Biocompatibility at Risk: The Hidden Threat of Di (2-ethylhexyl) Phthalate (DEHP) in Pediatric and Oncology Infusion Systems

Document Type : Original Article

Authors

Nursing Education Administration

Abstract

Background: Di (2-ethylhexyl) phthalate (DEHP), a common plasticizer in polyvinyl chloride (PVC)medical devices, has been linked to endocrine disruption, hepatotoxicity, and reproductive harm. Despite global regulatory alerts, DEHP-containing infusion systems—including IV sets and blood bags—remain in use, particularly in pediatric, oncology, and transfusion-dependent populations. Aim:. To assess DEHP-related risks and propose a nursing-led framework for safer, biocompatible infusion practices. Design: A narrative-based theoretical analysis integrating scientific literature, toxicological data, international regulatory positions, and economic considerations. Setting: review was conducted within a multidisciplinary academic framework, guided by international patient safety standards (e.g., JCI, CBAHI, and Magnet’s NK3). Tool of Data Collection: Structured comparative tables were used to synthesize findings related to toxicological markers, pharmacological interactions, risk stratification, regulatory gaps, labeling attributes, and cost-effectiveness. Results: DEHP exposure correlated with elevated FSH/LH, pubertal delay, liver enzyme abnormalities, and reduced fertility. Drug adsorption and compromised chemotherapy efficacy were observed with DEHP-lined IV sets. Regulatory reviews revealed fragmented global policies and weak substitution enforcement. DEHP-free alternatives (e.g., EVA, TOTM) demonstrated better safety profiles and were cost-justified in high-risk groups. A nurse-driven screening checklist was developed. A nurse-driven screening checklist was developed to support clinical decision-making. Conclusion: DEHP use in infusion systems represents a preventable hazard in vulnerable populations. Biocompatible alternatives offer superior clinical outcomes and should replace DEHP-containing devices in critical care settings. Recommendations: Healthcare institutions must adopt DEHP-specific labeling, enforce substitution policies, and implement mandatory biocompatibility training. Accrediting bodies such as JCI and CBAHI should revise patient safety metrics to include material-related risks, while procurement models must shift toward value-based, risk-informed approaches.

Keywords