PROBLEMS RELATED TO FIRST AID EQUIPMENT: ORGANIZATIONAL AND LEGAL ASPECT
The article examines organizational and legal problems related to state registration, production, procurement and use of medical devices for first aid. The study significance is accounted for by the need to find solutions to problems related to equipping first aid activities with medical devices, which is becoming extremely important for the modern Russian society. Moreover, a comprehensive study of these issues has not been undertaken so far. The purpose of the study is to develop a set of proposals of an organizational and legal nature to improve quality of medical devices for first aid and equipping all potential participants of first aid delivery with such devices. To eliminate the problem of low equipment of potential participants of first aid delivery with the means of delivery, the composition of firstaid kits, packs, sets, and packages for all categories of participants have to be approval by the Ministry of Health of the Russian Federation. The authors also propose organizational and legal measures to improve interdepartmental and intradepartmental cooperation in this direction with the Russian Ministry of Health playing the coordinating role. The authors have also identified the need for improving the procedure for state registration of the production of first aid devices either though amending the Federal Law "On the Basics of Public Health Protection in the Russian Federation" regarding the provision that firstaid kits, packs, sets, and packages equipped with medical devices registered in the prescribed manner are not subject to state registration. As an alternative, the authors propose amendments and additions to the Rules of the state registration of medical devices, providing for a simplified state registration of firstaid kits, packs, sets, and packages. In addition, the authors name arguments in favor of improving the clinical trial procedure for first aid medical devices and propose changes to Article 38 of the Federal Law “On the Basics of Public Health Protection in the Russian Federation” in terms of eliminating the problems of legal techniques in the definition of the term “medical device” regarding first aid.