Effects of flow rate on the migration of different plasticizers from PVC infusion medical devices

PLoS One. 2018 Feb 23;13(2):e0192369. doi: 10.1371/journal.pone.0192369. eCollection 2018.

Abstract

Infusion medical devices (MDs) used in hospitals are often made of plasticized polyvinylchloride (PVC). These plasticizers may leach out into infused solutions during clinical practice, especially during risk-situations, e.g multiple infusions in Intensive Care Units and thus may enter into contact with the patients. The migrability of the plasticizers is dependent of several clinical parameters such as temperature, contact time, nature of the simulant, etc… However, no data is available about the influence of the flow rate at which drug solutions are administrated. In this study, we evaluated the impact of different flow rates on the release of the different plasticizers during an infusion procedure in order to assess if they could expose the patients to more toxic amounts of plasticizers. Migration assays with different PVC infusion sets and extension lines were performed with different flow rates that are used in clinical practice during 1h, 2h, 4h, 8h and 24h, using a lipophilic drug simulant. From a clinical point of view, the results showed that, regardless of the plasticizer, the faster the flow rate, the higher the infused volume and the higher the quantities of plasticizers released, both from infusion sets and extension lines, leading to higher patient exposure. However, physically, there was no significant difference of the migration kinetics linked to the flow rate for a same medical device, reflecting complex interactions between the PVC matrix and the simulant. The migration was especially dependent on the nature and the composition of the medical device.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Equipment and Supplies*
  • Humans
  • Intensive Care Units
  • Plasticizers / chemistry*
  • Polyvinyl Chloride / chemistry*

Substances

  • Plasticizers
  • Polyvinyl Chloride

Grants and funding

This study is a part of the project ARMED (Assessment and risk management of medical devices in plasticized polyvinyl chloride) which has received the financial support of the French Medicine Agency (ANSM, Agence Nationale de Sécurité du Médicament et des Produits de Santé). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.