Evolution of sanitary control and risk assessment in blood establishments in manaus, the largest city in the pan-american amazon (2023–2025)
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1
Departamento de Vigilância Sanitária, Secretaria Municipal de Saúde de Manaus, MANAUS, Brazil
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Departamento de Vigilância Sanitária, Fundação de Vigilância em Saúde do Amazonas, MANAUS, Brazil
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Gerência de Sangue, Tecidos, Células, Órgãos e Produtos de Terapias Avançadas (GSTCO), Agência Nacional de Vigilância Sanitária, Brasília, Brazil
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Diretoria da Presidência, Fundação de Vigilância em Saúde do Amazonas - Dra. Rosemary Costa Pinto, Manaus, Brazil
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OPAS BRASIL, Organização Pan-Americana da Saúde (OPAS), Brasília, Brazil
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Subsecretaria de Vigilância Sanitária, Secretaria Municipal de Saúde de Manaus, Manaus, Brazil
Popul. Med. 2026;8(Supplement Supplement 1):
ABSTRACT
BACKGROUND:
Manaus, the largest city in pan-american Amazon, has 53.3% of the population in the state of Amazonas (AM) and has all the most complex healthcare services of the state, including the State Coordinating Blood Establishment. The city has 31 blood establishments (BEs); concentrates the majority of transfusions, as well as the production of blood components, but the reality of these BEs is marked by problems that classify most of them as High Potential Risk (HPR) according to the Potential Risk Assessment Methodology for Blood Establishments (MARP-SH). Therefore, National Health Regulatory System (SNVS) - ANVISA (national), DEVISA/FVS-RCP (state), and VISA MANAUS (municipality) - intensified BEs inspections, mapping risks and identifying opportunities for improvement through inter-institutional actions.
METHODS:
A retrospective longitudinal evaluation of all BEs in Manaus was conducted from 2023 to 2025. Each year, competent authorities inspected all BEs using the MARP-SH risk assessment methodology, classifying them from low to high risk. Two indicators were constructed: (1) mean interval between inspections per BE, reflecting monitoring capacity; and (2) annual average MARP-SH score, used to assess the impact of inspections on risk reduction and practice implementation.
RESULTS:
Between 2023 and 2025, Manaus demonstrated a substantial reduction in risk across BEs. The number of establishments out of HPR increased from five to 14, while the mean interval between inspections reduced from 1504 to 347 days; the annual average MARP-SH score increased from 39,2 to 54,5% and the majority of BEs (89,6%) demonstrated progress in risk assessment results.
CONCLUSIONS:
Such advances were possible due to coordinated actions among competent authorities, which enabled annual inspections of all establishments (100%). Furthermore, Inter-institutional collaboration represented essential support to guarantee progress in implementation of Good Practices in BEs of Manaus, constituting an experience that can be adapted and replicated in other complex contexts similar to the Amazon.