operations. International Journal of Environmental Science, 6.‏

Al-Okshi, A., Theodorakou, C., & Lindh, C. (2017). Dose optimization for assessment of periodontal structures in cone beam CT examinations. Dentomaxillofacial Radiology, 46(3), 20160311.‏

Amoore J. N. (2014). A Structured Approach for Investigating the Causes of Medical Device Adverse Events. Journal of medical engineering, 2014, 314138. https://doi.org/10.1155/2014/314138

Aronson, J. K., Heneghan, C., & Ferner, R. E. (2020). Medical Devices: Definition, Classification, and Regulatory Implications. Drug safety, 43(2), 83–93. https://doi.org/10.1007/s40264-019-00878-3

Bercovich, E., & Javitt, M. C. (2018). Medical Imaging: From Roentgen to the Digital Revolution, and Beyond. Rambam Maimonides medical journal, 9(4), e0034. https://doi.org/10.5041/RMMJ.10355

Bogner, M. S. (Ed.). (2018). Human error in medicine. CRC Press.‏

Caverly, R. H. (2015). MRI fundamentals: RF aspects of magnetic resonance imaging (MRI). IEEE Microwave Magazine, 16(6), 20-33.‏

Chau, M. (2024). Enhancing safety culture in radiology: Key practices and recommendations for sustainable excellence. Radiography, 30, 9-16.‏

Chau, M. (2024). Enhancing safety culture in radiology: Key practices and recommendations for sustainable excellence. Radiography, 30, 9-16.‏

Chong, S. T., Robinson, J. D., Davis, M. A., Bruno, M. A., Roberge, E. A., Reddy, S., ... & Friedberg, E. B. (2019). Emergency radiology: current challenges and preparing for continued growth. Journal of the American College of Radiology, 16(10), 1447-1455.‏

Code, S. (2024). Safety Procedures for the Installation, Use and Control of X-ray Equipment in Large Medical Radiological Facilities.‏

Craciun, H., Mankad, K., & Lynch, J. (2015). Risk management in radiology departments. World journal of radiology, 7(6), 134–138. https://doi.org/10.4329/wjr.v7.i6.134

Cross, N. M., Hoff, M. N., & Kanal, K. M. (2018). Avoiding MRI-related accidents: a practical approach to implementing MR safety. Journal of the American College of Radiology, 15(12), 1738-1744.‏ ‏

de Paula Freitas, F. (2020). Radiation Safety Behaviours Among Small Animal Veterinary Radiography and Fluoroscopy Workers. Saskatoon: University of Saskatchewan.‏

European Society of Radiology (ESR. (2019). Patient safety in medical imaging: A joint paper of the European Society of Radiology (ESR) and the European Federation of Radiographer Societies (EFRS). Radiography, 25(2), e26-e38.‏

Ferner, R. E., & Aronson, J. K. (2020). Medical devices: classification and analysis of faults leading to harms. Drug Safety, 43, 95-102.‏

Fiedler, B. A. (Ed.). (2016). Managing medical devices within a regulatory framework. Elsevier.‏

Gatta, G., Di Grezia, G., Cuccurullo, V., Sardu, C., Iovino, F., Comune, R., Ruggiero, A., Chirico, M., La Forgia, D., Fanizzi, A., Massafra, R., Belfiore, M. P., Falco, G., Reginelli, A., Brunese, L., Grassi, R., Cappabianca, S., & Viola, L. (2021). MRI in Pregnancy and Precision Medicine: A Review from Literature. Journal of personalized medicine, 12(1), 9. https://doi.org/10.3390/jpm12010009

Hartley, R., Kinshuk, Koper, R., Okamoto, T., & Spector, J. M. (2010). The education and training of learning technologists: A competences approach. Journal of Educational Technology & Society, 13(2), 206-216.‏

Hermena, S., & Young, M. (2023). CT-scan image production procedures. StatPearls.‏

