The implementation of priorities in the field of quality and safety of healthcare is supported at the international and national levels. The World Health Organization considers patient safety issues worthy of international attention, and the Russian Federation considers the increase in population, life expectancy, healthy life expectancy, the development of a quality management system of medical care, as well as the formation of new management decisions in this direction to be one of the main priorities for the development of healthcare. These positions make possible to speak about the importance of joint efforts of all participants of the healthcare system, including patients, medical workers, hospitals and insurance companies, state organizations in the field of healthcare. The formation and implementation of a national idea to ensure the quality and safety of healthcare with the participation of all stakeholders will ensure an optimal level of health care safety, will contribute to improving the quality and accessibility of medical care, as well as achieving the national goals of the Russian Federation.

The review describes the main points of the life cycle of a medical device, considers three stages of regulation of medical devices: pre-market, market and post-sale. The main attention is paid to post-sale supervision, as an activity for monitoring used medical devices, collecting information about the quality, safety and effectiveness of medical devices.

In the current conditions of the pandemic, the burden on the healthcare system, including the pharmacovigilance system monitoring the safety of pharmacotherapy, has significantly increased in all countries. An integral component in ensuring the safety of pharmacotherapy is the identification and prevention of the development of adverse drug reactions (ADR), which are a serious health problem worldwide. One of the modern problems of healthcare, including pharmacovigilance, was the lack of vaccines and drugs for the treatment and prevention of COVID-19 in the first waves of the pandemic, which led to the use of off-label a large number of drugs (hydroxychloroquine, azithromycin, ivermectin) for the treatment of patients with COVID-19 despite the fact that scientific data their benefits were of poor quality and based on in vitro studies. The accelerated approval of drugs and vaccines to combat the COVID-19 pandemic also highlighted the need for rapid data on the safety of drugs in the post-marketing period. However, despite the fact that pharmacovigilance is developing, it still lags behind the impressive scientific and technological achievements achieved in other areas of medicine. Unfortunately, spontaneous reporting does not assess the true prevalence of ADR well, since reporting indicators can vary significantly depending on the motivation, availability of time, qualifications, fear of punishment and similar factors of the sender. Given these known limitations of the spontaneous messaging method, additional strategies for detecting ADR are often used, including trigger tools, manual viewing of medical records and automated monitoring.

Safe in-hospital environment is a number one priority for any medical organization, with patients’ safety being the key indicator of satisfactory medical care provided. Nursing staff engagement into hospital safety strategy is critical in order for the strategy to function as needed with the best possible patient’s safety outcomes.

The adaptation of personnel in a medical organization is an integral part of the overall system of high-quality and safe medical activities, both in a specific medical organization and at the level of the subject of the federation. The current system of personnel training, the existing prejudices of graduates of medical universities regarding work in rural areas, the problems of securing specialists in medical organizations, especially in rural areas, make the issue of the need for effective adaptation of young specialists especially significant. A systematic approach and project management at the regional level make it possible to build an optimal system of adaptation of young employees in a short time and scale the experience of project participants, both in all medical organizations of the region and beyond.

The article presents the experience of organizing a system for managing the quality and safety of medical activities in the Primorsky Region, its development in accordance with current trends in the national policy of protecting the health of citizens in the Russian Federation. In accordance with the regional healthcare development strategy, a pilot project has been implemented since 2018, which includes a number of reasonable interrelated activities. A regional Competence Center in the field of quality and safety of medical activity was organized, closely interacting with the National Institute of Quality, mechanisms for financing the quality management system were developed. As part of the implementation of the regional project, a system for recording undesirable events in the Primorsky Region was developed and implemented. A regional model of the system for managing the quality and safety of medical activities has been adopted, and the principles of organizing the healthcare system in Primorsky Region have been described. The successes and difficulties of the project implementation are analyzed, the prospects for the development of a quality and safety management system for medical activities in the Primorsky Region are presented, taking into account the specifics of the geopolitical situation and demographic trends in the region.