Smiths Medical Gains CE Mark for Safety Catheter

The device is designed to reduce accidental needlesticks.

St. Paul, Minn.-based medical device manufacturer Smiths Medical’s Jelco IntuitIV Safety IV Catheter was CE Marked for clinical use in the Europe. The catheter, which is manufactured in Latina, Italy, is designed to reduce the risk of needlestick injury and its consequences.

Smiths Medical officials explained that 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 been increasingly requested by clinicians and institutions. Professional associations, such as the World Health Organization and government agencies worldwide have issued directives encouraging the adoption of practices that elevate caregiver safety, including the use of sharps safety devices. According to Smiths, the Jelco IntuitIV 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.

“Our Jelco line of safety devices has a long history of quality, innovation and safety,” said Srini Seshadri, president of Smiths Medical. “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.”

The company began delivery of the device in October and regional introductions will expand as country registrations and approvals are granted.

Part of Smiths Group, Smiths Medical provides specialist medical devices and equipment focusing on the medication delivery, vital care and safety devices market segments.


Keep Up With Our Content. Subscribe To Medical Product Outsourcing Newsletters