Evidence

Surveillance report 2018 – Donor milk banks: service operation (NICE guideline CG93)

Overview of 2018 surveillance methods

Overview of 2018 surveillance methods

NICE's surveillance team checked whether recommendations in donor milk banks: service operation (NICE guideline CG93) remain up to date. The surveillance process for NICE guideline CG93 followed the static list review process. It consisted of:

  • A search for new or updated Cochrane reviews.

  • A search for ongoing research.

  • Examining related NICE guidance and quality standards, government policy and guidance, and National Institute for Health Research (NIHR) signals.

  • Feedback from topic experts via a questionnaire.

  • Consultation on the decision with stakeholders.

For further details about the process and the possible update decisions that are available, see ensuring that published guidelines are current and accurate in developing NICE guidelines: the manual.

Evidence considered in surveillance

Search and selection strategy

We searched for new Cochrane reviews related to the whole guideline. We found 1 relevant Cochrane review published between January 2012 and April 2018[1]. This Cochrane review assessed the effectiveness of different methods of milk expression with the results considered to support current NICE guideline CG93 recommendations.

Topic experts identified 16 pieces of evidence, of which 13 were within the scope of the guideline[2]. These included guidelines in the area (none NICE accredited), plus studies assessing different pasteurisation techniques, and the use of human donor milk in England. These studies were considered relevant to NICE guideline CG93 but they did not provide enough evidence to suggest a need for the guideline to be updated.

Intelligence gathered during surveillance

Views of topic experts

We considered the views of topic experts, including those who helped to develop the guideline. We sent questionnaires to 9 topic experts and received 4 responses. One considered that CG93 recommendations do not need to be updated, and 3 considered that an update is needed in the following areas: 1) quality assurance, 2) recruiting donors, 3) screening and selecting donors, 4) serological testing, 5) handling milk donor at home and during transportation, and 6) tracking and tracing.

However, some of the suggested changes included adding links to guidelines that are not NICE accredited (for example, guidelines about decontamination of breast milk pump collection kits) or in areas already considered in the guideline (for example, the provision of relevant training for all staff working in banks, the use of containers made of food grade material to keep all donor milk, or the use of track and tracing systems). Some areas were felt to be out of scope, for instance, the need for clinical guidance about who should receive donor milk (including an assessment of the benefits and harms of the intervention).

Relevant changes were also suggested including changing a reference to the Health Protection Agency to Public Health England, the inclusion of internet and social media in the media features that could be used to recruit milk donors, and the UK's National Accreditation Body accreditation that will replace the clinical pathology accreditation (which will be withdrawn in the last quarter of 2018). These changes will be actioned through editorial amendments.

Views of stakeholders

Stakeholders are consulted on all surveillance decisions except if the whole guideline will be updated and replaced. Because this surveillance decision is to not update the guideline, we consulted on the decision.

Overall, 4 stakeholders commented: 2 agreed with the decision and 2 disagreed with the decision. Generally, stakeholders who disagreed with the no update proposal felt the guideline recommendations could be more detailed, particularly around temperatures for storing milk, transportation procedures (in relation to temperature and timeframe for transportation), tracking systems and nutritional health of the donors. These issues were considered in detail but felt to be covered by NICE guideline CG93 already or other NICE guidance, or there was insufficient evidence to warrant an update to the guideline.

See appendix A for full details of stakeholders' comments and our responses.

Equalities

No equalities issues were identified during the surveillance process.

Editorial amendments

During surveillance of the guideline, we identified editorial or factual corrections which should be actioned:

Recommendation 1.9

This recommendation needs to be amended to include internet and social media. The bold text is the new text that will be added:

When promoting the donation of breast milk, aim to reach as many potential donors as possible through a variety of channels, including:

  • providing written information to be left in:

    • GP surgeries

    • antenatal clinics and postnatal wards

    • volunteer and other organisations working in maternity and childbirth

    • children's or Sure Start centres

    • maternity shops

  • direct referrals or recommendations by:

    • current and previous donors

    • staff at neonatal intensive care units

    • paediatricians assessing babies' progress

    • health visitors (or other healthcare professionals providing postpartum care)

    • childbirth educators

    • organisers and attendees of prenatal and postnatal classes

    • breastfeeding mothers' support groups and related organisations

  • features in the media (including internet and social media).

Recommendation 1.12

This recommendation needs to be amended to change the hyperlink in the second bullet point with a hyperlink to the NHS Choices website, which includes more detailed information on alcohol intake when breastfeeding. Additionally, the link in the last bullet point will be changed from the Health Protection Agency (HPA) website to the Public Health England (PHE) website.

