Growth and Tolerance on Sterile, Ready To Feed Donor Human Milk
Purpose of Study: To report growth and tolerance data from a US NICU using a new sterile, ready to feed donor human milk (DHM) product. Methods: This is a retrospective chart review of growth and feeding tolerance outcomes in infants fed DHM (Co-op Donor Human Milk, Medolac Laboratories, Lake Oswego, OR) when mother’s breast milk (MBM) was unavailable. Infants were preterm (<37+0 weeks post-menstrual age) identified from DHM logs during the first 6 months of use (7/1/14 – 12/31/14). Electronic health records were reviewed for medical history, anthropometrics, and feeding history. Growth velocity (g/kg/d while under 2 kg; g/day from 2 kg to discharge), feeding type, and frequency of intolerance (n/group, interruptions to enteral feedings for 24 hours or more due to gastrointestinal intolerance) were calculated from raw data. Click here to download file.
Purpose of Study: To report growth and tolerance data from a US NICU using a new sterile, ready to feed donor human milk (DHM) product. Methods: This is a retrospective chart review of growth and feeding tolerance outcomes in infants fed DHM (Co-op Donor Human Milk, Medolac Laboratories, Lake Oswego, OR) when mother’s breast milk (MBM) was unavailable. Infants were preterm (<37+0 weeks post-menstrual age) identified from DHM logs during the first 6 months of use (7/1/14 – 12/31/14). Electronic health records were reviewed for medical history, anthropometrics, and feeding history. Growth velocity (g/kg/d while under 2 kg; g/day from 2 kg to discharge), feeding type, and frequency of intolerance (n/group, interruptions to enteral feedings for 24 hours or more due to gastrointestinal intolerance) were calculated from raw data. Click here to download file.
Analysis of the Influence of Processing on Human Milk's Macronutrient Concentration
Human breast milk is the optimal source of nutrition for all infants but especially for those born prematurely. As stated by the American Academy of Pediatrics, breast milk, especially in neonatal intensive care units is the optimal food for infants. When a mother is not able to produce enough milk for her infant, the next best source of nutrition is donated human breast milk. However, human breast milk is not a sterile fluid and therefore can contain microorganisms that could be transferred to the infants who consume it. Because of this risk donor milk must be processed to ensure its safety, but with processing the milk’s important nutritional components can be altered or removed entirely. The objective of this study was to assess the impact of the processing method on the macronutrients of human milk. During a 1-year period (2013-2014), more than 400 milk samples from individual donors were analyzed for fat, protein, lactose and energy density. Banked donor milk mean values (in weight/volume) were found to be 1.1% ± 0.04% for protein, 3.3% ± 0.03% for fat, 6.1% ± 0.6% for lactose, and mean total energy was 60 kcal/dL. Amino acids of pooled donor milk were also compared before and after processing. Our data shows that the processing only had a minor effect on the macronutrients of the donor milk. Additionally, the macronutrients were stable and remained constant over time. Click here to download this file.
Human breast milk is the optimal source of nutrition for all infants but especially for those born prematurely. As stated by the American Academy of Pediatrics, breast milk, especially in neonatal intensive care units is the optimal food for infants. When a mother is not able to produce enough milk for her infant, the next best source of nutrition is donated human breast milk. However, human breast milk is not a sterile fluid and therefore can contain microorganisms that could be transferred to the infants who consume it. Because of this risk donor milk must be processed to ensure its safety, but with processing the milk’s important nutritional components can be altered or removed entirely. The objective of this study was to assess the impact of the processing method on the macronutrients of human milk. During a 1-year period (2013-2014), more than 400 milk samples from individual donors were analyzed for fat, protein, lactose and energy density. Banked donor milk mean values (in weight/volume) were found to be 1.1% ± 0.04% for protein, 3.3% ± 0.03% for fat, 6.1% ± 0.6% for lactose, and mean total energy was 60 kcal/dL. Amino acids of pooled donor milk were also compared before and after processing. Our data shows that the processing only had a minor effect on the macronutrients of the donor milk. Additionally, the macronutrients were stable and remained constant over time. Click here to download this file.
Co-op Donor Milk Shelf Life at Refrigerated Temperatures
This experiment is to test the shelf life of Medolac CO-OP DONOR MILK after being poured 16 times per day in ambient air, stored in the refrigerator and plated in ambient air to simulate hospital conditions during use. Click here to download this file.
This experiment is to test the shelf life of Medolac CO-OP DONOR MILK after being poured 16 times per day in ambient air, stored in the refrigerator and plated in ambient air to simulate hospital conditions during use. Click here to download this file.
