Establishing a Human Milk Bank (HMB) in India requires meticulous planning and adherence to both medical standards and ethical guidelines. As India strives to reduce neonatal mortality rates, human milk banks are emerging as vital resources in neonatal care, providing critical support for premature and critically ill infants.
Here’s a step-by-step guide to successfully setting up a Human Milk Bank in India, ensuring compliance with essential regulations:
Understanding the Purpose
A Human Milk Bank serves as a facility for collecting, processing, testing, storing and distributing donor human milk to newborns who lack access to their mother’s milk. The goal is to provide safe, screened and pasteurized milk to improve survival rates and neonatal health outcomes.
Steps to Set Up a Human Milk Bank
1. Location Selection
Place the milk bank within a maternity hospital or NICU facility.
Ensure accessibility for lactating mothers, medical staff and safe logistics for milk handling.
2. Infrastructure and Equipment
Create dedicated spaces for:
Milk Collection: Hygienic areas for expression and storage.
Pasteurization & Testing: Holder pasteurizers (e.g., Sterifeed S90) and microbiological testing facilities.
Cold Storage: Deep freezers (-20°C), refrigerators (4°C) and sterile containers.
Documentation & Counseling Areas: Spaces to manage donor records and provide education.
Essential Equipment:
Electric/manual breast pumps, sterile storage bottles and milk analyzers (optional).
3. Staffing and Training
Employ trained professionals such as:
Lactation consultants, microbiologists, lab technicians and support staff.
Train personnel in aseptic techniques, donor screening, milk handling and record-keeping protocols.
4. Donor Screening and Consent
Accept milk from healthy, lactating mothers (no smoking or alcohol use, no infectious diseases).
Obtain written consent and conduct health screenings, including serological tests (HIV, Hepatitis B & C, Syphilis).
5. Collection, Testing and Pasteurization
Use sterilized containers for milk collection and maintain accurate labeling and logs.
Pasteurize using the Holder method (62.5°C for 30 minutes) and perform microbiological testing post-pasteurization.
Only distribute milk that passes all safety tests.
6. Documentation and Traceability
Maintain detailed records for donors, recipients, milk volumes, batch numbers and pasteurization details.
Implement strict labeling to ensure complete traceability.
7. Distribution Protocol
Dispense donor milk only under medical recommendation, typically for NICU babies (preterm, low birth weight, or critically ill).
Store milk at -20°C with a usage timeline of 3–6 months, as per ICMR guidelines.
Ensuring Compliance with Guidelines
Key Regulatory Bodies
--ICMR-NNF Guidelines (India): Framework for safe milk banking in hospitals.
--WHO & UNICEF Standards: Best practices for milk banking and neonatal nutrition.
--FSSAI Protocols: Ensuring hygienic handling and storage.
--Biomedical Waste Management Rules: For safe disposal of medical and biological waste.1
Building Awareness and Engaging Communities
Conduct education campaigns to promote breastfeeding and encourage milk donation.
Sensitize mothers, families and healthcare workers about the benefits of human milk banking.
Conclusion
Setting up a Human Milk Bank is a mission-driven initiative with the potential to save lives and transform neonatal care. By adhering to structured protocols and compliance guidelines, hospitals, NGOs and healthcare entrepreneurs can create facilities that operate ethically, efficiently and sustainably.
Through dedicated efforts in screening, safety and community engagement, Human Milk Banks are paving the way for better health outcomes for newborns and their families.
Comments
Post a Comment