Modern approaches to the evaluation of mechanical medical devices for stopping bleeding (tourniquets) for use in combat conditions

Abstract

Traumatic bleeding remains the leading preventable cause of deaths on the battlefield. Mechanical tourniquets are a key part of pre-medical care in both tactical and civilian medicine. At the same time, the variety of models, differences in design, and variability in application conditions make it necessary to have a standardized, comprehensive, and evidence-based evaluation of these medical devices (MD). A promising tool for solving this problem is health technology assessment (HTA) approaches adapted to the specificities of the military environment.

Aim. To substantiate a comprehensive HTA-based approach to evaluating tactical mechanical tourniquets, which can be used to make informed management decisions regarding the approval of MD for use in tactical and civilian medicine, budget-funded procurement, etc.

Materials and methods. The study was conducted using the HTA methodology as an interdisciplinary approach to the analysis of tactical tourniquets. The source materials were scientific publications, international recommendations and protocols (in particular, CoTCCC), standards and regulatory documents of the FDA, EU MDR, ISO, as well as national regulatory and methodological acts of Ukraine in the field of the medical device evaluation. Analytical-descriptive, comparative, and structural-logical methods were used.

Results. The application of HTA as an interdisciplinary methodological basis for the comprehensive assessment of mechanical tourniquets in the Ukrainian healthcare system, taking into account the conditions of martial law, has been substantiated. The key HTA domains for tactical tourniquets have been identified, including functional and clinical effectiveness, safety, mechanical reliability, ergonomics, compliance with international standards, economic feasibility, and post-marketing surveillance. Particular attention is paid to the role of real-world data and the military medicine experience in forming the evidence base. An HTA matrix for evaluating mechanical tourniquets and an algorithm for making managerial decisions have been proposed. It has been shown that the integration of НТА with regulatory requirements and public procurement mechanisms ensures scientifically sound selection, standardization, and the rational use of tourniquets, contributing to improved safety, quality, and cost-effectiveness of medical care.

Conclusions. A comprehensive assessment of mechanical tourniquets cannot be limited to technical or laboratory tests alone. It should include the analysis of biomechanical effectiveness (in particular, the achievement of arterial occlusion pressure), clinical effectiveness based on real combat injury registries, cost-effectiveness assessment, and operational suitability in extreme conditions of use. The use of the HTA approach provides a scientifically sound basis for making managerial decisions in the military medical support system and contributes to the more efficient use of resources in the defense and healthcare sectors.