Apr 13, 2010

Phthalate labeling in medical devices

Hello my friends, I am a little late, but a relatively new EU requirement per the revised Medical Device Directive (MDD) (93/42/EEC) is the identification of phthalates used in some common medical devices:

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.
This update was required by March 21, 2010 and your certificate of conformance was probably signed on that date. The main use of a phthalates in medical devices is DEHP in PVC. There are no limitations imposed, but labeling is required (I suggested "Portions of this device contain phthalates").

Since we're involved with tubing and IV bags, we are knee deep in PVC with DEHP. When we started design we had considered trying to go DEHP free, but found the DEHP free PVC alternatives not as robust and as customizable as we wanted. A review of the product risk analysis clearly showed that the risks of a IV bag or tubing leak were many times greater than even long term phthalate exposure (which is now mitigated with labeling...). Maybe the materials will improve in the near future, but right now it doesn't look like it warrants a separate project to go DEHP free, new materials can be worked in as part of other projects as they arise.

I know there was ample warning, but it caught us a bit off guard, luckily we do not have a large inventory to manage or relabel. If there is one lesson I have certainly learned over the past year, it is inventory makes you feel good, but we keep getting burned with costly rework orders due to various changes.


Tim Edgar said...

Re your link to DEHP you may like to direct it to the DEHP Information Centre website (www.dehp-facts.com) which has a great deal more information. Hope this is useful.

wellness in india said...

thanks for your kind information.

Peter said...


I was reading your January 2008 Q&A on Healthcare Packaging.

I wanted to know what packaging tests can be conducted to demonstrate that the package can maintain sterility of the product.

I would appreciate your guidance on this aspect.

Lauren said...

It's important to have these types of labels.