Safety

Mothers’ Milk Bank of North Texas (MMBNT) adheres to the strict guidelines set forth by HMBANA, as are published in Guidelines for the Establishment and Operation of a Donor Human Milk Bank. MMBNT is assessed for adherence to the guidelines by a member of the HMBANA board annually and has consistently been 100% compliant and exceeded these guidelines in several areas.

About the HMBANA Guidelines

Guidelines for the Establishment and Operation of a Donor Human Milk Bank were originally published in the 1980s and are reviewed and revised annually. These guidelines were written with input from the United States Food and Drug Administration and the Centers for Disease Control. Additionally, MMBNT complies with the United States Public Health, “Guidelines for the prevention of HIV through transplantation of human tissue and organs.”

All donor human milk is pasteurized using the Holder Method, a process of heating milk to 62.5° C for 30 minutes in a shaking water bath. The processed milk is then rapidly cooled and frozen and stored at -20°C or colder. Milk is only dispensed once a post-pasteurization culture shows no growth.

The pasteurization process kills bacteria, CMV and other viruses such as HIV while still preserving immunological properties unique to human milk. The macronutrients are unchanged by pasteurization.

Safe Packaging and Shipping

Donor human milk dispensed to hospitals is packaged in 100 mL bottles. These bottles are designed and tested specifically for the processing and distribution of donor human milk. It is made of a high density polyethylene (HDPE) that is Bisphenol A (BPA) and phthalate free. The material is stable and will not leach into the milk. It is safe to warm and freeze milk in this material. There is a tamper-evident break-away ring on the lid. Each bottle is labeled with the expiration date, the batch number and nutritional information specific to the milk contained in the bottle. Each bottle has barcoding that may be made compatible with hospital breastmilk inventory and feeding systems.

All milk is shipped to NICUs in new, clean insulated containers using new packing material to minimize contamination of the outside of the bottles that will be at the bedside of vulnerable infants. Milk bank staff packing the donor milk use clean techniques. Each container is packed with dry ice to insure the product remains frozen. Each insulated box is sealed with tamper evident tape. The NICU staff member that receives the shipping container should inspect the box to make sure the milk arrives with the tamper seal is in place.

Cold Chain Verification of Shipping

It has come to the attention of Mothers’ Milk Bank of North Texas that Joint Commission and/or regulatory agencies may ask that recipient hospitals provide verification that donor human milk remained at appropriate temperatures during the delivery process. MMBNT provides recipient hospitals with written verification of this process for their records.

A Cold Chain Verification form is included in all hospital orders. Temperatures are recorded prior to packing on dry ice and upon arrival to hospitals. Hospitals should keep these forms for their records and to provide to regulatory agencies that may ask for verification that the milk was shipped and received in a frozen state.

Milk dispensed in the Dallas/Fort Worth area is delivered by bonded courier in rolling ice chests on dry ice. Milk is transported in sealed bags to prevent contamination of the outside of the bottles. Each ice chest is thoroughly cleaned and sanitized between deliveries. Milk never leaves the possession of the courier and is signed in with the designated person at the receiving institution. Milk outside of the Dallas/Fort Worth area is shipped by Federal Express Priority Overnight in tamper-evident shipping coolers with cold chain indicators.

Nutritional Quality

Variability of macronutrient content in donor human milk is of concern to MMBNT because we prioritize service to VLBW infants. MMBNT has been using nutritional analysis of donors’ milk in order to target pool –intentionally mixing donors’ milk in volume-specific ways in order to obtain a minimum of 20 calories per ounce for hospital clients. Each bottle of milk contains a label that lists overall caloric content, and specific nutritive protein content. In order to determine and verify these values, milk is tested from each individual donor and from each pool of donor milk.

Donor human milk from MMBNT is analyzed using the Foss Electric MilkoScan FT120 which utilizes an automated full-spectrum infrared laser spectroscopy calibrated for human milk to evaluate macronutrient content. Working with the USDA, Federal Milk Market Administration, and Parker Analytical, the accuracy of the calibrations are maintained within the dairy standard of .02, with a repeatability factor of .006. The infrared method is defined in the Official Methods of Analysis of the Association of Official Analytical Chemists. Specifically: AOAC Official Method 972.16 Fat, Lactose, Protein and Solids in Milk.

The Risks of Using Donor Milk

In the decades of non-profit milk banking under the Human Milk Banking Association of North America there has not been a report of disease transmission or harm to a baby from properly pasteurized donor human milk from a milk bank. However, like any food, the risk of adverse events, even though very small, can never be stated as zero.