Medela’s NICU solutions for human milk safety and infection control
Hygienic collection of human milk
Milk can be contaminated at any point along the milk pathway when it comes into contact with foreign surfaces. In particular, contaminated pumps have been identified as reservoirs for bacteria, especially after being used by multiple mothers and cleaned inadequately between uses. Hygienic collection of milk should therefore begin prior to pumping:
- Mothers should maintain normal maternal breast hygiene; no additional cleaning of the breast prior to milk expression is required
- Mothers who use a breast pump are recommended to wash and dry their hands thoroughly prior to pumping
- Hand drying with clean, single-use paper towels is regarded as best practice, in conjunction with turning taps off in a way that does not recontaminate the hands
- Pumping mothers and especially healthcare personnel should keep their fingernails short and remove jewellery
Symphony breast pump system
Breast pumps and pump sets are potential carriers of pathogenic microorganisms. Every mother therefore needs her own pump set, consisting of breast shield, connector, valve head, valve membrane, bottle, tubing, membrane cap and protective membrane.
Medela’s milk overflow protection system
Medela’s Symphony breast pump system was developed to minimise the risk of contamination and is licensed by Health Canada as a multi-user medical device. Thanks to the innovative milk overflow protection system called media separation, a division is created between the pump and the milk thus preventing potential cross-contamination between mothers. This feature makes the Symphony a hygienic, multi-user breast pump.
Firstly, Medela’s breast shields have a splash guard that guides milk flow directly into the collection bottle. Secondly, the protective membrane of the media separation is placed on the pump with the membrane cap. This protective membrane helps ensure that no milk can flow into the breast pump. The mother can simply take her complete pump set, including tubing and protective membrane and membrane cap, directly from the Symphony.
Collection containers and Smyphony breast pumping kits
Medela’s collection containers and pump kits are an integral part of the Symphony pump system. The choice of which collection containers and pump sets to use in the NICU depends on many factors, including national regulations, internal guidelines, sterilization facilities and environmental considerations.
It is Medela's goal to present a comphrehisve offering which can accommodate the diverse needs of each hospital and their infection control decisions, Medela provides three types of Symphony breast pumping kits:
- Single-use, Kits
- Sterile, single-use, disposable
- 24 Hour Kits : Coming Soon!
- manufcatured as Ready-To-Use
- For use up to 24 hours or 8 uses
- Expected date of availability: January 2017
- Length-Of-Stay Kits
- Offered as single or double-pumping kits
- Manufactured Sterile
- Includes cleaning instructions
All kits are single-user
Medela's hospital products are available as EO-Sterile and others are offered as both Sterile and Ready-to-Use (Clean-By-Manufacturing).
Medela Ready-to-Use products are hygienically safe to use without prior cleaning (Deutsches Beratungszentrum für Hygiene, 2014).
Medela sterile products are validated according to the applicable EN/ISO standards for sterile medical devices. ‘Sterilized’ or ‘pre-sterilized’ products are not to be confused with ‘sterile’ products. Only the term and symbol ‘STERILE’ guarantee that the product is actually sterile.
Breast shields and containers: adaptable to all needs and processes
Breast shields for the hospital are available in five different sizes to cater to the needs of all mothers.
Medela collection containers have grading in small and precise volume increments so that the quantity of expressed breast milk can be checked accurately and easily. They are available in a range of different sizes, from 35ml colostrum containers to 250ml.
The Medela disposable Colostrum Container has been developed with healthcare professionals and mothers in mind. The container is designed for carefully dealing with small volumes of breast milk. The curved bottom allows the user to easily draw milk from the container into a syringe. With this ease of extraction, the chances of contaminating the milk during handling can be minimised.
Medela breast milk bottles, storage containers, feeding products and breast pump kits are made from food-grade materials that are BPA free.
Hygienic handling and storage practices
Hygienic practices after pumping are just as important as those that occur prior to and during pumping. To minimise the chances of bacterial growth and infection, proper cleaning of breast pump, kit components, and hospital surfaces should be followed.
In the NICU there is a requirement to transfer and store pumped milk. This comes with the potential hazard of nutrient loss and contamination. The NICU must optimise storage conditions to minimise the loss of nutrients, growth factors and many other protective components in milk, whilst also minimising the possibilities of contamination at the NICU or mother’s home. With both time and varying temperatures, components in human milk decrease in potency while the growth of pathogens increases.
Providing the right milk to the right infant
Appropriate labelling is one of the prerequisites for safe storage. Methods such as storage boxes for each individual mother that are kept in a freezer or fridge, as well as bar codes more commonly seen in milk banks, may also be advantageous. Similar to the handling of other critical fluids in the hospital, the four-eyes principle has been recommended for the distribution of human milk to infants.
