The following is an abbreviated and updated version of guidelines originally published in, Preparation of Formula for Infants: Guidelines for Health-care Facilities, American Dietetic Association, 1991. Updates are highlighted. Please note: the use of liquid infant formula (ready-to-feed or concentrated liquid formula prepared with sterile water using aseptic technique) is recommended in neonatal intensive care settings unless no alternative to powdered formula is available. Selection of an appropriate infant formula should be based on assessement of the individual patient and in consultation with the health-care team.

Physical Facilities

1. If infant formula is prepared on-site, there must be a separate room* that a) has the appropriate physical separation from patient care areas, b) has the preparation area divided from the secured storage room and anteroom areas, and c) is used solely for the purpose of preparing infant formula and enteral feedings by aseptic technique.

* It is recognized that not all health-care facilities will have a separate room to dedicate to infant formula preparation, but a separate area that can ensure the preparation of a safe infant formula using aseptic technique, and in keeping with these guidelines, should be provided.

2. A clean air supply with appropriate pressure gradient is required for the infant formula preparation room.

3. The surface of the floors, walls, and ceiling of the infant formula preparation room must be made of material that can be maintained in a sanitary condition.

4. A separate handwashing sink with controls for water that do not require the use of hands must be available within the infant formula preparation area.

Equipment, Utensils, and Supplies

1. The equipment and utensils in the infant formula preparation room must be in compliance with applicable health regulations and sanitation codes.

2. Supplies (e.g., gowns, bottles, nipples, sanitizing solutions, utensils, and equipment) must be adequate to implement aseptic technique in the preparation of infant formula.

3. The refrigerator in the infant formula preparation room must be lockable or securable and have an adequate refrigeration capacity to initially cool all prepared infant formula to 35° to 40° F (2° to 4° C) within four hours following preparation.

Personnel

1. Administrative responsibility for the infant formula preparation room must be assigned to a qualified individual, e.g., a registered dietitian, registered pharmacist, or registered nurse.

2. The supervisor of the infant formula preparation room must be experienced in formula room techniques and operations.

3. A written training policy must be developed and implemented that requires an orientation of sufficient duration and substance, training, in-service experiences, and evaluation of proficiency at appropriate intervals for each staff member responsible for preparation of infant formulas.

Formula Preparation and Handling

1. There must be written guidelines for safe storage of infant formula products and ingredients to maintain product integrity.

2. Care must be taken to avoid freezing temperatures or excessive heat in stock storage areas.

3. Expired or damaged infant formula products must be discarded in such a way as to prevent human consumption.

4. There must be written guidelines for ordering formulas, transmitting orders to the formula room, and maintaining formula order records for individual patients.

The infant formula order should include

a) patient's name
b) patient's medical record/lD number
c) patient's location
d) formula name plus additives
e) caloric density/volume/feeding frequency
f ) name of authorizing physician
g) date of order

5. Liquid infant formula (ready-to-feed or concentrated liquid prepared with sterile water using aseptic technique) should be used in neonatal intensive care settings unless no alternative is available. Selection of an appropriate infant formula should be based on assessement of the individual patient and in consultation with the health-care team.

6. Aseptic technique must be practiced for all infant formula preparation. Preparation procedures should be appropriate to the conditions in the specific facility.

7. There must be written guidelines for aseptic technique used in the infant formula preparation room, including: scrubbing, gowning, care of work area, equipment, and supplies. These policies and procedures must be reviewed periodically by the appropriate committees within the health-care facility, including the infection control committee.

8. The infant formula preparation room should be used for no other formula room activities while infant formulas are being prepared.

9. Written formulations should be maintained in the infant formula preparation room for all infant formulas prepared. Formulations must be verified for accuracy and appropriateness, preferably by a registered dietitian trained in infant formula preparation.

10. There is no clear consensus of the method of aseptic preparation for infant formula. The ADA guidelines issued in 1991 stated that only ingredient water (commercially sterilized water, or water made safe by bringing to a full rolling boil for five minutes and cooled) may be used in aseptic preparation of infant formula. That guideline stated that distilled, deionized, or bottled waters that are not commercially sterile must be brought to a full rolling boil for five minutes and cooled before use in infant formula preparation.
The FDA has also published recommendations which are posted on http://www.cfsan.fda.gov/%7Edms/inf-ltr3.html.

11. Written and dated batch records should be produced by the formula preparer at the time each batch of infant formula is prepared. These records should be initialed by the formula preparer and maintained according to the appropriate guidelines of the health-care facility.

12. Prepared infant formula must not be frozen.

13. There must be written guidelines governing acceptable ingredients that may be added to infant formulas. NO honey, syrups, raw eggs, or unpasteurized milks may be used in the preparation of infant formula. Issues related to the use of human milk must be considered separately. It is recommended that medications not be added to infant formula at the time of formula preparation.

14. Under emergency circumstances, terminal heating may be employed in the preparation of infant formula. There must be written guidelines for terminal heating in the preparation of infant formulas.

