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Round 1 – donor stopping

RECOMMENDATIONMedian1-34-67-9D/KRec based on medianConsensus based on 75% ruleConsensus based on D9RGDG considerationsRecommendation for Round 2
S1aDo not continue to accept milk from donors who supply
  • contaminated milk
44400UncertainNo consensusConsensusThe GDG interpreted ‘contaminated’ to mean milk that does not meet the bacteriological standards. This draft recommendation was based on one study where donors were ‘dismissed’ if they were not able to provide ‘clean’ milk.

The GDG considered those circumstances in which a milk bank would wish to ask a donor not to continue to collect milk; any recommendation would therefore need to cover most, if not all, circumstances. Also, it is not clear whether a donor should be asked to stop donating or to suspend donation for a defined time. In practice, few donors return once they have suspended donation.

It was also recognised that some mothers will always supply milk that does not meet the bacteriological standards, while others will need some support or simple intervention to prevent this happening. However, there is also the issue of whether and how to communicate the underlying concern to the mother.

Based on limited evidence, it is not clear that bacteriological contamination is a safety issue for babies, but the balance of risks and benefits may differ for donor milk in recipient babies; therefore, the bacteriological standards applied to donated milk may be stricter than those that would be applied to milk for a mother's own baby.
Consider no longer accepting milk from donors who supply
  • milk that does not meet the microbiological criteria despite support
S1b 4.52222UncertainNo consensusNo consensusRoutine measurement of protein content is not done, so the recommendation was removed.
S1c
  • small amounts of milk (less than 2 ounces daily after a week's trial).
35210Do not agreeNo consensusNo consensusAlthough the draft recommendation specifies a small amount, the GDG considered that, in practice, it may not be possible to define this; and if a milk bank needs milk then small amounts may be accepted. Also a week's trial is not generally sufficient.

The issue of resources was important, and the GDG considered that, if milk banks are to be financially accountable, then it may not be cost effective to collect very small amounts as a matter of routine. However, this may average across a milk bank if other donors provide larger amounts. In principle, the GDG agreed that it is legitimate and appropriate to consider not processing small amounts, particularly if they area one-off donations or from a long distance away. The definition of ‘small’ will therefore depend on local circumstances.
  • small amounts of milk
S2aAdvise women that
  • if they become ill, they can continue to donate milk.
36200Do not agreeConsensusConsensusThe GDG revised the wording to define ‘ill’.

The GDG also discussed whether it was relevant if a baby became ill, and it was felt to be relevant only where there was clear evidence that the baby's illness came from the mother. The GDG agreed therefore that the mother is the focus of this recommendation.

The concern over the illness will also depend on the treatment processes used for the milk, because many infections are destroyed with adequate processing.

If a mother has chicken-pox, the virus will be in the milk but after pasteurisation the risk will be minimised for both the recipient and the staff handling the milk.

Milk-bank staff may also need to consider the issue of illness retrospectively, because women may donate milk that has been stored.

Other considerations may be the physical effects of any illness (for example, not being able to get out of bed) and the implications for milk collection.
Advise women that if they develop a temperature or have contact with other exanthema, to contact the milk bank to discuss temporary suspension of milk donation.
S2b
  • if their baby becomes ill, they can continue to donate milk.
35210Do not agreeNo consensusNo consensusSee S2a.
S3Advise donor women who are taking short courses of medication for infection that they should stop collecting milk for donation.71250AgreeNo consensusNo consensusThe GDG agreed that it was the responsibility of the donor to inform the milk bank if she were taking any medication, and it was then the responsibility of the milk bank to advise on any action to be taken, including temporary suspension of donation.Advise donor women who begin taking medication that they should inform the milk bank to discuss temporary suspension of milk donation.
S4Advise donor women who are taking short courses of antimicrobial medication that they should stop collecting milk for donation.70350AgreeNo consensusConsensusSee S3.
S5Advise donor women who are taking short courses of medication that they should wait for 5 half-lives of the drug after the last ingested dose; in most cases, a wash-out period of 1 day will be sufficient.5.52510UncertainNo consensusNo consensusSee S3.
S6aAdvise donor women that they should temporarily discontinue to collect milk for donation if
  • they have herpetic lesions
80242AgreeNo consensusConsensusThe GDG discussed whether herpes infection should be considered a risk. Recurrent cold sores are localised, and the virus may not appear in milk; the risk may come from contamination after expression, not viral material in the milk.

As discussed before, the risk of any infection in the milk depends on the treatment processes used.

The recommendation was reworded to include breast infections or lesions. In these circumstances, there are many risks including risk to the mother with damage to the skin from the pump, or blood in the milk. The recommendation was also expanded to include any changes in the colour or consistency of the milk.

As with the use of medication, the recommendation was reworded to emphasise that women should inform the milk bank, with the milk bank then advising on any action to be taken.

Milk banks work in a climate of trust – but more monitoring and checking is appropriate. So any donor who becomes unable to meet the initial recruitment criteria should contact the milk bank for advice.
Advise donor women that they should inform the milk bank if
  • they have any breast lesions or infection (including mastitis) such as herpes to discuss temporary suspension of milk donation
  • they have any changes in the colour or consistency of the milk they have had any vaccination
  • they no longer meet the initial recruitment criteria
S6b
  • they have had a recent rubella vaccination (a minimum of 3 weeks before they can start to donate again).
81043AgreeNo consensusNo consensusSee S6a.
S7aAdvise donor women that they should discontinue to collect milk for donation if
  • they have herpetic lesions
53131UncertainNo consensusNo consensusSee S6a.
S7b
  • they have had a rubella vaccination in the past month.
34112Do not agreeNo consensusNo consensusSee S6a.
S8aAdvise donors who are taking medication for a period of time that they should
  • stop collecting milk for donation
52330UncertainNo consensusNo consensusSee S3.
S8b
  • they may continue to express, and any milk that contains contraindicated medication should be labelled and will be used for research projects
4.53410UncertainNo consensusNo consensusSee S3.

Milk banks do not need to register as tissue banks but, if milk were being collected for research, then they would need to register. Research governance now would not allow the collection of milk in this way.
S9NEWThe issue of when donors should be advised to stop expressing milk for donation was raised. Although there is general advice on how long breastfeeding should be continued, when to stop is still the decision of the mother. For milk donation, it may be appropriate to ask donors to stop when their own baby reaches a certain age.

This age would depend on the target population of the milk bank – generally, the main recipient population is pre-term babies, so it may be appropriate to restrict donation according to the age of the baby. The recipient population will differ by milk bank. The reason for such a criterion is based on evidence that suggests that levels of zinc in breast milk decrease over time; ‘more mature’ milk may therefore not be suitable in nutritional composition for pre-term babies.

Should donors who become pregnant be advised to stop donating? There is no evidence on this, and, based on the experience of the GDG, mothers will stop by choice. As in all milk donation, there is a need to respect the mother's decision if she wishes to continue to donate, but there may be implications for the mother because, by accepting the milk, there is an implicit support of that process‥It was agreed, therefore, not to make a recommendation on this.
Local policies should be set up to define when donors should be advised to stop donating milk based on the age of their own baby, and this should be based on the recipient population.

From: Appendix 3, Methods of guideline development

Cover of Donor Breast Milk Banks
Donor Breast Milk Banks: The Operation of Donor Milk Bank Services.
NICE Clinical Guidelines, No. 93.
Centre for Clinical Practice at NICE (UK).
Copyright © 2010, National Institute for Health and Clinical Excellence.

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