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Plasticizers for
Medical Devices
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By:
Mr. Carsten Goebel, Manager Asia Pacific, Speciality
Plasticizers, Petrochemicals Asia Pacific, BASF South
East Asia Pte Ltd
&
Dr. Rainer
Otter, Head Regulatory Toxicology Chemicals,
Department Product Safety, Regulations, Toxicology &
Ecology BASF SE |
Current Situation of Plasticizers
Public Focus on
Plasticizers:
Its a long and ongoing
discussion regarding plasticizers in flexible PVC products
and this particular will go all around Phthalates and
possible effects of Phthalates through contact of human
beings with these products. The Image ( Fig- 1) shows
headlines that came out in couple of years that ranges use
and effect of Pthalates used in Toys, food packaging and
many medical devices.
Plasticizers in Medical
devices : Current Scenario
Flexible PVC makes up a 30% of
disposable medical devices. And to make PVC extremely
flexible there is a need of plasticizer in terms of 40 % -
50 % which is added to the PVC Resin. The commonly used
plasticizer for medical devices is DEHP and is listed in
European Pharmacoepia as a product of choice for medical
devices and in the current situation it is commonly used.
But at the same time DEHP is classified as reproductive
toxin and labeled as toxic in European Union (EU).
Plasticisers content may reach 40 per cent per weight in
soft PVC articles. Plasticisers are not covalently bonded
into the polymer matrix and hence they tend to migrate out
of flexible PVC and hence human exposure to plasticizers
in specific scenarios is unavoidable and it is
particularly true in medical applications like bags,
tubings, toys , food packaging, etc.
DEHP - Classification and
Labeling in Europe
Have a closure look at current
classification and labelling in Europe and as well other
countries like USA and Korea :
EU : T - Toxic,
Reproductive Toxin (CMR Category 2)
S-phrases:
S53 : Avoid exposure -
Obtain special instructions before use
S45 : In case of
accident or if you feel unwell, see medical advice
immediately.
Korea: Recommendation to use alternatives in
infusion & blood bags.
US &EU: Recommendations
to search for alternatives for high-risk groups e.g.
neonates, pregnant women.
EU: Mandatory label for
medical devices containing CMR1&2 substances (e.g.DEHP) in
the EU by 2010
EU: REACH ( New
Legislation in Chemical Substances in EU ) - Authorisation
procedure for use of DEHP in finished articles likely and
granting will be dependent upon the availability of
alternatives.
The paper now discusses about
the alternative to DEHP innovated by BASF - The Chemical
Company.
Evaluation of DEHP in
Medical Devices:
Center for the Evaluation of
Risks to Human Reproduction (CERHR) (Ref: http://cerhr.niehs.nih.gov/chemicals/dehp/DEHP-Monograph.pdf,
Nov. 2006) has stated that:
"The available reproductive
and develop-mental toxicity data and the limited but
suggestive human exposure data indicate that human
exposures in this situation approach toxic doses in
rodents, which causes the Panel serious concern that
exposure may adversely affect male reproductive tract
development."
Conclusions:
There is insufficient evidence
in humans that DEHP causes male or female reproductive
toxicity. And hence as on today there is no legal
restrictions on the use of DEHP in any medical devices.
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