GUIDELINES FOR THE

ESTABLISHMENT & OPERATION

OF HUMAN MILK BANKS

Compiled by

Infant and Young Child Feeding Subspecialty Chapter of Indian

Academy of Pediatrics

2013
 PREFACE
Though wet nursing had been in practice since mythological ages, modern
human milk banking is in its infancy in India. Lack of awareness, leadership
deficit, infrastructural and maintenance cost, fewer NICU setups etc are some
reasons for the same. The first milk bank in Asia under the name of 'Sneha',
founded by Dr. Armeda Fernandez, was started in Dharavi, Mumbai on
November 27, 1989. Currently number of human milk banks has grown to
nearly 14 in all over India but the growth of human milk banks have been very
slow as compared to the growth of new neonatal intensive care units. One of the
major reasons for loss of interest in human milk banking was the promotion of
formula milk by the industry. India faces its own unique challenges, having the
highest number of low birth weight babies and significant mortality and
morbidities in VLBW population. Keeping in mind the complications associated
with formula feeding to the sick tiny preterm neonates and mothers’ inability to
breastfeed in the initial period, there is a need to establish human milk banks
in all level II and level III facilities. Hence there is a need to formulate guidelines
for establishment and operation of human milk banks in our country.
Though these guidelines are based on the experience and guidelines from other
countries, changes have been made to suit Indian culture and needs without
compromising scientific evidences. It does not intend to present detailed
scientific literature but is an attempt to backup the execution of establishment
and operation of human milk banking with scientific methods.
This document aims at providing expert opinion in the country regarding the
feasibility and operational guidelines for establishing the milk banks. The
purpose of this document is to ensure quality of donated breastmilk as a safe
end product. It addresses detailed technical aspects, safety concerns and legal
aspects. It is expected that all Human Milk Banks operating in India use this
Guideline to address issues arising out of its functioning and socio-political
willingness and environment.
The Infant and Young Child Feeding Subspecialty Chapter of Indian Academy of
Pediatrics is actively concerned about the quality assurance of growing human
milk banking in the country and need to maintain uniformity so that best
outcomes are possible. The National Consultative Meeting for forming this
guideline was summoned by the Chapter at Gurgaon on 30th June 2013, with
representation from various stakeholders like Pediatrics Academia and
Practices, WHO, UNICEF, NIPPI, GOI, Human Milk Banks, Preventive and
Social medicine, PFHI, PATH, FOGSI and other NGOs. After an extensive
literature review and discussions sessions at the meeting these guideline has
been drafted. The Chapter is open to critical suggestions for betterment of the
guidelines and its updating.
IMPORTANT INFORMATION
While using this guideline it is advised that health care professionals take
responsible decisions appropriate to the individual situations using their
clinical and scientific judgment, in communication with donor and recipients’
parents and guardians and be informed about the updated information in doing
so.

It is advised to all the organizations using this guideline to make their own
individualized written Standards of Operations and protocols.

Human Milk Banks should include activities which protect, promote and
support breastfeeding. They should comply by the laws of the land including
IMS Act.
ABBREVIATIONS
AAP: American Academy of KMC: Kangaroo Mother Care
Pediatrics
LBW: Low Birth Weight
BMI: Body Mass Index
LSCS: Lower Segment Cesarean
CFU: Colony Forming Units Section
CMV: Cytomegalo Virus NEC: Necrotizing Enterocolitis
COO: Chief Operating Officer NGO: Non Profit Government
Organization
CSSD: Central Sterile Services
Department NICE: National Institute for Health
and Care Excellence
ECFR: European Council For Fatwa
And Research NICU: Neonatal Intensive Care Unit
ELBW: extremely low birth weight NRHM: National Rural Health
Mission
FIFO: First In First Out
OPD: Out Patient Department
GI: Gastro Intestinal
PDHM: Pasteurized Donor Human
GIT: Gastro Intestinal Tract
Milk
Hb: Hemoglobin
PNC Ward: Post Natal Care Ward
HIV: Human Immunodeficiency
PPH: Post Partum Hemorrhage
Virus
RDA: Recommended Dietary
HMASA: Human Milk Banking
Allowance
Association of South Africa
SOP: Standard Operating Protocol
HMBANA: Human Milk Banking
Association of North America UIPS: Uninterrupted Power Supply
HSV: Herpes Simplex Virus UNICEF: United Nations
International Children’s Emergency
HTLV: Human T lymphotrophic
Fund
Virus
VDRL: Veneral Disease Research
IgA: Immunoglobulin A
Laboratory
ILO: International Labor
VLBW: very low birth weight
Organization
WHO: World Health Organization
IMS: Infant Milk Substitute Act
 TABLE OF CONTENTS

INTRODUCTION............................................................................................................. 1
INFRASTRUCTURE FOR HUMAN MILK BANK..................................................... 2
Location of human milk bank ...................................................................................................... 2
Space requirement for milk bank ................................................................................................ 2
Space requirement for milk expression/collection ..................................................................... 2
Equipments required in the milk bank ........................................................................................ 3
Equipment required at site of milk expression & collection ....................................................... 5
Administration and Staff of the milk bank .................................................................................. 6
Cost approximation of setting up & running a milk bank ........................................................... 9
LEGAL & ETHICAL ISSUES IN HUMAN MILK BANKING ................................ 10
DONOR MANAGEMENT ............................................................................................ 12
Donor Population ...................................................................................................................... 12
Counseling and Motivating........................................................................................................ 12
Consent ...................................................................................................................................... 13
Screening ................................................................................................................................... 13
Donor Selection ......................................................................................................................... 14
Serological Testing ..................................................................................................................... 15
BREASTMILK EXPRESSION ..................................................................................... 17
Manual Breastmilk Expression .................................................................................................. 17
Use of electrical breast pump ................................................................................................... 20
COLLECTION OF BREASTMILK ............................................................................. 21
Ways of Collection ..................................................................................................................... 21
The process of collection ........................................................................................................... 22
Transport of donated milk to the human milk bank ................................................................. 23
DONOR MILK PROCESSING..................................................................................... 24
Microbiological Screening of Donated Milk .............................................................................. 24
Pasteurization of Donated Breastmilk....................................................................................... 25
LABELING, PRESERVATION AND DISBURSAL .................................................. 27
Labeling ..................................................................................................................................... 27
 Preservation and Storage .......................................................................................................... 27
Distribution/Requisition Process ............................................................................................... 27
Recipients .................................................................................................................................. 28
Guidelines for Use of Donor milk in the Hospital Setting.......................................................... 29
Complications from administration of donated milk ................................................................ 30
RECORD KEEPING & TRACKING .......................................................................... 31
FLOW OF EVENTS IN HUMAN MILK BANK ........................................................ 33
ANNEXURE-I: DONOR SCREENING PERFORMA ............................................... 34
ANNEXURE-II: CONSENT FORMS .......................................................................... 35
Donor’s Consent Form............................................................................................................... 35
Recipient’s Consent Form.......................................................................................................... 36
ANNEXURE- III: Equipment Specifications & use .................................................... 37
Deep Freezer ............................................................................................................................. 37
Pasteurizer/Shaker Water Bath ................................................................................................. 37
Hot Air Oven/ Autoclave Sterilizer ............................................................................................ 38
Breast Pumps ............................................................................................................................. 38
REFERENCES................................................................................................................ 45
RECOMMENDED READING...................................................................................... 52
 INTRODUCTION
Breastfeeding is best method of infant feeding, because human milk continues
to be the only milk which is uniquely suited to the human infant. All mothers
should be encouraged to breast feed their own infants. When a mother, for
some reason, is unable to feed her infant, her breastmilk should be expressed
and fed to her infant. If mother’s own milk is unavailable or insufficient, the
next option is to use PDHM. In our country the burden of low birth weight
babies in various hospitals is about 30% to 40% with significant mortality and
morbidities (1),(2),(3). Feeding these babies with breastmilk can significantly
reduce the risk of infections.

There has been a definite cost effectiveness of using banked human milk in
neonatal intensive care units observed in western countries largely by reduction
in the rate of NEC (4). In a country like ours, the cost of running a milk bank
with potential cost saving due to reduction in NEC, sepsis rate and duration of
hospital stay have not been adequately evaluated. Given the high incidence of
sepsis and a large burden of premature births, this intervention may have the
potential to result in substantial saving for the nation.

It is clear that artificial formula will never provide the broad range of benefits of
human milk. Given the high rate of preterm births in the country and level of
malnutrition that ensues in the postnatal growth in such babies after birth,
there is an urgent need for establishing milk banks across the country
especially in the large NICUs of all hospitals.

Hence the Government, health experts and the civil society must join hands to
propagate the concept of human milk banking for the sake of thousands of low
birth weight and preterm babies.

In 1980 the World Health Organization and UNICEF jointly declared: “Where it
is not possible for the biological mother to breastfeed, the first alternative, if
available, should be the use of human milk from other sources. Human milk
banks should be made available in appropriate situations.”(5) The American
Academy of Pediatrics (6) has stated that human milk is superior for infant
feeding and is the preferred feeding for all infants, including sick and premature
newborns, with rare exceptions. When direct breastfeeding is not possible,
expressed human milk should be provided. The United Kingdom Association for
Human Milk Banking (www.ukam.org) (7) and the Human Milk Banking
Association of North America (HMBANA) (www.HMBANA.com) have both
published guidelines for the establishment and operation of Human Milk
Banks. Much of the information contained in this document has been taken
from these Guidelines with modifications to suit Indian culture and feasibility.

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INFRASTRUCTURE FOR HUMAN MILK BANK

Location of human milk bank

Human milk banks are primarily focused to provide donor milk to high risk
newborns admitted in neonatal unit. Breastmilk is of special importance for
sick preterm and low birth weight infants who are admitted to N.I.C.U (8). The
recently published N.R.H.M. guidelines also recommend this concept (9).
Presence of human milk banks in the NICUs is associated with elevated rates of
exclusive breast feeding rates in VLBW babies (10). Therefore a location in close
proximity or even inside the boundaries of neonatal unit is desirable. This also
helps in administrative supervision by medical staff. Donors will be available
where large numbers of lactating mothers is present like postnatal wards of
government hospitals and medical colleges where they can be encouraged to
donate milk by medical and nursing staffs.
N.G.O’s and Spiritual organizations with the help of medical professionals can
encourage lactating mothers in the community to donate their milk to help the
high risk neonates. Certain NGOs who take care of abandoned babies may have
a human milk bank in their facility.

Space requirement for milk bank

There is no standard recommended size for a milk bank. The minimum
requirement is a partitioned room of 250 square feet that can comfortably lodge
at least the equipment required for milk banking, a work area for the technician
as well as some storage space for records, administration and area for
counselling donors etc.

Space requirement for milk expression/collection

It is recommended to have an area earmarked for milk expression and collection
where mothers can express milk comfortably. It can be either in the area
adjacent to NICU or post natal wards or in the well baby care follow up OPD.
Privacy is of paramount importance. Provision of music/television and a crèche
helps in reducing stress of mothers. Teaching videos of KMC, expression of
breastmilk and advantages of breastmilk feeding can be shown under
supervision of milk bank staff.
This area also should serve the general purpose where the mothers have an
opportunity to interact with the lactation support nurses or lactation
counselors to seek help & support for their lactation problems, interact with
other mothers, an area where mothers can express milk for their own babies as

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well as the area where hospital based collections from donor mothers can be
carried out.
Besides this it is also desirable to have an area within the NICU where mothers
can comfortably express milk for their babies if they are on
gavage/spoon/dropper feeds.

Equipments required in the milk bank

(See detailed specifications and using instructions in Annexure – III)

Pasteurizer/ Shaker-Water Bath

It is essential to have a device to carry out heat treatment of all available donor
milk at the recommended temperature of 62.5°C for a period of 30 minutes
(Holder pasteurization) prior to its use. This can be achieved using a
conventional pasteurizer. However a conventional pasteurizer is extremely
expensive and generally of dairy industry size and is often not suitable for the
quantity of milk to be pasteurized in a human milk bank.
A well accepted alternative is the use of a shaker water bath with a micro-
processor controlled temperature regulator, an electronic timer device and a
shaker speed controller for pasteurization of donor milk. The breastmilk in the
container is heated through the steam and hot water in the water shaker bath.
To avoid coagulation of the milk and to ensure even distribution of heat, the
tray on which the breastmilk containers are placed is shaken/ wobbled.
This shaker water bath should be double walled. The inner chamber should be
of stainless steel and the outer chamber can be of stainless steel or mild steel.
The size of the shaker water bath varies according to the need of the milk bank,
as per the number of containers that need to be pasteurized at one time, with
the tray capacity varying from 9 to 24 flasks/stainless steel containers of 200 to
400 mL capacity.

Equipments for Flash Heat Treatment

Where pasteurizer is not available, an effective low cost alternative called flash
heat treatment can be used for pasteurization. This has been shown to
inactivate HIV (11) in donated breast milk samples and has been found to be
nutritionally safe as well (12). This needs a simple heater or hotplate, a pan that
is used to boil water, in which a glass jar containing the breastmilk can be
placed. Water in the pan is heated till it is boiled. At this time milk reaches a
temperature sufficient for effective pasteurization (13). The process can be
monitored through a common android phone application along with a
temperature sensor (14).

