Background Surgery is the main modality of cure for solid cancers and was prioritised to continue during COVID-19 outbreaks. This study aimed to identify immediate areas for system strengthening by comparing the delivery of elective cancer surgery during the COVID-19 pandemic in periods of lockdown versus light restriction. Methods This international, prospective, cohort study enrolled 20 006 adult (≥18 years) patients from 466 hospitals in 61 countries with 15 cancer types, who had a decision for curative surgery during the COVID-19 pandemic and were followed up until the point of surgery or cessation of follow-up (Aug 31, 2020). Average national Oxford COVID-19 Stringency Index scores were calculated to define the government response to COVID-19 for each patient for the period they awaited surgery, and classified into light restrictions (index <20), moderate lockdowns (20–60), and full lockdowns (>60). The primary outcome was the non-operation rate (defined as the proportion of patients who did not undergo planned surgery). Cox proportional-hazards regression models were used to explore the associations between lockdowns and non-operation. Intervals from diagnosis to surgery were compared across COVID-19 government response index groups. This study was registered at ClinicalTrials.gov , NCT04384926 . Findings Of eligible patients awaiting surgery, 2003 (10·0%) of 20 006 did not receive surgery after a median follow-up of 23 weeks (IQR 16–30), all of whom had a COVID-19-related reason given for non-operation. Light restrictions were associated with a 0·6% non-operation rate (26 of 4521), moderate lockdowns with a 5·5% rate (201 of 3646; adjusted hazard ratio [HR] 0·81, 95% CI 0·77–0·84; p<0·0001), and full lockdowns with a 15·0% rate (1775 of 11 827; HR 0·51, 0·50–0·53; p<0·0001). In sensitivity analyses, including adjustment for SARS-CoV-2 case notification rates, moderate lockdowns (HR 0·84, 95% CI 0·80–0·88; p<0·001), and full lockdowns (0·57, 0·54–0·60; p<0·001), remained independently associated with non-operation. Surgery beyond 12 weeks from diagnosis in patients without neoadjuvant therapy increased during lockdowns (374 [9·1%] of 4521 in light restrictions, 317 [10·4%] of 3646 in moderate lockdowns, 2001 [23·8%] of 11 827 in full lockdowns), although there were no differences in resectability rates observed with longer delays. Interpretation Cancer surgery systems worldwide were fragile to lockdowns, with one in seven patients who were in regions with full lockdowns not undergoing planned surgery and experiencing longer preoperative delays. Although short-term oncological outcomes were not compromised in those selected for surgery, delays and non-operations might lead to long-term reductions in survival. During current and future periods of societal restriction, the resilience of elective surgery systems requires strengthening, which might include...

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Páginas 90 a 107 91 qualidade relacionadas ao produto. Portanto, a certificação metrológica compulsória não é suficiente para garantir a qualidade das agulhas hipodérmicas, sendo necessário investimento em ações de Tecnovigilância.

Anticoagulant and preserving solutions are designed to maintain the viability of blood and blood components. Plastic bags used for human blood storage are classified as Class III product for health. The RDC No. 35 of June 12, 2014 is the legislation that describes the quality control of blood units in Brazil. According to the resolution of the physical and chemical tests to be performed on anticoagulants solutions is the determination of 5-hydroxymethylfurfural content (5-HMF), a highly toxic pollutant formed by thermal decomposition of glucose present in the solutions, which may lead the patient even to death, justifying the need for their control. This work aimed to optimize and validate the methodology for determining the 5-HMF as recommended by ANVISA and the Inmetro. The parameters analyzed in the analytical validation were: specificity, linearity, detection limit, quantification limit, accuracy, precision and robustness. The results showed that the method is very effective for determining the 5-hydroxymethylfurfural which culminated in their integration into technical regulations published in June 2014.Keywords: Analytical validation; liquid chromatography; quality control. ResumoAs soluções anticoagulantes e preservadoras têm o objetivo de manter a viabilidade do sangue e seus componentes. As bolsas plásticas utilizadas para armazenamento de sangue humano são classificadas como produto para saúde de classe III. A RDC n° 35 de 12 de junho de 2014 é a legislação que descreve o controle de qualidade das bolsas de sangue no Brasil. De acordo com esta resolução um dos ensaios físico-químicos que devem ser realizados em soluções anticoagulantes é a determinação do teor de 5-hidroximetilfurfural (5-HMF), um contaminante altamente tóxico formado pela decomposição térmica da glicose presente nas soluções, podendo levar o paciente até mesmo ao óbito, justificando a necessidade de seu controle. Este trabalho teve o objetivo de otimizar e validar a metodologia para determinação do 5-HMF conforme preconizado pela Anvisa e o Inmetro. Os parâmetros analisados na validação analítica foram: especificidade, linearidade, limite de detecção, limite de quantificação, exatidão, precisão e robustez. Os resultados encontrados comprovaram que o método é bastante eficaz para a determinação do 5-hidroximetilfurfural o que culminou com a sua inserção no regulamento técnico publicado em junho de 2014.Palavras-chave: Validação analítica; cromatografia líquida; controle de qualidade.