For Health Professionals

This section provides information for health professionals regarding infant nutrition including important safety steps when preparing infant formula.

Safety Issues For Health Care Professionals

Infants experience rapid growth and development during their first year of life. Thus, it is essential that infants, especially those who are premature and/or immunocompromised, receive adequate nutrition to support this rapid growth and development. Health care professionals, who are primarily responsible for the nourishment of hospitalized infants, understand the necessity for providing nutritionally appropriate infant feedings in a safe manner.

Breastfeeding

Breastfeeding is the preferred method of feeding infants, including those who are premature and/or hospitalized. Breast milk supplies the nutrients required for the term infant's growth and development; it supplies the proper balance of nutrients, minimizing the likelihood of excesses or deficiencies. (Preterm infants may need additional nutrients, which can be provided by human milk fortifiers, and the American Academy of Pediatrics has recently recommended routine vitamin D supplementation for all breastfed infants.) Breast milk may contain microorganisms typically found on the mother's skin. However, the presence of these organisms is of minimal concern because they do not have a chance to multiply in the milk when infants are breastfed directly or when breastmilk is expressed, refrigerated or frozen, and fed in accordance with clean technique. By breastfeeding, the mother will also transfer to her child some of her own immunity to infections to protect the baby during the first weeks of life before his/her immune system begins to mature.

The American Academy of Pediatrics (AAP) recommends:
"EXCLUSIVE BREASTFEEDING IS IDEAL NUTRITION AND SUFFICIENT TO SUPPORT OPTIMAL GROWTH AND DEVELOPMENT FOR APPROXIMATELY THE FIRST 6 MONTHS AFTER BIRTH. INFANTS WEANED BEFORE 12 MONTHS OF AGE SHOULD NOT RECEIVE COW'S MILK FEEDINGS BUT SHOULD RECEIVE IRON­FORTIFIED INFANT FORMULA."

Formula Feeding

When breast milk is not available to healthy term infants in the hospital, nutritionally appropriate ready­to­feed formulas are recommended, because they are commercially sterile. Years of development, careful clinical research and continuing improvements have resulted in commercially prepared ready­to­feed infant formulas that provide the needed protein, fat, carbohydrate, vitamins and minerals. Health care professionals can be assured that these formulas allow the infant to sustain a rapid rate of growth and development while not stressing the infant's developing organ systems. Further, these formulas will remain free of microbiological contaminants before opening as long as the container remains intact and is stored properly.

Premature and immunocompromised infants in neonatal intensive care units (NICU) often need specialized feedings formulated to meet their individual needs. In some cases, the health care professional may decide these individualized feedings require use of a powdered formula or supplement. Powdered formulas offer health care professionals the flexibility to provide specialized nutrition that simultaneously

• (1) delivers specific nutrients
• (2) allows fluid restriction when needed, and (3) improves growth. However, powder cannot be manufactured to be commercially sterile (i.e., free of all viable microorganisms capable of reproducing in the reconstituted formula under normal, non­refrigerated conditions of storage). Thus, to minimize the risk of infection, powdered formulas

are not recommended for use in premature or immunocompromised infants unless no appropriate nutritional alternative is available, and then only with strict medical supervision and careful preparation, storage and use.

When no alternative is available, preparation of these specialized powdered products requires careful handling to prevent contamination and minimize growth of microorganisms. Critical factors that influence possible microbial growth in prepared formula include:

• Formula preparation technique
• Cleanliness of formula preparation equipment
• Maintaining proper refrigeration times and temperatures
• Minimizing time the prepared formula is at room temperature or feeding temperature
• Observing appropriate hanging and feeding times
• Making regular tubing changes
• Complying with expiration dates
• Avoiding touch contamination of prepared formula at each step.

Learning from reports of illness traced to contaminated feedings in the NICU demonstrates the need to focus on careful preparation and handling of these special products. It is an important responsibility of the health care professional to explain this need to any parent or other caregiver whose at­risk child has been discharged and may continue to be fed powdered formula.

Specific instruction in the use of aseptic and secure preparation techniques for infant formulas, including powder, are available in the American Dietetic Association's (ADA) 2004 publication, Infant Feedings: Guidelines for Preparation of Formula and Breastmilk in Health Care Facilities. By carefully following these guidelines, health care personnel can continue to feed infants with confidence.

Good Manufacturing Practices

The infant formula industry recognizes the importance of human milk and breastfeeding and fully acknowledges breastfeeding as the preferred feeding practice for babies. Additionally, the industry is committed to providing the highest quality formula alternatives possible. In keeping with this commitment, International Formula Council members1 rigorously follow all provisions of the Infant Formula Act of 1980 and subsequent amendments to this Act, to further assure the safety of infant formula. All infant formulas marketed in the United States are manufactured under strict adherence to Good Manufacturing Practices (GMP).

