Donor Human Milk for Preterm Infants: A Cost-Consequence Analysis of Alternative Preservation Methods.

OBJECTIVES: To perform cost-consequence and cost-effectiveness analyses of 2 methods of donor human milk (DHM) preservation-Holder pasteurization (HoP) and high-pressure processing (HPP)-in human milk banks in Poland. METHODS: We used the results of the LACTOTECHnology as an answer to special nutritional requirements of preterm infants (LACTOTECH) preclinical study on the impact of different preservation methods on the content of bioactive milk components. The cost analysis was performed from the hospital perspective. To estimate the Diagnosis-Related Group (DRG) tariff for enteral feeding with DHM preserved by HPP, the pricing process used by the Polish health technology assessment agency (Agencja Oceny Technologii Medycznych i Taryfikacji) was followed. One-way deterministic and probabilistic sensitivity analyses on costs and human milk component parameters were undertaken. RESULTS: HPP maintains an average of 55% more potentially beneficial DHM components than HoP, but is more expensive (€35 750 vs €5066). The DRG tariff relating to milk from human milk banks preserved by the HPP method should be about €54 (130%) higher than with HoP. The cost-effectiveness ratio ranged from €0.84 to €10.27 per 1% gain in the active compound content in a daily portion of DHM. Sensitivity analysis showed that the cost of an HPP device had the most significant impact on pascalization expenses. CONCLUSIONS: HPP is a potentially more beneficial method of DHM preservation than HoP, but it is also about 7 times more expensive. Because of high pascalization costs, the cost-effectiveness analysis based on clinically significant endpoints will play an important role in decision making regarding the implementation of HPP into clinical practice of human milk banking.

Effect of the PiAstra Benchtop Flash-Heating Pasteurizer on Immune Factors of Donor Human Milk.

INTRODUCTION: PiAstra is a simulated flash-heat (FH) pasteurization temperature monitoring system designed using Raspberry Pi technology for the pasteurization of human milk. This study analyzed the effect of the PiAstra FH method on human milk immune components (immunoglobulin A [IgA] and lactoferrin activity). METHODS: Donor milk samples (N = 45) were obtained from a human milk bank, and pasteurized. Concentrations of IgA and lactoferrin activity were compared to their unpasteurized controls using the Student's t test. RESULTS: The PiAstra FH method retained 34.2% of IgA (p < 0.0001) and 40.4% of lactoferrin activity (p < 0.0001) when compared to unpasteurized controls. The retention of IgA by the PiAstra is similar to previous FH studies, while retention of lactoferrin activity was higher than previous FH studies. DISCUSSION: The high-technology, low-cost PiAstra system, which is able to retain vital immune components of human milk, provides safe donor milk for low-resourced settings. This enables the use of pasteurized donor milk when human milk is not available, potentially saving vulnerable infant lives.

Cost and Use of Pasteurized Donor Human Milk at a Children's Hospital.

OBJECTIVE: To determine the cost and use of pasteurized donor human milk (PDHM) at a children's hospital with a strong human milk culture. DESIGN: A retrospective descriptive cohort study. SETTING: A children's hospital in the northeastern region of the United States. PARTICIPANTS: Infants (N = 281) younger than 1 year of age at the time of hospitalization who received PDHM between January 2011 and November 2014. Infants older than 1 year of age at the time of hospitalization were excluded from the study sample. METHODS: For each eligible infant, the following descriptive characteristics were abstracted from the electronic health record: gestational age, birth weight, primary diagnosis, unit/floor, total volume of PDHM fed to infant, total number of days the infant received PDHM, diet order on day of discharge, and total length of stay in days. Descriptive statistics were used to analyze all data. RESULTS: Of the sample, 70% (n = 197/281) were cared for in the NICU and 30% (n = 84/281) were cared for outside of the NICU. The mean number of days an infant received PDHM was 23 days (range = 1-134 days) and the mean volume consumed daily was 195 ml (range = 6-1,335 ml). Using a purchase cost of U.S. $4.50 per ounce, the average purchase cost of PDHM per day was U.S. $29.19 (range = U.S. $0.90 to U.S. $200.23). CONCLUSION: PDHM is a low-cost intervention compared with many other interventions for the care of hospitalized infants.

Comparative analysis of solar pasteurization versus solar disinfection for the treatment of harvested rainwater.

