Update on the prevention of exposure to CMR substances 1A, 1B, and endocrine disruptors

13/04/20

The new MDR medical device regulation 2017-745 makes it very clear in appendix I (General safety and performance requirements) in chapter II concerning the requirements relating to the design and manufacture of medical devices, that attention particular attention must be paid, for example, to the choice of materials, their intrinsic properties, their biocompatibility, etc.


Point 10.4 specifically concerns substances in order to reduce the risks associated with their use. In paragraph two of point 10.4.1, the infusion devices are particularly targeted.

REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL - Annex I, Chapter II

Devices, or parts of devices or materials used that:

  • are invasive and come into direct contact with the human body, or
  • are intended for (re)introducing and / or withdrawing a drug, body fluids or other substances, including gases, into the body, or
  • are intended for transporting or storing medicines, body fluids or other substances, including gases, intended to be (re) introduced into the body

contain the following substances in a concentration greater than 0.1% by mass fraction (m / m) only when justified, in accordance with section 10.4.2:

  • category 1A or 1B carcinogenic, mutagenic or toxic for reproduction substances, in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council (1); or
  • substances with endocrine disrupting properties, for which it is scientifically proven that they can have serious effects on human health and which have been identified either in accordance with the procedure laid down in Article 59 of the Regulation (EC ) No 1907/2006 of the European Parliament and of the Council (2), either in accordance with the criteria relevant to human health among those established in the delegated act which has been adopted by the Commission in accordance with Article 5 (3), first paragraph, of Regulation (EU) No 528/2012 of the European Parliament and of the Council (3).

In point 10.4.3 particular attention is paid to the use of phthalates in medical devices

The committee’s mandate provides for at least a benefit / risk assessment of the presence of phthalates belonging to one of the groups of substances referred to in section 10.4.1, points a) and b). The benefit / risk assessment takes into account the destination and the context in which the device is used, as well as the substances and materials and the alternative medical designs and / or treatments available.


For ten years, for Phthalates (in particular DEHP), then more recently for Bisphenol A, Didactic, thanks to a sustained regulatory watch, has initiated a fundamental approach to limit the exposure of patients and caregivers to CMR substances and endocrine disruptors. This commitment and this work led to the marketing under the Infineed brand of the DEHP-free and Bisphenol A “Gravity 5.5” infusion line in 2019.


 


Thus the Gravity 5.5 infuser was born.


In its 3-way versions, it has its characteristic green tap to facilitate its identification.

As a reminder:

  • The European authorities since 2007 had imposed the marking of packaging of infusion sets containing phthalates CMR 1A and 1B
  • France had added an additional restriction by prohibiting the use of perfusion devices containing this type of phthalates in neonatology, pediatrics and obstetrics.
  • Bisphenol A has been registered since 2016 as a candidate substance to join Annex 14 of the REACH regulation due to its reprotoxic properties as endocrine disruptor for humans.
  • In 2017 ECHA (European CHemical Agency) supports the French proposal for consider Bisphenol A as SVHC (Substance of Very High Concern), for its action as an endocrine disruptor for human health and the committee of ECHA member states registers it on the list of substances of very high concern authorization, for the additional reason of its properties as an “endocrine disruptor for the environment”

 

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