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Deep Freezer
A deep freezer to store the milk at -200 C is essential in the milk bank. This may
be a vertical model with refrigerator-like shelves. Such models are available in
larger sizes of 285 to 300 liters. For smaller capacity deep freezers, the
horizontal models with racks can also be used.
It is desirable to order a deep freezer with a digital display of the temperature
inside the deep freezer with an alarm setting if the temperature rises above the
set temperature.
A separate deep freezer for preprocessed milk is needed to keep the donated raw
milk which awaits pasteurization.
It is desirable to have two deep freezers for processed milk:
1. First for storage awaiting culture: It is used for storage of the milk till the
post pasteurization milk culture reports are available. This freezer should
be locked at all times with access only to the technician, so that no milk is
accidentally used till the culture reports are available.
2. The second deep freezer is used for storage of the pasteurized milk once
the culture reports are available and are negative and the milk is
considered safe for disbursement.
In case of space constraints, different shelves of the same deep freezer may be
earmarked for storing milk with reports available and those awaited but must
strictly be operated by the milk bank technician with no access to the end user
unit staff.

Refrigerators
Separate refrigerators are required for:
1. To store the milk till whole day’s collection is over and ready to be mixed
for further processing. (In case where separate deep freezer is not
available for this purpose)
2. Thawing the milk that is to be dispatched for use.

Hot Air Oven / Autoclave

A hot air oven / autoclave in the milk bank or centralized service is essential for
sterilizing the containers used for collection from donors, containers for
pasteurizing and storing the milk, and the test tubes needed for sending milk
culture samples to the microbiology lab. CSSD facility of the hospital can be
utilized for this purpose.

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Generator / Uninterrupted Power Supply

Every milk bank should have a dedicated source of uninterrupted power supply
in the form of a generator, UIPS or inverter to run the deep freezers &
refrigerators in case of electricity failure.

Additional desirable equipments

It is desirable to have a milk analyzer using infra-red spectroscopy technology,
for macro nutrient analysis of breastmilk to estimate the calorie, protein & fat of
a milk sample, in teaching hospitals as a step towards lacto engineering.

Equipment required at site of milk expression & collection

Breastmilk pumps
Different types of milk pumps are available including manual, battery operated
or electrical (for specifications see annexure III)
• For milk banking hospital grade electrical pumps are preferred as they
result in better volumes of expressed milks and are relatively painless and
comfortable to use. There is no major difference in the types of electrical
breast pumps (15). Electrical breast pumps are very effective for long term
expression as they create a pumping rhythm similar to that of a sucking
baby and may elicit the milk ejection and prolactin reflexes more efficiently.
However the problem of these breast pumps is that they are costly and can
cause damage to mother’s nipple if suction pressure is too high.
• If there are cost constraints, Manually operated breastmilk pumps designed
to operate more physiologically by simulating the infant's compressive action
on the areola during breastfeeding can be used with lower cost implications
(16). As a piston type of milk pump costs around Rs. 2000/- per pump, it is
cost effective to have several of these for breastmilk expression as they can
be reused.
• Breast pumps can be a source of infection (17) and hence pump and its
parts should be sterilized / disinfected properly as per manufacturer's
instructions.
• The bicycle horn type of milk expression pumps should never be used as
they are difficult to keep clean.

Containers for milk collection & storage

• All containers must be labeled properly.
• Containers should not be filled full as milk expands when frozen.
• Containers should have tight fitting/screwable lids to avoid spillage.

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Different collection & storage containers that are used include:

• Polythene milk storage bags are fragile, easily punctured and it is difficult
to pour milk from them. Also the risk of contamination is greater (18). Milk
bags should not be used for milk storage. They are associated with loss of
lipids and vitamins and there is a risk of contamination, although some
studies have challenged the loss of lipids (19).
• Hard plastic containers of polycarbonates, pyrex or propylene are used in
many milk banks abroad. They do not interact with nutrients and cellular
components of milk. However lactoferrin, lysozyme & the titers of S-IgA and
antibodies to E.Coli have been observed to be reduced significantly. However
these containers need to be used carefully as they may crack easily. They
have to be discarded after single use because with repeated use of poly-
carbonate plastic containers, there is a fear of increased migration of
bisphenol-A into the milk, posing hazards to babies.
• Stainless steel containers of cylindrical shape and wide mouth with
capacity of about 200 mL and tight fitting/screwed caps are used In
developing countries, as they are easily available and are durable, easy to
clean and autoclave. Experience at the Indian milk banks shows that
stainless steel containers are most suitable containers in Indian
circumstances. There is no significant decrease in nutrient composition on
storage; however, cellular components are reduced.
• Glass containers can also be used but then be checked for chipping. They
can be re-used but have to be well washed and sterilized or washed on high
temperature cycle in a washer like dishwasher.

Administration and Staff of the milk bank

Human Milk Banks should have a panel of consultants to guide overall
development and functioning. It can include representatives from the areas of
pediatrics/neonatology, lactation, microbiology, nutrition, public health and
food technology. In cases of banks established by NGOs there can be a
governing body headed by a Director.

1. The Director
Generally, the head of the neonatal services serves as the Milk Bank Director
who is overall in-charge of milk bank and whose role is planning, developing,
implementing and evaluating milk bank services. This is a part time position
involving no extra cost.

2. Milk Bank Officer /Chief Operating Officer

Milk Bank Officer is usually a doctor preferably from public health and
responsible for overall day to day functioning, administration, training,
promotion and updating of the milk bank, taking consents from donor and

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recipients and taking decisions on medical technical and nontechnical

administrative aspects. S(he) has to report to the head of the unit.

3. Lactation Management Nurses

For milk banking to become established and effective, the lactation
management nurses play a pivotal role. This is a full time job.
There should be at least one dedicated lactation nurse whose primary job is to
help mothers with lactation problems, to motivate mothers to donate milk, to
organize the milk collection, to dispatch the donated milk to the bank & to
ensure cleaning, disinfection and sterilization of pumps and other equipments
as required.
Depending on the work load of the bank and to ensure collection in different
areas like the postnatal wards, well-baby clinic, additional dedicated lactation
nurses may be required.

4. Milk Bank Technician

Milk Bank Technician looks after all the day to day activities in the milk bank,
is responsible for pasteurization of milk, microbiological surveillance, collection
of culture reports, maintenance of records and disbursement of milk.

5. Milk Bank Attendant

Milk Bank Attendant’s job is to clean and sterilize the milk containers and
breastmilk pumps, to transport the milk to the milk bank from the collection
sites, to take samples for culture to the microbiology department and to collect
the reports; to maintain hygiene levels in the office and other rooms.

6. Microbiologist
Microbiologist carries out the cultures and sends the reports to the milk bank.
If there is an infection control committee in the hospital then infection control
microbiologist may share this workload and be responsible for infection control
practices including screening of donors.

7. Receptionist cum Record keeper

• Counsels women who come to milk bank and maintains Counseling Register
containing data updated about women counseled, who agreed to donate,
who will get back to the bank etc.,
• Does documentation filing and maintenance of the Donor Record Files and
Recipient Record Files,
• Maintains inventory of stationery items used in the office,
• Maintains comfort and decorum of waiting area.

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Minimum staff requirement:

• If it is not feasible to have all the above staffs, then basic minimum staffs
required are Lactation Management Nurse and Milk Bank Technician.
Sister-in-charge of NICU can co-ordinate the collection and transport of milk
to the bank and regular hospital attendant can take up the job of cleaning.
Technician can maintain the records of collection and disbursal. Unit head
can be overall in charge for the functioning of the bank. Microbiology work
can be shared with the regular hospital microbiology staff.

General guidelines for staff

• Gloves should be worn and changed between handling raw and heat-treated
milk.
• Staff should adhere to the SOP of the milk bank which should be displayed
at proper places as in case of a NABL accredited laboratory.
• Staff should follow hygienic practices like proper hand wash, donning
gowns, mask, gloves, trimming nails, locking long hairs.
• Staff should undergo regular health checks and be immunized against
Hepatitis-B.

Training of personnel working in milk banks

A formal training course for all technical staffs is required in lactation
management, breastfeeding support and promotion, and communication skills.
Receptionist and other staffs involved in non medical work should also undergo
training in communication skills and breastfeeding support and promotion.
Visit to a well established functioning milk bank by the team of doctor, nurse
and technician and microbiologist for 2 to 3 days observing and understanding
all the steps of milk banking should be a part of training of staff of milk banks
being newly established.
All milk bank staffs should be given ongoing training related to their job
responsibilities and record of it should be maintained.
At the end staffs should
• fully understand the technical aspects of their jobs,
• fully understand how the milk bank, its health, safety and quality system
works,
• fully understand the regulatory, legal and ethical aspects of their work,
• be competent in doing their jobs.

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Cost approximation of setting up & running a milk bank

• Deep Freezer: Rs.40,000 to 1 lakh
• Pasteurizer: Rs. 40,000 to 1 lakh
• Refrigerator: Rs. 25,000
• Milk Pumps with adequate lacta sets: Rs. 60,000 to Rs. 1 lakh
• Hot air Oven: Rs. 50, 000
• UPS / generator: 1 to 2 lakh.
• Total: 3 to 6 lakhs.
• Recurring Cost: Staff salaries - 10 to 12 lakhs per year.
• No financial incentives to donors, no cost to recipients.

A majority of banks have voluntary donors. In North America, not for profit milk
banks (HMBANA) are generally hospital based and sometimes community
based, function independently, and are operated with hospital or grant funding.
Each bank charges a processing fee for dispensed donor milk ranging from $ 3
to $5 per ounce (20). Most milk banks in India are not charging for the
collection or dispensing of milk. The donation is voluntary and donors are not
paid for it.

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 Legal & Ethical Issues in Human Milk Banking

LEGAL & ETHICAL ISSUES IN HUMAN MILK

BANKING
The human milk or breastmilk must be provided to those children who are
compromised or in vulnerable state of health because of their nutrition and
body needs. One of the major issues milk banking faces is the possibility of
transmission of an infectious disease via the donated milk. Parents may fear
accepting donated milk for this reason, while doctors may feel that the benefits
of donated milk are outweighed by the possible legal implications (21). Getting
the best possible start in the life is the birth right of each and every newborn
baby. Similarly giving the best possible nourishment to its offspring is the right
of each and every mother. These rights are protected not only under the
Constitution of India in the Article 47, which states that it is the duty of the
state to raise the level of nutrition and the standard of living and to improve
public health but also under the Convention on the Rights of the Child 1989,
the Innocenti Declaration 1990, the International Code 1981, the ILO convention
2000, the IMS Act 1993 as amended in 2003 and the various World Health
Assembly resolutions declared from time to time.
WHO and UNICEF, made a joint statement in 1980: "Where it is not possible for
the biological mother to breast feed, the first alternative, if available, should be
the use of human milk from other sources. Human milk banks should be made
available in appropriate situations." (5)

Legal and ethical issues related to human milk banking are:

1. Establishment of human milk bank: At present there are no laws
governing human milk banks in India. France is the only country where
human milk banks are governed along with blood banks. Therefore every
neonatal unit can establish a human milk bank on its own after obtaining
appropriate permission from their respective institutes/hospitals.
2. Payments to the donor: Whereas most milk banks run on free voluntary
donations from mothers, some donors can be paid their cost of travel and
screening charges. A milk bank cooperative in USA pays 1$ /oz of milk
supplied (22).
3. Commercialization of human milk bank: Efforts to setup a company
that sells human milk bank have been made in past (23). The government
must ensure that such activities are nipped in the bud.
4. Claims on transmission of infection:
a. Due to feeding of donated milk from milk bank in the event of an
outbreak due to contamination of supplied milk: There is only a single
report of outbreak due to contamination of pasteurizer so far in the
literature (24).

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b. However, it is a potential problem and should be taken care of during

the process of informed consent to the family of the recipient. Failure to
do so and document it may lead to legal problems.
c. Due to feeding of donated milk from milk bank in the event of a baby
contracting a hospital acquired infection while still in neonatal unit:
This aspect must be taken care during information sharing and
consent taken from recipient’s parents.
d. Due to feeding from milk bank after discharge of a baby if a baby
develops infections known to be transmitted through breastmilk. This
aspect must be taken care during information sharing and consent
taken from recipient’s parents.
5. Religious issues like milk kinship among Muslims: This issue has been
debated among Muslim scholars. There is no unanimity of opinion.
However, European Council for Fatwa and Research (ECFR) in 2004 has
accepted donation by Muslim mothers and acceptance of milk by Muslim
baby as legal. Most countries in Arab world have not accepted this idea
(25). At present there is no official position among Indian Muslim scholars
on it.
6. Duration of keeping records of the donors and recipients. HMBANA
recommends that records of donor and recipients be stored till the
recipient is of 21 years age (26). Whereas NICE guidelines recommend that
records be kept till the recipient is 30 years old (7). As incubation period
for most infection varies from a few weeks to six months and appearance of
symptoms is faster in infants and children, there seems to be no rationale
for keeping records beyond five years, unless one is working in an area
where milk kinship issue is of paramount importance. In India the blood
bank records are retained for a minimum period of five years (27).
Therefore, the donor mother as well as recipient mother should be counseled
and informed written consent should be obtained for both donation of milk from
donor and for feeding the donated milk from recipients’ parents. There is need
to provide quality assured safe human milk to the recipient.
There is need for the government and the policy makers to frame the guidelines,
legislations and rules so as to protect the rights of the mother and child. There
is every possibility that the breastmilk i.e. “Liquid Gold” can be sold in the
commercial market once it is available in the milk banks. The government
should ensure that there is no commercialization of human milk by various
stake holders specially the multi-nationals.
The gender discrimination and exploitation of the mother and misuse of the
human milk must be prevented at all cost.