Amino Acid Retention
Amino acid comparison between samples from pre and post processing. Three random drum samples and three finished samples from each production run (Lot #1, #2, #3) were pulled and sent to a reputable third party laboratory for amino acid analysis. Click here to download this file.
Amino acid comparison between samples from pre and post processing. Three random drum samples and three finished samples from each production run (Lot #1, #2, #3) were pulled and sent to a reputable third party laboratory for amino acid analysis. Click here to download this file.
Homogenization
Co-op Donor Milk is homogenized. According to anecdotal data this may help reduce clogged feeding tubes. Data indicate homogenization of human donor milk may improve fat absorption in preterm infants, click here for more information.
Co-op Donor Milk is homogenized. According to anecdotal data this may help reduce clogged feeding tubes. Data indicate homogenization of human donor milk may improve fat absorption in preterm infants, click here for more information.
Is the Donor Milk Used in your NICU Commercially Sterile?
Vegetative cells, spores and toxins can and do survive pasteurization. Medical professionals may be unaware of the differences between commercial sterility and pasteurization and the methods used by process authorities to professionally process a wide range of food, now including human donor milk. This article is intended to guide the medical professional through the technical and legal aspects of thermal processing methods as well the scientific literature that supports the need for commercially sterile milk for fragile neonates. The foundation for the next generation of human donor milk products is commercial sterility. My company made this decision to improve safety for preterm infants as well as the economy of scale and ease of use by adopting the same professional processing method utilized by the infant formula industry for many years to process commercially sterile preterm infant formula. The process is not new, nor is it experimental.
Since introducing Co-Op Donor milk, over 1,000 preterm infants have received the product with good results. Growth and tolerance studies are complete and data will be released shortly. This type of process has never been used for human milk only because there has never been enough volume of donor milk to make it possible. The founding of the Mother’s Milk Cooperative has changed all that. Nursing mothers have voted with their
membership and an unprecedented volume of qualified donor milk has been collected as a result. More...
Vegetative cells, spores and toxins can and do survive pasteurization. Medical professionals may be unaware of the differences between commercial sterility and pasteurization and the methods used by process authorities to professionally process a wide range of food, now including human donor milk. This article is intended to guide the medical professional through the technical and legal aspects of thermal processing methods as well the scientific literature that supports the need for commercially sterile milk for fragile neonates. The foundation for the next generation of human donor milk products is commercial sterility. My company made this decision to improve safety for preterm infants as well as the economy of scale and ease of use by adopting the same professional processing method utilized by the infant formula industry for many years to process commercially sterile preterm infant formula. The process is not new, nor is it experimental.
Since introducing Co-Op Donor milk, over 1,000 preterm infants have received the product with good results. Growth and tolerance studies are complete and data will be released shortly. This type of process has never been used for human milk only because there has never been enough volume of donor milk to make it possible. The founding of the Mother’s Milk Cooperative has changed all that. Nursing mothers have voted with their
membership and an unprecedented volume of qualified donor milk has been collected as a result. More...
Value Analysis Metrics for the Assessment of Donor Milk Vendors
Hospital value analysis has evolved from what was a simple exercise in optimization of resources to today’s more comprehensive model which includes a range of analytical touch points including quality, safety, infection control, reimbursement, cost, sourcing, and health outcomes, including technological and procedural evaluations. As hospitals seek products that provide the best clinical and financial value, new or expanding product offerings require more extensive scrutiny and evaluation. Donor human milk is one such product area experiencing a sharp increase in usage driven by the growing evidence of patient benefits. But donor milk from different sources are not equal since procedures for donor testing and qualification, milk quality and safety testing and milk processing methods differ greatly and often lack validation or verification. Hospital decision makers may not be aware that basic food safety guidelines are sometimes not followed by small processors simply because they lack technical capacity and the equipment necessary to take such measures. For example, small processors have been known to thaw frozen milk at room temperature and lack the cleaning, safety processes and expertise needed to avoid biofilm formation on equipment. Although not required by law, donor milk processors should look to relevant parts of the Pasteurized Milk Ordinance for guidance or adopt other suitable global standards that require pre-process microbiological screening. More..
Hospital value analysis has evolved from what was a simple exercise in optimization of resources to today’s more comprehensive model which includes a range of analytical touch points including quality, safety, infection control, reimbursement, cost, sourcing, and health outcomes, including technological and procedural evaluations. As hospitals seek products that provide the best clinical and financial value, new or expanding product offerings require more extensive scrutiny and evaluation. Donor human milk is one such product area experiencing a sharp increase in usage driven by the growing evidence of patient benefits. But donor milk from different sources are not equal since procedures for donor testing and qualification, milk quality and safety testing and milk processing methods differ greatly and often lack validation or verification. Hospital decision makers may not be aware that basic food safety guidelines are sometimes not followed by small processors simply because they lack technical capacity and the equipment necessary to take such measures. For example, small processors have been known to thaw frozen milk at room temperature and lack the cleaning, safety processes and expertise needed to avoid biofilm formation on equipment. Although not required by law, donor milk processors should look to relevant parts of the Pasteurized Milk Ordinance for guidance or adopt other suitable global standards that require pre-process microbiological screening. More..
