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PVC and DEHP in Medical Products

Plasticizers are organic compounds added to polymers to increase the flexibility and toughness of the finished product. Di (2-ethylhexyl) phthalate (DEHP) is a plasticizer in the phthalate family that is commonly added to polyvinyl chloride (PVC) as a softener. Many industrial and consumer products contain phthalates, and humans can potentially be exposed to high amounts of the chemical.1

Plasticizer Use Around the World:

  • Flexible polyvinyl chloride accounts for up to 90% of world plasticizer consumption.2
  • It is estimated that about 80 thousand metric tons of PVC per year is used for the manufacture of small diameter flexible tubing used in medical applications for fluid and air transfer.3
  • North America accounts for about 13% of the worldwide plasticizer consumption and the North American demand for plasticizers is expected to grow over 2% each year through 2018.2
  • Consumption of PVC resin in the United States and Canada in 2007 totaled 6,426 thousand metric tons.3
  • Approximately 3×104 tons of plasticized PVC is used for medical applications annually in Europe4, such as IV and blood bags and infusion tubing, enteral and parenteral nutrition feeding bags, and tubing used in devices for cardiopulmonary bypass and extracorporeal membrane oxygenation.

DEHP is one of the eight chemicals that are included in the Environmental Protection Agency’s (EPA) Phthalates Action Plan.1 The EPA has concerns regarding phthalates’ toxicity and the evidence of pervasive human and environmental exposure to it.1 A number of studies have revealed a link between phthalate exposure and human health. However, no causal connection has been established. Much scientific attention is currently focused on the cumulative effect that several phthalates can have on the reproductive system.1

PVC and its toxic breakdown product, DEHP, can be found throughout the hospital when patients are exposed to:

  • Cardiopulmonary bypass
  • Enteral and parenteral feeding bags
  • Extracorporeal membrane oxygenation
  • Hemodialysis
  • Infusion administration sets
  • IV and blood bags
  • Peritoneal dialysis bags and tubing
By choosing products that are not made with PVC and DEHP, you can help eliminate potential toxins and other safety hazards that could affect your staff, your patients and the environment.

Awareness in Healthcare

More than four decades ago, B.Braun recognized the environmental and patient risks posed by products containing PVC and DEHP. Medical devices containing these chemicals pose potential health hazards to people during medical care and to the environment during waste disposal. As a result, B.Braun was the first medical device manufacturer to remove these harmful substances from many of its products, eliminating PVC and DEHP from IV solution containers and IV sets.

In the past five years, B. Braun has spent $500 million in developing innovative ways to offer PVC and DEHP-free product lines. Additionally, we actively support policies calling for the industry-wide reduction of these chemicals in medical devices in an effort to raise awareness and encourage change. Today, we remain the industry leader in processes, products, and green manufacturing.

B. Braun continues to lead the way in offering the only full line of IV solutions in containers that are manufactured biologically inert using non-toxic plasticizers. 
Learn more about some of B. Braun’s infusion therapy products that are not made with PVC or DEHP. 

Patient Populations

Who is at Risk? 

Products not made with PVC or DEHP help protect susceptible populations: critically ill male neonates, pregnant and lactating women, pediatric patients, adolescent boys, peritoneal dialysis and chemotherapy patients.

