The US FDA has issued clearance allowing a modification of the weight range for the EZ-IO 25mm needle set so that is can be used in patients who are 3kg or over.
Teleflex has announced FDA 510(k) clearance for restated indications for use of the EZ-IO vascular access system. The EZ-IO 25mm needle set is now indicated for patients 3kg or over. Teleflex recently announced its acquisition of Vidacare Corporation, developer of the EZ-IO vascular access system.
“In my clinical work in a free-standing, academic paediatric emergency department and level 1 trauma centre, as well as in a large community hospital emergency department, rapid identification and treatment of serious conditions is paramount,” states Mark L Waltzman, chief of Pediatrics, South Shore Hospital, assistant professor, Department of Pediatrics at Harvard Medical School and affiliation with the Division of Emergency Medicine at Boston Children’s Hospital, Boston, USA.
“The restated indication for the EZ-IO 25mm needle set to be used in patients 3kg or over will help to avoid confusion and streamline care. Clinicians now will simply assess the tissue depth and choose the correct needle size. This is something we ‘in the trenches’ clinicians have requested from the company and I am gratified they have heard our feedback and pushed for this change.”
New weight ranges for the EZ-IO vascular access System are now as follows:
- The EZ-IO 45mm needle is indicated for patients who are 40kg or over
- The EZ-IO 25mm needle patients who are 3kg or over
- The EZ-IO 15mm needle is indicated for who are 3–39kg