Quality and Safety Indicators for Human Milk and Donor Milk Use in the NICU
The chronic shortage of donor milk has triggered widespread rationing to such a degree that many preterm babies are now being denied access because they don’t fit into the narrow definition of babies who “qualify”. Mounting evidence of short and long term improved outcomes has prompted more neonatal units to use donor milk when mother’s milk supply is short or unavailable.1 While they are unable to meet the growing demand, community milk banks are asking legislators to create new laws that could very well violate anti-trust rules. These new laws would attempt to prevent mothers from sharing their milk outside the tax exempt milk banking system while refusing to acknowledge the legitimate role of commercial milk banks. In an attempt to maintain a steady supply, hospitals are now forced to place numerous small orders at multiple milk banks across the country. Even so, they often receive only a fraction of what they ordered. In the desperate race to procure human milk, the question of quality and safety is not given sufficient scrutiny. More...
The chronic shortage of donor milk has triggered widespread rationing to such a degree that many preterm babies are now being denied access because they don’t fit into the narrow definition of babies who “qualify”. Mounting evidence of short and long term improved outcomes has prompted more neonatal units to use donor milk when mother’s milk supply is short or unavailable.1 While they are unable to meet the growing demand, community milk banks are asking legislators to create new laws that could very well violate anti-trust rules. These new laws would attempt to prevent mothers from sharing their milk outside the tax exempt milk banking system while refusing to acknowledge the legitimate role of commercial milk banks. In an attempt to maintain a steady supply, hospitals are now forced to place numerous small orders at multiple milk banks across the country. Even so, they often receive only a fraction of what they ordered. In the desperate race to procure human milk, the question of quality and safety is not given sufficient scrutiny. More...
This is a copy of an article published in the Breastfeeding Medicine © 2013 copyright Mary Ann Liebert, Inc.; Breastfeeding Medicine is available online at: http://online.liebertpub.com.
Increasing the Global Supply and Affordability of Donor Milk
Human milk banking was virtually discontinued at the start of the human immunodeficiency virus era amid fears that the virus might be transmitted to preterm infants receiving donor milk. However, the demand for donor breast milk has continued to be driven by decades of research that have increasingly demonstrated the benefits of breast- milk in neonatal care regarding the reduction of life- threatening necrotizing enterocolitis and infection, as well as improving long-term outcomes, notably neurodevelopment and bone health. Despite the progressive return of milk banking during the past two decades, the demand for breast milk has not been met. Now, this problem has been greatly compounded by a recent, radical increase in demand for human donor milk resulting from compelling new research that is changing the standards for how preterm infants are fed. more...
Human milk banking was virtually discontinued at the start of the human immunodeficiency virus era amid fears that the virus might be transmitted to preterm infants receiving donor milk. However, the demand for donor breast milk has continued to be driven by decades of research that have increasingly demonstrated the benefits of breast- milk in neonatal care regarding the reduction of life- threatening necrotizing enterocolitis and infection, as well as improving long-term outcomes, notably neurodevelopment and bone health. Despite the progressive return of milk banking during the past two decades, the demand for breast milk has not been met. Now, this problem has been greatly compounded by a recent, radical increase in demand for human donor milk resulting from compelling new research that is changing the standards for how preterm infants are fed. more...
Other Resources
The resources below provide an excellent starting point for understanding issues around the Safety and Quality of Donor Milk. Be sure to visit our Publications section for additional resources.
The resources below provide an excellent starting point for understanding issues around the Safety and Quality of Donor Milk. Be sure to visit our Publications section for additional resources.
- The U.S. Food and Drug Administration (FDA) is part of the U.S. Department of Health and Human Services. The FDA has issued standards of identity for milk and whey ingredients as part of the U.S. Code of Federal Regulations. Of particular relevance is the Pasteurized Milk Ordinance (2009 revision).
- Internationally, the Codex Alimentarius Commission, created by the World Health Organization (WHO) and the Food and Agriculture Organization (FAO), is charged with protecting the health of consumers and ensuring fair trade practices. It serves as a source for international standards, codes of practice, guidelines, and recommendations with respect to food safety and food production. Not only does it cover ingredient standards, but it also provides standards on the feeding of special populations.
- Our safety methods include extensive testing and controls, including considerations outlined in the FDA Working Group on Banked Human Milk.
