Labeling is Not Enough: A Nursing Perspective on the Mismatch Between Biocompatibility Claims and Clinical Safety in IV Infusion Devices | ||
| Egyptian Journal of Health Care | ||
| Volume 16, Issue 4, December 2025, Pages 1-27 PDF (909.08 K) | ||
| Document Type: Original Article | ||
| DOI: 10.21608/ejhc.2025.457273 | ||
| Authors | ||
| Selwan Hamza Elgazzar1; Yasmin Moustafa Ayoub2; Eman Ramadan shabib2; Abdulaziz Alanazi2; Raeed Alanazi2 | ||
| 1Nursing Education Administration, King Saudi Medical City, Saudi Arabia | ||
| 2Nursing Education Administration | ||
| Abstract | ||
| Background: The continued use of di(2-ethylhexyl) phthalate (DEHP)-containing intravenous (IV) infusion devices in healthcare - particularly in Arab countries - poses significant clinical and ethical risks. Despite global regulatory alerts, the concept of biocompatibility is often misrepresented, leaving patients and nurses exposed to leachable toxins. The absence of enforceable standards in local procurement systems exacerbates these dangers. Aim: To explore the gap between biocompatibility claims and real-world safety in DEHP-based IV systems, while highlighting the nursing role in clinical risk detection, advocacy, and policy reform. Design: Narrative review employing a thematic synthesis approach across toxicological, regulatory, and clinical domains. Scope: The review covers international regulatory frameworks and nursing practice, with emphasis on high-risk environments such as neonatal intensive care units (NICUs), oncology wards, and dialysis units in Arab hospitals. Methods (Tool of Data Collection): A structured literature search was conducted in PubMed, Science Direct, Scopus, and Google Scholar, targeting publications from 2000 to 2025. Grey literature and official reports were retrieved from the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER), European Chemicals Agency (ECHA), Agency for Toxic Substances and Disease Registry (ATSDR), Health Care without Harm (HCWH), BBraun, and regional authorities. Inclusion focused on toxicological, regulatory, and nursing-related documents. Sources were thematically synthesized across five domains: toxicological risks, labeling and regulatory gaps, patient safety outcomes, occupational exposure, and nurse-led advocacy. Results: Strong toxicological evidence was identified linking DEHP exposure to endocrine disruption, reproductive toxicity, and carcinogenicity. Regulatory definitions of biocompatibility lacked transparency, particularly in Arab healthcare systems where DEHP-based devices remain prevalent due to the absence of binding material safety regulations. Nurses were identified as both frontline users and at-risk individuals due to occupational exposure and insufficient labeling. A thematic model was proposed to guide nursing-led safety interventions and procurement reform. Conclusion: DEHP use in IV devices remains an overlooked clinical and occupational threat. Misaligned biocompatibility labels and weak regulatory enforcement compromise the safety of IV therapy, especially in vulnerable patient populations. Recommendations: Nurses must lead advocacy for DEHP-free infusion systems, regular biocompatibility audits, and patient-centered procurement policies. Arab regulatory bodies should align with international directives (e.g., SCHEER, WHO) and empower nursing staff through transparent labeling, standardized training, and sustainable procurement reforms. | ||
| Keywords | ||
| di (2-ethylhexyl) phthalate (DEHP); intravenous infusion; biocompatibility; nursing safety; regulatory gaps; Arab healthcare systems | ||
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