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 Donor Management

DONOR MANAGEMENT

Donor Population
The mothers, who are lactating and willing to give extra breastmilk for other
babies without compromising the nutritional needs of their own baby, form the
donor population. They may be:
• Mothers who have babies admitted in the neonatal unit or wards,
• Mothers who come to attend outdoor department for well baby care,
immunizations and other ailments,
• Lactating staffs working in the hospital,
• Mothers who have lost their babies or cannot give milk to their own babies
due to some reason but are willing to donate their breastmilk voluntarily,
• Lactating mothers motivated by community and other awareness means.
Human Milk Banks should have policy of taking breastmilk donations on
voluntary basis. Donors are not paid for their donation.

Counseling and Motivating

Maximum donor population should be reached using variety of avenues.
Spreading awareness about possibility of breastmilk donation in society by
various means of mass communication can help motivating donors.
Possible routes of recruiting donors can be:
• Those who have already donated and by their recommendation
• Staff of NICU/PNC ward/Pediatric clinics
• Pregnancy and child birth educators/counselors and their class attendees
• Breastfeeding support groups especially women’s social clubs
• Mass Medias
Counseling and motivation sessions may be conducted by health care workers,
lactation experts, trained nurses or social workers in groups or individually in
post-natal wards, nurseries, outdoor departments, immunization clinics and
social group’s gatherings. Involvement of NGOs and formation of peer groups
can also help a lot.
Counseling may be verbal or aided by pictures, posters, videos, role plays and
utilization of various media.

The donor mothers should be counseled regarding:

• The need and efficacy of donated human milk and its benefits to the
recipient baby without harming her own baby,

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 Donor Management

• Donor evaluation prerequisites: the process of screening, giving authentic

medical records, serologic testing and her physical examination for medical
conditions mentioned in donor selection criteria,
• Procedure of consent,
• Process of breastmilk collection, transport to the milk bank, processing,
storage and disbursal of donated milk to the needy babies,
• Maintenance of lactation and tackling with problems related to it.
Potential donor can be counseled in person or telephonically. Generally a face to
face communication along with video on the process of breastmilk collection is
most effective method of counseling as it provides opportunity for answering the
questions of donor mothers and alleviates anxiety.
Counseling and consent document should be preferably in local language easily
understood by the one being counseled or addressed. It should be in clear and
non-technical language.

Consent
After counseling and motivating donor mother’s written informed consent
should be obtained. Donor mothers should know about the process of milk
donation, medical screening and serologic testing and have to understand that
they have no claim over the donated milk once donated. Records need to be
maintained for 5 years as recommended by blood banks5. (See consent forms –
Annexure-II)

Screening
After counseling, motivation and consent, the donor mothers should be
screened for suitability of donation by reviewing her health records and asking
relevant questions regarding criteria mentioned in the section of donor selection
below. The following should be enquired and documented before breastmilk
collection in a donor screening Performa (see Annexure - I) (7):
1. Health of the donor mother’s own baby.
2. Historical data of drug intake, smoking, exposure to chemicals, high risk
behavior and other data mentioned in donor selection section. It can be
done through a questionnaire given to mother and filled by her with help
of trained person.
3. Examination of local breast lesions and disease states of mother to
ensure eligibility as given below in section of donor selection.
4. Serological screening (see details below).

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 Donor Management

Donor Selection
Donor mothers must:
1. Be in good health and health related behaviors.
2. Not be regularly on most medications or herbal supplements (with the
exception of postnatal vitamins, human insulin, thyroid replacement
hormones, nasal sprays, asthma inhalers, topical treatments, eye drops,
progestin-only or low dose estrogen birth control products).
3. Be willing to undergo blood testing for screening of infections. (usually it is
at the milk bank’s expense).
4. Have enough milk after feeding her baby satisfactorily and the baby is
thriving nicely.

A woman would NOT be a suitable donor if she: (7),(28),(20),(29)

1. Uses illegal drugs.
2. Smokes or uses tobacco products or nicotine replacement therapy.
3. Regularly takes more than two ounces of alcohol or its equivalent per day
or more than three caffeinated drinks (total of about 150 to 200 mL) daily.*
4. Has a positive blood test result for HIV, HTLV, Hepatitis B or C, or
Syphilis.
5. Has high risk behavior for HIV transmission.
6. Had a sexual partner at risk for HIV, HTLV or Hepatitis and venereal
diseases in the past 12 months:
a. Including anyone with hemophilia or anyone who has used a needle for
injection of illegal or non-prescription drugs.
7. Has received organ or tissue transplant, any blood transfusion/blood
product within the prior 12 months.
8. Is taking radioactive drugs.
9. Has chemical environmental exposure known to be toxic to the neonate
and excreted in breastmilk.
10. Is taking category L3, L4 and L5 drugs e.g. amiodarone, antineoplastic
drugs, diethylstilbestrol, disulfiram and tamoxifen. (further information
may be availed from http//toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?Lact) *
(30)
11. Has viral exanthema at present. *
12. Has active lesions of herpes or chickenpox on the breast.*

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 Donor Management

13. Daily uses over-the-counter medications or systematic prescription not

permitted for donor milk. For medication compatibility/safety with
breastfeeding check out with standard literature. Medical advice should
err on the side of caution.
* may be a temporary contraindication for donation.
** for Creutzfeldt-Jacob disease

Temporary disqualification
Active donors are temporarily disqualified from donating milk under the
following conditions:
1. Any acute infection, including clinical mastitis and monilial/fungal
infections of the nipple or breast.
2. During the 4 week period following a case of rubella or varicella in the
household starting from when the lesions crust over.
3. During the one week period following a reactivation of latent infection with
HSV or varicella zoster of the breast or thorax starting from when the
lesions crust over.
4. During the 12 hour period following consumption of alcohol (hard liquor,
beer or wine).
5. During the 8 days following donors’ or its partner’s receipt of a tattoo
administered in a regulated site using sterile needles and single-use only
dyes.
6. During 28 days following donors’ receipt of live virus vaccine for measles,
mumps and rubella.
7. During the 3 months following receipt of any live virus vaccine including
chicken pox, rotavirus, polio and typhoid.
During continuing donation period donors are instructed to report an
illness/high risk behavior amounting disqualification in them or in the
household to the milk bank. The Milk Bank Officer may temporarily disqualify
the donor for illness or medication issues. Redonation can be resumed later at
the discretion of the Milk Bank Officer.

Serological Testing
All tests should be undertaken in a standard reliable laboratory and preferably
in the same hospital where milk bank is established. Ensure that laboratories
communicate the results of serological testing clearly and that they provide
appropriate interpretative comments.

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 Donor Management

All reports must be attached with the consent form and checked at the time of
collecting donation.
A donor having positive blood testing should be referred to a health care
provider of her choice for follow-up, and a copy of the lab report sent to her and
her health care provider. Any milk from this potential donor, which has been
held at the milk bank should be disposed off safely.

Tests to be done
• Serological Screening for HIV-1, HIV-2, VDRL and Hepatitis B and C can
be taken as mandatory (20). Each country can modify these perquisite
tests as per local epidemiologic data (31). Hepatitis B and C may be placed
as optional in resource poor settings in accordance to south African
guidelines (32).
• Screening CMV is not recommended for pasteurized milk and as HTLV is
not reported in India, its testing is not required (33),(34). Blood banking
guidelines also do not recommended routine screening of CMV and HTLV
(35).
Perform all serological screening tests at the time of enrolling for donation after
taking consent. If they have been done recently in last 3 months (as in the
present pregnancy) there is no need to repeat the tests unless there is a history
of any recent viral illness or high risk behavior. If there is concern about the
donor’s HIV status, a repeat rapid HIV test should be done every three months
(32).

Retesting
The NICE guideline does not recommend repeat serological testing while the
donor is donating milk, but current UKAMB guidance recommends that ‘ideally’
donors should be retested at 2-monthly intervals (36). Expert opinion indicates
that milk banks in UK currently screen donors a maximum of 3 times a year,
with some milk banks screening at the time of enrolment and not routinely
repeating.
Repeating the test is not required when mother continues to donate, unless
history is suggestive of contraindications/disqualification as listed in section of
donor selection or in the event of high risk behavior in donor or her sexual
partner. High risk behavior includes multiple sex partners, overt alcoholism.
Persons likely to be at high risk include injection-drug users and their sex
partners, persons who exchange sex for money or drugs, sex partners of HIV-
infected persons, and MSM or heterosexual persons who themselves or whose
sex partners have had more than one sex partner since their most recent HIV
test (37).

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 Breastmilk Expression

BREASTMILK EXPRESSION
Breastmilk production
Milk is produced in the secretory alveoli of breast tissue. Each alveolus is
surrounded by myoepithelial cells, which contract under the influence of
oxytocin and ejects milk into lobules. The lobules drain into ductules which
unite to form a larger lactiferous duct. They are easily compressible and dilate
with expulsion of milk from the alveoli during milk ejection reflex.

Techniques of breastmilk expression

Breastmilk expression can be done either manually or by a breast pump.

Manual Breastmilk Expression

Manual expression is a low cost and effective means of expression and
associated with the least risk of contamination. Manual expression is the most
preferred technique of milk expression when a mother is expressing milk to feed
her own baby. Earlier studies showed that the incidence of bacterial
contamination was lesser with manual expression if the first 5-10 mL were
discarded. However this has not been verified in subsequent studies (38),(18).
Drip milk i.e. the milk that drips from the non-feeding breast in 20% of
lactating mothers, collected with the help of breastmilk shells has been found to
be nutritionally inferior with lower fat content and is not recommended for
banking (39),(40).

Technique of manual breastmilk expression

The most accepted technique of manual expression of breast milk is the Marmet
Technique (after Chele Marmet) (41).
It is done in 3 steps (see Figure 1):
• Position the thumb and 2 fingers about 1” to 1½” behind the nipple on the
outer edge of areola. Place the thumb pad above and the finger pads below
in form of the letter C. The fingers are on the milk reservoirs which lie
beneath them. Avoid cupping the breast.
• Push back the fingers towards the chest wall but avoid spreading the fingers
apart. For large breasts, first lift the breast and then push towards the chest
wall.
• Roll / compress thumb and fingers together towards each other at the same
time. This empties milk from the ducts.
Repeat the same sequence rhythmically: position-push-roll-position-push-roll.
This movement should be repeated at about one per second.

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 Breeastmilk Expression

Nex
xt position the thum
mb and fing
gers sidewise and repeat the s
same seque
ence to
emp
pty all duc
cts.

Figure 1: Technique of
o Manual Exprression of Breasstmilk: The Possition, Push, Ro
oll sequence

C
Change ha
ands
Righ
ht Hand Leftt Hand

Adv
vices to m
mother fo
or manua
al express
sion
Motther must be explain
ned about hygiene w while expre
essing breastmilk. She
S has
to thoroughly
t y wash herr hands wiith soap an
nd running water annd then drry them
with
h a clean towel. Shhe should also be taught
t ab
bout breast stimulattion by
stro
oking and massage to
t improve ejection.

Millk ejectio
on can be
e improve
ed by
• Massaging g the milk producing g cells and
d ducts:
• Start at thhe top of the
t breast,, press firm
mly into thhe chest, m
move finge ers in a
circular motion
m on one
o spot on n the skin..
• After a few
w seconds repeat the e same in another
a are
ea.
• Spiral arouund the brreast towaards the are eola using
g this masssage.
• Stroking the breastt area from m the top of o the breaast to the nipple witth light
tickle like strokes. Do
D that aro ound the w whole breaast. This he
elps in rela
axation
and stimu ulates moree milk ejec
ction.
• Shaking tthe breast while lean ning forwa ard so thatt gravity w
will help th
he milk
ejection (s
see Figure 2)

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 Breeastmilk Expression

Massage Stroke Shake

Figure 2: Massagge, Stroke an

nd Shake meethods to faccilitate milk ejection

• Expressing frequenttly and em mptying thee breasts completely

c y stimulatees more
milk produ uction.
• Baby’s suc ckling cauuses nipple
e stimulatioon and theereby stim
mulates more milk
production n. Hence even if th he baby is preterm and on ga avage feed
ds, non
nutritive sucking
s will improve lactation.
• If expression is by a breast pump,
p then double (simultane eously fromm both
breasts) pu umping yields more milk (42) as prolactiin levels arre higher in
i such
cases.
• If milk flow
w is not go
ood then a warm flan nnel can bee kept on tthe breast for few
minutes.
• Having a p photo of th
he baby or thinking about
a the baby
b stimuulates milkk flow.
• Mother ca an express s milk sooon after fe
eeding herr own bab by or in between
b
feeds. Morre emptyin ng makes more
m milk.

