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Patient Safety and Sustainability

Our Commitment to the Use of Safe Materials

More than 40 years ago, B. Braun recognized the environmental and patient risks posed by medical products containing PVC and DEHP. We were the first medical device manufacturer to remove these harmful substances from many of our products, and remain the only supplier offering a full line of IV drug and solution containers not made from PVC or DEHP.

We extended our commitment to develop safer products in 2021 with the launch of CARESAFE™, the first robust portfolio of IV administration sets in the US not made with PVC or DEHP.

Reducing Patient Exposure to Toxic Chemicals

A growing body of evidence shows that Americans receiving care in hospitals and other settings can be overly exposed to dangerous levels of phthalates, a family of toxic chemicals. Diethylhexyl phthalate (DEHP), which is used to soften polyvinyl chloride (PVC), is the phthalate most commonly used in medical products.1

Some medical products such as IV bags and tubing can contain up to 40% DEHP by weight, resulting in significant levels of exposure for neonates and other vulnerable patient populations.2

The American Medical Association, among other professional organizations, encourages hospitals and physicians to reduce and phase out the use of PVC medical device products, especially those containing DEHP.3

Facts About PVC and DEHP

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By choosing products that are not made with PVC and DEHP, you can help eliminate potential toxic chemicals and other safety hazards that could affect your staff, your patients and the environment.

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Patient Populations

Who is at Risk? 

Products not made with PVC or DEHP help protect susceptible populations: male neonates, pregnant and lactating women, pediatric patients, 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. 10
  • Neonatal exposure to DEHP is from both direct and indirect contact with PVC devices.11
  • For a neonate, a substantial percentage of the estimated tolerable intake level can be reached just from intravenous infusion.11
  • 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.10
  • 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.12
  • In the US, DEHP is no longer used in baby bottle nipples, teethers, or infant toys.13
  • Very recent investigations have presented proof that DEHP can inhibit testosterone production in the adult human testis.14
  • Adverse reproductive system outcomes, including reduced semen quality and altered male genital development, have been reported.15
  • Many phthalates are endocrine disrupting compounds, chemicals that can alter hormonal signaling with potential effects on developing reproductive and nervous systems, metabolism, and cancer.16
  • Several Medications, including 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.10
  • Health concerns about phthalate plasticizers are currently the subject of considerable scientific, legislative, and media debate. Academia and industry have continually worked together to address the concerns and conduct necessary research.

Taking Action to Protect Patients

B. Braun is working with government leaders, healthcare providers, educators, scientists, industry leaders and other stakeholders to support the adoption of public policies that ensure the safety of patients is protected each time they engage with the healthcare system.

We have called on the FDA to review and update its guidelines on the use of phthalates and other harmful chemicals in medical products, and called for the establishment of a multi-agency task force to examine and recommend steps to reduce patient exposure to toxic materials in the healthcare system.

For additional information on B. Braun’s proposals to improve patient safety, view our Policy Recommendations.

 

References:

1 Schettler, T. Polyvinyl chloride in health care. Health Care Without Harm. January 2020.

2 Karpf, A. MD. Making patient safety a policy priority. Modern Healthcare. February 2021.

3 American Medical Association. (2016). Encouraging Alternatives to PVC/DEHP Products in Health H-135.945.

4 Vinyl chloride: what is vinyl chloride? National Cancer Institute. Reviewed December 28, 2018. Accessed November 12, 2021. https://www.cancer.gov/about-cancer/causes-prevention/risk/substances/vinyl-chloride

5 Public health statement: Vinyl Chloride. Agency for Toxic Substances and Disease Registry. July 2006. Accessed November 12, 2021. https://www.atsdr.cdc.gov/toxprofiles/tp20-c1-b.pdf

6 Polyvinyl chloride and copolymers production: national emission standards for hazardous air pollutants (NESHAP) – 40 CFR 63 subparts J & H. U.S Environmental Protection Agency. Updated February 23, 2021. Accessed November 12, 2021. https://www.epa.gov/stationary-sources-air-pollution/polyvinyl-chloride-and-copolymers-production-national-emission-0.

7 NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Di(2-Ethylhexyl) Phthalate (DEHP), National Toxicology Program, Department of Health and Human Services, Retrieved at: https://ntp.niehs.nih.gov/ntp/ohat/phthalates/dehp/dehp-monograph.pdf

8 US Consumer Product Safety Commission (CPSC) to Expand Phthalates Restriction under CPSIA. October 25, 2017. AccessedDecember 17, 2021. https://www.sgs.com/en/news/2017/10/safeguards-16217-us-cpsc-to-expand-phthalates-restriction-under-cpsia

9 OEHHA Science for Health California. Proposition 65 Warnings Office of Environmental Health Hazard Assessment: Di(2-ethylhexyl)phthalate (DEHP). June, 2017. https://www.p65warnings.ca.gov/fact-sheets/di2-ethylhexylphthalate-dehp

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

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

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

13 US Consumer Product Safety Commission (CPSC Prohibition of Children’s Toys and Child Care Articles Containing Specific Phthalates. October 27, 2017. Accessed December 17, 2021.

14 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]

15 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

16 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.

17 Maas, B., Huber, C. & Krämer, I. Plasticizer extraction of Taxol®-infusion solution from various infusion devices. Pharm World Sci 18, 78–82 (1996). https://doi.org/10.1007/BF00579710