Hirshfeld, J. W., Ferrari, V. A., Bengel, F. M., Bergersen, L., Chambers, C. E., Einstein, A. J., ... & Wann, L. S. (2018). 2018 ACC/HRS/NASCI/SCAI/SCCT expert consensus document on optimal use of ionizing radiation in cardiovascular imaging: best practices for safety and effectiveness: a report of the American College of Cardiology Task Force on Expert Consensus Decision Pathways. Journal of the American College of Cardiology, 71(24), e283-e351.‏

Hoff, M. N., McKinney IV, A., Shellock, F. G., Rassner, U., Gilk, T., Watson Jr, R. E., ... & Kanal, E. (2019). Safety considerations of 7-T MRI in clinical practice. Radiology, 292(3), 509-518.‏

Holloway, M. D., Nwaoha, C., & Onyewuenyi, O. A. (Eds.). (2012). Process plant equipment: Operation, control, and reliability. John Wiley & Sons.‏

Huebner, C., & Flessa, S. (2022). Strategic Management in Healthcare: A Call for Long-Term and Systems-Thinking in an Uncertain System. International journal of environmental research and public health, 19(14), 8617. https://doi.org/10.3390/ijerph19148617

Hussain, S., Mubeen, I., Ullah, N., Shah, S. S. U. D., Khan, B. A., Zahoor, M., ... & Sultan, M. A. (2022). Modern diagnostic imaging technique applications and risk factors in the medical field: a review. BioMed research international, 2022(1), 5164970.‏

Hussain, S., Mubeen, I., Ullah, N., Shah, S. S. U. D., Khan, B. A., Zahoor, M., Ullah, R., Khan, F. A., & Sultan, M. A. (2022). Modern Diagnostic Imaging Technique Applications and Risk Factors in the Medical Field: A Review. BioMed research international, 2022, 5164970. https://doi.org/10.1155/2022/5164970

Hyman, W. A. (2018). Errors in the use of medical equipment. In Human error in medicine (pp. 327-347). CRC Press.‏

Ilyas, F., Burbridge, B., & Babyn, P. (2019). Health care–associated infections and the radiology department. Journal of medical imaging and radiation sciences, 50(4), 596-606.

Islam, S. M. S., Nasim, M. A. A., Hossain, I., Ullah, D. M. A., Gupta, D. K. D., & Bhuiyan, M. M. H. (2023). Introduction of medical imaging modalities. In Data Driven Approaches on Medical Imaging (pp. 1-25). Cham: Springer Nature Switzerland.

Jamshidi A, Rahimi SM, Ait-kadi D (2014) Medical devices inspection and maintenance; a literature review. In: Guan Y, Liao H (eds) Proceedings of the industrial and systems engineering research conference

Johnson, J. A. (2012, June). FDA regulation of medical devices.‏

Junaid, S. B., Imam, A. A., Balogun, A. O., De Silva, L. C., Surakat, Y. A., Kumar, G., Abdulkarim, M., Shuaibu, A. N., Garba, A., Sahalu, Y., Mohammed, A., Mohammed, T. Y., Abdulkadir, B. A., Abba, A. A., Kakumi, N. A. I., & Mahamad, S. (2022). Recent Advancements in Emerging Technologies for Healthcare Management Systems: A Survey. Healthcare (Basel, Switzerland), 10(10), 1940. https://doi.org/10.3390/healthcare10101940

Kim, H., Sefcik, J. S., & Bradway, C. (2017). Characteristics of qualitative descriptive studies: A systematic review. Research in nursing & health, 40(1), 23-42.‏

Lftta, J. G. J., Zahra, A. N. A. A., Ashour, A. H. J., Nasser, A. H. K., & Shanawa, A. N. (2024). X-Rays and Their Uses on The Human Body. Current Clinical and Medical Education, 2(8), 91-115.‏‏

Li, J., Mao, Y., & Zhang, J. (2022). Maintenance and Quality Control of Medical Equipment Based on Information Fusion Technology. Computational intelligence and neuroscience, 2022, 9333328. https://doi.org/10.1155/2022/9333328