Moovements s to be AV
VOIDED during
d ma
anual bre
eastmilk expressio
on
(see
e Figure 3):
Figure 3:
3 MOVEMENTS TO AVOID
D WHILE MAN
NUAL EXPRE
ESSION OF B
BREASTMILK

Squueezing Pulling S
Sliding

Avoid squeeezing the breaast. Avoidd pulling out the

t nipple Avoid slidinng on the breaast.
This can cause
c bruisingg and breast. This can
c cause This can cauuse skin irritattion,
tissue damaage burns aand bursting

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 Breastmilk Expression

Use of electrical breast pump

• Mother should be explained about how to use it.
• Breastmilk expression must be maintained at least 8 times/day till the baby
is ready to put to the breast.
• Elicit the milk ejection reflex before applying the pump. Breasts can be
gently massaged with the flat of the fingers.
• Breastmilk expression should begin immediately after stimulation.
• During breastmilk expression gently stroke or massage the breast.
• Ensure that the pump is attached properly.
• Use the lowest suction to maintain the flow.
• Cease expression when milk flow stops.
• Equipment needs to be washed thoroughly with detergent and stored dry in
between two uses.
• Simultaneous breast expression in breastfeeding women is more efficacious
than sequential breast expression (42).
• Double pumping can be encouraged if possible.

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 Collection of Breastmilk

COLLECTION OF BREASTMILK

Ways of Collection
Designated milk collection areas
Donor mothers may be sent to designated milk collection rooms in the milk
bank or in the milk collection centers/posts like outpatient department or
indoor department of hospitals. Their milk is collected by trained staff from the
milk bank department. This procedure is generally followed in milk banks in
our country (28).

Home collection system

The mothers can also become donors from home. Milk bank or health care
workers identify and get in communication with potential donors or these may
be the same mothers who were donating milk while they were in hospital.
Donor mothers can themselves contact the milk bank or health care workers.
Donors may themselves transport the milk to the milk banks or it can be
collected by the centre. In resource limited setting home collection and donation
from home is not advisable as it entails additional risk of infection. In India at
present there is no home collection system. At most banks usually the donor
population is cross-sectional i.e. donations are done till mother is in hospital or
when she attends well baby clinic or at camps. With increasing longitudinal
donor population (i.e. same donor donating for prolonged time like weeks or
months continuously) a home collection system may need to be in place with
proper precautions and specific counseling process.

Mass collection at camps

Another unique method for collection of large amount of milk quickly is to
organize human milk donation camps like blood donation camps. Donations are
taken under supervision and support of milk bank staffs. Donor mothers are
invited and motivated by women’s social groups, pediatricians, obstetricians
and other volunteers. Originally conceptualized and successfully organized
regularly at Surat by Surat Pediatric Association Charitable Trust, now it is
practiced at other places like Udaipur also. Maintaining cleanliness during
collection and transportation is of utmost importance.

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 Collection of Breastmilk

The process of collection

• Donor should be given written and verbal guidelines on expression, handling
and storage of breastmilk and also operation and maintenance of breast
pumps if they opt for expression by breast pumps.
• Method of expression: She is explained about the procedure of manual
expression versus breast pump expression. She is explained use and
maintenance of breast pumps, and then she chooses the method of
expression.
• The donor collection area should have comforting quiet environment and
privacy. It should be away from area where contamination can occur like
bathrooms or general visiting areas.
• After counseling, checking suitability for donation, getting a written
informed consent, history taking, physical examination and blood sampling
when required, the donor is sent to the designated collection area.
• She is made comfortable in the collection area. If needed she may breastfeed
her own child and put her/him in the cradle. An attendant or relative or
milk bank staff assists in doing so.
• Both the donor and lactation management nurse performs thorough and
rigorous hand wash with soap and running water, and then dry them on
hand drier or clean disposable towel. Hand washing is to be done even if
expression is not manual.
• The lactation management nurse cleans the breast using clean lukewarm
water. Washing the breast with simple water before expression is as good as
washing with disinfectant (43). Donors should observe good hygiene and
should have daily bath. Breasts should not be washed with bactericidal or
routine soaps frequently.
• Donor is explained the procedure of breast massage which can stimulate
breastmilk production and let down.
• The donor undergoes breast massage with help/supervision from nurse.
Nurse monitors the comfort level of donor.
• Next the donor expresses breastmilk into sterile container for collection of
fresh raw breastmilk donation. The container should have a label with donor
ID number and date of expression.
• After completion of collection breasts are cleaned with tissue paper/sterile
cloth.
• Donated breastmilk is sent for further processing.
• After each use the electric or manual pump is dismantled and sterilized for
next use.

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 Collection of Breastmilk

• The donor mother is given a DONOR CARD with her registration number on
it for future donations. If the milk bank practices giving human milk to
recipients outside their hospital she can also be given REPLACEMENT CARD
• While undergoing multiple donations over a long period donor mother is
given ongoing support and advices on breastfeeding and its maintenance
and troubleshooting related problems. She is advised to contact milk bank
in case of any deviation in her and her sexual partner’s health status and
health behavior amounting to disqualification.

Transport of donated milk to the human milk bank

Freshly expressed breastmilk should be transported to the human milk bank at
the earliest, preferably within two hours and should be stored in refrigerator or
ice till it reaches the milk bank. The transport container used must be
insulated, rigid; clean and disinfected. Coolant blocks should be used in it and
the empty space in the container should be filled with bubble wrap.
If stored in the refrigerator, the containers should be placed in the coldest area,
distant from the door and should be transported to the human milk bank at the
earliest, not later than 24 hours.
Donor is explained this so that she understands it properly if milk is
transported from outside.

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 Donor Milk Processing

DONOR MILK PROCESSING

The fresh raw breastmilk should be kept in pre-process milk
freezer/refrigerator. Fresh raw milk should not be added to the frozen milk
since this can result in defreezing with hydrolysis of triglycerides (44). While
mixing fresh raw breastmilk to frozen raw breastmilk previously collected from
same donor, it should be chilled before adding to frozen milk. For sick or
preterm babies it is advisable to use a new container for each pumping. Whole
day’s collection should be processed by mid-day so that cultures can be sent in
time to the laboratory.
Mixing & Pooling: Donated breastmilk from multiple donors is transferred
from donations collected in small containers to larger glass flasks/pasteurizer
containers. Each pool (which usually includes milk from 3 to 5 donors) should
be thoroughly mixed to ensure an even distribution of milk components. Names
& ID of donors in each pool should be recorded.

Microbiological Screening of Donated Milk

Microbiological screening of donated and pooled milk should be done as soon as
possible after and/or before pasteurization according to the protocol of the
bank. The contamination level should be maintained at zero level at all possible
areas.

Pre-pasteurization culture
In developing countries it is not feasible because of cost constraints. Pre-
pasteurization microbiology can result in wastage of milk to the tune of 30% in
some cases (31). In western countries it is done wherever possible in order to
know the extent of contamination and the efficacy of pasteurization process.
Before treatment, there are no set levels for colony count levels, but a rough
guide is as follows:
• <103CFU/mL: milk is used
• >105CFU/mL: milk is not used
• 103to 105CFU/mL: milk is only used if organisms are skin commensals.
Heavily contaminated milk is discarded because pasteurization process is not
effective on heavily contaminated sample.
Heavily contaminated milk with specific bacteria (e.g. S. aureus, E.coli) may
contain enterotoxins and thermostable enzymes even after pasteurization,
expert panel selected 105 CFU/mL for total bacterial count, 104 CFU/mL for
Enterobacteriaceae and S. aureus as threshold values which are in consonance
with milk banks operating in other parts of the world (45).

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 Donor Milk Processing

Post-pasteurization culture
• Each container of pasteurized breastmilk is subjected to microbiological
culture test. It is done in every human milk bank before the milk is
dispensed.
• No amount of growth is acceptable in processed pasteurized milk. Entire
batch tray is discarded if it doesn’t meet acceptable bacteriological
standards.
• During storage after first mandatory microbiological testing, at regular
intervals of a fortnight or on monthly basis a unit of PDHM is randomly
chosen from each batch tray and sent for bacteriological test. This helps in
quality control checking.

Method of culture
• Milk sample is incubated in the culture media for 48 hours at 35°C.
• McConkey agar media is widely used for the purpose.
• Hence a certified microbiology laboratory and lab technicians are must in
the institution where milk bank is established.

Pasteurization of Donated Breastmilk

Pasteurization of human milk is necessitated by the fact that majority of milk
samples grow one or more bacteria before milk pasteurization. 62% of the
pooled samples grew one lactose-fermenting gram negative rod and 19% grew
another bacterium. 4% samples were contaminated with Staphylococcus
aureus and 8% with alpha streptococci. After pasteurization 93% samples did
not grow bacteria reflecting efficacy of holder pasteurization (46).
The fresh raw donated milk should be immediately pasteurized after collection.
Pending that it should be kept in refrigerator specially designated for such milk.
That refrigerator should not be used for storing post pasteurized milk.

Method of Pasteurization
Holder method of pasteurization using 62.5°C for 30 minutes is widely used.
Properties are better preserved at this temperature without compromising
bacteriological safety.
Use of other safer methods of pasteurization with better preservation of
nutrients and other properties, like flash heat treatment, HTST (High
Temperature Short Time: 72°C for 16 seconds) (47) and ultra violet irradiation
are still not being used in human milk banks routinely.

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 Donor Milk Processing

Recently a low cost but effective flash heat method has been developed in Africa
& is recommended to be used where there is no access to pasteurization facility
and this method has shown to effectively inactivate HIV (11).

Operation of pasteurizer
• The stainless steel containers for the pasteurizer/shaker-water bath should
be cleaned & sterilized.
• The fresh raw individual donated breastmilk collected in small sterilized
containers is poured in the larger sterilized stainless steel containers
suitable to size of the pasteurizer. Collection from multiple donors can be
pooled. Containers should not be filled more than four-fifths full in the
container to allow for expansion of milk when heated.
• The containers are then placed in their specific slots inside the machine tray
and clamped to avoid spillage. The bath canner is filled with water enough to
submerge ¼ to ½ portions of the steel containers.
• The temperature is set at 62.5°C; time is set to 30 minutes and shaking
speed control to Level 1.
• After 30 minutes, containers are taken out, sealed tight and allowed to cool
rapidly in slurry of ice, sample for post pasteurization culture is drawn and
containers are kept in the deep freezer at -20°C. Post pasteurization no
tampering should be done likelihood of contamination like aliquoting or
transferring to other containers.
• Each containers of same batch of pasteurization are placed in one labeled
Batch Tray. Then it is stored in the freezer designated for post-
pasteurization milk awaiting cultures report. That should not be disbursed
till culture reports come negative.
• After each batch of pasteurization the containers are sent for autoclaving
after cleaning.

Post pasteurization culture

• It is done in every set-up before the milk is dispensed.
• No amount of growth is acceptable.
• 1 to 2 mL from each batch should be sent to microbiology lab for culture
from each container. If the test report is positive then the entire pasteurized
batch/container’s pool is discarded depending on culture reports of other
containers of the same batch of pasteurization

The containers with negative culture reports are transferred to deep freezer
designated for culture negative pasteurized milk ready for disbursal.

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 Labeling, Preservation and Disbursal

LABELING, PRESERVATION AND DISBURSAL

Labeling
• Labeling material should be water resistant to avoid spoiling while handling
and information clearly readable.
• Label of the sterile containers for fresh raw milk donation collection should
have identifying details of donor like ID number and date of expressing.
• When there is pooling, record should be maintained on how many donor’s
milk is mixed and pooled in each pool with their ID numbers. The record
keeping should have pool number with IDs of the pooled donations.
• The label code on pasteurized container should have: container serial
number; batch number ID; pool number; date of pasteurization; date of
freezing and expiry date.
• Batch wise information of which donor’s milk is there in each batch tray
should also be maintained.

Preservation and Storage

• Fresh raw breastmilk is safe for four to six hours at room temperature i.e.
15°C to 25°C. It can be stored in the freezer compartment of the refrigerator
for five to seven days and in the deep freezer at minus 20°C for six months.
• Storage should be done in the same container which is used for
pasteurization. It is advisable not to transfer processed milk in other
containers as it has risk of contamination.
• The pasteurized containers with negative culture reports are tightly sealed
and then placed into a labeled Batch Tray. According to its date of collection
the Batch Trays are placed in the post process deep freezer at minus 20°C.
The milk can be stored for 3 to 6 months without any bacterial growth.
• Practice FIFO method i.e., old milk should be first used up.

