B. Braun - PVC-Free and DEHP-Free Facts

PVC and DEHP Facts:

The Case for Achieving
Patient and Environmental Safety

What is DEHP?
DEHP – Di (2–ethylhexyl) phthalate – a plasticizer used in many medical products made of polyvinyl chloride (PVC) – is commonly found in:

IV bags and tubing • Blood bags and tubing • Nasogastric feeding tubes • Respiratory tubing
Umbilical catheters • Extra Corporeal Membrance Oxygenation (ECMO) tubing

Why is DEHP a cause for concern?

In 1987 the EPA identified DEHP as a probable human carcinogen.
Numerous animal studies indicate that DEHP is a reproductive carcinogen.
PVC–based medical devices contain an average of 20% – 40% DEHP¹
DEHP leaches out into IV solutions.
Levels of DEHP in IV solutions packaged in PVC bags are 830 times higher than the amount permitted in drinking water.

Pediatric DEHP exposure, particularly in male neonates may result in developmental and reproductive abnormalities.

In response to the public's concern about the negative effects of DEHP, the following organizations have published cautions outlining the potential health risks:

National Toxicology Program Expert Panel (NIH): cerhr.niehs.nih.gov/news/index.html

California Medical Association: www.sfbaypsr.org/work_env2.html

Food and Drug Administration (FDA) – Safety Assessment: www.fda.gov/cdrh/ost/dehp-pvc.pdf

American Medical Association: www.ama-assn.org/am1/upload/mm/interim01/E06l01.rtf

Health Canada Expert Advisory Panel: http://www.hc-sc.gc.ca/hpb-dgps/therapeut/zfiles/english/
advcomm/eap/dehp/eap-dehp-final-report-2002-jan-11_e.pdf

FDA Public Health Notification - PVC Devices Containing the Plasticizer DEHP: www.fda.gov/cdrh/safety/dehp.html

Health Care Without Harm: "A Summary of the Expert Panel Report of the National Toxicology Program on DEHP and its Risks to Human Reproduction" Source document: NTP - CERHR Expert Panel Report on Di (2-ethylhexyl) phthalate. National Toxicology Program. U.S. Department of Health and Human Services, Center for Evaluation of Risks to Human Reproduction, October 2000.