Recent research has found that new-borns in intensive care units are in contact with a variety of medical products that contain harmful endocrine-disrupting chemicals (EDCs) such as bisphenol A (BPA) and parabens.
A major concern with these substances is that they can interfere with the normal functioning of the hormone system, which impairs physiological and developmental processes.
Whilst medical devices play a critical role in modern healthcare, they can contain hazardous substances in their composition, which can leach into patients during use, compromising their safety.
The considerable body of scientific evidence on the adverse health and environmental impacts of BPA is already significant enough for the European Chemicals Agency to list it as a “substance of very high concern”. Similarly, the EU has stated that it is a substance that “has toxic effects on our ability to reproduce”.
Early-life exposure to EDCs such as BPA has been identified as particularly harmful, associated with later-life neurodevelopmental and metabolic disorders in humans.
Despite this, recent research has found that new-born babies in intensive care units are regularly being exposed to these harmful substances.
According to the study, published online in the peer-reviewed journal Environmental Health Perspectives, BPA was detected in almost 60% of the tested medical devices used in neonatal intensive care units and parabens in more than 85%. One-quarter of the item extracts showed estrogenic activity, and one-tenth showed anti-androgenic activity.
Government bodies, healthcare professionals, scientists, and civil society have therefore raised concerns about vulnerable patient groups’ potential chemical exposure to these hazardous substances.
Speaking to EURACTIV on the sidelines of a recent Healthcare Without Harm event, Petra De Sutter, who is the chair of the European Parliament’s Internal Market and Consumer Protection Committee (IMCO), and a medical doctor by training, said pregnant woman, foetuses and newborn children are especially sensitive to all kinds of endocrine action.
However, she said it can be very difficult to prove a direct causal relationship between EDCs and health effects and there is sometimes confusion over the science. She said that regulation must, therefore, err on the side of caution and adopt the precautionary principle.
The precautionary principle enables decision-makers to adopt precautionary measures when scientific evidence about an environmental or human health hazard is uncertain and the stakes are high.
“If there is confusion, and if there is even a possibility that it’s carcinogenic, you should ban it. That is the precaution that you should take” De Sutter said.
She said that Commission proposals to encourage companies to use alternatives to these substances do not go far enough, and explained that regulation on medical devices is clearly “written from the perspective of the industry and not public health”.
Der Sutter stated that companies must be “forced to look for alternatives” and that until a substance is banned, there is “no incentive” to change. “Innovation leads to new regulation and regulation leads to new innovation, and we don’t have to be afraid of that,” she added.
Speaking at the event, Dr Carmen Warden, a senior researcher at the Instituto de Investigación Biosanitaria de Granada and one of the researchers who worked on the study, concurred, saying that “your first nine months shapes the rest of your life” and that the “precautionary principle is not integrated into policy”.
Natacha Cingotti, health and chemicals policy officer at the Health and Environment Alliance (HEAL), said that “these findings raise significant concerns about the failure of current regulations to protect the population from exposure to known endocrine disruptors in the most critical periods of development, when every effort should be made to prevent such exposure”.
She added that to really make a health difference, the new Commission “must commit measures to guarantee that every new-born is truly protected from substances that harm their development; this should be self-evident for babies in intensive care units and also requires protection from exposure before birth.”
Speaking at the event, Stefan Kolb, vice president of health care company Fresenius Kabi, said that while companies were committed to replacing harmful substances wherever possible, it can take time to find appropriate alternatives.
He highlighted that the benefits must be weighed against the risks and that products must be carefully evaluated and judged on a case by case basis.
Using the example of a blood bag, he said there has not yet been a suitable alternative that adequately stabilises blood and that, in this case, the use of EDCs is justifiable in light of the life-saving benefits they offer.
He said regulators must, therefore, adopt a “common sense approach” which must be careful not to reject all useful plastics.
[Edited by Zoran Radosavljevic]