Distribution/Requisition Process
• Donor milk should be dispensed by prescription from the recipient's
physician after informed consent from recipient’s parents.
• The health care provider has to fill in the PDHM requisition form. The form
data should be kept in records.
• The PDHM should be taken out of processed deep freeze on FIFO basis i.e.,
oldest milk being used first. It is then allowed to come to room temperature.
As per the requisition, the exact quantity in mL, with the name &
registration number of the baby, should be transported in ice cold packs,
preferably in vaccine carriers.
• It should be transported to the recipient hospital under cold storage at
earliest. Usually it is in the same premises hence the time taken is very less.

GUIDELINES FOR THE ESTABLISHMENT & OPERATION OF HUMAN MILK BANKS Page 27
 Labeling, Preservation and Disbursal

• Maintain record of disbursed PDHM with details of recipient and details of

disbursed milk.

Recipients
Donor Human Milk can be prescribed for treatment of medical
conditions like:
• Prematurity: The potent benefits of human milk are such that all preterm
infants should receive human milk (20). If mother’s own milk is
unavailable despite significant lactation support donor breastmilk should
be used. The premature infant will have a better start in life (48). In
extremely preterm infants given exclusive diets of
preterm formula versus human milk, there was a significantly greater
duration of parenteral nutrition and higher rate of surgical NEC in infants
receiving preterm formula (49).
• Necrotizing Enterocolitis: Donor breastmilk is associated with a lower
risk of NEC and the presence of active enzymes in the breastmilk
enhances the maturation of the underdeveloped gut (48),(50). Babies with
necrotizing enterocolitis benefit from PDHM the most.
• GIT Conditions: Therapeutic benefits are noted in short gut syndrome,
sepsis, and post surgical gut healing in omphalocele, gastroschisis, bowel
obstruction and intestinal fistulas, etc. (20). In infants having mal-
absorption, feeding intolerance, immunodeficiency & chronic or persistent
diarrhea, who are bottle fed or receiving top feeding, it has been well
documented that once given donor human milk their condition resolves
(51). It is possible to administer trophic feeds / gut priming exclusively
with human milk (52).

If supplies of banked milk are sufficient:

Other then above mentioned indications PDHM may be dispensed by
prescription for a large variety of situations, including but not limited to:
• Absent or insufficient lactation: Mothers who deliver twins, triplets or
quadruplets, who can’t, secrete sufficiently to breastfeed their neonates can
opt for this best option.
• Adoption or surrogacy: For babies of non-lactating mother who adopted a
neonate if induced lactation is not possible, donor milk is the next best
option.
• Abandoned neonates and sick neonates from orphanage admitted to
NICU or Pediatric ward, will be benefited from donor human milk (53).
• Temporary interruption of breastfeeding: Babies separated from their
mothers due to maternal illness, postpartum problems and emergencies like
post-partum hemorrhage, eclampsia and other serious medical illnesses;

GUIDELINES FOR THE ESTABLISHMENT & OPERATION OF HUMAN MILK BANKS Page 28
 Labeling, Preservation and Disbursal

neonates of mothers with acute or chronic illnesses who are unable to

breast feed their baby can be provided with this option.
• Infant at health risk from breastmilk of the biological mother.
• Babies of mother who dies in the perinatal period.

Recipient priority in case of short supply:

• Preterm babies especially in the first few days, till their mothers are able to
secrete adequate milk.
• Sick preterm infants, with illnesses like necrotizing enterocolitis, GI
surgeries.
• Babies of mothers with postpartum illnesses.
• Babies whose mothers have lactation failure till their milk output improves.
• Babies delivered by cesarean section when mother’s own milk not available.

Guidelines for Use of Donor milk in the Hospital Setting

• The amount which will be required for 24 hours can be taken out from deep
freeze of milk bank and stored in regular refrigerator for 24 hours.
• As time permits, thaw frozen breast milk by transferring it to the refrigerator
for thawing or by swirling it in a bowl of warm water bath at a temperature
not exceeding 370C, or under running lukewarm water taking care that the
cap does not come in contact with the water as it is likely to get
contaminated (24),(54),(55). Frozen PDHM should be completely thawed,
brought to room temperature and gently agitated to make a homogenous
mixture before use and be used preferably within 3 hours to prevent
contamination.
• Microwave heating is not recommended because microwave action can
continue after removal from oven, there is a risk of burns if the milk is used
too soon. Hot spots may occur and overheating can damage protein and
vitamins. this results in reduction in the IgA content of the milk (56).
• Thawed pasteurized milk should not be refrozen; it increases hydrolysis of
lipids and increases risk of contamination.
• Preterm baby should preferably get PDHM from preterm donors.
• A copy of the recipient consent form must accompany first orders. A copy
should also accompany the recipient’s medical records.

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 Labeling, Preservation and Disbursal

Complications from administration of donated milk

Complications from administration of PDHM from human milk banks are rare.
They could arise if safety standards are not maintained and could be from:
From donor
• If donor has not been screened appropriately.
• If donor conceals facts about medications, drug abuse, high risk behavior,
etc.
• History of recent infection.
From processing of milk
• Contamination of donated milk while handling.
• Loss of immune modulatory proteins, immune active cytokines, antioxidants
and growth factors due to heat treatment (57).
AAP recommends use of pasteurized human milk when mother’s own milk is
not available with strict quality control and with adequate monitoring in spite of
the above risks (6).

GUIDELINES FOR THE ESTABLISHMENT & OPERATION OF HUMAN MILK BANKS Page 30
 Record Keeping & Tracking

RECORD KEEPING & TRACKING

Human Milk Banks should have an operational objective of ensuring full
traceability from individual donation to recipient and maintaining a record of all
storage and processing conditions. There should be standard operating
procedures written and followed. Confidentiality should be preserved by the
milk bank about its records and data. Though rarely required, complications
can be prevented with appropriate labeling and meticulous record keeping.
As incubation period for most infection varies from a few weeks to six months
and appearance of symptoms is faster in infants and children, there seems to
be no rationale for keeping records beyond five years, unless one is working in
an area where milk kinship issue is of paramount importance. In India the
blood bank records are kept for a minimum period of five years (27).
For every donor a Donor Record File should be maintained with the Donor
Consent Form; Donor Registration details; Donor Screening Performa; &
Serological Reports; Date of birth and gestational age of infant and its health
condition and record of each donation made by the donor.
Similarly Recipient’s Record File with name of responsible person giving
requisition, details of recipient, Recipient Consent Form, PDHM batch tray &
container details, indication of use and feedback if any should be maintained.

The following records should be maintained:

By the collection staff
• Name, donor ID and indoor number (for donors from hospital) of donor.
• Record of donor’s blood testing reports of HIV, VDRL and any other tests done
such as Hepatitis B etc.
• Date of breastmilk collection.
• Place of collection like PNC wards, NICU, Preterm care unit, OPD follow up
cases, Camp, Designated collection center/post, etc.
• Volume of breastmilk collected.
• Whether pooled or not.
By milk bank technician
• Date of collection.
• Received container from which area.
• Volume of breastmilk in container.
• Date of pasteurization and sending sample for culture.
• Culture report.
• Suitability of PDHM for use based on culture report.
• Date of issue (on FIFO basis)
• Place of issue.
• Number of babies receiving banked milk.

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 Record Keeping & Tracking

By recipients feeding staff

• A copy of the recipient consent form must accompany first orders.
• A copy should also accompany the recipient’s medical records.

GUIDELINES FOR THE ESTABLISHMENT & OPERATION OF HUMAN MILK BANKS Page 32
 Flow of Events in Human Milk Banking

FLOW OF EVENTS IN HUMAN MILK BANK

Donor management • Thawing of donated milk once
• Identification & motivation of donor’s serology comes negative
donor • Pooling of donated breastmilk in
• Counseling of donor pasteurizer’s containers
• Selection of eligible donor • Pasteurization of donated milk
• Donor registration with all • Post pasteurization microbiology
necessary details testing of all batches
• Written informed consent of
donor Storage
• Screening of donor with history, • Tight sealing of PDHM
physical examination and • Labeling of milk batch with expiry
serological testing date
• Preparing batch tray of
Collection pasteurized containers
• Taking donor to designated milk • Keeping PDHM in separate locked
expression area freeze till microbiology report
• Education and training in arrives
expression of breastmilk • Discarding microbiologically
• Selection of method of expression positive PDHM
• Hand washing by donor and • Transfer of microbiologically
nursing assistant negative PDHM in post process
• Expression of breastmilk in deep freeze
sterilized labeled container • Testing of random milk sample
• Dismantling and sterilization of for bacteriology before disbursal
pumps if used for collection
• Preparation and giving a Donor Disbursal
Card for donor • Receiving request for PDHM
supply
Processing • Written consent from parent(s) of
• Refrigeration of individual the recipient baby
donated container till serology • FIFO system to take out frozen
reports arrive PDHM
• Discarding donations from • Dispatch of PDHM under proper
serology positive donor. Informing storage conditions.
positive report to donor and • Thawing of milk and storing in
advising necessary follow up with NICU freeze till used
physician

GUIDELINES FOR THE ESTABLISHMENT & OPERATION OF HUMAN MILK BANKS Page 33
 ANNEXURE-I: DONOR SCREENING PERFORMA
(This information will be treated as confidential)
ID number: Date:
Demographic data:
Name:
Phone no.:
Address: Age of donor: years
Birth date/age of child:
Collection Center ID: Referring doctor:
History:
Y/
Tobacco consumption: Alcohol use: Y/N
N
Medicines/herbs/addictive Y/
Details:
drugs/others: N
Present illness:
Y/
Past illnesses/chronic disorders: HIV: Y/N
N

Detail: Jaundice: Y/N

Y/
High risk behavior: Tattoo in last 3 mo.: Y/N
N
Y/
Blood product/transplant in last 1 yr: Silicone implant: Y/N
N
Y/
Live vaccine to donor in last 3 mo.: TB Y/N
N
Y/
High risk behavior in partner/donor Child thriving well: Y/N
N

Laboratory reports:
HIV 1&2: HBsAg: VDRL:
Others:
Details:
Examination:
Breasts: Mastitis / local skin lesions / other
General & Systemic examination:

Name of Counselor: Sign

GUIDELINES FOR THE ESTABLISHMENT & OPERATION OF HUMAN MILK BANKS Page 34
 ANNEXURE-II: CONSENT FORMS
• These forms should be printed & filled in local/vernacular language.
• They should be in triplicates so that a copy is placed in milk bank, with
recipient’s hospital records and with donor/recipient.

Donor’s Consent Form

I/We have been informed about the human milk banking, wet nursing etc. We
have also been explained about advantages and disadvantages of mother’s milk
as far as the nutrition, growth & development of the baby is concerned. We
have also been informed that if I donate my milk as per the guidelines my baby
will still get adequate milk as far as its needs are concerned.
I/We have been informed about the processing of donated breastmilk and its
intended uses. I/We have been informed that once donated the milk will not be
returned back to me/us. I/We have also been informed that the milk shall be
used for the needy babies irrespective of religious, commercial and any other
nonmedical considerations.
I also declare that I am not suffering from any illness/disorder or having
behavior which can be risky through my breastmilk to the recipient baby.
I agree to undergo necessary clinical examinations and laboratory blood reports
and share the findings of past and present reports with the human milk bank.
I/We have been explained all these in the language known to me/us and I/we
are signing this form without any pressure/coercion and after satisfying
my/our queries/doubts.

Donor ID number: Signatures

Name of the Donor:
Age:
Address:

Name of the relatives Relationship with

donor

Witnesses
1)

2)
Place: Date & time:

GUIDELINES FOR THE ESTABLISHMENT & OPERATION OF HUMAN MILK BANKS Page 35
Recipient’s Consent Form
I/We have been informed about the human milk banking, wet nursing etc. We
have also been explained about advantages and disadvantages of mother’s milk
as far as the nutrition, growth & development of the baby is concerned as
compared to other milks.
I/We have been informed about the processing of donated breastmilk and its
intended uses.
I/ We have been informed that all the precautions have been taken to make the
donated breastmilk disease free, safe and quality assured. But, still some
diseases may be transmitted to the recipient. After knowing various details and
after satisfying my doubts /queries, I/we are willing to use this pasteurized
donated milk for my/our baby.
I/We know that donor milk stocks are finite and it may not always be possible
to meet every order.
I/We have been explained all these in the language known to me/us and I/we
are signing this form without any pressure/coercion.

Requisition ID number
Name of the recipient:
Age: Signatures
Address:
Name of father:
Name of mother:
Name of the relatives Relationship with
recipient

Witnesses
1)

2)
Place: Date & time:

GUIDELINES FOR THE ESTABLISHMENT & OPERATION OF HUMAN MILK BANKS Page 36
 ANNEXURE- III: Equipment Specifications & use
All equipments should be used, maintained and calibrated/validated according
manufacturer’s instructions and a record maintained of it.

