Medical Device Management Based on a Process Approach

Highlights Scientific novelty and practical significance of the presented work is seen in the relationship between the development of medical equipment management system and quality management in health care institutions and medical science. The application of the principles of international ISO 9001:2015 to the system of medical equipment management, which has its own special features in this industry makes the author’s approach unique. The role of the process approach in ensuring the sustainable functioning of medical equipment is shown in the study. The performance of the medical equipment management system based on the principles of international standard ISO 9001:2015 has been analyzed. The positive dynamics in terms of achieving the target performance indicators of this process in 2013–2021 is revealed. Aim . To analyze the experience of applying the process approach in the management of medical equipment based on the principles of the international standard ISO 9001:2015. Methods. The basis of the study was “Research Institute for Complex Issues of Cardiovascular Diseases” (NII KPSSZ). The object of the study is the quality management system of the Research Institute for Complex Issues of Cardiovascular Diseases. The subject of the study is the process of equipment and measuring instruments management. The main methods of this study were: system analysis, unity of historical and logical. The period of the study was 2013–2021. Results. The process approach in medical device management is considered within the framework of the quality management system of NII KPSSZ. During the study period there was an increase in equipment units by 2.58 times (from 976 to 2520 units, respectively, 2013–2021), which led to an increase in scheduled maintenance (SM) by 4.25 times (due to the introduction of pre-checking maintenance). The relative number of repairs to the total amount of equipment in different years amounted to 33.4–54.3% or on average 40.3%, the increase in current repairs of medical equipment relative to 2013 in 2021 amounted to 2.68 times. There is a positive dynamic in terms of decrease in the number of comments and increase in the number of proposals to improve the process during 2013–2021. Conclusion. The analysis of performance indicators in the period under the study indicates the determining role of the quality management system in ensuring the sustainability and stability of the medical equipment management system. The implementation of research tasks allowed the authors to form a holistic vision of the role of the process approach in solving the problem of finding effective organizational solutions that ensure the quality and safety of medical care. The presented experience can be replicated for any medical organization.