  • In a NICU setting, a neonate is exposed to DEHP from multiple medical procedures. These procedures can result in exposure to significant levels of DEHP.5
  • Neonatal exposure to DEHP is from both direct and indirect contact with PVC devices.6
  • For a neonate, a substantial percentage of the estimated tolerable intake level can be reached just from intravenous infusion.7,8
  • Given the uncertainty of the aggregate exposure to DEHP from various therapies, scientists believe that the levels of DEHP exposure from medical products in a NICU are not safe for the neonatal population.5
  • Animal studies have shown DEHP to be particularly harmful to a developing fetus leading to adverse effects in the reproductive system, including changes in the testes.9 
  • Pregnant women exposed to high levels of phthalates may have increased risk of having sons with malformations of the genitals (hypospadias and cryptorchidism), low sperm count and increased risk of testis cancer.10
  • In the US, DEHP is no longer used in baby bottle nipples, teethers, or infant toys.11 
  • Very recent investigations have presented proof that DEHP can inhibit testosterone production in the adult human testis.12
  • Adverse reproductive system outcomes, including reduced semen quality and altered male genital development, have been reported.13
  • Many phthalates are endocrine disrupting compounds, chemicals that can alter hormonal signaling with potential effects on developing reproductive and nervous systems, metabolism, and cancer.14,15
  • Beneath other factors, DEHP seems to have a role in the development of peritoneal sclerosis, a serious complication of peritoneal dialysis therapy. 
  • Research results suggest that levels of DEHP in dialysate stored in DEHP bags are sufficient to initiate the process of peritoneal sclerosis and to produce sclerosis. 
  • The clinical significance of peritoneal sclerosis cannot be underestimated because patients with reduced dialytic capacity of the peritoneal membrane must be switched to hemodialysis.16
  • Blood products and several medications, such as Taxol®, exacerbate leaching of DEHP from PVC containers.17 
  • Patients can be affected adversely by adsorption of medications onto the walls of PVC IV containers. This adsorption can result in delivery of less than the prescribed doses of necessary medications.5
  • Health concerns about phthalate plasticizers are currently the subject of considerable media, legislative and scientific debate. Academia and industry have continually worked together to address the concerns and conduct necessary research, making phthalates some of the most researched and best understood chemicals today.18

1 United States Environmental Protection Agency (EPA). Existing Chemicals: Phthalates.http://www.epa.gov/oppt/existingchemicals/pubs/actionplans/phthalates.html

2 IHS. Chemical Economics Handbook: Plasticizers. https://www.ihs.com/products/plasticizers-chemical-economics-handbook.html

3 http://www.pvc.org/upload/documents/The_Economics_of_PVC.pdf 

4 SCENIHR opinion on the safety of medical devices containing dehp plasticized pvc or other plasticizers on neonates and other groups possibly at risk 2008.

5 FDA CEDRH. Safety Assessment of Di(2-ethylhexly) Phthalate (DEHP) Released from PVC Medical Devices. FDA CEDRH 1 –118,2003.

6 EB Mallow and  MA Fox. (2014). Phthalates and critically ill neonates: device-related exposures and non-endocrine toxic risks. Journal of Perinatology, 1-6.

7 Dextrose Injection USP in VIaFlex Plastic Container Package insert, Rev. September 2001

8 ThophAmine (6% and 10% Amino Acid Injections) Package Insert

9 Rais-BAHRAMI et al.  Environmental Health Perspectives,  2004;13/112.

10 Sharpe RM, Skakkebaek NE (2008)  Testicular dysgenesis syndrome: mechanistic insights and potential new downstream effects. Fertil Steril 2008; 89(2 Suppl):e33-e38.

11 National Toxicology Program (NTP) Expert Panel Report: NTP – CERHR Expert Panel Report on Di (2-ethylhexyl) phthalate. National Toxicology Program, U.S. Department of Health and Human Services, Center for the Evaluation of Risks to Human Reproduction, October 2000.http://cerhr.niehs.gov/news/index.html

12 Desdoits-Lethimonier C, Albert O, Le Bizec B, Perdu E, Zalko D, Courant F, Lesné L, Guillé F, Dejucq-Rainsford N, Jégou B (3/2012)  Human testis steroidogenesis is inhibited by phthalates.  Hum Reprod; 2012 Mar 8. [Epub ahead of print]

13 Dodson RE, Nishioka M, Standley LJ, Perovich LJ, Brody JG, Rudel RA  Endocrine Disruptors and Asthma-Associated Chemicals in Consumer Products  Online 8 March 2012

14 Hannas BR, Furr J, Lambright CS, Wilson VS, Foster PM, Gray LE (2011)  Dipentyl phthalate dosing during sexual differentiation disrupts fetal testis function and postnatal development of the male Sprague-Dawley rat with greater relative potency than other phthalates.  Toxicol Sci 120(1):184-193.

15 Colborn T, vomSaal F, Soto A (1993)  Developmental effects of endocrine-disrupting chemicals in wildlife and humans.  Environ Health Perspect 101(5):378-385.

16 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080457.pdf  

17 Bristol-Meyers Squibb Oncology. Taxol® (Paclitaxel) Injection Administration Equiptment. 11/99 Tax1001a.doc/1322-LKE.

18 http://www.pvc.org/en/p/Health_concerns_about_Phthalate_plasticisers