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22대 대한민국 국회 국회정보길라잡이 국회의원검색
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Title page 1

Contents 4

Preface 5

Acknowledgements 8

Abbreviations and acronyms 9

Executive summary 10

1. Introduction, purpose and scope 12

2. Methodology 14

3. Key objectives and operational priorities influencing how human milk banks should be organized 16

Providing a supply of donor human milk 16

Ensuring safety and quality 17

Facilitating lactation support to mothers 17

Optimizing costs 19

Fitting within the policy and regulatory framework 20

Respecting cultural and societal norms 20

4. Characteristics of human milk bank models 22

Overview of human milk banking model characteristics 22

Physical setting 22

Donor population 26

Distribution of donor human milk 29

Governance structure 32

Funding model 38

Shared operations with other medical products of human origin 41

5. Regulatory classification of human milk banking 45

DHM classification as a food 46

DHM classification as a medical product of human origin (MPHO) 48

DHM classification as a nutrition therapy or medical/functional food 50

DHM classification as its own class 51

6. A way forward 53

References 54

Annex. External expert group, stakeholder workshop attendees, and key informants for case studies 56

Tables 23

Table 1. Considerations related to physical setting 23

Table 2. Considerations influencing the location of HMB donors (in-facility versus community donors) 26

Table 3. Considerations for distributing donor milk to single sites versus multiple sites 30

Table 4. Considerations related to governance structure (centralized, decentralized or hybrid) 33

Table 5. Considerations related to funding structures 38

Table 6. Considerations for integrating HMB within services for other medical products of human origin 41

Case Studies 4

CASE STUDY 1. National human milk bank programmes designed to facilitate lactation support in Brazil and India 18

CASE STUDY 2. A low-cost approach to human milk banking in Uganda 19

CASE STUDY 3. A culturally responsive approach to human milk banking in the Islamic Republic of Iran 21

CASE STUDY 4. A hospital-based model of human milk banking in Kenya 29

CASE STUDY 5. The hybrid/coordinated governance model of the Human Milk Banking Association of North America 37

CASE STUDY 6. Integration of human milk banking and blood banking in Switzerland 44

CASE STUDY 7. Regulation of donor human milk as a food in Brazil 47

CASE STUDY 8. Regulation of donor human milk as a medical product of human origin in France 50

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