Deep Freezer
• Storage capacity 200 liters
• Provides temperature of -20°C to -25˚C
• Good quality micro temperature controller system with LED display of the
temperature inside the cabinet with PT 100 sensor probe and audio visual
alarm system to make user aware, if the temperature below or above set
temperature due to mechanical or electrical error/fault
• Racks for storage of containers
• The door and walls be insulated with sufficient thickness high quality CFC
free PUF insulation
• The door provided with good quality magnetic type gasket on inner side, so
as to have the door sealed perfectly when locked
• Suitable for operation on 220 to 240 volt, single phase, 50 Hz, A.C. power
supply
• Refrigerant used be non toxic, non hazardous, CFC/HCFC free

Pasteurizer/Shaker Water Bath

• Water bath shall be made up of double walled inner and outer chamber of
stainless steel.
• Micro-processor controlled temperature regulation should provide
temperature of 62.5˚C and temperature constancy ±0.5˚C.
• Optimum temperature distribution should be throughout bath interior.
Temperature display and setting digitally via LED display, in 0.1˚C
increments.
• Exact reproducibility of the preset temperature should be possible.
• Over-temperature cut out electronically, 5˚C above set temperature, and
electromechanical > 99˚C.
• Instrument should have electronic timer with display and buzzer to provide
set temperature for a fixed period time from 10 minutes to 2 hours.
• Constant shaking frequency, independent of load, should be possible.
• Maintenance free and durable shaking device electronically controlled and
continuously set tables shaking motion with gentle start-up.
• Bath interior and shaking rack made up of stainless steel.
• Drain cock to empty the bath.
• Tray capacity of 16-20 flasks/stainless steel containers of 200 to 400 mL
each

GUIDELINES FOR THE ESTABLISHMENT & OPERATION OF HUMAN MILK BANKS Page 37
 • Shaking device
d by AC/DC ge eared mottor 10-150 0 rpm & s speed con ntrol by
electronic speed reguulator
• Shaking trray made ofo stainlesss steel 304
4 quality with
w clamps
s for flaskss
• Facility fo
or securing g each co
ontainer on n the tray
y during ppasteurizaation to
prevent sppillage
• The clamp ps for the flask madde of stainless steel 304 qualitty, to screew onto
shaking trray, suppliied comple
ete with fixxing materiial
• Cleaning PProcess
• The machine is clean ned once in
i every 3d days or dep
pending uppon the scaling.
• The entiree water is drained
d ou
ut from the e Drainage Point.
• The machine is dry cleaned
c ussing a soft cotton clo
oth.

Ho
ot Air Ov
ven/ Au
utoclave
e Steriliz
zer
• The oven uses
u dry heat
h to sterrilize articles at 100°C for 30 mminutes.
• The mach hine is dig gitally con ntrolled to o maintain n the tem mperature with a
thermostaat.
• Indicators
s and contrrols for tem mperature and holdin ng time.
• The double walled insulation n with air filled spa ace keeps the heat in and
conserves energy, the inner layer l being a poor conductor
c and oute
er layer
being meta allic.
• Fan at thee top helps s in uniform m distribu ution of thee heat.
• The machine is fitted d with the adjustable wire mes sh plated trays
t
• The Glass s containers are la aid down on the racks wh hereas thee other
equipmentts are plac ced in the sterilizatio
s on drum.
• A complette cycle in nvolves he eating the oven to the t temperature of 100°C,
maintaininng that tem mperature e for 30 minutes,
m urning the machine off and
tu
cooling thee articles in
i the close ed oven tilll they reacch room teemperature
e.

Bre
east Pum
mps
All breast
b pumps consist of a few ba asic partss: (58)
a. Bre
east Shield
d: a cone-s shaped cuup that fits
s over the nipple
and th
he circularr area surrrounding th
he nipple (the areola
a).
b. Pum
mp: createes the genttle vacuum
m that exppresses milk. The
pump p may be attached tto the bre east-shield
d or have plastic
tubingg to connect the pum
mp to the breast-shie
b eld.
c. Milk Containe er: a detacchable con ntainer that fits bellow the
breastt-shield an nd collects milk as itt is pumpeed. The con ntainer
is typiically a reu
usable one e or dispossable bag that can be
b used
to store
s the m
milk.

DELINES FOR TTHE ESTABLISH

GUID HMENT & O PERATION OF HUMAN M ILK
K BANKS Page 38
Typ
pes of Breast Pumps

The
ere are thre
ee basic ty
ypes of bre
east pumps
s:
• Manual pu umps
• Battery-poowered pum mps
• Electric pu
umps
A breast
b pum
mp is typically held in
i place by
y hand or by a nurs
sing bra, a breast
pum
mping bra or a band.
Breeast pumpps extract milk fromm the brea asts by crreating a seal around the
nipple and appplying an
nd releasin
ng suction to the nip
pple, whichh expresse es milk
m the brea
from ast. Each suction
s andd release combinatio
c on is called
d a cycle.
Man
nual Pump
ps
Oncce the breaast-shield is placed over the n handle or lever is
nipple and areola, a h
squ
ueezed to ccreate sucttion and exxpress milk from the The breast milk is
e breast. T
then collected
d in an atta
ached container.
Somme manual pumps have
h a smaall tube wh
hich is pum mped in annd out of a larger
tub
be to creatte a vacuu
um that expresses
e milk and collects itt in an atttached
con
ntainer.
Anoother type of manual pump, ca
alled a bicy
ycle horn pump, con nsists of a hollow
rub
bber ball attached
a t a breast-shield. Some
to S expeerts discou
urage the use of
bicy
ycle horn p
pumps beccause they
y may be difficult to clean
c and dry.
Batttery-Powe
ered and Electric
E Pumps
A powered bre
east pumpp uses battteries or a cord plugg
ged into an
n electrica
al outlet
to power
p a sm
mall motorrized pump
p that crea ates suctio
on to extra
act milk frrom the

DELINES FOR TTHE ESTABLISH

GUID HMENT & O PERATION OF HUMAN M ILK
K BANKS Page 39
breasts. It may have one or more long tubes connecting the breast-shield to the
electric pump. The pump has a control panel with a dial or switch to control the
degree of suction.
Some powered breast pumps can be adjusted to create different patterns of
suction. Some manufacturers claim the adjustable suction allows the user to
find a setting that closely mimics her nursing baby, including features with
phases such as let-down. Let-down is the natural reflex which starts the release
of milk when the nipple area is stimulated, such as by breastfeeding or breast
pumping.
Because these breast pumps rely on a power source, women who use powered
breast pumps should be prepared for emergency situations when electricity or
extra batteries may not be available. If breastfeeding is not an option, having
extra supplies for pumping and a back-up method, such as a manual breast
pump, may help a woman maintain her breast pumping schedule during an
emergency.
Pumping Types
There are two different pumping types: single and double.

Pumping Type How it Works Types of Breast Pumps

Single Extracts milk from one breast Most manual breast pumps are
at a time. single pumps.
Most battery-powered pumps are
single pumps.

Double Can be used to extract milk Some electric pumps are double
from both breasts at the same pumps.
time.
A separate breast-shield can
be attached to each breast to
stimulate both nipples at the
same time.

Using a Breast Pump

Before using your breast pump for the first time it is a good idea to read
through the entire instruction manual. The instruction manual can help you
learn the correct way to assemble and use your pump. It should also include
the manufacturer’s contact information. If the instruction manual is missing
from the box, check the outside of the box for a customer service line you can
call to request a copy.

GUIDELINES FOR THE ESTABLISHMENT & OPERATION OF HUMAN MILK BANKS Page 40
General Tips for Using a Breast Pump
Wash and Dry Your Hands
Before using your pump, wash your hands with soap, scrubbing for 10-15
seconds, then rinse with plenty of warm water. After washing, dry your hands
thoroughly with a clean paper towel.
You do not need to wash your breasts before you pump unless you have been
using a cream, ointment, or other product on your breasts that must be
removed first. Check the labels on products you have been using and ask your
doctor for advice.
Assemble Your Pump
Consult your pump’s instruction manual for the proper way to assemble your
pump.
Get Comfortable
Find a clean and comfortable place where you can relax and not be disturbed
while pumping. If you have an electric pump, find an area near an outlet so you
can plug the pump in. Some mothers find it helpful to hold their baby, or to
have a picture of their baby in front of them while they pump.
Position the Breast-Shield(s)
Consult your instruction manual for tips on positioning your nipple in the
breast-shield(s). Your nipple should fit comfortably in the center of the opening
in the breast-shield(s). Gently adjust the breast-shield(s) until it feels
comfortable without pinching, pulling or otherwise irritating your nipple or
breast tissue.
Begin Pumping
If your pump is electric or battery-powered, turn the switch to the on position
and the lowest suction and/or speed (cycle) setting. If you are using a manual
pump, begin pumping. Consult your instruction manual for suggestions on an
appropriate pumping speed. Adjust the speed until you find one that is
comfortable for you.
What to Expect While Pumping
A qualified health professional, such as a certified lactation consultant, can
help determine the best pumping method for you. Keep in mind that the
amount of milk produced is different for everyone. A typical pumping session
lasts about 10-15 minutes per breast, but you should only pump as long as it is
comfortable and productive for you.
Your breast milk may not flow immediately after you start pumping, so try to be
patient. When it does flow, your milk should be collected in the container
attached to your pump. If milk is leaking out of your pump, stop pumping and

GUIDELINES FOR THE ESTABLISHMENT & OPERATION OF HUMAN MILK BANKS Page 41
make sure you have assembled the pump correctly before trying again. If your
pump continues to leak, call the manufacturer’s customer service line for help.
When you have finished pumping, gently insert a finger between your breast and
the breast-shield to break the vacuum seal. Remove the container or bag of
collected milk from the rest of the pump, and label it with the date and time of
pumping before storing it in the refrigerator or freezer.
Cleaning Breast Pump Parts
• All breast pump parts that come in contact with breast milk, such as
containers, valves and breast shields, should be cleaned after each use. It is
not possible to completely sterilize breast pump parts at home, even if you
boil them. However, sterilization is not necessary to keep these parts safe
and sanitary. You can do that by thoroughly washing away germs and
bacteria with liquid dishwashing soap and warm water.
• Some breast pumps parts can be put in the top rack of a dishwasher.
Consult your instruction manual to make sure pieces are dishwasher safe
before you put them in the dishwasher.
• It is not necessary to clean breast pump tubing unless it comes in contact
with breast milk. If you wash your tubing, make sure you hang it to air dry
before attaching it to your breast pump. If small water drops (condensation)
appear in the tubing after you have pumped, turn the pump on for a few
minutes until the tubing is dry.
• Microwave sterilizers are available for breast pump parts, but these
sterilizers do not meet the US FDA definition of sterilization. However, they
will sanitize the parts, which is sufficient for processing between uses for a
single user.
Cleaning the Electrical Unit for a Powered Breast Pump
• Electrical units, which hold the motor and batteries, should be wiped down
with a clean paper towel or soft cloth after each use.
• The electrical unit should never be put into water or other liquids for
cleaning. It should also never be cleaned using a microwave sterilizer.
• Some breast pump manufacturers make wipes just for cleaning breast
pumps, which can make cleaning more convenient when you are away from
home. Even if these wipes are used, breast pump parts that come into
contact with breast milk should still be cleaned using liquid dishwashing
soap and warm water before pumping.
Basic Cleaning Method
• Consult the instruction manual to determine which parts should be washed
and the best method for removing parts that must be cleaned.
• Rinse each piece that comes into contact with breast milk in cool water as
soon as possible after pumping.

GUIDELINES FOR THE ESTABLISHMENT & OPERATION OF HUMAN MILK BANKS Page 42
 • Wash each piece separately using liquid dishwashing soap and plenty of
warm water.
• Rinse each piece thoroughly with hot water for 10-15 seconds.
• Place the pieces neatly on a clean paper towel or in a clean drying rack and
allow them to air dry.
• Avoid using cloth towels to dry your pump parts because they can carry
germs and bacteria that are harmful to your breast milk and your baby.
• Once the pump parts are dry, assemble the pump before you store it or use
it.
• Try not to touch the inside of any parts that will come in contact with your
breast milk.
Hospital Grade Milk Pump
• The Funnel area has soft round edges of Advanced Sealing Air Cushion
which provides an airtight seal over the entire areola. This structure allows
steady expression of milk with only a light suckling sensation.
• Only electric breast pumps with an isolated motor, which does not connect
with the tubing, are suitable for multiple uses. Here each mother should
have her own set of tubing.
• A suction strength dial of five pressure level settings and a suction cycle
controller for regulating the speed of suction and adjustable vacuum facility
• Has a container stand which can be used as Funnel cover. This supports
pump when left standing and hygienically protects the pump.
• The entire machine parts can be dismantled which makes sterilization easy
and handy.
• Fully automatic operation with physiologically natural suction rhythm
• Silent vibration-free electric motor
• Single and double pumping should be possible
• Runs on electricity
• Overflow protection. No overflow into the pump possible.
• Can be used along with reusable kits or ready to use kit
• Working on 2-Phase Expression Technology preferable
• Operation
• The breast area of the donor mother is cleaned using clean cloth and
lukewarm water.
• The funnel is placed on the mother’s breast to cover the entire areola.
• The machine is switched on and the suction strength & cycle speed are set
as per the comfort level of the mother.
• Milk expression begins and the milk is collected in the container attached to
the machine.
• Once the milk is expressed, the machine is switched off. The Fresh Raw Milk
in the containers is placed in the pre-process Freezer at (-5)°C.
• Mother’s breast is cleaned with a damp cloth.