15. Each unit of prepared formula must have a label that should include

a) patient's name
b) patient's medical record/ID number
c) patient's location
d) formula name plus additives
e) caloric density/volume
f) volume in container
g) expiration date and time
h) "For enteral use only"
i) "Refrigerate until use"

16. A registered dietitian, registered nurse, registered pharmacist, or designee must check the labeled formula unit for accuracy against the individual patient infant formula order prior to dispensing the formula to the patient care unit.

17. Facility prepared infant formula should be packaged for individual patient use in food grade quality containers in quantities required for a feeding or up to a 24-hour period. Infant formula not immediately refrigerated must be used within four hours or discarded. Refrigerated infant formula must be used within 24 hours after preparation or be discarded.

18. Hang time for infant formula used for continuous feedings should not exceed four hours.

19. Refrigerators in the infant formula preparation room and patient care units must maintain a temperature of 35° to 40° F (2° to 4° C). Note: Quality control must be in place to ensure accuracy in temperature.

20. In the infant formula preparation room and on patient care units, locked or secured refrigeration for infant formula must be provided separate from refrigerated biologicals (e.g., specimens, medications). Written guidelines for refrigeration must meet regulatory agency standards and be approved by the appropriate committees of the health-care facility.

21. There must be written guidelines for the safe transport of infant formula that ensure maintenance of the appropriate temperature until it reaches the patient care unit refrigerator.

22. If formula is warmed before feeding, the warming process should take less than 15 minutes.

23. Only flowing warm water or warmers that do not permit contact of bottles or hands with standing water may be used to warm formula in bottles.

24. Microwave ovens must NEVER be used to warm infant formula for feeding.

25. There must be label verification of infant formula by a designated person prior to feeding an individual patient.

26. For infants being nipple fed, infant formula remaining in the bottle one hour after the start of nipple feeding should be discarded.

27. There should be written guidelines regarding appropriate disposal of expired facility prepared infant formula on patient care units.

28. There should be written guidelines developed between the department responsible for preparation and the Department of Nursing that prescribe proper clean handling and storage of infant formula on patient care units.

29. There should be written guidelines for systems of reporting and follow-up of facility prepared infant formula that is flawed in any way (defective, adulterated, contaminated, preparation error, etc).

30. There should be written guidelines for reporting and follow-up of recalled formula products in the health-care facility. Formula products recalled by the manufacturer or a regulatory agency should be handled in accordance with their instructions.

31. The infant formula container or ingredient container must be inspected before use. The product must not be used if it is beyond its expiration date or if the container is damaged, leaking, or swollen.

32. The product contents must be inspected after opening the container. The product must not be used if it appears adulterated, contaminated, or otherwise abnormal (e.g., lumpy, grainy liquid; clumped powder).

33. Guidelines must be established for all ingredients added to infant formula as well as all materials coming in contact with the formula (e.g., bottle and nipple assembly).

Infection Control

1. The infection control committee must ensure that its health-care facility has written guidelines covering

a) handwashing
b) aseptic technique
c) formula preparation
d) terminal heating
e) housekeeping and cleaning of infant formula preparation room, as well as all facility areas where infant formula is fed
f) storage and expiration date and time for all infant formula products
g) sanitation of all equipment and containers used for infant formula preparation and storage, including refrigerators in patient care areas
h) quality control checks for all heating, cooling, and cleaning equipment
i) employee health (as defined by health policies and appropriate regulatory agencies) including exclusion from work in the infant formula preparation room for the infant formula room technician in the event of proven or suspected infectious illness
j) in-service education and training
k) surveillance, reporting, and follow-up of formula-related infections

2. Infant formula preparation room personnel should be included in surveillance, investigation, management, and follow-up of known or suspected formula-related infections.

3. The infection control committee should periodically review infant formula preparation procedures.

Quality Control

1. The department responsible for infant formula preparation must establish a quality control plan following HACCP guidelines that includes continuous monitoring/evaluation functions as well as corrective action and follow-up, when deemed necessary.

2. The quality control plan must include measurable indicators for use in monitoring.

3. The quality control plan must be integrated with the facility's overall quality control program.

4. Results of the quality control monitoring/ evaluation must be routinely reviewed by the facility's quality control committee and the quality control plan revised, when appropriate.

To report illness from an infant formula, health-care providers can report this by calling FDA's MedWatch hotline at 800/FDA-1088 or by using the Web site www.fda.gov/medwatch/report/hcp.htm. The MedWatch program allows health-care providers to report problems possibly caused by FDA-regulated products such as drugs, medical devices, medical foods and dietary supplements. The identity of the patient is kept confidential.

Consumers may also report an adverse event or illness they believe to be related to the use of an infant formula by calling FDA at 800/FDA-1088 or using the Web site www.fda.gov/medwatch/report/consumer/consumer.htm. FDA would like to know when a product causes a problem even if consumers are unsure the product caused the problem or even if consumers and the baby do not visit a doctor or clinic.

The FDA and CDC each have issued warnings and suggestions for formula handling practices in hospitals.

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