Ways to Address the Unification of Medical Equipment Certification Systems in the UK, EU, and UA

Abstract

Viktoria A. Kondratenko* and Leonid Slovianov

A seemingly simple task—assessing the suitability of a given piece of medical equipment for use in healthcare—evolves into a complex and critical challenge when it involves a comprehensive evaluation, often in quantitative numerical terms, of both the harm and benefit to human health and the environment posed by each human-made device across the entire spectrum of its impact.

“... everything is poison, and everything is remedy...” (Paracelsus). The knowledge available to people in well- established areas of efficiency and safety assessment is formalized into standards and regulations. These are used by experts who are also professionally equipped with knowledge of potential environmental hazards associated with the use of the device. Experts may conduct various experiments and assess their outcomes. Although this process may seem straightforward, the main challenge lies not in the quantitative assessment of certain indicators, but in determining how to account for ALL significant harmful factors and their correlations with the beneficial effects of a particular device.

To address this issue, the authors propose the use of logical procedures—a methodology of automatic formal assessment— to serve as a theoretical evaluation preceding experimental research.

When analyzing medical equipment assessment procedures in the United Kingdom, the European Union, and Ukraine, with the aim of developing unified evaluation methods for these countries, the authors recommend the application of a logical formal assessment procedure. This proposal seeks to reduce the influence of subjective expert judgement in favor of a formal and objective assessment of the entire body of existing knowledge on the subject at a given point in time.

The proposed procedure for assessing the suitability of equipment for medical use does not exclude the experimental verification of particular conclusions. Rather, it introduces a formal theoretical evaluation process that can shorten both the current theoretical assessment procedures and the necessary volume of experimentation required to validate the formal theoretical evaluation. This is particularly important when assessments span a wide range of knowledge domains.

The focus of the article is on the provability of conclusions and the role of evidence as a driving force in the scientific development of industrially significant intellectual fields.

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