New studies presented at last week's 2006 ASA Annual
Meeting add to the more than 100 independent studies validating Masimo
SET as the gold standard; technology is the foundation that enables
Pulse CO-Oximetry
Irvine, California October 27, 2006 - Masimo, the
inventor of Pulse CO-Oximetry and read-through motion and low perfusion
pulse oximetry, reported that multiple independent studies were
presented last week at the 2006 American Society of Anesthesiology
(ASA) Annual Meeting in Chicago, each reinforcing the superiority of
Masimo SET in providing accurate, reliable pulse oximetry readings. In
the studies, Masimo SET was shown to "work better for patient safety"
during the most difficult clinical conditions of motion and low
peripheral perfusion.
Masimo SET is the foundational technology that allowed the company
to introduce Masimo Rainbow SET Pulse CO-Oximetry-the first and only
monitoring platform that allows for the continuous and noninvasive
measurement of carbon monoxide (COHb), methemoglobin (MetHb), oxygen
saturation (O2Hb), pulse rate and
perfusion index. Masimo introduced the first bedside monitors,
Radical-7, to feature this groundbreaking technology at last week's ASA
meeting, and hosted a pre-ASA symposium on clinical implications of
noninvasive and continuous monitoring of MetHb and COHb using Masimo
Rainbow SET. Specific findings of the studies include:
Masimo shown to be "better for patient safety"
In a study entitled "Comparison of Three New Generation Pulse
Oximeters during Motion & Low Perfusion in Volunteers" performed by
Nitin Shah, MD and Laverne Estanol, MS at the VA and UC Irvine Medical
Centers in Long Beach, CA, the researchers stated that pulse oximeter
accuracy is often compromised by low perfusion states and motion
artifact that can jeopardize patient safety in the OR, PACU, and ICU,
adding that "manufacturers keep improving their technology in an
attempt to solve this problem". To asses the effectiveness of the
newest technologies, the study compared Masimo SET with the Nellcor
N-600 and GE Datex-Ohmeda TruSat, under conditions of low perfusion and
motion in hypoxic and normoxic states in volunteers between the ages of
18 and 40 years old.
The results showed that Masimo had the lowest level of false alarms,
performing nearly six times better than the Nellcor N600. For the rate
of missed true events, the Masimo unit again had the lowest level,
performing 17 times better than the Nellcor N600. The researchers
concluded that during hypoxic/normoxic and low perfusion states,
"Nellcor N-600 and Datex Ohmeda TruSat performed inferior to Masimo
Radical with respect to maintaining accurate readings during both
machine generated and self generated motions". They added that "it
appears from this study that Masimo Radical may work better for patient
safety, especially at critical times in OR, PACU, and ICU."1
In a separate report entitled "Impact of Motion and Low Perfusion on SpO2
& Pulse Rate in Three New Generation POs in Volunteers", Shah and
Estanol found that the Masimo SET device was within 7 percent of the
true saturation measurement 98 percent of the time as compared to 72.7
percent for the Nellcor N-600, concluding that Masimo "performed the
best in this vigorous testing schedule for both SpO2 and pulse rate" and added that "Masimo will give reliable SpO2 & PR values for a greater period of time as compared to Datex-Ohmeda TruSat and Nellcor N-600 in the OR, PACU, and ICU". 2
In another abstract, entitled "Failure Rates & Recovery Times of
New Generation POs during Motion and Low Perfusion in Volunteers", Shah
and Estanol explained that patient movement and low perfusion due to
lower temperature is common in the PACU and OR, especially during
extubation. They examined the failure rate, the percentage of times
that the monitor was more than 7 percent off from the actual SpO2
reading, and the recovery time, the average amount of time taken for
the monitor to return to accurate values. The most significant finding
was the difference in SpO2 failure
rates with Masimo SET was more than 10 times better than Nellcor N-600,
concluding that "Masimo may serve better for patient safety."3
Masimo accuracy cited as beneficial to children with cyanotic congenital heart disease
Additional studies presented at the ASA included "The Accuracy of
Masimo SET and Nellcor N-595 in Children with Cyanotic Congenital Heart
Disease" conducted by Yuichiro Toda, M.D., Mamoru Takeuchi, M.D.,
Tatsuo Iwasaki, M.D., Kazuyoshi Shimizu, M.D., Kiyoshi Morita, M.D.