GUIDELINES FOR THE ESTABLISHMENT & OPERATION OF HUMAN MILK BANKS Page 43
 Cleaning
• After each use the machine is dismantled, rinsed with clean water to remove
milk then washed with soapy water. All the parts are sterilized in the Pump
Sterilization Machine.
• The container is sterilized by placing it in its unit and other parts like
funnel, pipe, etc are placed in the accessories tray.
• Sterilization is done at 100°C for 9 minutes. No chemicals are used for
sterilization of these parts.

GUIDELINES FOR THE ESTABLISHMENT & OPERATION OF HUMAN MILK BANKS Page 44
 REFERENCES
1. Das BK, Mishra RN, Mishra OP, Bhargava V, Prakash A. Comparative
outcome of low birth weight babies. Indian Pediatr [Internet]. 1993 Jan
[cited 2013 Dec 15];30(1):15–21. Available from:
http://www.ncbi.nlm.nih.gov/pubmed/8406701

2. Bharati P, Pal M, Bandyopadhyay M, Bhakta A, Chakraborty S.

Prevalence and causes of low birth weight in India. Malays J Nutr
[Internet]. 2011 Dec [cited 2014 May 30];17(3):301–13. Available from:
http://www.ncbi.nlm.nih.gov/pubmed/22655452

3. UNICEF & WHO. Improving newborn survival in India. State of Newborns.

[Internet]. Available from:
http://www.unicef.org/india/Newborn_Fact_sheet_Final_21_june_2010.p
df

4. Arnold LDW. The cost-effectiveness of using banked donor milk in the

neonatal intensive care unit: prevention of necrotizing enterocolitis. J
Hum Lact [Internet]. 2002 May [cited 2013 Oct 23];18(2):172–7. Available
from: http://www.ncbi.nlm.nih.gov/pubmed/12033080

5. WHO/UNICEF meeting on infant and young child feeding. J Nurse

Midwifery [Internet]. [cited 2013 Oct 13];25(3):31–9. Available from:
http://www.ncbi.nlm.nih.gov/pubmed/6900060

6. SECTION ON BREASTFEEDING. Breastfeeding and the use of human

milk. Pediatrics [Internet]. 2012 Mar 1 [cited 2013 Sep 19];129(3):e827–
41. Available from:
http://pediatrics.aappublications.org/content/129/3/e827.full

7. NICE. Donor breast milk banks [Internet]. NICE; [cited 2013 Oct 17].
Available from: http://guidance.nice.org.uk/cg93

8. Renfrew MJ, Craig D, Dyson L, McCormick F, Rice S, King SE, et al.

Breastfeeding promotion for infants in neonatal units: a systematic review
and economic analysis. Health Technol Assess [Internet]. 2009 Aug [cited
2013 Oct 13];13(40):1–146, iii–iv. Available from:
http://www.ncbi.nlm.nih.gov/pubmed/19728934

9. NRHM Guidelines - National Rural Health Mission [Internet]. Available

from: http://nrhm.gov.in/about-nrhm/guidelines/nrhm-guidelines.html

10. Arslanoglu S, Moro GE, Bellù R, Turoli D, De Nisi G, Tonetto P, et al.

Presence of human milk bank is associated with elevated rate of exclusive
breastfeeding in VLBW infants. J Perinat Med [Internet]. 2013 Mar [cited
2013 Oct 23];41(2):129–31. Available from:
http://www.ncbi.nlm.nih.gov/pubmed/23241582

GUIDELINES FOR THE ESTABLISHMENT & OPERATION OF HUMAN MILK BANKS Page 45
11. Israel-Ballard K, Donovan R, Chantry C, Coutsoudis A, Sheppard H,
Sibeko L, et al. Flash-heat inactivation of HIV-1 in human milk: a
potential method to reduce postnatal transmission in developing
countries. J Acquir Immune Defic Syndr [Internet]. 2007 Jul 1 [cited 2013
Oct 19];45(3):318–23. Available from:
http://www.ncbi.nlm.nih.gov/pubmed/17514015

12. Israel-Ballard K, Chantry C, Dewey K, Lönnerdal B, Sheppard H, Donovan

R, et al. Viral, nutritional, and bacterial safety of flash-heated and
pretoria-pasteurized breast milk to prevent mother-to-child transmission
of HIV in resource-poor countries: a pilot study. J Acquir Immune Defic
Syndr [Internet]. 2005 Oct 1 [cited 2013 Oct 23];40(2):175–81. Available
from: http://www.ncbi.nlm.nih.gov/pubmed/16186735

13. K.Israel-Ballard, B.Abrams, A.Coutsoudis, C.J.Chantry, A.W.Sturm,

F.Karim. Flash-heated and Pretoria Pasteurized destroys HIV in breast
milk & Preserves Nutrients! Flash-heated Pretoria Pasteurized destroys
HIV in breast milk Preserv Nutr [Internet]. 2008 Sep 15 [cited 2013 Oct
19];07(03):32–5. Available from:
http://www.advancedbiotech.in/archives_sep 08 _Flash-heated.html

14. Chaudhri R, Vlachos D, Borriello G, Israel-Ballard K, Coutsoudis A,

Reimers P, et al. Decentralized human milk banking with ODK sensors.
Proceedings of the 3rd ACM Symposium on Computing for Development -
ACM DEV ’13 [Internet]. New York, New York, USA: ACM Press; 2013
[cited 2013 Oct 18]. p. 1. Available from:
http://dl.acm.org/citation.cfm?id=2442882.2442887

15. Burton P, Kennedy K, Ahluwalia JS, Nicholl R, Lucas A, Fewtrell MS.

Randomized trial comparing the effectiveness of 2 electric breast pumps
in the NICU. J Hum Lact [Internet]. 2013 Aug [cited 2013 Oct
23];29(3):412–9. Available from:
http://www.ncbi.nlm.nih.gov/pubmed/23776081

16. Fewtrell MS, Lucas P, Collier S, Singhal A, Ahluwalia JS, Lucas A.

Randomized trial comparing the efficacy of a novel manual breast pump
with a standard electric breast pump in mothers who delivered preterm
infants. Pediatrics [Internet]. 2001 Jun [cited 2013 Oct 23];107(6):1291–7.
Available from: http://www.ncbi.nlm.nih.gov/pubmed/11389245

17. Gransden WR, Webster M, French GL, Phillips I. An outbreak of Serratia

marcescens transmitted by contaminated breast pumps in a special care
baby unit. J Hosp Infect [Internet]. 1986 Mar [cited 2013 Oct
23];7(2):149–54. Available from:
http://www.ncbi.nlm.nih.gov/pubmed/2871077

18. Karimi M, Eslami Z, Lotfi MH, Nori S, Zandi H, Taghipour-Zahir S, et al.

Bacterial Contamination of Expressed Breast Milk in Neonatal Intensive
Care Unit. Zahedan J Res Med Sci [Internet]. Zahedan Journal of

GUIDELINES FOR THE ESTABLISHMENT & OPERATION OF HUMAN MILK BANKS Page 46
 Research in Medical Sciences; 2013 Jan 4 [cited 2013 Oct 18];15(4):48–
52. Available from: http://www.zjrms.ir/browse.php?a_code=A-10-1301-
1&slc_lang=en&sid=1

19. Janjindamai W, Thatrimontrichai A, Maneenil G, Puwanant M. Soft

Plastic Bag Instead of Hard Plastic Container for Long-term Storage of
Breast Milk. Indian J Pediatr [Internet]. 2013 Oct [cited 2013 Oct
23];80(10):809–13. Available from:
http://www.ncbi.nlm.nih.gov/pubmed/23355013

20. Landers S, Hartmann BT. Donor human milk banking and the emergence
of milk sharing. Pediatr Clin North Am [Internet]. 2013 Feb [cited 2013
Oct 18];60(1):247–60. Available from:
http://www.ncbi.nlm.nih.gov/pubmed/23178068

21. Nash C, Amir L S on maternal and child health. Human Milk Banking: A
Review [Internet]. [cited 2013 Oct 18]. Available from:
http://www.breastfeedingindia.com/breastfeeding/human_milk_banks.ht
ml

22. FAQ - mothers milk cooperative [Internet]. Available from:

http://www.mothersmilk.coop/faq.html

23. humanmilkpatentpending: The Bitter Pill of Human Milk Banking

[Internet]. Available from: http://vwmcclain.blogspot.in/2012/12/the-
bitter-pill-of-human-milk-banking.html

24. Gras-Le Guen C, Lepelletier D, Debillon T, Gournay V, Espaze E, Roze JC.

Contamination of a milk bank pasteuriser causing a Pseudomonas
aeruginosa outbreak in a neonatal intensive care unit. Arch Dis Child
Fetal Neonatal Ed [Internet]. 2003 Sep [cited 2013 Oct 18];88(5):F434–5.
Available from:
http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1721613&to
ol=pmcentrez&rendertype=abstract

25. Ghaly M. Milk banks through the lens of Muslim scholars: one text in two
contexts. Bioethics [Internet]. 2012 Mar [cited 2013 Oct 18];26(3):117–27.
Available from: http://www.ncbi.nlm.nih.gov/pubmed/21091982

26. Sakamoto P. HUMAN MILK BANKING: Using Someone Else’s Milk When
Mom’s Own is Not Available - UCM235619.pdf [Internet]. Available from:
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeeting
Materials/PediatricAdvisoryCommittee/UCM235619.pdf

27. Documentation in Transfusion Services. Standards for blood banks and

blood transfusion services [Internet]. New Delhi: National AIDS Control
Organisation Ministry of health and family Welfare, Government of India;
2007. p. 90. Available from:

GUIDELINES FOR THE ESTABLISHMENT & OPERATION OF HUMAN MILK BANKS Page 47
 http://www.iapsmgc.org/userfiles/10_Standards_for_Blood_Banks_and_
Blood_Transfusion_Services.pdf

28. Armida Fernandez, Jayshree Mondkar WK. Human Milk banking in

developing countries. In: Dipak Guha, Arvind Saili, Swarnarekha Bhat et
al, editor. Guha’s Neonatology Principles and Practice. 3rd edi. V. New
Delhi: Jaypee brothers; 2005. p. 160–1.

29. Puopolo KM. Maternal Medications and Breastfeeding. In: John P.

Cloherty, Eric C Eiderwald ARH, editor. Manual of Neonatal Care. 7th ed.
Wolters Kluwers; 2012. p. 973–84.

30. Drugs and Lactation Database (LactMed) Search [Internet]. Available

from: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT

31. Simmer K, Hartmann B. The knowns and unknowns of human milk

banking. Early Hum Dev [Internet]. 2009 Nov [cited 2013 Oct
22];85(11):701–4. Available from:
http://www.ncbi.nlm.nih.gov/pubmed/19766412

32. Guidelines for the Operation of a Donor Human Milk Bank - HMBASA
guidelines.pdf [Internet]. Human Milk Banking Association of South
Africa. 2011 [cited 2013 Aug 5]. Available from:
http://www.hmbasa.org.za/HMBASA guidelines.pdf

33. Grøvslien AH, Grønn M. Donor milk banking and breastfeeding in

Norway. J Hum Lact [Internet]. 2009 May [cited 2013 Oct 18];25(2):206–
10. Available from: http://www.ncbi.nlm.nih.gov/pubmed/19414822

34. Kumar H, Gupta PK. Is seroprevalence of HTLV-I/II among blood donors

in India relevant? Indian J Pathol Microbiol [Internet]. 2006 Oct [cited
2013 Oct 12];49(4):532–4. Available from:
http://www.ncbi.nlm.nih.gov/pubmed/17183844

35. Testing of donated blood. Standards for blood banks and blood
transfusion services [Internet]. New Delhi: National AIDS Control
Organisation, Ministry Of health and family Welfare, Government of India;
2007. p. 33–4. Available from: www.nacoonline.org

36. Costing statement: donor breast milk banks [Internet]. National Institute
for Health and Clinical Excellence (NICE). Available from:
http://www.nice.org.uk/nicemedia/live/12811/47504/47504.pdf

37. Branson BM, Handsfield HH, Lampe MA, Janssen RS, Taylor AW, Lyss
SB, et al. Revised recommendations for HIV testing of adults, adolescents,
and pregnant women in health-care settings. MMWR Recomm Rep
[Internet]. 2006 Sep 22 [cited 2013 Oct 19];55(RR-14):1–17; quiz CE1–4.
Available from: http://www.ncbi.nlm.nih.gov/pubmed/16988643

GUIDELINES FOR THE ESTABLISHMENT & OPERATION OF HUMAN MILK BANKS Page 48
38. Boo NY, Nordiah AJ, Alfizah H, Nor-Rohaini AH, Lim VK. Contamination
of breast milk obtained by manual expression and breast pumps in
mothers of very low birthweight infants. J Hosp Infect [Internet]. 2001
Dec [cited 2013 Oct 12];49(4):274–81. Available from:
http://www.ncbi.nlm.nih.gov/pubmed/11740876

