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PVC as a biomedical polymer--plasticizer and stabilizer toxicity.

C R Blass1

  • 1Hydro Polymers, Newton Aycliffe, County Durham, UK.

Medical Device Technology
|March 9, 1992
PubMed
Summary

Polyvinyl chloride (PVC) is a versatile biomaterial in medical devices. While effective, its plasticizers, like DEHP, pose toxicological risks, questioning the human relevance of animal testing for safety assessments.

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Area of Science:

  • Polymeric biomaterials
  • Toxicology
  • Medical device materials

Background:

  • Polyvinyl chloride (PVC) is a widely studied polymeric biomaterial extensively used in medical devices.
  • PVC's success stems from its tunable properties like flexibility and low toxicity, achieved through various formulations.
  • Plasticizers are crucial for PVC formulation but pose toxicological risks due to potential extraction into biofluids.

Purpose of the Study:

  • To analyze PVC compound formulations and the toxicological impact of plasticizers.
  • To review studies on di(2-ethylhexyl)phthalate (DEHP), the most common plasticizer.
  • To evaluate the validity of animal testing for human risk assessment of PVC-related toxicity.

Main Methods:

  • Review of PVC compound ingredients and plasticizer influence on toxicity.
  • Detailed examination of studies involving di(2-ethylhexyl)phthalate (DEHP).
  • Analysis of commercial PVC production, pharmacopoeia, and national standards.

Main Results:

  • Plasticizers, particularly DEHP, are identified as the primary toxicological concern in PVC medical devices.
  • The efficacy and relevance of animal testing for assessing human health risks associated with DEHP are questioned.
  • Commercial production processes and regulatory standards for PVC polymers are described.

Conclusions:

  • The formulation of PVC, especially the choice and potential leaching of plasticizers, is critical for biomaterial safety.
  • Further research is needed to validate the extrapolation of animal study results to human risk assessment for PVC biomaterials.
  • Understanding PVC production and regulatory landscapes is essential for safe medical device development.

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