Advise a potential donor that she is not eligible to donate milk if she:

  • currently smokes or uses nicotine replacement therapy (NRT)

  • regularly exceeds recommended alcohol levels for breastfeeding mothers (1 to 2 units, once or twice a week; see NHS Choices website for information on alcohol and breastfeeding)

  • is using, or has recently used, recreational drugs

  • has previously tested positive for HIV 1 or 2, hepatitis B or C, human T‑lymphotropic virus (HTLV) type I or II, or syphilis

  • is at an increased risk of Creutzfeldt–Jakob disease (CJD; see PHE website for information on the risk of CJD).

Include this information in recruitment material so that potential donors can self-screen for these criteria.

Recommendation 1.13

A cross-referral will be added from recommendation 1.13 in NICE guideline CG93 to recommendation 10 in the NICE guideline on maternal and child nutrition (PH11), which advises mothers that a healthy diet is important for everyone and that they do not need to modify their diet to breastfeed.

Recommendation 1.32

In footnote 1 of the recommendation, the link to the UK Drugs in Lactation Advisory Service is broken and it needs to be updated to the new link.

Recommendation 1.19

Once UK's National Accreditation Body accreditation is fully in place, this recommendation will be reassessed.

Overall decision

After considering the impact on current recommendations of the evidence, views of topic experts and stakeholder, and other intelligence, we decided not to update at this time.

ISBN: 978-1-4731-3005-0


[1] Becker GE, Smith HA, Cooney F. Methods of milk expression for lactating women. Cochrane Database of Systematic Reviews 2016, Issue 9. Art. No.: CD006170. DOI: 10.1002/14651858.CD006170.pub5

[2] Price E, Weaver G, Hoffman P, Jones M, Gilks J, O'Brien V, Ridgway G. Decontamination of breast pump milk collection kits and related items at home and in hospital: guidance from a Joint Working Group of the Healthcare Infection Society and Infection Prevention Society. J Hosp Infect. 2016;92(3):213-21

Hartmann BT. Ensuring Safety in Donor Human Milk Banking in Neonatal Intensive Care. Clin Perinatol. 2017;44(1):131-149

Calvo J, García Lara NR, Gormaz M, Peña M, Martínez Lorenzo MJ, Ortiz Murillo P, Brull Sabaté JM, Samaniego CM, Gayà A. Recommendations for the creation and operation of maternal milk banks in Spain. An Pediatr (Barc). 2018 Feb 26

Arslanoglu S, Bertino E, Tonetto P, De Nisi G, Ambruzzi AM, Biasini A, Profeti C, Spreghini MR, Moro GE; Working Group on Guidelines of the Italian Association of Human Milk Banks. Amendment to 2010 Italian guidelines for the establishment and operation of a donor human milk bank. J Biol Regul Homeost Agents. 2012;26(3 Suppl):61-4

Peila C, Moro GE, Bertino E, Cavallarin L, Giribaldi M, Giuliani F, Cresi F, Coscia A. The Effect of Holder Pasteurization on Nutrients and Biologically-Active Components in Donor Human Milk: A Review. Nutrients. 2016;8(8). pii: E477

Adhisivam B, Vishnu Bhat B, Rao K, Kingsley SM, Plakkal N, Palanivel C. Effect of Holder pasteurization on macronutrients and immunoglobulin profile of pooled donor human milk. J Matern Fetal Neonatal Med. 2018 Mar 27:1-4

Picaud JC, Buffin R. Human Milk-Treatment and Quality of Banked Human Milk. Clin Perinatol. 2017;44(1):95-119

Baro C, Giribaldi M, Arslanoglu S, Giuffrida MG, Dellavalle G, Conti A, Tonetto P, Biasini A, Coscia A, Fabris C, Moro GE, Cavallarin L, Bertino E. Effect of two pasteurization methods on the protein content of human milk. Front Biosci (Elite Ed). 2011;3:818-29

Czank C, Simmer K, Hartmann PE. Simultaneous pasteurisation and homogenisation of human milk by combining heat and ultrasound; effects on milk quality. J Dairy Res 2010; 77: 183-189

Permanyer M, Castellote C, Ramírez-Santana C, Audí C, Pérez-Cano FJ, Castell M, López-Sabater MC, Franch A.: Maintenance of breast milk immunoglobulinA after high pressure processing. J Dairy Sci 2010; 877-883.

Haiden N, Ziegler EE. Human Milk Banking. Ann Nutr Metab. 2016;69 Suppl 2:8-15

Daniels B, Reimers P, King T, Schmidt S, Coutsoudis A. Effect of the PiAstra Benchtop Flash-Heating Pasteurizer on Immune Factors of Donor Human Milk. Breastfeed Med. 2018 Mar 22

Battersby C, Marciano Alves Mousinho R, Longford N, Modi N; UK Neonatal Collaborative Necrotising (UKNC-NEC) Study Group. Use of pasteurised human donor milk across neonatal networks in England. Early Hum Dev. 2018;118:32-36


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