As of 21 March 2010 all medical device containing the phthalates DBD, BBP and
DEHP must be labeled. The new EU directive coincides with the 10th anniversary
of Coloplast's phthalate free catheter SpeediCath.
"There is no reason to expose users or the environment to a risk that can be
avoided merely by thinking in new ways. This is the case with SpeediCath in
which we have entirely avoided the usage of phthalates by substituting PVC with
other materials”, explains Peter Skals, environmental specialist at Coloplast.
Today, SpeediCath is one of Coloplast's bestselling products and it is sold in
33 countries. The global success is, however, not due to the product being
phthalate free, but rather because it is easy and comfortable to use.
“In our experience, many customers are unaware that their catheter might
contain phthalates and that these are problematic. Therefore, we hope that the
new labeling requirement will raise awareness and thereby give catheter users a
better chance of choosing products free of problematic phthalates”, says Peter
Skals.
Coloplast has offered the phthalate-free SpeediCath range since 2000. Today,
the range covers five different variants, including SpeediCath Compact for
women, which enables freedom and discretion through an innovative lipstick-like
design. The product won the Danish Design Award in 2004.
CONTACTS
Peter Skals
Environmental Specialist
Morten Sørensen
Media Relations Manager
+45 4911 2632
dkmoso@coloplast.com
FACTS
What is the new EU directive on phthalate labelling about?
As of March 21 2010, all medical devices that contain classified phthalates
must be factory labeled, either on the package or in the instruction for use.
As it must be labeled at the factory, it can take a while before the labels
reach the market. The label is a triangle with round corners in scripted with
the letters PHT, and next to or beneath the triangle the specific phthalate is
stated, e.g. DEHP.
What are phthalates?
Phthalates are chemicals used to soften the plastic material PVC, which is
often used in the production of consumer products and medical devices. Experts
suspect that the content of hormone disturbing chemicals can affect certain
processes in our bodies, such as puberty and human reproduction.
Why the need to use a catheter?
There are many reasons why some people cannot urinate voluntarily and need to
empty their bladder via a catheter. The nerve supply to your bladder may have
been damaged; you may suffer from back problems or an enlarged prostate.
Catheterisation may also be necessary after certain types of surgery, or it may
be caused by a particular condition you were born with.
What is a catheter?
Intermittent catheters are fine hollow tubes inserted into the bladder to drain
away urine. They come in different lengths and sizes for men, women and
children. The most advanced catheters have a thin surface coating. When
immersed in water this ‘hydrophilic' coating swells to a smooth, slippery film
making the catheter safer and more comfortable to insert.
What is SpeediCath?
The SpeediCath range represents the newest generation of intermittent
catheters. Its hydrophilic' coating offers ease of use, greater comfort and
minimal risk of urethral micro-trauma for all catheter users. The entire
SpeediCath range is PVC-free and does not contain phthalates. The SpeediCath
range consists of a number of innovative products, including SpeediCath Compact
- a discrete catheter for women, and SpeediCath Control which provides extra
control for men with impaired hand function.
The history of Coloplast's SpeediCath range
• 2000 SpeediCath - the first ready to use hydrophilic catheter
• 2003 SpeediCath Compact for women
• 2005 SpeediCath Complete
• 2009 SpeediCath Control for men
• 2010 SpeediCath Compact Plus
