Nellcor gets US nod for adhesive-free sensors:
This article was originally published in Clinica
Executive Summary
Nellcor has gained US FDA 510(k) clearance to sell its SoftCare family of adhesive-free pulse oximetry sensors, which are designed to protect the delicate skin of neonates, geriatrics and other patients with compromised skin integrity. Designed for use with the firm's OxiMax pulse oximeters and other manufacturers' multi-parameter monitoring systems equipped with the OxiMax technology, the sensors fastens around the sensor site with Velcro instead of adhesive tape to eliminate adhesive-related skin trauma. Research has shown that adhesives are the primary cause of skin breakdown among neonatal intensive care unit patients, says the Pleasanton, California firm. Pulse oximetry sensors were cited as one of the therapeutic interventions that can potentially cause skin injury.