How to Label Medical Devices that contain Phthalates.

[SteveK]

Hi Peter,

Find the actual REACH EU regulation (1907/2006) at:

(broken link removed)

Go to page 440 (big document!) - the 0.1% relates to toys and childcare items, but by definition a medical device containing DEHP in contact with a child will be covered by the regulation (i.e. as per Annex I, section 7.5, MDD 93/42/EEC).

Hope this meets the reference requirements.

Steve

 

[Vanoost]

Hi All,

Can someone help me with an example of a statement of justification to use DEHP according to the paragraph 7.5 2007/74?
I have a discussion with our supplier of blood transfusion bags about this statement and cannot come to an agreement.

Thanks!

 

[drewsky1]

Regulatin::

Where in the MDD or ERC does it indicate "If the intended use of the device does not exclude pregnant women, nursing women and children, a justification for the use of the device (including residual risks and precautionary measures) must be included in the Tech File/Design Dossier and instructions for use." ? We have labeled our products that contain DEHP with the harmonized symbol for DEHP and "Contains phalthates" but have not seen this mandate anywhere.

 

[Ronen E]

Regulatin::

Where in the MDD or ERC does it indicate "If the intended use of the device does not exclude pregnant women, nursing women and children, a justification for the use of the device (including residual risks and precautionary measures) must be included in the Tech File/Design Dossier and instructions for use." ? We have labeled our products that contain DEHP with the harmonized symbol for DEHP and "Contains phalthates" but have not seen this mandate anywhere.

Hi,

Please refer to the MDD, Annex I, section 7.5 (last paragraph):

If the intended use of such devices includes treatment of children or treatment of pregnant or nursing women, the manufacturer must provide a specific justification for the use of these substances with regard to compliance with the essential requirements, in particular of this paragraph, within the technical documentation and, within the instructions for use, information on residual risks for these patient groups and, if applicable, on appropriate precautionary measures.

Cheers,
Ronen.

 

[drewsky1]

Thank you!

 

[Edward Reesor]

Regarding the use of phthalates (not DEHP, DBP or BBP, but another phthalate used as a PVC plasticizing agent) and applications with children, what if the device is used for critical care/CPR and there are child and infant sizes? What is the justification besides the risk high of death if you don't use the product versus receiving trace amounts of a carcinogen if you do?

How can one acknowledge the requirements but not sound snarky?

 

[Ronen E]

Regarding the use of phthalates (not DEHP, DBP or BBP, but another phthalate used as a PVC plasticizing agent) and applications with children, what if the device is used for critical care/CPR and there are child and infant sizes? What is the justification besides the risk high of death if you don't use the product versus receiving trace amounts of a carcinogen if you do?

How can one acknowledge the requirements but not sound snarky?

Hello and welcome to the Cove

1. It's a little difficult to make objective references to the use of a phthalate unless you state which one is referred. As far as I know most of the debate and objective evaluations relate to DEHP. Although the regulation relates to Phthalates in general, I'm not aware of a single coherent body of knowledge related to the use of this entire group in medical devices, let alone in children etc.

2. The scenario you describe is less relevant. Risk management (i.e. weighing the risk vs. the benefit) should be conducted at the design stage, when a manufacturer chooses to use phthalate over an alternative (and usually there are alternatives). So the real choice is not between "using phthalates or letting someone die", but rather between using various kinds of plasticizers (or using plastics other than PVC), each with their cost, performance, known and unknown risks etc. Of course, in a scenario where the only choices are saving someone's life while risking their reproductive system, and letting them die, the preferred one is quite clear, I think.

3. The concerns I'm aware of WRT DEHP are not about it being carcinogenic but about effects on the reproductive system (which may or may not be present in humans).

Cheers,
Ronen.