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

D

dcraig

#31
I have a queation regarding product already in the Distribution pipeline. For example if we shipped something 3 months ago that contained DEHP but was not labeled as such, it could still be in the distributer or hospitals inventory. Are we suppose to take steps to retrieve any product that does not meet the labeling requirements? Is it just anything sent into the EU after march 21st or is it also anything in the EU? TIA
 
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Ronen E

Problem Solver
Staff member
Moderator
#32
...We supply products “…intended to administer and/or remove medicines…..” which have a PVC (and therefore phthalate)...
Just a quick note -

Not all PVC grades contain phthalate plasticizers. There is a whole range of non-phthalate plasticizers, including "dry" plasticizers that are designed not to leach out of the PVC during use. In cases where the intended use really requires no phthalates (and sometimes customers require "no phthalates" simply out of ignorance or herd-culture), the solution may be a conversion to another PVC grade. Suppliers are currently becoming more aware of the issue and therefore such solutions are becoming more and more available, although it seems that pricing of the alternative may still be a bit higher than the common phthalate versions.

Cheers,
Ronen.
 
M

MIREGMGR

#33
Note in regard to substituting other PVC formulatory approaches, i.e. non-phthalate plasticizers, that:

1. Short- and long-term interactions with adhesives may be substantially different.
2. Likewise thermal welding performance.
3. In some cases, contact-migration to and effect of plasticizers on other polymeric materials may be different.
4. Holdout of, and stability in contact with, various medical-usage fluids may be different.
5. Retention and aeration-dissipation of EtO sterilization residuals, including H2O-reaction breakdown products, may be substantially different.
6. Gamma may have different material-degradation effects.
7. Validated processes will require re-validation.
8. While the substitute plasticizers are presently regarded as not hazardous or at least less hazardous, the statistically relatively small harm-occurrence-likelihood (albeit high severity) exposure risk associated with phthalates is based on a multi-decade, hundreds-of-millions-of-units statistical base, while the conclusion of non- or lesser harm likelihood for the substitutes is based on much less research and a relatively small and brief human-exposure base. Thus it may be appropriate to consider the risk that the substitute eventually may be determined to not be safer.
 
M

MIREGMGR

#34
Is the Eucomed interpretation ("however, only for the purpose of (re)entering the body") authoritative and binding regarding European legal compliance, and in regard to NB audit?
 
M

MIREGMGR

#35
It's well understood that medical device companies continue to want to use phthalate-based PVC film in certain non-fluid-circuit, non-pediatric/pregnant-woman, strength-dependent, cost-sensitive medical devices. Alternate materials are significantly higher in cost, and customers are very resistant to higher costs. Their argument is that, in an era of medical-cost concern, the amount of medical care that is providable is dependent on cost control.

Does REACH's evolving restrictive stance on phthalate reproductive harm create a context in which the use of such materials is indefensible for non-fluid-circuit adult-human-contact (i.e. short-term contact with unbroken skin) device applications from a risk perspective?

Is it ever justifiable to consider cost control and thereby affordability of medical care in analyzing a material-related risk when the alternatives are higher cost?
 

Marcelo

Inactive Registered Visitor
#36
Is it ever justifiable to consider cost control and thereby affordability of medical care in analyzing a material-related risk when the alternatives are higher cost?
yes it it´s; costs and others factors can always be used a justification for not using a technical solution to a risk control measure. However, this is true when you have the option of choosing more than onw technical solution. In the case of regulation which prohibit, for example, certain material, yoou do not have this option because doing so would mean you would be against the regulation.
 
M

MIREGMGR

#37
yes it it´s; costs and others factors can always be used a justification for not using a technical solution to a risk control measure. However, this is true when you have the option of choosing more than onw technical solution. In the case of regulation which prohibit, for example, certain material, yoou do not have this option because doing so would mean you would be against the regulation.
I would agree that that's a state of the art response, but I would also note that it rests on multiple subjective judgements on the part of the participants in the decision process and their auditors.

In the present phthalate instance, one interpretation of the rule is that phthalates may be used in regulated instances if a sufficient rationale is presented. Could such a rationale rest on an economic argument?

I.e.:

1. Provision of health care is a social good.
2. Health care of course must be paid for, and society has limited resources.
3. Quantity of health care able to be provided by society is dependent on costs including device costs.
4. Phthalate-plasticized-PVC technical solutions are substantially lower in cost for a given clinically adequate level of mechanical performance.

Is such an argument precluded on its face, and a manufacturer duty-bound to ignore social good and just obey orders?

And on the other hand, if such an argument may be allowed, how can regulations be implemented in an objective manner, and who shall make the needed judgements?

Perhaps those who formulate and adopt directives and standards are responsible for such value-balancing judgements, so that they do not have to be made in multiple individual instances. One problem with this is that history has shown that the process for creating such directives and standards is slow and ponderous, and sometimes results in outcomes that are non-optimum in regard to social healthcare economic goals but benefit the particular participants' commercial needs.

As I suppose this discussion reveals, I regard the balancing of small probabilities of substantial harm with certainty of increased cost, in an era of social inability to pay for an adequate amount of care, as one of the more subtle and difficult aspects of risk based device manufacturing.
 
S

SteveK

#38
FYI

Just had an updated copy of a Standard (Respiratory therapy equipment -
Part 2:Tubing and connectors; BS EN 13544-2:2002+A1: 2009, addendum dated 31.3.10).

It looks like the issue with phthalates and labelling has now kicked-in in the Standards area. Notice that the added section (attached) contradicts Annex I of the MDD which gives the option to label the packaging not necessarily the device.

Steve
 

Attachments

Michael Malis

Quite Involved in Discussions
#40
I have a queation regarding product already in the Distribution pipeline. For example if we shipped something 3 months ago that contained DEHP but was not labeled as such, it could still be in the distributer or hospitals inventory. Are we suppose to take steps to retrieve any product that does not meet the labeling requirements? Is it just anything sent into the EU after march 21st or is it also anything in the EU? TIA
I ask this question 4 months ago and here is our Notified Body answer:

"Any product that is in Distribution Center prior to March 21st is OK.
If you shipped product from your facility after or product received by Distribution center after March 21st must comply to amended MDD."
 
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