Enhancing Enteral Nutrition Safety: A Review of Current Practices and Research Opportunities
Main Article Content
Abstract
Ensuring the safe preparation and administration of enteral nutrition is a critical component of clinical care, yet manual processes remain prone to significant errors. This scoping review examined 41 publications—21 research studies and 20 regulatory or best practice guidelines—to evaluate the impact of centralized preparation and bar code scanning technology on patient safety across the lifespan. The review categorized enteral nutrition risks into three primary domains: microbial contamination, preparation inaccuracies, and misadministration. The review identified research reporting manual enteral nutrition error rates as high as 26% to 31%, highlighting the significant risk associated with non-automated workflows.
Research outcomes revealed that transitioning from bedside preparation to a centralized location staffed by dedicated technicians significantly reduces microbial growth. Specifically, facility-prepared formulas were 24 times more likely to show contamination when handled at the bedside. Furthermore, the integration of bar code scanning technology emerged as the most effective barrier against errors, with studies identifying a high volume of "near misses" that may have otherwise gone undetected. Technology also delivered measurable operational benefits, including improved documentation accuracy (rising from 60% to 100% in one study) and substantial time savings for nursing staff, which allowed for more direct patient care.
The review highlights a transformative shift in the regulatory landscape, particularly with the adoption of Regulation (EU) 2024/1938 (the SoHO Regulation). This legislation mandates rigorous standards for the traceability and handling of human milk, requiring European facilities to adopt automated systems, 30-year data retention protocols, and the Single European Code (SEC) by 2027. Despite the clear benefits of these interventions, the review identified a significant geographical gap, as all 21 research studies were conducted in the United States. Future research should prioritize European-based clinical studies, formal cost-benefit analyses across diverse hospital settings, and the impact of these safety frameworks on long-term clinical outcomes such as reduced rates of necrotizing enterocolitis. Ultimately, the transition from manual, reactive processes to proactive digital frameworks is essential for clinical excellence and regulatory compliance in enteral nutrition management.
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References
2. IPAC Canada Paediatric and Neonatal Interest Group. Practice Recommendations for Handling of Expressed Human Milk in Healthcare Facilities. Fall 2020. https://www.cjic.ca/pdfs/fall2020/Practice_Recommendations_for_Handling_of_Expressed_Human_Milk_in_Healthcare_Facilities.pdf. Accessed December 2, 2025.
3. ISMP. Use barcode scanning to prevent errors with enteral nutrition feedings. ISMP Medication Safety Alert! Acute Care. 2024;29(16):1-5. Use Barcode Scanning to Prevent Errors with Enteral Nutrition Feedings (ecri.org).
4. Pediatric Nutrition Practice Group. Steele C, Collins E, eds. Infant & Pediatric Feedings: Guidelines for Preparation of Human Milk and Formula in Health Care Facilities. Chicago, IL. Academy of Nutrition and Dietetics, 2019.
5. Boullata JI, Carrera AL, Harvey L , et al. ASPEN Safe Practices for Enteral Nutrition Therapy J Parenteral Enteral Nutr. 2017;41(1):15-103.
6. Steele C, Bixby C. Centralized Breastmilk Handling and Bar Code Scanning Improve Safety and Reduce Breastmilk Administration Errors. Breastfeeding Med. 2014;9(9):426-429.
7. Steele C, Bixby C. Bar Code Scanning of Human Milk and Enteral Formulas Improves Efficiency and Patient Safety: A 7-Year Review. Nutr in Clin Pract. 2022;37(4):921-928. https://doi.org/10.1002/ncp.10765.
8. Steele C, Albert D. Bar Code Scanning of Ready-to-Feed Enteral Nutrition Formulas Improves Patient Safety and Reduces Risk of Misadministration in Pediatric Patients Ages 1-18: A Quality Improvement Project in a Single Children’s Hospital. Nutr Clin Pract. 2025;40:1606–1611. Doi: https://doi.org/10.1002/ncp.70003
9. American Academy of Pediatrics. Stark AR, et al. Standards for Levels of Neonatal Care: II, III, and IV. Pediatrics. 2023;151(6):e2023061957.
10. Malone A, Nieman Carney L, Long Carrera A, Mays A, eds. ASPEN Enteral Nutrition Handbook. Silver Spring, MD: American Society for Parenteral and Enteral Nutrition; 2019.
11. Mannel R, Taylor S, eds. Best Practice for Expressing, Storing, and Handling Human Milk in Hospitals, Homes, and Child Care Settings. 5th ed. Fort Worth, TX. Human Milk Banking Association of North America, 2024.
12. Facility Guidelines Institute. Recommended Standards for Newborn ICU Design, 9th ed. Recommended NICU Standards_2020-08-31. Accessed August 20, 2025.
13. Steele C, Alessi S. Use of Dedicated Technicians and Bar Code Scanning Technology for Fortified Human Milk Feeding Preparation in a Neonatal Intensive Care Unit Reduces Risk of Preventable Adverse Events. J Acad Nutr Diet. 2024;124(5):559-563.
14. Steele C, Short R. Centralized Infant Formula Preparation Room in the Neonatal Intensive Care Unit Reduces Incidence of Microbial Contamination. J Am Diet Assoc. 2008;108:1700-1703.
15. Alessi S, Hamsi P, Steele C. Bar Code Scanning of Infant Formulas at the Time of Feeding Reduces Risk of Formula Misadministration. Nutr Clin Pract. 2025. https://doi:10.1002/ncp.70035.
16. Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on Standards of Quality and Safety for Substances of Human Origin Intended for Human Application and Repealing Directives 2002/98/EC and 2004/23/EC. Official Journal of the European Union. July 17, 2024. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202401938. Accessed December 2, 2025.
17. Schwarz E, Nass O, Giocondo V, et al. Identification of Enteral Nutrition Errors in a Single‐Center Quality‐Improvement Audit. Nutr Clin Pract. 2023. https://doi.org/10.1002/ncp.11076.
18. Citty SW, Chew M, Hiller LD, et al. Enteral nutrition: An Underappreciated Source of Patient Safety Events Nutr Clin Pract. 2024;39(4):784-99. https://aspenjournals.onlinelibrary.wiley.com/doi/10.1002/ncp.11153.
19. Zhang B, LaFleur EA, Ballweg DD, et al. Use of Healthcare Failure Mode and Effects Analysis (HFMEA) to Quantify Risks of the Human Milk Feeding Process. J Nurs Care Qual. 2014;29(1):30-37.
20. Drenckpohl D, Bowers L, Cooper H. Use of the Six Sigma Methodology to Reduce Incidence of Breast milk Administration Errors in the NICU. Neonatal Network. 2007;26(3):161-166.
21. Luton A, Bondurant PG, Campbell A, et al. Got (the Right) Milk? Adv Neonatal Care. 2015;15(5):345-353.
22. Dougherty D , Giles V . From Breast to Baby: Quality Assurance for Breast Milk Management. Neonatal Network. 2009;19(7):21-25.
23. Oza-Frank R, Kachoria R, Dail J, et al. A Quality Improvement Project to Decrease Human Milk Errors in the NICU. Pediatrics. 2017;139(2):S1-S13.
24. Paul E. Minimizing Patient Safety Events Through a Multidisciplinary Approach to Human Milk Management. ICAN: Infant, Child, & Adolescent Nutr. 2015;7(5):258-261.
25. Brock WW, Cunningham CA, Brandon DH, et al. Improving the Process of Enteral Nutrition Preparation with Milk Technicians, Perceptions of Cost, Time, and Quality. Adv Neonatal Care. 2016;16(2):124-134.
26. Wolford S, Smith C, Harrison M. A Retrospective Two Year Study of Breast Milk Error Prevention in the Neonatal Intensive Care Unit. Neonatal Intensive Care. 2013;26(2):41-42.
27. Gabrielski L , Lessen R . Centralized Model of Human Milk Preparation and Storage in a State-of-the-Art Human Milk Lab. ICAN: Infant, Child, & Adolescent Nutr. 2011;3(4) 225-232.
28. Dumm M, Peel L, Jones A, et al. Technician Training Reduces Formula Preparation Errors. ICAN: Infant, Child, & Adolescent Nutr. 2010;2(4):258-260.
29. Steele C, Czerwin A, Bixby C. Breast Milk Bar Code Scanning Results in Time Savings and Staff Efficiency. J Acad of Nutr Diet. 2015;115(1):23-26.
30. Steele C, Smith S. Barcode Scanning versus Manual Processes for Infant Feedings and Recipe Calculations Improves Safety, Reduces Errors, and Enhances Staff Efficiency. Neonatal Intensive Care (The Journal of Perinatology-Neonatology). 2025;38(2):8-10.
31. Chew MM Rivas S, Chesser M, et al. Improving Administration and Documentation of Enteral Nutrition Support Therapy in a Veteran Affairs Health Care System: Use of Medication Administration Record and Bar Code Scanning Technology. J Patient Safety. 2023;19(1):23-28.
32. The Joint Commission. Requirements for the Hospital Accreditation Program. HAP Standards Report Jan 2026. Accessed August 20, 2025.
33. U.S. Food and Drug Administration. 2022 Food Code. Food Code 2022 | FDA. Accessed Feb 4, 2025.
34. U.S. Food and Drug Administration. Food and Drug Omnibus Reform Act (FDORA) of 2022. Accessed January 13, 2026. https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/food-and-drug-omnibus-reform-act-fdora-2022.
35. U.S. Food and Drug Administration. Food Safety Modernization Act Final Rule on Requirements for Additional Traceability Records for Certain Foods, Section 204. Accessed January 13, 2026. https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods.
36. American Society for Parenteral and Enteral Nutrition. Practice tool. Preventing Errors with Barcode Scanning for Enteral Nutrition. Updated April 10, 2025. Accessed February 11, 2025. https://nutritioncare.org/wp-content/uploads/2025/01/Barcode-Scanning-EN.pdf.
37. Moro GE, Arslanoglu S, Bertino E, et al. Human Milk in Feeding Premature Infants: From Tradition to Bioengineering. Proceedings of a Consensus Development Conference–EXPO 2015, Milan, Italy, May 15–16. J of Ped Gastroenterology Nutr (JPGN). 2015;61(S1):S1-S19.
38. Steele C. Safe Handling of Human Milk Within the Hospital Setting. Neonatal Intensive Care (The Journal of Perinatology-Neonatology). 2020;33(3):11-14. https://doi.org/10.1016/j.jand.2021.01.008
39. Steele C. Best Practices for Handling and Administration of Expressed Human Milk and Donor Human Milk for Hospitalized Preterm Infants. Frontiers in Nutrition. 2018;5(76):1-5. doi: 10.3389/fnut.2018.00076.
40. Matus BA, Bridges KM, Logomarsino JV. Evaluation of Key Factors Impacting Feeding Safety in the Neonatal Intensive Care Unit: A Systematic Review. Adv Neonatal Care. 2019;19(1):11-20.
41. European Commission's Health & Food Safety - Commission Directive (EU) 2015/565. Blood, tissues, and cells. Accessed August 26, 2025. https://health.ec.europa.eu/document/download/86a1c8cf-405e-478f-b9e1-1eef7a627432_en#:~:text=speci… .
42. Weaver G, Berino E, Gebauer C, et al. Recommendations for the Establishment and Operation of Human Milk Banks in Europe: A Consensus Statement From the European Milk Bank Association (EMBA). Frontiers in Pediatrics. 2019. 7:53.
43. ISBT 128 and the Single European Code. ICCBBA Technical Bulletin. 2016. https://www.isbt128.org/technical-documents. Accessed January 5, 2026.
44. ISBT 128 Standard for Coding Medical Products of Human Origin. PMC. 2017. https://www.isbt128.org/technical-documents. Accessed January 6, 2026.