BackgroundIdentifying food safety risks when handling enteral formulations at home is important to restore and maintain the health of patients. Therefore, this study developed and validated a food safety assessment checklist for handling home enteral nutrition (HEN).MethodsThis methodological study developed a checklist based on a literature review and interviews with food safety professionals. The content validation, which was conducted by food safety and enteral feeding experts, assessed the relevance, clarity, and simplicity of the checklist using the content validity index of items (CVI‐I), categories (CVI‐C), and the entire instrument (CVI‐EI). Each item was rated as either essential, necessary, or recommended according to the risk in relation to foodborne diseases.ResultsThe Food Safety for Handling Home Enteral Nutrition checklist (FSHEN checklist) that was developed includes 40 items and the following eight categories: physical structure; cleaning of facilities, equipment, furniture, and utensils; pests and waste; water supply; food handlers; ingredients and packaging; handling of enteral formulations; and the bottling and storage of enteral formulations. The CVI‐EI was above the recommendation (≥0.93) for the three assessed criteria, as was the CVI‐C in terms of clarity (≥0.95), relevance (≥0.98), and simplicity (≥0.84). A total of 52.5% of the items were rated as essential, 32.5% as necessary, and 15% as recommended.ConclusionThe FSHEN checklist is relevant, clear, and easy to use. It can help health professionals and individuals working in the field to assess and prioritize items to improve food safety in the management of HEN.