CE Clearance for New Safety IV Catheter

  CE Clearance for New Safety IV Catheter

    Device Helps Protect Clinicians and Healthcare Workers from Unintended

Business Wire

ST. PAUL, Minn. -- October 30, 2012

Smiths Medical, a leading global medical device manufacturer, today announced
that its Jelco IntuitIV Safety IV Catheter™ for intravenous infusion is CE
marked for clinical use in the European Economic Area (EEA) and other
countries accepting CE-marked devices. The catheter, manufactured in Latina,
Italy, is intended to reduce the risk of needlestick injury and its

Among clinicians and healthcare workers, accidental needlesticks with “sharps”
occur frequently, at an estimated rate of 3.5 million incidents per year
worldwide. Many of these cases can be attributed to the use of IV catheters, a
device that consists of a length of tubing and an access port through which
fluid or medication can be delivered to a patient’s bloodstream. The catheter
tube is placed into a blood vessel on a guide needle. When using a
conventional IV catheter, once the catheter tube is in position, the guide
needle is removed from the blood vessel, leaving the sharp, blood covered
needle exposed. Until it is properly disposed of, the device has the potential
to come in contact with the caregiver, a bystander or a hospital staffer.
Needlestick injuries are costly for healthcare institutions and can be
medically serious to a victim.

Safety IV catheters, which are equipped with mechanisms to either shield or
encapsulate the sharp tip of a guide needle, have become increasingly
requested by clinicians and institutions. Professional associations, such as
the World Health Organization (WHO), and government agencies worldwide have
issued directives encouraging the adoption of practices that elevate caregiver
safety, including the use of sharps safety devices. Jelco IntuitIV Safety IV
Catheter™ is a passive safety device, because its safety mechanism activates
automatically upon removing the guide needle from the patient’s blood vessel.
A cylindrical tip protector encapsulates the tip to help prevent the sharp
point from coming in contact with anyone other than the patient.

Smiths Medical President Srini Seshadri commented: “Our Jelco® line of safety
devices has a long history of quality, innovation and safety. We are pleased
to be able to offer a solution that helps to keep clinicians and healthcare
workers safe from needlestick injury and the potentially detrimental
consequences. It is Smiths Medical’s goal to help make every medical
intervention successful for the patient as well as the caregiver.”

First deliveries of the Jelco IntuitIV Safety IV Catheter™ commenced October
2012. Regional introductions of the Jelco IntuitIV IV Catheter™ will expand as
country registrations and approvals are granted.

Product(s) described may not be licensed or available for sale in all
countries. Jelco IntuitIV Safety IV Catheter is a trademark of Smiths Medical.
There is no connection between Smiths Medical and Intuitive Surgical.

About Smiths Medical

Smiths Medical www.smiths-medical.com is a leading supplier of specialist
medical devices and equipment for global markets, focusing on the medication
delivery, vital care and safety devices market segments. It is part of Smiths
Group www.smiths.com, a global leader in applying advanced technologies for
markets in threat and contraband detection, energy, medical devices,
communications and engineered components. Smiths Group employs around 22,000
people in more than 50 countries.


Smiths Medical
Judith Rossi, +1 781-792-2539
Mobile: +1 978-621-3613
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