Just out of curiosity does anyone know if the tubing and catheters we use in our pumps free of BPA and phthalate? I have been reading about it for some of the other things I do for work and basically think if it isn’t anyone including me who wears a pump is in trouble.
Research was scary… anyone know more about this?
Would love to know any ones input on it.
I’d like to know this too. Have you posed this question directly to any of the pump manufacturers or infusion set makers?
In 2011 the EU released a new directive to label products containing phthalate:
EN 15986:2011 – "Symbols for Medical Devices Containing Phthalates"
The modifications of Directive 2007/47/EC on Annex I, section 7.5 of the Medical Devices Directive (Directive 93/42/EEC) imposed the requirement that certain medical devices that contain particular phthalates be labeled as such. The amended Directive reads as follows:
If parts of a device (or a device itself) intended to administer and/or remove medicines, body liquids or other substances to or from the body, or devices intended for transport and storage of such body fluids or substances, contain phthalates which are classified as carcinogenic, mutagenic or toxic to reproduction, of category 1 or 2, in accordance with Annex I to Directive 67/548/EEC, these devices must be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging as a device containing phthalates.
Here is the symbol: