Recurso poderá ser aplicado na conduta de Úlceras Venosas Crônicas, Úlceras Arteriais Isquêmicas, Feridas Infecciosas Agudas e lesões decorrentes do Pé Diabético
ÍCARO AMBRÓSIO – ASCOM (AMBRÓSIO COMUNICAÇÃO – icaro@ambrosiocomunicacao.com)
O Conselho Federal de Medicina (CFM) publicou a Resolução nº 2.445/2025 que autoriza e regulamenta o uso da Ozonioterapia em condições médicas específicas. De acordo com a nova norma, a Terapia poderá ser aplicada no tratamento de Úlceras Venosas Crônicas, Úlceras Arteriais Isquêmicas, Feridas Infecciosas Agudas e Lesões decorrentes do Pé Diabético.
Além disso, foi autorizada como tratamento adjuvante para Osteoartrite de Joelho e Dor Lombar causada por Hérnia de Disco. Em resumo, a Ozonioterapia utiliza uma mistura de Oxigênio e Ozônio, um Gás de Alta Capacidade Oxidativa Controlada, que apresenta efeitos antimicrobianos, moduladores da resposta inflamatória e de estímulo à oxigenação tecidual.
A autorização chega após anos de pressão de Entidades Médicas e Associações de Profissionais que defendem a prática. As primeiras solicitações de reconhecimento da Ozonioterapia no Brasil remontam a 2011. Desde então, o tema foi avaliado diversas vezes pelo CFM, sempre sob o crivo da falta de evidências científicas robustas.
“O cenário começou a mudar com a Lei Federal nº 14.648/2023, que permitiu o uso da Ozonioterapia como procedimento complementar em todo o território nacional. Cabia, no entanto, ao CFM definir critérios, limites e indicações médicas. Agora, com base em revisões sistemáticas e relatórios técnicos elaborados pelo seu Departamento de Ciência e Pesquisa, a autarquia decidiu regulamentar o procedimento”, esclarece o advogado Thayan Fernando Ferreira, Especialista em Direito de Saúde e Direito Público, membro da Comissão de Direito Médico da OAB-MG e diretor do escritório Ferreira Cruz Advogados.
Os estudos analisados pelo CFM indicam que a Ozonioterapia apresenta maior consistência de resultados em feridas crônicas, sobretudo no Pé Diabético, condição de alto impacto para a Saúde Pública. Revisões sistemáticas apontaram melhora na cicatrização, menor tempo de internação e redução de amputações. Já para a Dor Musculoesquelética, a eficácia é considerada de nível moderado. Ensaios clínicos mostram que as Injeções Intra-Articulares de Ozônio podem reduzir a dor e melhorar a função em pacientes com Osteoartrite de Joelho. Em relação à Hérnia de Disco, estudos sugerem benefício no alívio da Dor Lombar, mas os riscos de complicações exigem que a aplicação seja restrita a ambientes hospitalares e conduzida por especialistas.
“É preciso destacar que a Ozonioterapia não é autorizada para o tratamento de Cânceres nem de Feridas Neoplásicas, salvo em contexto de pesquisa clínica aprovada. O CFM deixa claro esse limite, em consonância com o princípio da precaução e da não maleficência na Medicina. Com essa Resolução, o Conselho cumpre sua função legal de disciplinar atos médicos, nos termos da Lei nº 3.268/1957 e do Decreto nº 44.045/1958, estabelecendo as condições seguras de uso”, explica o advogado.
A Resolução estabelece critérios técnicos e éticos rigorosos. O uso é considerado Ato Médico Exclusivo e deve ser precedido de diagnóstico Nosológico Preciso, para evitar riscos de uso inadequado. Além disso, a Norma determina que os equipamentos de Ozonioterapia devem ter registro regularizado na Agência Nacional de Vigilância Sanitária (Anvisa) e que os procedimentos sejam devidamente documentados em Prontuário Clínico. “O artigo 7º da Resolução nº 2.445/2025 é claro ao afirmar que a indicação de Ozonioterapia exige diagnóstico Nosológico obrigatório. Isso significa que apenas médicos habilitados podem prescrever e executar o tratamento, resguardando a segurança do paciente e a responsabilidade profissional”, finaliza Thayan.
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