Human milk should be refrigerated or frozen as soon as possible if it is not to be used within four hours of expression. Each hospital should have policy recommendations for mothers about storage containers, conditions and times as well as specific recommendations that differentiate between donor milk and own mother’s milk, especially when fortifier has been added. Mothers transporting milk from home to hospital should be instructed on how to keep milk cool during transport with cooler bags.
Storage guidelines for human milk in the NICU
Guidelines for storing and thawing milk will differ according to the environment and the medical condition of the infant. In all instances, storage times should be kept as short as possible. The following recommendations are research-based and cover the human milk pathway in the NICU.
Pasteurisation and the use of donor milk
Pasteurisation is a process commonly utilised to reduce bacterial load and to eliminate viruses that may be passed from the mother to the milk. When milk from an infant’s own mother is either not available or not acceptable in a NICU setting, pasteurised donor human milk is the next best option. The downside of current pasteurisation processes is the loss of some immunological and nutritional components. The loss of the anti-infective activity of human milk means that the bacterial growth rate of pasteurised human milk is higher than in untreated human milk.
Medela offers bottles that can withstand pasteurisation temperatures and are suitable for the milk volumes handled in centralised milk kitchens or milk banks. In addition, the multi-user Symphony breast pump system, with its hygienic pump sets, serves as a partner for the collection of milk from donors.
Due to the high nutritional demands of preterm infants, fortification is recommended for those born weighing less than 1500g. Despite the benefits of fortification, bacterial growth in milk stored at refrigerator temperature is significantly greater in fortified milk compared with unfortified milk. Milk storage recommendations are therefore impacted.
The addition of fortifiers using aseptic techniques at room temperature or lower has been suggested to help minimize changes in osmolality levels.
Safe, hygienic and gentle warming of human milk
The thawing and warming of human milk are the final stages of preparing milk for feeding. Controlling the temperature of milk is not only important for maintaining its integrity, but may also be beneficial for the high-risk infant. Fluids such as saline and blood are usually warmed prior to infusion in order to avoid decreases in infant body temperature. In line with this, it has been theorised that milk temperature can also impact infant body temperature. Therefore, warming neonatal feeds has become a common practice in many NICUs, with the idea that feeds warmed to body temperature may improve infant outcomes, such as the infant’s ability to tolerate gavage feeds.
Water-based methods have been used for both thawing and warming human milk. These usually involve placing bottles or containers of milk in water baths or water-filled containers that should not exceed 37 °C. Regulating and achieving optimal temperature with these various water-based methods is challenging. Additionally, water, particularly when warm, can harbour pathogens.
Historically, contaminated hospital tap water used in bottle warmers has been identified as a source of nosocomial infection and outbreak in the NICU. Consequently, some NICUs now use dry, waterless warmers such as Medela’s Calesca.
Waterless Milk Warming: Safe, Reliable, Efficient
Medela offers the Waterless Milk Warmer, a waterless warming and thawing device that helps optimise and standardise best human milk handling processes and minimize the challenges associated with human milk handling. Designed for individual care in the NICU, the Waterless Milk Warmer aims to maintain the integrity of human milk by warming it towards body temperature without exposing it to high temperatures or the danger of water-borne pathogens.
Schanler, R.J. et al. Breastmilk cultures and infection in extremely premature infants. J Perinatol 31, 335-338 (2011).
Boo, N.Y., Nordiah, A.J., Alfizah, H., Nor-Rohaini, A.H., & Lim, V.K. Contamination of breast milk obtained by manual expression and breast pumps in mothers of very low birthweight infants. J Hosp Infect 49, 274-281 (2001).
el-Mohandes, A.E., Schatz, V., Keiser, J.F., & Jackson, B.J. Bacterial contaminants of collected and frozen human milk used in an intensive care nursery. Am J Infect Control 21, 226-230 (1993).
Tan, L., Nielsen, N.H., Young, D.C., & Trizna, Z. Use of antimicrobial agents in consumer products. Arch Dermatol 138, 1082-1086 (2002).
Aiello, A.E., Larson, E.L., & Levy, S.B. Consumer antibacterial soaps: Effective or just risky? Clin Infect Dis 45 Suppl 2, S137-S147 (2007).
Pittet, D., Allegranzi, B., & Boyce, J. The World Health Organization guidelines on hand hygiene in health care and their consensus recommendations. Infect Control Hosp Epidemiol 30, 611-622 (2009).
Human Milk Banking Association of North America 2011 Best practice for expressing, storing and handling human milk in hospitals, homes, and child care settings (HMBANA, Fort Worth, 2011).
Brown, S.L., Bright, R.A., Dwyer, D.E., & Foxman, B. Breast pump adverse events: Reports to the food and drug administration. J Hum Lact 21, 169-174 (2005).