BACKGROUND: Numerous pathogens and opportunistic pathogens have been detected in harvested rainwater. Developing countries, in particular, require time- and cost-effective treatment strategies to improve the quality of this water source. The primary aim of the current study was thus to compare solar pasteurization (SOPAS; 70 to 79 °C; 80 to 89 °C; and ≥90 °C) to solar disinfection (SODIS; 6 and 8 hrs) for their efficiency in reducing the level of microbial contamination in harvested rainwater. The chemical quality (anions and cations) of the SOPAS and SODIS treated and untreated rainwater samples were also monitored. RESULTS: While the anion concentrations in all the samples were within drinking water guidelines, the concentrations of lead (Pb) and nickel (Ni) exceeded the guidelines in all the SOPAS samples. Additionally, the iron (Fe) concentrations in both the SODIS 6 and 8 hr samples were above the drinking water guidelines. A >99% reduction in Escherichia coli and heterotrophic bacteria counts was then obtained in the SOPAS and SODIS samples. Ethidium monoazide bromide quantitative polymerase chain reaction (EMA-qPCR) analysis revealed a 94.70% reduction in viable Legionella copy numbers in the SOPAS samples, while SODIS after 6 and 8 hrs yielded a 50.60% and 75.22% decrease, respectively. Similarly, a 99.61% reduction in viable Pseudomonas copy numbers was observed after SOPAS treatment, while SODIS after 6 and 8 hrs yielded a 47.27% and 58.31% decrease, respectively. CONCLUSION: While both the SOPAS and SODIS systems reduced the indicator counts to below the detection limit, EMA-qPCR analysis indicated that SOPAS treatment yielded a 2- and 3-log reduction in viable Legionella and Pseudomonas copy numbers, respectively. Additionally, SODIS after 8 hrs yielded a 2-log and 1-log reduction in Legionella and Pseudomonas copy numbers, respectively and could be considered as an alternative, cost-effective treatment method for harvested rainwater.

A decision-making tool to determine economic feasibility and break-even prices for artisan cheese operations.

Artisan cheese makers lack access to valid economic data to help them evaluate business opportunities and make important business decisions such as determining cheese pricing structure. The objective of this study was to utilize an economic model to evaluate the net present value (NPV), internal rate of return, and payback period for artisan cheese production at different annual production volumes. The model was also used to determine the minimum retail price necessary to ensure positive NPV for 5 different cheese types produced at 4 different production volumes. Milk type, cheese yield, and aging time all affected variable costs. However, aged cheeses required additional investment for aging space (which needs to be larger for longer aging times), as did lower yield cheeses (by requiring larger-volume equipment for pasteurization and milk handling). As the volume of milk required increased, switching from vat pasteurization to high-temperature, short-time pasteurization was necessary for low-yield cheeses before being required for high-yield cheeses, which causes an additional increase in investment costs. Because of these differences, high-moisture, fresh cow milk cheeses can be sold for about half the price of hard, aged goat milk cheeses at the largest production volume or for about two-thirds the price at the lowest production volume examined. For example, for the given model assumptions, at an annual production of 13,608kg of cheese (30,000 lb), a fresh cow milk mozzarella should be sold at a minimum retail price of $27.29/kg ($12.38/lb), whereas a goat milk Gouda needs a minimum retail price of $49.54/kg ($22.47/lb). Artisan cheese makers should carefully evaluate annual production volumes. Although larger production volumes decrease average fixed cost and improve production efficiency, production can reach volumes where it becomes necessary to sell through distributors. Because distributors might pay as little as 35% of retail price, the retail price needs to be higher to compensate. An artisan cheese company that has not achieved the recognition needed to achieve a premium price may not find distribution through distributors profitable.

Demonstrating the efficacy of the FoneAstra pasteurization monitor for human milk pasteurization in resource-limited settings.

UNLABELLED: Human milk provides crucial nutrition and immunologic protection for infants. When a mother's own milk is unavailable, donated human milk, pasteurized to destroy bacteria and viruses, is a lifesaving replacement. Flash-heat pasteurization is a simple, low-cost, and commonly used method to make milk safe, but currently there is no system to monitor milk temperature, which challenges quality control. FoneAstra, a smartphone-based mobile pasteurization monitor, removes this barrier by guiding users through pasteurization and documenting consistent and safe practice. This study evaluated FoneAstra's efficacy as a quality control system, particularly in resource-limited settings, by comparing bacterial growth in donor milk flash-heated with and without the device at a neonatal intensive care unit in Durban, South Africa. MATERIALS AND METHODS: For 100 samples of donor milk, one aliquot each of prepasteurized milk, milk flash-heated without FoneAstra, and milk pasteurized with FoneAstra was cultured on routine agar for bacterial growth. Isolated bacteria were identified and enumerated. RESULTS: In total, 300 samples (three from each donor sample) were analyzed. Bacterial growth was found in 86 of the 100 samples before any pasteurization and one of the 100 postpasteurized samples without FoneAstra. None of the samples pasteurized using FoneAstra showed bacterial growth. CONCLUSIONS: Both pasteurization methods were safe and effective. FoneAstra, however, provides the additional benefits of user-guided temperature monitoring and data tracking. By improving quality assurance and standardizing the pasteurization process, FoneAstra can support wide-scale implementation of human milk banks in resource-limited settings, increasing access and saving lives.

Computer simulation of energy use, greenhouse gas emissions, and costs for alternative methods of processing fluid milk.

