Covidien, a global provider of patient monitoring and respiratory care devices, has received US FDA 510(k) clearance with labelling for the use of its Nellcor pulse oximeters in newborn screening for critical congenital heart disease (CCHD).
Covidien devices that feature the new CCHD labels include Nellcor Bedside SpO2 patient monitoring system; Nellcor Bedside respiratory patient monitoring system and Nellcor N-600x pulse oximetry monitoring system.
Approximately 7,200 newborns in the US suffer with this heart condition, which can be easily detected and treated.
However, nearly one in three newborns with CCHD leave the hospital undiagnosed, which can later lead to long-term disability or sudden death.
Every year, 100 to 200 newborns fall victim to CCHD.
Covidien Respiratory and Monitoring Solutions vice president and general manager Matthew Anderson said that CCHD is a life-threatening condition that can be detected and treated early through proper screening.
"We truly hope our CCHD resources, the educational support we offer clinicians and our pulse oximetry portfolio help make an important difference in the fight against CCHD," Anderson said.
The company claims that Nellcor pulse oximeters have demonstrated that the device can provide accurate readings even during patient movement, which is especially vital in the case of newborns.
According to the company, Nellcor pulse oximeters are now the only oximeters available in the market that are certified to be in compliance with ISO 80601-2-61.
Nellcor pulse oximetry technology offers accurate readings in neonates (+/-2% accuracy) as it depends on cardiac-based signals to generate readings closely tied to the patient’s physiology.
Compared with other technologies, Nellcor pulse oximetry technology is claimed to offer accurate results even during a number of challenging conditions such as patient motion, noise and low perfusion, all of which can obstruct the assessment of patients’ respiratory status.