39. Lucas A, Gibbs JA, Baum JD. The biology of human drip breast milk.
Early Hum Dev [Internet]. 1978 Dec [cited 2013 Oct 18];2(4):351–61.
Available from: http://www.ncbi.nlm.nih.gov/pubmed/571325

40. Davies DP. Human milk banking. Arch Dis Child [Internet]. 1982 Jan
[cited 2013 Oct 18];57(1):3–5. Available from:
http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2863269&to
ol=pmcentrez&rendertype=abstract

41. Manual Expression of Breast Milk: Marmet Technique [Internet]. La Leche

League International. 2003 [cited 2013 Oct 26]. Available from:
http://lllrochester.weebly.com/uploads/7/9/5/4/795404/marmet_techn
ique_tearoff.pdf

42. Prime DK, Garbin CP, Hartmann PE, Kent JC. Simultaneous breast
expression in breastfeeding women is more efficacious than sequential
breast expression. Breastfeed Med [Internet]. 2012 Dec [cited 2013 Oct
23];7(6):442–7. Available from:
http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=3698671&to
ol=pmcentrez&rendertype=abstract

43. Thompson N, Pickler RH, Munro C, Shotwell J. Contamination in

expressed breast milk following breast cleansing. J Hum Lact [Internet].
1997 Jun [cited 2013 Oct 23];13(2):127–30. Available from:
http://www.ncbi.nlm.nih.gov/pubmed/9233203

44. Morera Pons S, Castellote Bargalló AI, López Sabater MC. Evaluation by
high-performance liquid chromatography of the hydrolysis of human milk
triacylglycerides during storage at low temperatures. J Chromatogr A
[Internet]. 1998 Oct 9 [cited 2013 Oct 23];823(1-2):467–74. Available
from: http://www.ncbi.nlm.nih.gov/pubmed/9818420

45. Hartmann BT, Pang WW, Keil AD, Hartmann PE, Simmer K. Best practice
guidelines for the operation of a donor human milk bank in an Australian
NICU. Early Hum Dev [Internet]. 2007 Oct [cited 2013 Oct
23];83(10):667–73. Available from:
http://www.ncbi.nlm.nih.gov/pubmed/17913402

46. Landers S, Updegrove K. Bacteriological screening of donor human milk

before and after Holder pasteurization. Breastfeed Med [Internet]. 2010
Jun [cited 2013 Oct 19];5(3):117–21. Available from:
http://www.ncbi.nlm.nih.gov/pubmed/20509779

GUIDELINES FOR THE ESTABLISHMENT & OPERATION OF HUMAN MILK BANKS Page 49
47. Terpstra FG, Rechtman DJ, Lee ML, Hoeij K Van, Berg H, Van
Engelenberg FAC, et al. Antimicrobial and antiviral effect of high-
temperature short-time (HTST) pasteurization applied to human milk.
Breastfeed Med [Internet]. 2007 Mar [cited 2014 Jan 26];2(1):27–33.
Available from: http://www.ncbi.nlm.nih.gov/pubmed/17661617

48. Arnold LDW. Global health policies that support the use of banked donor
human milk: a human rights issue. Int Breastfeed J [Internet]. 2006 Jan
[cited 2013 Oct 19];1(1):26. Available from:
http://www.internationalbreastfeedingjournal.com/content/1/1/26

49. Cristofalo EA, Schanler RJ, Blanco CL, Sullivan S, Trawoeger R, Kiechl-
Kohlendorfer U, et al. Randomized Trial of Exclusive Human Milk versus
Preterm Formula Diets in Extremely Premature Infants. J Pediatr
[Internet]. 2013 Aug 20 [cited 2013 Oct 22]; Available from:
http://www.ncbi.nlm.nih.gov/pubmed/23968744

50. Boyd CA, Quigley MA, Brocklehurst P. Donor breast milk versus infant
formula for preterm infants: systematic review and meta-analysis. Arch
Dis Child Fetal Neonatal Ed [Internet]. 2007 May [cited 2013 Oct
19];92(3):F169–75. Available from:
http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2675323&to
ol=pmcentrez&rendertype=abstract

51. Huffman SL, Combest C. Role of breast-feeding in the prevention and

treatment of diarrhoea. J Diarrhoeal Dis Res [Internet]. 1990 Sep [cited
2013 Oct 19];8(3):68–81. Available from:
http://www.ncbi.nlm.nih.gov/pubmed/2243179

52. De Nisi G, Berti M, De Nisi M, Bertino E. Early enteral feeding with

human milk for VLBW infants. J Biol Regul Homeost Agents [Internet].
[cited 2013 Oct 23];26(3 Suppl):69–73. Available from:
http://www.ncbi.nlm.nih.gov/pubmed/23158518

53. Life-Saving Donor Breast Milk On Its Way to Sick and Orphaned Babies
in South Africa - Clinical Trial & Cold Chain Logistics | QuickSTAT
[Internet]. Available from: http://quick.aero/quickstat/blog/life-saving-
donor-breast-milk/

54. Breastfeeding: Recommendations: Handling Breastmilk | DNPAO | CDC

[Internet]. Webpage of Center of Disease Control and Prevention, Atlanta.
[cited 2013 Dec 15]. Available from:
http://www.cdc.gov/breastfeeding/recommendations/handling_breastmil
k.htm

55. Eglash A. ABM clinical protocol #8: human milk storage information for
home use for full-term infants (original protocol March 2004; revision #1
March 2010). Breastfeed Med [Internet]. 2010 Jun [cited 2013 Dec

GUIDELINES FOR THE ESTABLISHMENT & OPERATION OF HUMAN MILK BANKS Page 50
 15];5(3):127–30. Available from:
http://www.ncbi.nlm.nih.gov/pubmed/21548822

56. Sigman M, Burke KI, Swarner OW, Shavlik GW. Effects of microwaving
human milk: changes in IgA content and bacterial count. J Am Diet Assoc
[Internet]. 1989 May [cited 2013 Oct 23];89(5):690–2. Available from:
http://www.ncbi.nlm.nih.gov/pubmed/2723294

57. Donovan SM, Hintz RL, Rosenfeld RG. Insulin-like growth factors I and II
and their binding proteins in human milk: effect of heat treatment on IGF
and IGF binding protein stability. J Pediatr Gastroenterol Nutr [Internet].
1991 Oct [cited 2013 Oct 19];13(3):242–53. Available from:
http://www.ncbi.nlm.nih.gov/pubmed/1724266

58. Breast Pumps [Internet]. US FDA, Health, Center for Devices and
Radiological. Center for Devices and Radiological Health; 2013 [cited 2013
Oct 23]. Available from:
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/Ho
meHealthandConsumer/ConsumerProducts/BreastPumps/ucm061950.h
tm

GUIDELINES FOR THE ESTABLISHMENT & OPERATION OF HUMAN MILK BANKS Page 51
 RECOMMENDED READING
1. Guidelines for the establishment and operation of a donor human milk
bank. Italian Association of Human Milk Banks Associazione Italiana
Banche del Latte Umano Donato (AIBLUD: www.aiblud.org). The Journal of
Maternal-Fetal and Neonatal Medicine, September 2010; 23(S2): 1–20.
2. Mother’s milk cooperative FAQ. http://www.mothersmilk.coop/faq.html.
3. Human Milk patent pending. http://vwmcclain.blogspot.in/2012/12/the-
bitter-pill-of-human-milk-banking.html.
4. Agarwal R.K. Guidelines for the Establishment and Operation of Mother Milk
Bank. 2013.
5. Guidelines for Enhancing Optimal Infant and Young Child Feeding
Practices. Ministry of Health and Family Welfare, Government of India,
2013.
6. Lois DW Arnold. Global Health Policies that support the use of banked
donor human milk: a human right issue. International Breast feeding
Journal.2006, 1:26.
7. Gareth Jones, Richard W Steketee, Robert E Black, Zulfiqar A Bhutta, Saul
S Morris, and the Bellagio Child Survival Study Group. Lancet 2003; 362:
65–71.
8. Sullivan S, Schanler RJ, Kim JH, et al. An exclusively human milk-based
diet is associated with a lower rate of necrotizing enterocolitis than a diet of
human milk and bovine milk-based products. J Pediatr. 2010;156:562–7.
9. Sandhya K, Ashwini H. Human milk bank: where every precious drop
counts.Medical Journal of West India2013; 41:45-47.
10. Schanler RJ, Lau C, Hurst NM, et al. Randomised trial of donor human
milk versus preterm formula as substitutes for mother’s own milk in the
feeding of extremely premature infants. Pediatrics 2005; 115(2):400-6.
11. Bernshaw NJ. Milk banking: an idea that has come of age Non-profit milk
banks. Utah Breastfeeding Coalition
Meeting.http://www.utahbreastfeeding.org/business/2006_08_MilkBankNo
tes.pdf.
12. Karen M. Puopolo: Maternal Medications and Breastfeeding. In: John P.
Cloherty, Eric C Eiderwald, Anne R. Hansen et all: Manual of Neonatal Care
7thedi. WoltersKluwers 2012. p.973-984.

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Members at the National Consultative Meeting: Dr. RK Agarwal, Dr. Ketan
Bharadva, Dr. Satish Tiwari, Dr. CR Banapurmath, Dr. Balraj Singh Yadav, Dr.
Sudhir Mishra, Dr. Jayashree Mondkar, Dr. Poonam Singh, Dr. Sandhya
Khadse, Dr. Kanya Mukhopadhyay, Dr. Sailesh Gupta, Dr. Sila Deb (Deputy
Commissioner - Child Health, MOHFW), Dr. Karan Veer Singh (UNICEF), Dr.
Arun Singh (NIPPI), Dr. Manoj Patki (PHFI), Dr. Deepti Agarwal (MOHFW), Dr.
Ruchika (MOHFW), Dr. Shailesh Jagtap (PHFI), Dr. Ashfaq Ahmed Bhatt (Senior
Health Advisor Norway), Dr. Lysandar Menezes (PATH), Dr. S. Aneja, Dr. Geeta
Gathwala, Dr. Kundan Mittal, Dr. Vishesh Kumar, Dr. Swati Patki, Dr. Sarath
Gopalan, Dr. AK Dutta, Dr. Meenakshi, Dr. Vinita Yadav, Dr. Sushila Yadav,
Dr. C.P. Bansal (could not attend), Dr. Sushil Kr. Gupta (Advocate Supreme
Court), Dr. Vijay Yewale (could not attend), Dr. Piyush Gupta (could not attend).
Writing Committee: Dr. Ajay Khera, Dr. Ketan Bharadva, Dr. Sudhir Mishra,
Dr. Jayashree Mondkar, Dr. Poonam Singh, Dr. Sandhya Khadse, Dr. Satish
Tiwari, Dr. Balraj Singh Yadav, Dr. Vishesh Kumar, Dr. Kanya Mukhopadhyay,
Dr. CR Banapurmath, Dr. Sanjay Wazir, Dr. RK Agarwal, Dr. Arun Kumar, Dr.
Karan Veer Singh, Dr. Lysandar Menezes, Dr. Sailesh Gupta.
Acknowledgements:
We thankfully acknowledge the help, co-coperation, assistance and guidance
from the Ministry of Health-Family Welfare Government of India, Hon’ble Health
& Medical Education Minister, Haryana Rao Narender Singh, WHO, UNICEF,
PHFI, PATH, NIPPI, Human Milk Banks and NGOs. We thank Dr. Rakesh
Kumar (Joint Secretary-MOHFW), Dr. Ajay Khera, Deputy Commissioner (Child
Health & Immunization) MOHFW, Dr. Sila Deb (Deputy Commissioner - Child
Health, MOHFW) for their constant help, guidance & support in organizing this
National Meet. We specially thank and acknowledge Dr. Ajay Khera, Deputy
Commissioner (Child Health & Immunization) MOHFW and Smt. Santra Devi
Health & Educational Trust for designing and technical assistance; without
whose support, guidance, help and co-operation this National Meet would have
been a distant dream. We are thankful to Dr. Vinay Kulkarni for his efforts in
drafting.
Correspondence to:
Dr. Ketan Bharadva, 3 Yogi Krupa Society, Opp. Nova Apex apt, Behind Sneh
Sankul wadi, Adajan, Surat, 395009 Gujarat, India. [email protected]
Dr. Satish Tiwari, Yashoda Nagar No. 2, Amravati 444-606, Maharashtra, India.
[email protected]
Funding: Smt. Santra Devi Health & Educational Trust
Competing Interest: None

GUIDELINES FOR THE ESTABLISHMENT & OPERATION OF HUMAN MILK BANKS Page 53
 Team 2013-2014 : IAP IYCF Chapter
President Dr. RK Agarwal

Dr. CR Banapurmath
Vice Presidents
Dr. MMA Faridi

Hon. Secretary Dr. KG Bharadva

Joint Secretary Dr. BS Yadav

Treasurer Dr. S. Borade

East Zone Representative Dr. CM Chhajer

West Zone Representative Dr. HK Takwani

North Zone Representative Dr. R Gulati

South Zone Representative Dr. NK Subramaniam

Cental Zone Representative Dr. A Gaur

GUIDELINES FOR THE ESTABLISHMENT & OPERATION OF HUMAN MILK BANKS Page 54