Safety of Enteral and Parenteral Nutrition Products: Emerging Risks from Production to Clinical Use

Safety of enteral nutrition (EN) and parenteral nutrition (PN) products depends on manufacturing quality and changes during storage, preparation, and administration. This critical narrative review examines microbiological, chemical, and physicochemical hazards, distinguishing finished-product measurements, experimental models, and patient outcomes. The evidence documents secondary microbial contamination, material-derived plasticizer exposure, and oxidative changes in selected formulations, while also identifying conditions in which administration introduces no measurable additional contamination. Mechanistic susceptibility of eicosapentaenoic acid and docosahexaenoic acid to oxidation does not establish harmful exposure from contemporary commercial products. We propose Patient-Exposure-Oriented Nutritional Product Safety (PEONPS), a framework linking release quality, post-release change, terminal-line quality, and delivered exposure. Its proposed contribution is to integrate hazard-specific measurements with time-resolved administered dose and a prespecified test of whether the additional information changes a safety decision. Existing exposure studies provide precedents; PEONPS does not claim to introduce exposure assessment itself. Validation should compare its incremental value with established manufacturing, compounding, and administration controls. The framework offers a testable research agenda for targeted safety assessment, rather than a validated clinical score or a requirement for routine bedside testing. Supplementary targeted checks of official standards and selected safety-event and workflow studies were used to contextualize mechanical integrity and human factors; these searches were not intended to constitute exhaustive systematic retrieval.