Lobo, M. D., Miravent, S., & de Almeida, R. P. P. (2024). Emerging Trends in Ultrasound Education and Healthcare Clinical Applications: A Rapid Review. Emerging Technologies for Health Literacy and Medical Practice, 263-287.‏

Martz, H. E., Logan, C. M., Schneberk, D. J., & Shull, P. J. (2016). X-ray Imaging: fundamentals, industrial techniques and applications. CRC Press.‏

Mattox, E. (2012). Medical devices and patient safety. Critical care nurse, 32(4), 60.‏

Moyano, D. B., Paraiso, D. A., & González-Lezcano, R. A. (2022). Possible Effects on Health of Ultrasound Exposure, Risk Factors in the Work Environment and Occupational Safety Review. Healthcare (Basel, Switzerland), 10(3), 423. https://doi.org/10.3390/healthcare10030423

Nabrawi, E., & Alanazi, A. T. (2023). Imaging in Healthcare: A Glance at the Present and a Glimpse Into the Future. Cureus, 15(3), e36111. https://doi.org/10.7759/cureus.36111

Natella, R., Winter, S., Cotroneo, D., & Suri, N. (2018). Analyzing the effects of bugs on software interfaces. IEEE Transactions on Software Engineering, 46(3), 280-301.‏

Nayak, K. S., Lim, Y., Campbell‐Washburn, A. E., & Steeden, J. (2022). Real‐time magnetic resonance imaging. Journal of Magnetic Resonance Imaging, 55(1), 81-99.‏

Nguyen, T., & Tran, H. (2017). Evaluation of Occupational Radiation Exposure among Radiographers in Diagnostic Radiology Departments. Radiation Protection Dosimetry, 143(1), 32-45.

Nordenskjöld, A. (2018). Long-term health hazards from diagnostic X-ray exposure (Doctoral dissertation, Karolinska Institutet (Sweden)).‏

Northrop, R. B. (2017). Non-invasive instrumentation and measurement in medical diagnosis. CRC press.‏

O’Malley, P. (2014). Technology management in complex health care settings. Foundations of Clinical Nurse Specialist Practice, 331.‏

Odeh, Z., Abatli, S., & Qadi, M. (2023). Radiology Department: A Potential Source of Multidrug-Resistant Microorganisms: A Cross-Sectional Study at Tertiary Hospital, Palestine. The Canadian journal of infectious diseases & medical microbiology = Journal canadien des maladies infectieuses et de la microbiologie medicale, 2023, 4441338. https://doi.org/10.1155/2023/4441338

Panichello, J. J. (2017). X-ray repair: a comprehensive guide to the installation and servicing of radiographic equipment. Charles C Thomas Publisher.‏

Park, S., Kim, M., & Kim, J. H. (2022). Radiation safety for pain physicians: principles and recommendations. The Korean Journal of Pain, 35(2), 129-139.‏ ‏

Patey, S. J., & Corcoran, J. P. (2021). Physics of ultrasound. Anaesthesia & Intensive Care Medicine, 22(1), 58-63.‏

Power, S. P., Moloney, F., Twomey, M., James, K., O’Connor, O. J., & Maher, M. M. (2016). Computed tomography and patient risk: Facts, perceptions and uncertainties. World journal of radiology, 8(12), 902.‏

Rockall, A. G., Justich, C., Helbich, T., & Vilgrain, V. (2022). Patient communication in radiology: moving up the agenda. European Journal of Radiology, 155, 110464.‏

Salam, A., Wireko, A. A., Jiffry, R., Ng, J. C., Patel, H., Zahid, M. J., Mehta, A., Huang, H., Abdul-Rahman, T., & Isik, A. (2023). The impact of natural disasters on healthcare and surgical services in low- and middle-income countries. Annals of medicine and surgery (2012), 85(8), 3774–3777. https://doi.org/10.1097/MS9.0000000000001041

Scheek, D., Rezazade Mehrizi, M. H., & Ranschaert, E. (2021). Radiologists in the loop: the roles of radiologists in the development of AI applications. European Radiology, 31, 7960-7968.‏

