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Human Milk Bank Processes: King Edward Hospital Fuchs Milk Bank, Durban, South Africa Anna Coutsoudis Professor, Dept Paediatrics & Child Health. University KwaZulu-Natal Durban, South Africa [email protected] Background info Brief description How did your human milk bank (HMB) began? When? Began in response to a need for low birth weight infants in the NICU whose mothers could not provide breatmilk to receive donor milk instead of preterm formula milk. Risk of NEC and feed intolerance were reported by staff and head of NICU to be a major problem. Began in 2009 Who provided initial funding? How are ongoing operations funded? Integrated into government services? Initial funding provided by Carl and Emily Fuchs Foundation. Sicne 2011 when funding ran out Prof Coutsoudis has been paying the salary of the breastmilk bank manager from her own discretionary research funds - Not integrated into government services. Who regulates /oversees HMB in your country/region (if any)? Oversight (very limited) provided by Human Milk Banking Association of South Africa. No government oversight yet, although is being planned. How many HMBs are part of your system? Where are they? 1 Is there a central HMB that processes milk and distributes or many HMBs that process milk and distribute? (Centralized vs decentralized) Decentralised – but current province local government plans are to have a central bank that processes and then distributes. Banks will collect their own donor milk and transport to central bank. How many NICU/Neonatal wards/community homes does each bank serve? Are they collocated? Serves its own neonatal ward How many babies does your facility/system serve annually? About 80– could be much more if had more milk and more ownership from the whole health care team How many liters/year does your facility/system process annually? 70 – 80 litres How many donor mothers initiate donation to your facility/system annually? 60-70 Page 2 Process Brief description of processes Staffing • 1 breastmilk bank manager who is responsible for screening mothers and organsing HIV testing (sometimes assisted by the counsellor). She is also trained as a lactation consultant and is expected to assist mums with breastfeeding and to encourage women to donate Donor recruitment • In the hospital from mothers whose babies are not yet ready for discharge – low birth weight babies being fed on expressed breastmilk Donor screening • Screening form for lifestyle risks – similar to blood donor screening and HIV and syphylis tests from pregnancy – if HIV test from pregnancy is negative then a repeat test is done on the day of screening. Recipient eligibility and selection • No infections, healthy mother Handling and storage of donor milk (from donation to feeding) • Mothers given sterile glass bottle into which to express breastmilk. Before expressing mothers wash hands and wipe breasts down with antibacterial swab. Once milk is expressed mothers record donor number and date of expression on bottle. Milk is given to breastmilk bank manager who immediately pasteurizes it and after cooling freezes it or it can be placed in fridge for immediate use. If she is too busy to pasteurise immediately, milk is frozen for later pasteurisation. 4 Process Brief description of process Transport of milk • Manager collects milk from mothers’ homes or collection depots in cooler box with ice packs and transports it to milk bank Pasteurization • Flash heating – using newly developed MMM pasteuriser Tracking and record keeping • Each pasteurisation has batch number, temperature logging on phone screen and can be relayed to remote server. Assessing milk quality and safety (ie. microbiology assays) • Micro assays on post-past’n sample –each new donor has first sample assayed. Quality assurance • Screening of mothers, HIV and syphilis test results, issue of sterile collection bottles; temperature control of freezers; temperature monitoring of pasteurising and cooling; batch numbers and donor number on each bottle; expiry date on each bottle Equipment/Location Brief description of process What is used/how many? • 1 x MMM pasteuriser • 1 x Freezer for unpasteurised and pasteurised milk – kept separate • 1 x Refrigerator • 450 ml glass milk collection bottles • 125 ml glass storage bottles Additional HMB equipment • Separate room with stainless steel surfaces and washing facilities requirements? Referral/feeder/depot facilities? • none Neonatal ward equipment requirements? • none • none Organizational Successes Brief description of top 3-5 successes Policy • Advocacy work together with PATH led to National/regional policy and support for breastfeeding as well as roll out of donor milk banks. • Publication on feasibility and safety of setting up a low cost donor milk bank in resource limited settings (BMC Public Health 2011) Operational • Improved health outcomes – see case studies …… Technology • Originally were using flash heating methodology developed by IsraelBallard et al – discomfort with certain things eg heating without lid, only one bottle at a time; no temperature monitoring – concern with over-or under-heating – collaboration with PATH and UW – Gates Foundation funding developed MMM pasteuriser. Page 7 Case Study • Infant A was born at 32 weeks gestation (birth weight: 1.7kg) to a 33year old HIV negative, para 3 mother following a caesarian section for severe pre-eclampsia. Mother had left arm paralysis since adolescence following a head injury. She had chosen to breastfeed antenatally, however the nurses decided as she had a paralytic arm, she would be unable to hold her baby and started her baby on formula. NEC developed on day 2 following formula feeds (abdominal distension; feed intolerance; severe umbilical flare; dilated visible bowel loops; and pneumatoses on abdominal X-ray). Feeds were discontinued for 2 days, following which breastfeeding was initiated by the mother supported by the study doctor. Donor milk was given for four days while the mother’s milk was coming down. NEC resolved after 6 days on treatment. Baby was doing well and discharged on breastfeeds and expressed breastmilk top-ups, 4 days after resolution of NEC. 8 Case Study • Infant B was born at 29 weeks gestation (birth weight 1.1kg) to a 41 yr old HIV negative, para 4 mother, with previous breast cancer and therefore not planning to breastfeed. Infant received formula milk feeds for the first 3 weeks of life and developed NEC (abdominal distension, vomiting, bloody stools and thickened bowel wall on abdominal X-Ray). He was taken off feeds for 5 days and then commenced on donor breastmilk for a further 3 weeks until discharge. Did extremely well on donor breastmilk and showed marked clinical improvement. In fact during the period of receiving donor breast milk the nursing staff attempted re-introducing formula feeds but these were not tolerated at all and were accompanied by projectile vomiting so were discontinued and donor breastmilk re-introduced. 9 Organizational Challenges Brief description of top 3-5 challenges Policy • Uncertainty around importance of donor milk, health care workers more comfortable working with formula milk, more experience. • Lack of policy level support for breastfeeding promotion. • Lack of guidance from Ministry of Health Operational • Funding for dedicated staff – staff normally wearing 2 or 3 hats • Insufficient donor milk due to insufficient donors – poor breastfeeding promotion – leads to many women discontinuing breastfeeding at 4 months Technology • Achieving optimal pasteurization throughput balanced against wastage on the neonatal ward with higher processing volumes (Pasteurizing in 125ml bottles when only 25 ml/baby is used) Page 10