Use of Phthalates (PVC) - MDD 2007/47/EC - Has anyone started Labelling Devices

[dcraig]

So I am going through all of this and I am a little confused. While some are saying all products containing any Phthalates will now require labeling others seem to say it is only necessary with certain Phthalates or certain types of devices (ala Eucomed 5.0). So if a Phthalate such as DINP is not on the SVHC or mentioned on the 67/548/EEC does that mean products containing it do not require labeling? I am getting mixed messages and want to be sure I am not just hearing what I want to. TIA

 

[Marcelo]

Just an additional information: ISO 15223-1 on labeling is on revision right now and there´s a chance that the symbol on phtalates will be added to the standard. So this might go to the international level quickly.

 

[Marcelo]

But the upshot is, in my professional opinion, where there is no harmonized standard for an essential requirement, only EN ISO 14971 must be applied

Great tip. This is exactly what is needed. In fact, this even pointed out in ISO/TR 16142.

 

[Marcelo]

You may ask what to do since the essential requirement is so specific (labelling is required)

The point here is, as written, the essential requirement is already a risk control measure (labeling - third option of risk control). This situation occurs in some of the essential requirements (they say the how intead of only saying the what).

Anyway, the suggested path seems to be the only one - the risk management uses the draft symbol as the third option of risk control measure. I think that in practice this will not be a problem if done that way (the symbol will not change before publication, for ex.).

The only extra point is that, as the draft is not a standard and is not harmonized, it does not give presumption of conformity and it´s use must be justified, but this is simply enough.

 

[chris1price]

Hi
Whilst using a harmonised symbol for DEHP free is the best solution, if there is no harmonised symbol we have to use words and translate the information into each appropriate language.

I thought all phthalate fell under this definition, including both DEHP and DINP.

Chris

 

[MikeEmergo - 2010]

There is an excellent article on this subject at

MPO magazine, Nov/Dec 2009, page 18, in the Euro News section called "The Great Phthalate Debate".

Mike Johnson

 

[adlcisa]

Eucomed Said:

The presence of Phthalates will not automatically require specific labelling. The labelling is required
when all of these elements apply:​

- The device contains phthalates AND​

- The phthalates are classified as carcinogenic, mutagenic or toxic to reproduction, of category 1 or 2, in accordance with Annex I to Directive 67/548/EEC AND​

- The phthalates are present above a threshold of 0.1% w/w AND​

- The device is intended to administer and/or remove medicines, body fluids or other substances to or from the body or devices intended for transport and storage of such body fluids or substances, however, only for the purpose of (re)entering the body AND​

- The phthalates might possibly leach out of the medical device and possibly expose to the patient via administration of medicines, of body liquids or other substances AND​

- The quantity of Phthalates which can leach to the patient is above the recognized acceptable daily intake for reproductive toxicity or the device is intended to be used explicitly for treatment of children or treatment of pregnant or nursing women. Today ADI limits are under development by ISO TC194 WG11 using as the reference material a well recognized standard “EN ISO 10993-17:2002, Biological evaluation of medical devices – Part 17: Establishment of allowable limits for leachable substances”

so this mean that are not needed updated labels if the DEHP is a percentage less than 0.01%? And 0.01% is concerning to the component, the fluid path or the full medical device? ​

 

[MIREGMGR]

I haven't checked lately, but my recollection is that all of the other phthalate plasticizers of similar physical chemistry and plasticization effectiveness to DEHP; suitability for room temperature applications, as are typical of medical uses; and moderate cost, are also listed and thus subject to regulation.

Thus in a conventional medical-device formulation that either contains mixed phthalate plasticizers or nominally is based on a phthalate plasticizer other than DEHP, it nonetheless is likely that the resulting flexible PVC will be subject to regulation per points 1, 2 and 3 above, based on regulatory application to the large-percentage plasticizer ingredient.

Thus my guess is that only rarely will there be a practical need to conduct difficult chemical extractions and assays to identify very small percentages of particular plasticizers. If the material is PVC, and is flexible at room temperature, and is generally known to have been formulated using a phthalate approach, points 1, 2 and 3 will be affirmative.

 

[adlcisa]

Thanks!

 

[Adele]

And adlcisa - I recall seeing somewhere that it is only if the phthalate is of 0.1% w/w of the finshed medical device. Unfortunately I can't recall where at the moment.

Has anyone started putting together a "specific justification for the use of these substances"?