• P-ISSN 0974-6846 E-ISSN 0974-5645

Indian Journal of Science and Technology

Article

Estimation and Risk Assessment of Di(2-ethylhexyl) Phthalate (DEHP) in Cardiac Catheter Sets
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Indian Journal of Science and Technology

DOI: 10.17485/IJST/v16i26.Balaje

Year: 2023, Volume: 16, Issue: 26, Pages: 1997-2007

Original Article

Estimation and Risk Assessment of Di(2-ethylhexyl) Phthalate (DEHP) in Cardiac Catheter Sets

R M Balaje1, M R Murali1, T N Sathya1, Sangeetha V Naveen1, K R Navaneethakrishnan1, S S Murugan1, T S Kumaravel1*

1GLR Laboratories Private Limited, Chennai, India

*Corresponding Author
Email: [email protected]

Received Date:25 November 2022, Accepted Date:19 June 2023, Published Date:11 July 2023

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

Abstract

Objectives: To conduct a toxicological risk assessment of di(2-ethylhexyl) phthalate (DEHP) in cardiac catheter (CC) set, following a chemical characterization study and systematic review of toxicity literature. Methods: CC set was subjected to chemical analysis study for estimation of DEHP in the PVC containing parts using HPLC-PDA. Toxicity literature on DEHP was collected from online database literature search and reports of international monitoring bodies. From the existing knowledge of DEHP toxicity, tolerable intake for humans was derived from the critical toxicity endpoint. This was compared to the levels of DEHP in CC to make scientific judgement on this risk to patients. Findings: During clinical use of medical devices like CC tubing set, intravenous infusion set, storage of blood in blood bags there is a possibility of DEHP leaching in to the patient body via fluids or blood. Based on the chemical analysis of device extract, the content of DEHP in the CC tubing set was estimated to be 38.18 mg per device. The patient exposure of DEHP was calculated assuming clinical use of one device per day. Review of extensive toxicity literature revealed the critical toxicity endpoints of DEHP toxicity. Activation of peroxisome proliferatoractivated receptor alpha (PPAR-a) in rodents leading to hepatic tumors and disruption of normal endocrine function of gonads are the primary concerns of toxicity. Human tolerable exposure derived from the NOAEL obtained from a key reproductive toxicity study was used to evaluate the toxicological risk of DEHP. From the assessment, the level of DEHP leaching out from the CC tubing set is concluded to be safe in humans. Novelty: This manuscript describes a method for risk assessing DEHP toxicity in medical devices using a case study of CC set. This approach is based on generating patient exposure using chemical analysis and comparing this with toxicology data from literature to make informed decisions on patient safety.

Keywords: DEHP; Risk Assessment; Medical Device; Toxicity

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Copyright

© 2023 Balaje et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Published By Indian Society for Education and Environment (iSee)

  • 12 July 2023

Year: 2023, Volume: 16, Issue: 26

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