The MSP approves technical standard for Human Milk Collection Centers

The Ministry of Public Health (MSP) approved and authorized the publication of the Technical Standard “Implementation and Operation of Human Milk Collection Centers” through Ministerial Agreement No. 00011-2026, signed on September 9, 2026, by Minister Juan Carlos Aveiga Parra. The instrument was published in the Supplement of the Official Registry No. 372 on Friday, September 18, 2026, spanning 73 pages, and is mandatory for health establishments of the National Health System (SNS) that have or implement these centers.

The agreement was signed under Executive Decree No. 446 of July 10, 2026, which designated Aveiga Parra as the highest health authority. The standard was developed by the Undersecretariat for Governance of the National Health System and the National Directorate of Quality, Patient Safety, and Sanitary Control, with contributions from professionals from public hospitals, the Ecuadorian Social Security Institute (IESS), and the National Police.

Background: a network of ten banks

The MSP promoted Human Milk Banks (HMB) with a pilot project at the Isidro Ayora Gynecology and Obstetrics Hospital (HGOIA) in 2007. Since then, the country has consolidated a national network of ten HMBs, distributed in Quito, Guayaquil, Cuenca, Ambato, Riobamba, Portoviejo, Chone, and Babahoyo.

The standard cites the National Survey on Child Malnutrition (ENDI) 2023-2024: 49.9% of children under one year of age started breastfeeding early, 53.1% of those under six months receive exclusive breastfeeding, and continued breastfeeding in girls and boys aged 12 to 15 months reaches 70%. It also incorporates the international recommendation of one milk bank for every 10,000 to 15,000 annual births.

Requirements for new centers

Human Milk Collection Centers (HMCC) will be logistically linked to the nearest HMB and must have five minimum zones:

• Registration zone.
• Changing zone.
• Preparation zone.
• Extraction zone.
• Storage zone (refrigeration).

The work team will consist of three people: a manager, a technician, and a driver. Processing, laboratory analysis, and pasteurization are the exclusive competence of the HMBs.

Cold chain, deadlines, and donors

• Raw human milk will be stored in exclusive freezers at -3 °C.
• Jars may remain in the HMCC for a maximum of twelve days, ideally seven.
• Transport to the reference HMB may not exceed six hours, with temperature recorded at the beginning and end of the journey.
• Mandatory tests for the donor are HIV, syphilis/VDRL, hepatitis B, and complete blood count, repeated every three months.
• Donation is free, voluntary, and gratuitous, and may not generate any economic incentive.

The standard includes 14 annexes with donor selection forms, informed consent, vial traceability, and non-conformity management. It also establishes a discarded milk indicator, with a baseline of 9.45% in 2025 and a progressive reduction goal to 5.00% by 2029.

Impact for newborns

The implementation of the HMLBs seeks to expand the availability of pasteurized milk for premature and hospitalized newborns, reduce the use of substitutes, and decrease neonatal morbidity and mortality. The National Directorate of Quality, Patient Safety, and Sanitary Control will evaluate the operability, quality, and safety indicators semi-annually, while provincial and district levels will conduct quarterly supervision of goal compliance.

Source: Official Registry, Supplement No. 372, Friday, September 18, 2026, p. 1 (official reference: Ministerial Agreement No. 00011-2026).