Time to phase out hazardous chemicals from medical devices

Grazia Cioci, HCWH Europe Policy Director, discusses endocrine disrupting chemicals (EDCs) in medical  devices and HCWH Europe's new report: Non-toxic Healthcare: Alternatives to Phthalates and Bisphenol A in Medical Devices.

Endocrine disrupting chemicals (EDCs) have been the subject of intense political debate in recent years due to their widespread use in consumer and healthcare products and the hazard they pose to the environment and human health. 

"An endocrine disruptor is an exogenous substance or mixture of substances that can interfere with any aspect of hormone action." 

The Endocrine Society

EDCs interfere with the functioning of the endocrine system in such a way that exposure even to low concentrations of EDCs has been associated with increasing trends of endocrine-related diseases and disorders, as well as chronic illnesses later in life. Infertility, prostate and breast cancers, learning disabilities, autism, diabetes, obesity, cardiovascular diseases, Alzheimer’s and Parkinson’s diseases have all been linked to EDCs. 

Foetuses, babies and children are the subject of great concern because they are particularly vulnerable to the effects of exposure. Unborn children and infants are not able to process chemicals in the same way adults do, given that their organs are still developing and their endocrine systems are not yet mature. As a result, exposure in early life has been linked to the occurrence of developmental diseases later in life.

Medical devices are sources of exposure to EDCs

Medical devices usually contain phthalates and/or bisphenol A (BPA).  These chemical substances have documented or suspected endocrine disrupting properties. In addition, phthalates are classified as toxic to reproduction by EU legislation. Phthalates and BPA alike are shown to be leaching from medical devices, posing a hazard for the health of patients using the device.

Phthalates are a group of chemical substances primarily used as plasticizers (softeners) in plastic and they are abundant in PVC-based medical devices such as blood bags, nutrition pockets, tubing, umbilical venous catheters or disposable gloves. Bisphenol A is a chemical substance that is present in polycarbonate plastic and other plastic like PVC. BPA can be found in medical tubing, hemodialysers, newborn incubators, syringes and nebulizers.

Substitution with safer alternatives is a must

The mounting scientific evidence on the leaching and potential hazard of phthalates and BPA contained in medical devices should prompt manufacturers to substitute these substances with safer alternatives that are available on the market for nearly all applications in healthcare. For this reason HCWH Europe created a database listing PVC-free, phthalate-free and BPA-free medical devices to link responsible manufacturers with healthcare procurers. HCWH Europe’s new report  Non-toxic Healthcare: Alternatives to Phthalates and Bisphenol A in Medical Devices, emphasises that substitution of these hazardous substances is not only possible but it is on the way.

Many alternatives with better toxicological profiles are available on the market and they are being used in place of phthalates and BPA by manufacturers, hospitals, health systems and healthcare practitioners. Some known best practices: the PVC-free Paediatrics and Neonatology Department in the Westfriesgasthuis in the Netherlands, the substitution project of the Hospital of Southern Jutland in Denmark, the Karolinska University Hospital substitution programme in Sweden and the PVC-free Neonatal Intensive Care Units of the Vienna Hospitals Association in Austria. All of which are discussed in Non-toxic Healthcare.

Time for the EU to act on EDCs

Now is the time to phase out hazardous chemicals from medical devices! A proposal for the regulation of medical devices was published by the European Commission in 2012. The European Council is currently debating the proposal. This follows a debate at the European Parliament where MEPs took a strong position in favour of phasing out chemicals with endocrine disrupting properties and those with carcinogenic, mutagenic and reprotoxic properties when safer alternatives are available and technically feasible.

The European Institutions have a responsibility to adopt a regulation that protects patients, especially those in the most vulnerable groups like neonates, children and dialysis patients. They must create the conditions to rapidly reduce or eliminate human exposure to hazardous chemicals like phthalates and BPA in medical devices.

To create the conditions to allow for a phase-out, the EU’s green public procurement guidelines should provide incentives for the substitution of hazardous chemicals in medical devices with safer alternatives. In addition, funding should be prioritised for research and development of alternative substances and products and for clinical and epidemiological projects that compare the performance of these alternatives.

The EU must do everything in its power to protect its citizens from exposure to hazardous chemicals. The time to act is now.

– Grazia Cioci, Policy Director of Health Care Without Harm Europe




Read the report: Non-toxic Healthcare: Alternatives to Phthalates and Bisphenol A in Medical Devices.

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