Mulheres na gestão de tecnologias e engenharia clínica: o caso dos ventiladores pulmonares na Covid-19 / Women in technology management and clinical engineering: the case of pulmonary ventilators at Covid-19

RESUMO O risco iminente de desabastecimento de ventiladores pulmonares nos serviços de saúde acarretou diversas frentes de trabalho para disponibilizar o maior número possível desses equipamentos para o tratamento dos pacientes acometidos. O agravamento da crise sanitária colapsou serviços de saúde com busca isocrônica por leitos. Em meio ao colapso, foi detectada nova variante da linhagem Sars-CoV-2 e confirmado o primeiro caso de reinfecção. Entre os pontos críticos, foi destaque a escassez caótica de oxigênio e taxas de ocupação de leitos acima de 90%. Pretende-se relatar a participação das autoras nas iniciativas para o enfrentamento da pandemia de relevância internacional. Destacar a participação de mulheres em atividades que são cruciais para responder, em tempo oportuno, às demandas oriundas de emergências sanitárias. Por meio de método de pesquisa de abordagem descritiva e exploratória, buscou-se verificar o perfil das mulheres atuantes na gestão de tecnologias no enfrentamento da pandemia. Destaca-se a pesquisa recente da Associação Brasileira de Engenharia Clínica que verificou que apenas 19% dos associados respondentes eram mulheres, enquanto 81% eram do sexo masculino. Assim, divulgar e dar amplo conhecimento das ações de mulheres nessa área pode colaborar para o alcance da igualdade de gênero e empoderar todas as mulheres e meninas.

ABSTRACT The imminent risk of shortage of pulmonary ventilators in health services has resulted in several work fronts to maintain and make available the largest possible number of equipment available for the treatment of patients. The worsening of the health crisis has collapsed health services with an isochronic search for beds. Amid the collapse, a new variant of the Sars-CoV-2 strain was detected and the first case of reinfection was confirmed. Among the critical points was the chaotic oxygen scarcity and bed occupancy rates above 90%. We intend to report the participation of the authors in the initiatives to face the pandemic; highlight the participation of women in activities that are crucial to respond, in a timely manner, to the demands arising from health emergencies. Through a research method with a descriptive and exploratory approach, we sought to verify the profile of women working in the management of technologies in facing the pandemic. The recent survey by the Brazilian Association of Clinical Engineering stands out, which found that only 19% of the respondent associates were women. Thus, disseminating and giving broad knowledge of women´s actions in this area can collaborate in achieving gender equality and empower all women and girls.

Principles for evaluating the clinical implementation of novel digital healthcare devices

With growing interest in novel digital healthcare devices, such as artificial intelligence (AI) software for medical diagnosis and prediction, and their potential impacts on healthcare, discussions have taken place regarding the regulatory approval, coverage, and clinical implementation of these devices. Despite their potential, ‘digital exceptionalism’ (i.e., skipping the rigorous clinical validation of such digital tools) is creating significant concerns for patients and healthcare stakeholders. This white paper presents the positions of the Korean Society of Radiology, a leader in medical imaging and digital medicine, on the clinical validation, regulatory approval, coverage decisions, and clinical implementation of novel digital healthcare devices, especially AI software for medical diagnosis and prediction, and explains the scientific principles underlying those positions. Mere regulatory approval by the Food and Drug Administration of Korea, the United States, or other countries should be distinguished from coverage decisions and widespread clinical implementation, as regulatory approval only indicates that a digital tool is allowed for use in patients, not that the device is beneficial or recommended for patient care. Coverage or widespread clinical adoption of AI software tools should require a thorough clinical validation of safety, high accuracy proven by robust external validation, documented benefits for patient outcomes, and cost-effectiveness. The Korean Society of Radiology puts patients first when considering novel digital healthcare tools, and as an impartial professional organization that follows scientific principles and evidence, strives to provide correct information to the public, make reasonable policy suggestions, and build collaborative partnerships with industry and government for the good of our patients.