from Okayama University Medical School in Japan. In this study, the
researchers compared the performance of Masimo SET and specifically
Masimo's Blue sensor to the Nellcor 595 and the Max-I Sensor on infants
with cyanotic congenital heart disease, a patient population with a
reputation for causing erroneous pulse oximetry readings. The Masimo
Blue sensor was specifically designed for this patient population. The
researchers found that overall, the bias (error) of the Nellcor sensor
was approximately 18 times that of Masimo's, but on the sickest
patients with the lowest blood flow, the Nellcor bias (error) was more
than 21 times that of the Masimo Blue Sensor prompting the researchers
to conclude "Masimo blue sensor presented smaller bias compared with
Nellcor sensor" and that "Nellcor presented wider bias during low
perfused state than that at normal perfusion". They concluded that of
the two technologies, "Masimo blue sensor provides the accurate
measurement of pulse oximetry in patients with cyanotic congenital
heart disease". 4
These and all the studies referencing the superiority of Masimo
technology were presented in abstract form at the ASA Annual Meeting
and are available for viewing on the ASA website at www.asa-abstracts.com.
Joe E. Kiani, Chairman & CEO of Masimo stated; "It is gratifying
to see so many independent researchers taking the time to evaluate
Masimo SET and to communicate the positive impacts on patient care and
safety that can be realized through its use. We are confident that the
introduction of Masimo Rainbow SET will further enable clinicians to do
what's right for patient care by giving them a more accurate picture of
their patients' status with the continuous and noninvasive monitoring
of oxyhemoglobin, methemoglobin, carboxyhemoglobin, perfusion index and
pulse rate."
About Masimo
Masimo develops innovative monitoring technologies that
significantly improve patient care-helping solve "unsolvable" problems.
In 1995, the company debuted Read-Through Motion and Low Perfusion
pulse oximetry, known as SET, and with it virtually eliminated false
alarms and increased pulse oximetry's ability to detect
life-threatening events. More than 100 independent clinical studies
have confirmed that Masimo SET technology allows clinicians to
accurately monitor blood oxygen saturation in critical care situations-
establishing the technology as the "gold standard" pulse oximetry and
substantially contributing to improved patient outcomes. In 2005 Masimo
introduced Masimo Rainbow SET Pulse CO-Oximetry, which, for the first
time, noninvasively monitors the level of carbon monoxide and
methemoglobin in the blood, allowing early detection and treatment of
potentially life-threatening conditions. Masimo, founded in 1989, has
the mission of "Improving Patient Outcome and Reducing Cost of Care by
Taking Noninvasive Monitoring to New Sites and Applications."
Additional information about Masimo and its products may be found at www.masimo.com.
- Nitin Shah, M.D., Laverne Estanol, M.S. Anesthesiology, Long Beach
VA Medical Center; UC Irvine Medical Center, Long Beach, California.
Anesthesiology 2006; 105: A929
- Nitin Shah, M.D., Laverne Estanol, M.S. Anesthesiology, Long
Beach VA Medical Center; UC Irvine Medical Center, Long Beach,
California. Anesthesiology 2006; 105: A1433
- Nitin Shah, M.D., Laverne Estanol, M.S. Anesthesiology, Long
Beach VA Medical Center, UC Irvine Medical Center, Long Beach,
California. Anesthesiology 2006; 105: A242
- Yuichiro Toda, M.D., Mamoru Takeuchi, M.D., Tatsuo Iwasaki,
M.D., Kazuyoshi Shimizu, M.D., Kiyoshi Morita, M.D., Dept. of
Anesthesiology and Intensive care medicine, Okayama University Medical
School, Okayama-shi, Okayama-ken, Japan. Anesthesiology 2006; 105: A1704
Contact:
Tom McCall
Masimo Corporation
949-297-7075
Masimo, SET, Signal Extraction Technology, Rainbow, Radical,
APOD, SpCO, and Improving and Reducing Cost of Care by Taking
Noninvasive Monitoring to New Sites and Applications are registered
trademarks of Masimo Corp. Radical-7, Rad-57, SpMet and Pulse
CO-Oximeter are trademarks of Masimo Corp.