Sehmbi, H., & Perlas, A. (2022). Basics of ultrasound imaging. In Regional Nerve Blocks in Anesthesia and Pain Therapy: Imaging-guided and Traditional Techniques (pp. 33-52). Cham: Springer International Publishing.‏

Sekkat, H., Madkouri, Y., Khallouqi, A., & El Rhazouani, O. (2024). Risk Management and Failure Analysis in Diagnostic X-ray Equipment: A Comprehensive Analysis and Novel Approaches for Failure Prevention and System Reliability. Journal of Failure Analysis and Prevention, 1-14.‏

Sharpe Jr, R. E., Mehta, T. S., Eisenberg, R. L., & Kruskal, J. B. (2015). Strategic planning and radiology practice management in the new health care environment. Radiographics, 35(1), 239-253.‏

Sinnott, B., Ron, E., & Schneider, A. B. (2010). Exposing the thyroid to radiation: a review of its current extent, risks, and implications. Endocrine reviews, 31(5), 756-773.‏

Smith, J., & Johnson, A. (2018). Assessment of Radiation Dose and Associated Risks from Computed Tomography Scans at a Tertiary Care Hospital. Journal of Radiological Sciences, 12(3), 45-56.

Smith, T., Quencer, K., Smith, T., & Agarwal, D. (2021). Radiation effects and protection for technologists and other health care professionals. Radiologic technology, 92(5), 445-458.‏

Srivastava, Y., Virk, S., Hazra, S., & Ganguli, S. (2021). An overview of the various medical devices for diagnosis, monitoring, and treatment of diseases. Electronic Devices, Circuits, and Systems for Biomedical Applications, 379-403.‏

Talapko, J., Talapko, D., Katalinić, D., Kotris, I., Erić, I., Belić, D., ... & Škrlec, I. (2024). Health Effects of Ionizing Radiation on the Human Body. Medicina, 60(4), 653.‏

Ventola, C. L. (2008). Challenges in evaluating and standardizing medical devices in health care facilities. Pharmacy and Therapeutics, 33(6), 348.‏

Vogel, D. A. (2011). Medical device software verification, validation and compliance. Artech House.‏

Wald, L. L., McDaniel, P. C., Witzel, T., Stockmann, J. P., & Cooley, C. Z. (2020). Low‐cost and portable MRI. Journal of Magnetic Resonance Imaging, 52(3), 686-696.‏

Wall, B. F., Haylock, R., Jansen, J. T. M., Hillier, M. C., Hart, D., & Shrimpton, P. C. (2011). Radiation risks from medical X-ray examinations as a function of the age and sex of the patient (pp. 12-13). Didcot: Health Protection Agency.

Winter, L., Seifert, F., Zilberti, L., Murbach, M., & Ittermann, B. (2021). MRI‐related heating of implants and devices: a review. Journal of Magnetic Resonance Imaging, 53(6), 1646-1665.

Wolbarst, A. B. (1999). Looking within: how X-ray, CT, MRI, ultrasound, and other medical images are created, and how they help physicians save lives. Univ of California Press.‏

Yang, E., Suzuki, M., Nazarian, S., & Halperin, H. R. (2022). Magnetic resonance imaging safety in patients with cardiac implantable electronic devices. Trends in Cardiovascular Medicine, 32(7), 440-447.‏

Matanda, E. (2022). Research Methods and Statistics for Cross-Cutting Research: Handbook for Multidisciplinary Research. African Books Collective.‏

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Ritesh Kumar, Dharmesh Sisodiya, Anuj Kumar Sharma, Vichitra Kaushik, Jashanjit Singh, Rupali Bhimrao Patil, Ruchi Gupta, and Durgesh kumari Gupta. 2024. “Assessing Medical Device Risks in Radiology Departments: A Critical Review”. Metallurgical and Materials Engineering 30 (4):26-48. https://doi.org/10.63278/10.63278/mme.v31.1.

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