Blood Oxygen Sensors Get FDA Okay

Masimo’s RD SET sensors with Masimo Measure-through Motion and Low Perfusion SET pulse oximetry have received FDA clearance with improved SpO2 accuracy specifications for all patients weighing greater than 3 kg. The latest RD SET sensors’ SpO2 accuracy specifications during patient motion have improved for adult, pediatric, and infant patients to 1.5% (at 1 SD), compared to previous accuracy specifications of 3%.

 

In addition to offering improved accuracy, RD SET sensors are designed to enhance patient comfort, optimize clinician workflows, and help hospitals meet green initiatives. The sensors are lightweight and have a flat, soft cable with smooth edges, so that they lie comfortably on a patient’s hand or foot. They feature an intuitive sensor-to-cable connection and a lightweight design that results in up to 84% less waste.

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Observed clinical benefits include:

  • Significantly reduce rates of severe retinopathy of prematurity (ROP) and the need for laser treatment.1
  • Masimo SET enabled pulse oximetry screening for critical congenital heart disease (CCHD) helped save many full-term newborns’ lives whose disease would otherwise have gone undiagnosed.2-4
  • In Masimo SET on post-surgical wards, rescue calls and ICU transfers were reduced by 65% and 48%, respectively.5
  • Post-operative continuous surveillance monitoring, combined with Masimo SET, led to zero preventable deaths or brain damage due to opioids over fiveyears.6

In addition, the SET platform with rainbow is labeled as the only oximetry technology that also allows clinicians to measure physiological parameters such as total hemoglobin, carboxyhemoglobin, methemoglobin, and PVi. For more details, checkout Masimo’s clinical studies.

 

References

1. Castillo et al. Prevention of retinopathy of prematurity in preterm infants through changes in clinical practice and SpO2 Technology. Acta Pediatric. 2011Feb;100(2):188-92.

2. Zhao et al. Pulse oximetry with clinical assessment to screen for congenital heart disease in neonates in China: a prospective study. Lancet. 2014 Aug30;384(9945):747-54.

3. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009; Jan 8;338.

4. Ewer A et al. Pulse Oximetry Screening for Congenital Heart Defects in Newborn Infants (Pulseox): A Test Accuracy Study. Lancet. 2011 Aug 27;378(9793):785-94.

5. Taenzer AH et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology.2010:112(2):282-287.

6. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.

7. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.

8. Estimate: Masimo data on file.

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