Jones, B. et al. An outbreak of Serratia marcescens in two neonatal intensive care units. J Hosp Infect 46, 314-319 (2000).
Deutsches Beratungszentrum für Hygiene. Conclusion of the Risk Assessment of the Production Method for “Ready-to-Use” Products (2014).
DIN EN ISO 11135-1. Sterilization of health care products – Ethylene oxide – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
DIN EN ISO 11607-1. Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems, DIN EN ISO 11607-2. Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes. Gilks, J., Price, E., Hateley, P., Gould, D., & Weaver,G. Pros, cons and potential risks of on-site decontamination methods used on neonatal units for articles indirectly associated with infant feeding, including breast pump collection kits and neonatal dummies. J Infect Prev 13, 16-23 (2012).
Meier, P.P., Engstrom, J.L., Mingolelli, S.S., Miracle, D.J., & Kiesling, S. The Rush Mothers’ Milk Club: Breastfeeding interventions for mothers with very-lowbirth-weight infants. J Obstet Gynecol Neonatal Nurs 33, 164-174 (2004).
American Academy of Pediatrics - Section on Breastfeeding. Breastfeeding and the use of human milk. Pediatrics 129, e827-e841 (2012)
Dougherty, D. & Nash, A. Bar coding from breast to baby: A comprehensive breast milk management system for the NICU. Neonatal Netw 28, 321-328 (2009).
Drenckpohl, D., Bowers, L., & Cooper, H. Use of the six sigma methodology to reduce incidence of breast milk administration errors in the NICU. Neonatal Netw 26, 161-166 (2007).
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 5, 127-130 (2010).
Centers for Disease Control and Prevention. Assisted Reproductive Technology. http://www.cdc.gov/art/ (2012).
Food and Drug Administration. Breast milk. http://www.fda.gov/medicaldevices/productsandmedicalprocedures/homehealthandconsumer/consumerproducts/breastpumps/ucm061952.htm (2012).
Kurath, S., Halwachs-Baumann, G., Muller, W., & Resch, B. Transmission of cytomegalovirus via breast milk to the premat. Clin Microbiol Infect 16, 1172-1178 (2010).
National Institute for Health and Care Excellence. Donor milk banks: The operation of donor milk bank services. 2010. http://www.nice.org.uk/guidance/CG93/chapter/1-Guidance (2014).
Christen, L., Lai, C.T., Hartmann, B., Hartmann, P.E., & Geddes, D.T. The effect of UV-C pasteurization on bacteriostatic properties and immunological proteins of donor human milk. PLoS One 8, e85867 (2013).
American Academy of Pediatrics - Committee on Nutrition. Nutritional needs of low-birth-weight infants. Pediatrics 75, 976-986 (1985).
Jocson, M.A., Mason, E.O., & Schanler, R.J. The effects of nutrient fortification and varying storage conditions on host defense properties of human milk. Pediatrics 100, 240-243 (1997).
Barash, J.R., Hsia, J.K., & Arnon, S.S. Presence of soil-dwelling clostridia in commercial powdered infant formulas. J Pediatr 156, 402-408 (2010).
WHO. Safe preparation, storage and handling of powdered infant formula guidelines (2007).
Knobel, R. & Holditch-Davis, D. Thermoregulation and heat loss prevention after birth and during neonatal intensive-care unit stabilisation of extremely low-birthweight infants. J Obstet Gynecol Neonatal Nurs 36, 280-287 (2007).
Meier, P. Bottle- and breast-feeding: Effects on transcutaneous oxygen pressure and temperature in preterm infants. Nurs Res 37, 36-41 (1998).
Eckburg, J.J., Bell, E.F., Rios, G.R., & Wilmoth, P.K. Effects of formula temperature on postprandial thermogenesis and body temperature of premature infants. J Pediatr 111, 588-592 (1987).
Gonzales, I., Durvea, E.J., Vasquez, E., & Geraghty, N. Effect of enteral feeding temperature on feeding tolerance in preterm infants. Neonatal Netw 14, 39-43 (1995).
Büyükyavuz, B.I., Adiloglu, A.K., Onal, S., Cubukcu, S.E., & Cetin, H. Finding the sources of septicemia at a neonatal intensive care unit: Newborns and infants can be contaminated while being fed. Jap J Infect Dis 59, 213-215 (2006).
The Regulation and Quality Improvement Authority. Independent review of incidents of Pseudomonas aeruginosa infection in neonatal units in Northern Ireland - Final report (2012).
Molina-Cabrillana, J. et al. Outbreak of Pseudomonas aeruginosa infections in a neonatal care unit associated with feeding bottles heaters. Am J Infect Control 41, e7-e9 (2013).