Computer simulation is a useful tool for benchmarking electrical and fuel energy consumption and water use in a fluid milk plant. In this study, a computer simulation model of the fluid milk process based on high temperature, short time (HTST) pasteurization was extended to include models for processes for shelf-stable milk and extended shelf-life milk that may help prevent the loss or waste of milk that leads to increases in the greenhouse gas (GHG) emissions for fluid milk. The models were for UHT processing, crossflow microfiltration (MF) without HTST pasteurization, crossflow MF followed by HTST pasteurization (MF/HTST), crossflow MF/HTST with partial homogenization, and pulsed electric field (PEF) processing, and were incorporated into the existing model for the fluid milk process. Simulation trials were conducted assuming a production rate for the plants of 113.6 million liters of milk per year to produce only whole milk (3.25%) and 40% cream. Results showed that GHG emissions in the form of process-related CO2 emissions, defined as CO2 equivalents (e)/kg of raw milk processed (RMP), and specific energy consumptions (SEC) for electricity and natural gas use for the HTST process alone were 37.6g of CO2e/kg of RMP, 0.14 MJ/kg of RMP, and 0.13 MJ/kg of RMP, respectively. Emissions of CO2 and SEC for electricity and natural gas use were highest for the PEF process, with values of 99.1g of CO2e/kg of RMP, 0.44 MJ/kg of RMP, and 0.10 MJ/kg of RMP, respectively, and lowest for the UHT process at 31.4 g of CO2e/kg of RMP, 0.10 MJ/kg of RMP, and 0.17 MJ/kg of RMP. Estimated unit production costs associated with the various processes were lowest for the HTST process and MF/HTST with partial homogenization at $0.507/L and highest for the UHT process at $0.60/L. The increase in shelf life associated with the UHT and MF processes may eliminate some of the supply chain product and consumer losses and waste of milk and compensate for the small increases in GHG emissions or total SEC noted for these processes compared with HTST pasteurization alone. The water use calculated for the HTST and PEF processes were both 0.245 kg of water/kg of RMP. The highest water use was associated with the MF/HTST process, which required 0.333 kg of water/kg of RMP, with the additional water required for membrane cleaning. The simulation model is a benchmarking framework for current plant operations and a tool for evaluating the costs of process upgrades and new technologies that improve energy efficiency and water savings.

Computer simulation of energy use, greenhouse gas emissions, and process economics of the fluid milk process.

Energy-savings measures have been implemented in fluid milk plants to lower energy costs and the energy-related carbon dioxide (CO2) emissions. Although these measures have resulted in reductions in steam, electricity, compressed air, and refrigeration use of up to 30%, a benchmarking framework is necessary to examine the implementation of process-specific measures that would lower energy use, costs, and CO2 emissions even further. In this study, using information provided by the dairy industry and equipment vendors, a customizable model of the fluid milk process was developed for use in process design software to benchmark the electrical and fuel energy consumption and CO2 emissions of current processes. It may also be used to test the feasibility of new processing concepts to lower energy and CO2 emissions with calculation of new capital and operating costs. The accuracy of the model in predicting total energy usage of the entire fluid milk process and the pasteurization step was validated using available literature and industry energy data. Computer simulation of small (40.0 million L/yr), medium (113.6 million L/yr), and large (227.1 million L/yr) processing plants predicted the carbon footprint of milk, defined as grams of CO2 equivalents (CO2e) per kilogram of packaged milk, to within 5% of the value of 96 g of CO 2e/kg of packaged milk obtained in an industry-conducted life cycle assessment and also showed, in agreement with the same study, that plant size had no effect on the carbon footprint of milk but that larger plants were more cost effective in producing milk. Analysis of the pasteurization step showed that increasing the percentage regeneration of the pasteurizer from 90 to 96% would lower its thermal energy use by almost 60% and that implementation of partial homogenization would lower electrical energy use and CO2e emissions of homogenization by 82 and 5.4%, respectively. It was also demonstrated that implementation of steps to lower non-process-related electrical energy in the plant would be more effective in lowering energy use and CO2e emissions than fuel-related energy reductions. The model also predicts process-related water usage, but this portion of the model was not validated due to a lack of data. The simulator model can serve as a benchmarking framework for current plant operations and a tool to test cost-effective process upgrades or evaluate new technologies that improve the energy efficiency and lower the carbon footprint of milk processing plants.

The knowns and unknowns of human milk banking.

The provision of donor human milk instead of formula is an important contribution to the nutrition and protection from infections for preterm infants. Systematic reviews suggest a lower risk of necrotizing enterocolitis with pasteurized donor human milk (PDHM) as opposed to artificial formula, although evidence supporting PDHM use from randomized control trials is limited. Human milk banks (HMBs) must have a risk management system to maintain a safe product especially as many operate in an unregulated environment. To ensure safety, the HMB in Australia has committed to meet the appropriate standards recommended in the Code of Good Manufacturing Practices (Blood and Tissues) and models risk management during processing on Codex HACCP (Hazard Analysis Critical Control Point) requirements. There is scope to continually reevaluate the screening of donors and quality standards recommended during HMB. This will be most effective if strong networks of HMBs are developed with regional reference laboratories to encourage compliance with safety guidelines. Further research and development is needed to refine technology for treating donor milk such as thermal ultrasound and ultraviolet light, aimed at the retention of full bioactivity. HMB networks will facilitate collection of evidence for refining HMB practice which should translate to improved outcomes for preterm and sick infants. Cost effectiveness is most likely when HMBs are associated with large neonatal intensive care units.