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Tuesday 3 December 2019
Avenue Des Arts 56, 1000 Brussels
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. Government bodies, healthcare professionals, scientists, and civil society have raised concerns surrounding vulnerable patient groups’ potential chemical exposure to these hazardous substances.
Bisphenol A (BPA) and phthalates (notably DEHP) are examples of hazardous substances often found in medical devices that are of particular concern. Phthalates are commonly used as softeners in PVC-based medical devices, whilst BPA is used to produce certain plastics such as polycarbonates and epoxy resins that have applications in the medical device industry. A major concern with these substances is that they are endocrine disrupting chemicals (EDCs) that can interfere with the normal functioning of the endocrine (hormone) system and present a hazard to physiological and developmental processes. Endocrine disruptors can impact at very low concentrations and combine to produce additive effects. Evidence shows that foetuses, children, and pregnant women are the most vulnerable groups affected by EDCs.
Health Care Without Harm (HCWH) Europe invites policy makers, national authorities, healthcare providers, and medical device manufacturers to join us in December to discuss how we can accelerate the phase-out of harmful substances in healthcare.
In this half-day workshop, we will address the implementation of the Medical Devices Regulation (MDR) focusing on new provisions that help phase out CMRs and EDCs - particularly phthalates in medical devices when safer alternatives are available and technically feasible.
During the workshop, we aim to understand:
- The current state of play for EDCs in medical devices (with a focus on phthalates, DEHP, and BPA)
- The opportunities, challenges, and barriers to substitution
- How we can increase commitment and action from all stakeholders to reduce patients’ exposure to harmful chemicals, particularly for vulnerable groups
This workshop will also feature the updated, second edition of HCWH Europe’s 2014 report Non-toxic Healthcare. Health Care Without Harm Europe’s mission is to raise awareness of hazardous substances in medical devices, the potential risks to patients, and most importantly the opportunities for substitution by showing that many alternatives are available.
Change is not only possible but it is already on the way; the Medical Devices Regulation (MDR), which fully comes into force 26 May 2020, introduces some provisions that can provide an engine for substituting medical devices containing harmful chemicals with safer alternatives.