Additional GMP control procedures to prevent adulteration of formula product by biological, chemical or physical hazards were introduced in the Food and Drug Administration's (FDA) 1996 Proposed Rule: Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for the Production of Infant Formula. To control microbiological growth, liquid formulas are subjected to high temperatures for sufficient time to make the product commercially sterile until it is opened. Powdered infant formulas are also heat treated during processing but cannot be made commercially sterile. Attempts to sterilize powdered infant formula by steam or dry heat would destroy nutrient content. Thus, powdered infant formulas, like many commonly consumed foods, may contain extremely low levels of microorganisms. Formulas are routinely tested to exclude pathogenic microorganisms of public health significance. Prior to reconstitution, the extremely low water content of properly stored powdered formula prohibits bacterial growth.

Enterobacter Sakazakii

A microorganism of particular concern, and which can survive in powdered infant formula, is Enterobacter sakazakii (E. sakazakii). E. sakazakii is an opportunistic pathogen that poses little risk to healthy, term infants. However, in certain highly vulnerable infants this microorganism can cause serious infection that can present severe and life­threatening conditions, including meningitis. This most commonly occurs in low birth weight and immuno­compromised infants, in whom isolated outbreaks of E. sakazakii infections have been reported in a few hospital settings. Some of these cases have been linked to the improper preparation and storage of reconstituted powdered infant formula. For example, blenders used to reconstitute formula have been shown to harbor bacteria. Because reconstituted powdered infant formula is rich in nutrients and is not sterile, it provides a good medium for microbial growth under certain conditions. For example, prolonged periods of storage or administration of prepared powdered infant formula at room temperature will increase the bacterial load. Thus, proper handling and use of powdered infant formula in the health care setting is an important patient safety issue.

Recommendations to Reduce Risk of E. Sakazakii

ADA and the Centers for Disease Control and Prevention (CDC) have proposed ways to reduce the risk of E. sakazakii in at­risk infants, including the following key recommendations:

• Formulas should be selected based on nutritional needs; alternatives to powder should be chosen when possible.
• Trained personnel should prepare powdered formula using sanitary technique in a designated preparation room. Formula should not be prepared at the bedside.
• Manufacturer's instructions should be followed; if formula is to be saved for later use, it should be reconstituted with chilled, sterile water, refrigerated immediately and used within 24 hours after preparation. Any unused formula should be discarded.
• Blenders are not recommended for formula preparation.
• The administration or "hang" time for continuous enteral feeding by feeding tube should not exceed 4 hours.
• Written hospital guidelines should be available in the event of a manufacturer's product recall, including notification of health care providers, a system for reporting and follow­up of specific

formula products used, and retention of recall records.

FDA further recommends preparing only a small amount of reconstituted formula for each feeding to reduce the time that a formula is held at room temperature prior to and during feeding.

Safe Infant Feedings

By following infant formula manufacturers' preparation instructions on the label, as well as guidelines provided by CDC, FDA and ADA for appropriate formula use, any risk associated with infant feeding in the hospital is greatly reduced. Further, it is the health care professionals' responsibility to inform parents of highly vulnerable infants of these safety precautions whenever these at­risk infants are to be fed powdered infant formula in the home.

References

1 International Formula Council members are: Mead Johnson Nutritionals; Nestlé USA, Inc., Nutrition Division; Ross Products Division, Abbott Laboratories; Solus Products; and Wyeth Nutrition.

American Dietetic Association. Infant Feedings: Guidelines for Preparation of Formula and Breastmilk in Health Care Facilities. www.eatright.org

Centers for Disease Control and Prevention. Enterobacter sakazakii Infections Associated with the use of Powdered Infant Formula ­Tennessee 2001. MMWR. 2002;51:297­300.

Food and Drug Administration. Health professionals letter on Enterobacter sakazakii infections associated with use of powdered (dry) infant formulas in neonatal intensive care units. Center for Food Safety and Applied Nutrition. April 11, 2002.

Infant Formula Act of 1980. Public Law No. 96­359, 94 Stat. 1190 [codified at 21 U.S.C. § 350a, and adding/amending 21 U.S.C. §§ 321(aa), 331(s), 374(a)]. September 26, 1980.

Infant Formula Act Amendments of 1986. Public Law No. 99­570, 100 Stat. 3207 Sec. 4014. Infant Formulas [amending 21 U.S.C. §§ 350a, 331(s)]. October 27, 1986.

The American Academy of Pediatrics. Work Group on Breastfeeding. Breastfeeding and the Use of Human Milk. Pediatrics. 1997;100:1035.