Genesis and evolution of KIMIE: New cost-effective indigenous human breast milk pasteurizer

INTRODUCTION

Pasteurized donor breast milk (PDBM) is the next best feeding option for neonates when natural mother’s breast milk (BM) is not available, insufficient, or contraindicated.^[1,2]

GENESIS

A female baby (nick name KIMIE), B.W. 850 g, G.A. 27 weeks, was born to G4 P3 mother by vaginal delivery. By the 3^rd day, while treated with moderate respiratory support and 30 ml/kg/day of expressed breast milk (EBM), the mother died unexpectedly. Since the other siblings were also premature, baby’s father was familiar with prematurity related morbidities including NEC. He expressed a strong desire not to feed any formula. Various feeding options were discussed in detail. The level II NICU at Centinela Hospital (CH) did not have the tissue license (State of California) to use DBM obtained from a donor breast milk bank (DBMB). One nurse suggested of using another mother’s EBM who had a premature baby born at 32 weeks GA. This lady was negative times two for HIV, RPR, and hepatitis B and was rubella immune. Her EBM was in excess, well tolerated by her son, and clinically, there was no suspicion for bacterial contamination. Although there was difference of opinion, there was consensus that the risk of developing NEC due to the use of formula was high as compared to the potential of acquiring bacterial or viral infection using raw donor breast milk (DBM). While use of unpasteurized DBM may be an accepted practice in other countries, there was no such precedence in the health-care system. There was a discussion among the NICU team, the hospital administrator, father of the baby, and the potential BM donor. After extensive discussion and obtaining informed written consent by everyone, decision was made to use unpasteurized DBM milk.

After extensive search regarding availability of small breast milk pasteurizer (BMP), SafeGard used in the dairy industry was discovered [Figure 1].

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Figure 1:

SafeGard used in dairy industry.

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An extensive search regarding the availability of a small BMP was performed. SafeGard used in the dairy industry was discovered [Figure 1]. While this pasteurizer uses the principle of holder pasteurization, cooling is performed manually using ice-cold water [Figure 2]. For the next 5 days, DBM pasteurized using SafeGard was fed. Subsequently, DBM obtained from the commercial DBMB was used till the baby was discharged.

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Figure 2:

Prototype mini-pasteurizer.

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Based on the basic design of the SafeGard, modified prototype was developed by Dr. Devaskar [Figure 2]. The concept was discussed with the chief of the biomedical engineering department at UCLA. While the idea to develop first prototype was introduced, it needed two engineers for at least 6 months needing initial investment of ~500,000 dollars was anticipated.

Thereafter, UD, VH, and SUK met with two engineers SW and AK. It was concluded to develop a portable human BMP capable of pasteurizing 300 ml during each cycle using the holder technique incorporating modern automated technology for heating, holding, and cooling [Figure 3].

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Figure 3:

Holder technique.

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EVOLUTION

It was discovered that within the existing pasteurizers used in human milk banks (e.g. Sterifeed, HSC, etc.), the plumbing is connected to a water supply for filling the chamber and a separate plumbing is required to empty the water. A submersible heater of very high power is employed. To distribute heat equally, they incorporate a water stirrer. Use of a submersible water heater was concerning due to a risk of electrical shock. In addition, the waste of enormous quantity, ~80 L, of water once every cycle was problematic. Numerous choices to manufacture a compact, portable, user- and eco-friendly, and cost-efficient device using modern technology were thought of. It was determined to use two separate water tanks, one for heating and one for cooling. Two totally different water pumps were connected to the respective tanks. During this closed-loop system, every pump propels water within the chamber that warms or cools DBM and water returns to its respective tank. The capability of heating and cooling tanks was arbitrarily decided to be 1750 and 2750 ml, respectively. Thus, only 4250 ml of water would be used and will be recycled. Other discussions included the technical and tubing design, the method of water circulate across the milk container, the components required and their placement, the kind of water pumps for heating and cooling, the specified flow rate, its sturdiness, the kind of heaters and their wattage, the sort of cooling mechanism (chiller) and their ability, the scale, and form of DBM container. The first prototype capable of pasteurizing 300 ml of EBM during each cycle was developed within 3 months [Figure 4]. Then, the second prototype was developed [Figure 5]. The major limitation of the prototypes was: They could pasteurize a single sample of 300 ml during each cycle. Finally, the third prototype able to pasteurizing five different EBM samples and a total of 500 ml were developed [Figure 6]. The information of the engineering and bacteriologic sterility information has been described [Table 1]. In short, to be eco-friendly, for easy cleaning and to be cost-effective, grade 304 stainless steel cylinders rather than the disposable plastic bottles were used. In this prototype, Perplex that’s a better cloth as compared to plastic is used.

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Figure 4:

Kimie 300 – first prototype.

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Figure 5:

Kimie 500 – second prototype.

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Figure 6:

Kimie 500 – third prototype.

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In 2018, Kimie obtained the ECU certificate of compliance (no 1810170911101) for a human milk pasteurizer and met standards EN 6060-1, EN 60601-1-2, and EN 60601-1-6 to illustrate conformity. In the USA, BM milk pasteurizer does not require FDA approval as it is considered a catering device. Kimie was imported to CH underneath commodity code 84198998.

Kimie [Figure 6] has been successfully used in several hospitals in India for more than 2½ years and at CH for >10 months. It was quickly recognized that there has been a need for production a system able to pasteurizing extra than 500 ml. Kimie [Figure 6] is the today’s prototype able to pasteurizing 3000 ml during each cycle and has six different cylinders like Kimie-500. Selling price of Kimie-500 and Kimie-3000 is 5 and 8 lakh rupees, respectively.

DISCUSSION

The origins and evolution of a home-grown, compact, portable, fully automated, user-friendly, cost-effective BMP that uses modern technology, needs less space, has no special plumbing, and can recycle water are described in this paper. Stainless steel is preferred by regulatory agencies in the food industry for heating, cooling, and drying food because it avoids reactions between the food and the container. Safety, durability, corrosion resistance, non-absorbency, adequate weight and thickness to withstand repeated washing, a smooth, easy-to-clean surface, and resistance to pitting, chipping, crazing, scratching, and scoring are all requirements. As a result, stainless steel grade 304 bottles are used rather than plastic bottles.

The indications for using pasteurized BM have been listed in detail and are briefly discussed below.^[3]

CONCLUSION

Necessity breeds ingenuity, and disaster breeds opportunity. Kimie’s development and evolution is an excellent example of clinicians and engineers collaborating. More partnerships like this are needed with the common aim of improving the health of neonates all over the world.