RISK-BASED APPROACH IN THE MANAGEMENT OF MEDICAL DEVICE IN THE CARE OF CVD
Authors:   Federal State Budgetary Scientific Institution ", Milinevskiy Nikolay Igorevich ,   Research Institute of Complex Problems of Cardiovascular Diseases",   , Kemerovo Russian Federation, Kushch O. V. ,   Federal State Budgetary Scientific Institution "Research Institute of Complex Problems of Cardiovascular Diseases", Kemerovo Russian Federation, Artamonova G. V. ,   Federal State Budgetary Scientific Institution "Research Institute of Complex Problems of Cardiovascular Diseases", Kemerovo Russian Federation
Published: October 2023

Introduction. The use of equipment in the provision of medical care is associated with risks of harm to health and life with the likelihood of adverse events, for this reason, a risk-based approach is a prerequisite in modern realities. The goal is to identify the risks of operating medical equipment (MO) in a cardiac surgery clinic. Material and methods. The Research Institute for Complex Problems of Cardiovascular Diseases (NII KPSSZ) used the technique of failure cause and effect analysis (FMEA) to identify risks. By the number of points of the generalized quantitative characteristic of the risk of non-compliance (priority risk number - RPR), all risks are divided into levels: low, medium, high and catastrophic. The obtained data were systematized in the "Risk Passport", including: the definition of risk, its indicator, indicator, level, source. The cause and consequences of the risk, as well as measures to manage them are indicated. The whole process is formalized within the framework of the Quality Manual and documented QMS procedures. Results. Indicators of the equipment of the Ministry of Defense and the performance of the engineering service of the Research Institute of the KPSS for the period from 2012 to 2022 indicate a high load on the management system of the Ministry of Defense, in particular, an increase in the number of units of the Ministry of Defense (from 976 units to 2520 units, the average annual (chain) growth rate was 13%), carried out Maintenance (from 555 to 2361) and repair of the Ministry of Defense (335-897). In the process, 8 risks were identified, including two high levels (purchase of low-quality spare parts, consumables and improper operation of the MO). The consequences of high risks include: violations in the operation of medical equipment, reduction of service life, deterioration of performance, downtime, unscheduled maintenance, repairs and the risk of obtaining erroneous diagnostic results, injury hazard for personnel and patients. Consequence management includes: compliance with the procedure for acceptance of consumables and spare parts, organization of claims work, timely repairs, internal investigation of cases of violations. The medium level of risk includes “improper maintenance of the MO by the outsourcer’s personnel”, the consequences of which may also be a decrease in the resource and deterioration in performance, downtime for repairs. Measures to manage the causes of this risk were the development of technical specifications for the conclusion of a contract with qualification requirements. The low level of risk includes: delay in the procedure for preparing documents for write-off, the reasons for which are the short deadlines for completing the task, the limited horizontal links with related services, difficulties in identifying by the departments allowing the write-off; violation of the requirements for the terms of delivery of MO (the reason is the violation by the supplier of the manufacturer's requirements for the conditions of storage and transportation, violation of the delivery time); lack of conditions for launching a new MO (the reason is non-compliance with the procedure for organizing the purchase of equipment); MOs requiring verification may not be included in the lists, and some of the already verified equipment may mistakenly be included in the lists of verified measuring instruments (the reason is errors made in the preparation and approval of statements according to F3.5-15, F3.5-17); refusal of the CMS to verify the MO due to a malfunction or incompleteness (the reason is a violation of the procedure for preparing equipment for verification of the measuring instruments) - the control measure is the introduction of a pre-verification control of the technical condition. Conclusion. A risk-based approach when working with MO allows medical organizations to prevent, identify and prevent risks that pose a threat to the life and health of both patients and staff, to minimize the consequences of their occurrence by improving approaches to the implementation of medical activities.