Consorta Education Network

PVC and DEHP in Medical Devices: Problems and Solutions
 

Polyvinyl chloride (PVC) is one of the most widely used plastics in medical products. It is a plastic produced with fillers, stabilizers, pigments, plasticizers, lubricants, anti-oxidants, and flame retardants. In its production and disposal, PVC raises many public health and environmental impacts, including the creation of dioxin/furans, leaching of plasticizers, stabilizers, and direct patient health concerns from the leaching of di(2-ethylhexyl) phthalate (DEHP).

DEHP is a plasticizer added to PVC medical devices to make them soft and more pliable. Unfortunately, DEHP does not bind with the PVC and, therefore, leaches out of medical devices and can enter a patient’s body. Exposures to DEHP are of particular concern to pediatric patient populations and subsets of the general population. Fetuses, newborn infants, and children may be at particular risk. The FDA has issued a public health notification, recommending that health care practitioners take action to reduce exposures, including replacing DEHP-containing products, particularly in the treatment of vulnerable populations.

The presentation, “PVC and DEHP in Medical Devices: Problems and Solutions,” reviews the science of PVC and DEHP, presents an overview of the advantages and disadvantages of PVC as a plastic for medical devices, identifies the populations and medical procedures at highest risk of exposure, reviews the actions regulatory agencies have taken in regard to DEHP, and presents information about alternatives. 

Objectives

At the conclusion of this program, participants should be able to:

  1. Report on the widespread use of PVC.

  2. Identify the advantages and disadvantages of PVC.
  3. Recognize the mechanisms whereby DEHP leaches from PVC medical devices.
  4. Name those patients and procedures at highest risk of DEHP exposure.
  5. Summarize the accumulating evidence on health effects of DEHP, as identified in animal studies.
  6. Summarize evidence on neonatal exposures to DEHP, as identified in studies out of Harvard School of Public Health.
  7. Describe the actions regulatory agencies have taken to protect patients from DEHP exposure.
  8. Identify the alternatives available for practitioners who wish to eliminate PVC and/or DEHP products from their practices and some case examples from hospitals that have eliminated DEHP use in their NICUs.

Presenters

Ted Schettler MD, MPH has a medical degree from Case Western Reserve University and a Masters in Public Health from Harvard University. Dr. Schettler is science director of the Science and Environmental Health Network (www.sehn.org) and is also co-chair of the Human Health and Environment Project of Greater Boston Physicians for Social Responsibility. Dr. Schettler co-authored Generations at Risk (MIT Press, 1999), which examines the reproductive health effects of exposure to a variety of environmental toxicants, and In Harm's Way -- Toxic Threats to Child Development, which examines the impacts of environmental contaminants on children's neurological development. He is also the author of numerous journal articles. Schettler has served on the advisory committees of the US EPA and National Academy of Sciences. He is on the medical staff of Boston Medical Center.

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Supporting
Documents

A Pledge for Consorta Hospitals in Support of Reducing PVC and DEHP

Alternatives to PVC and DEHP Medical Devices