Prioritization of risks in thrombolysis catheter production process by KEMIRA-M method

Risk assessment is important for medical device manufacturing processes as well as for all production processes. Any risk related with medical devices may result in irreversible consequences. Risks occurring in medical devices may cause serious damage to the patient, the operator using the device and the environment. Successful application of a medical device to a patient is a very difficult and complex procedure Risk management in medical devices is extremely important for the entire process to be carried out meticulously. In this context, ISO 14971 standard has been developed for risk management for medical devices by the International Standard Organization (ISO). There are many medical devices used for treatment purposes in the health sector. Among these devices, catheters are widely used equipments in many fields of medicine. Although there are different types of catheters, according to their usage purposes and areas, thrombolysis catheters constitute the most widely used type of catheter. In this context, as in all medical devices, TS EN ISO 14971 standard is used in the production of thrombolysis catheters to perform risk analysis effectively. However, the approach suggested by the standard for risk assessment has some aspects that need improvement. The risk assessment approach proposed by the standard evaluates the risks that may arise in medical devices based on a qualitative risk matrix, which is based on severity and probability criteria. However, considering different qualitative and quantitative criteria in risk analysis will increase the sensitivity of the study. However, risk assessment is a process with a Multi-Criteria Decision Making (MCDM) structure. In MCDM problems, more than one alternative is evaluated by more than one decision-maker by considering more than one criterion. Accordingly, in risk assessment, more than one risk type is evaluated by a team, taking into account more than one risk . Accordingly, the types of risks that may arise during thrombolysis catheter production process were evaluated using Modified Kemeny Median Indicator Ranks Accordance (KEMIRA-M), a recent method among MCDM methods. In the KEMIRA-M method, risk criteria that are structurally similar can be grouped under separate groups, evaluation can be made regardless of the number of criteria, and qualitative and quantitative criteria evaluations can be used together. In addition, the criteria priorities of the experts can also be reflected in the decision process. Bringing all these advantages of KEMIRA-M to the medical device risk assessment process will contribute to both the practitioners and the literature.