Without evidence of benefit, an intervention should not be presumed to be beneficial or safe.

- Rogue Medic

Bad Advice on Masimo’s RAD-57 – Part IV

Also posted over at Paramedicine 101 (now at EMS Blogs). Go check out the rest of the excellent material there.

Continuing from Bad Advice on Masimo’s RAD-57 – Part I from Bad Advice on Masimo’s RAD-57 – Part II and from Bad Advice on Masimo’s RAD-57 – Part III.

Carbon monoxide is a leading cause of poisoning morbidity and mortality in the United States.1 Symptoms of carbon monoxide poisoning are nonspecific and include headache, fatigue, malaise, confusion, nausea, dizziness, visual disturbances, chest pain, shortness of breath, loss of consciousness, and seizures. Although carboxyhemoglobin levels are inconsistently related to the degree of toxicity, in the absence of a clear history, detection in the blood may be the only means of confirming suspected exposure.1[1]

Based on the criticism from Marshall J. Washick and Dr. Wesley we should only use the RAD-57 on pale people, we should only accept numbers that are above zero, and we should not pay attention to research that is not paid for by Masimo.[2] Golly, I will run out and buy 2 of these.

Maybe not.

Furthermore, the RAD-57 could prevent a firefighter from being covered for illness due to on the job exposure to carbon monoxide.

Look at the numbers! It’s not carbon monoxide!

If this were pulse oximetry that was not even able to identify half of the cases of hypoxia that the hospital’s pulse oximetry could identify –

What would we do?

If this were waveform capnography that was not even able to identify half of the misplaced endotracheal tubes that the hospital’s waveform capnography could identify –

What would we do?

If this were a 12 lead ECG (ElectroCardioGram) that was not even able to identify half of the heart attack patients that the hospital’s 12 lead ECG could identify –

What would we do?

Not to worry. This is the RAD-57 and we are medical professionals.

What do we do?

We make excuses for the faulty equipment.

If the zero readings are an indication of an error, then the RAD-57 should be designed to indicate Error, not zero.

Dr. Wesley states that the zero readings are errors. This should be a simple fix, but Masimo has criticized the research rather than improve the function of the RAD-57.

This does not inspire confidence in the RAD-57, in Masimo, or in the ability of the technology to be used by non-specialists.

Does the Masimo training stress that we should ignore zero readings?

I haven’t seen anything from Masimo that says ignore zero readings – and Masimo has sent me material to try to convince me that the research is wrong.

Did Masimo design the RAD-57 to indicate Error, rather than zero?

They could have done this, but they chose not to. This would be one way to get around part of the problems of operator error and equipment malfunction. After the study, Masimo could have retrofitted the RAD-57 to show Error, rather than zero, but Masimo chose not to.

The attitude of Masimo does not appear to be one of concern about the possible danger to patients, but only of concern about a possible danger to the bottom line. If they make a good product and stand behind it, they should profit from that, but that is not what I see.

Masimo is saying Ignore that independent research.

The independent researchers are making a different statement.

Importance

Demonstration of adequate agreement between measurements made with the RAD device and standard laboratory measurement is essential before this noninvasive method of carbon monoxide detection can appropriately be substituted for arterial or venous measurement in clinical care.[1]

We should pay attention to the independent researchers, unless we want to kill firefighters.

Until there is a reliable and accurate noninvasive device available, we need to rely on the blood tests in the hospital, not a machine with blinking lights producing inaccurate, but reassuring results.

If this were pulse oximetry, waveform capnography, or 12 lead ECG, we would not feel comfortable with a company telling us to ignore research that points out problems with the equipment. We should not accept this when the device is even less well understood, such as this novel non-invasive carboxyhemoglobin measurement device, the RAD-57.

Footnotes:

[1] Performance of the RAD-57 pulse CO-oximeter compared with standard laboratory carboxyhemoglobin measurement.
Touger M, Birnbaum A, Wang J, Chou K, Pearson D, Bijur P.
Ann Emerg Med. 2010 Oct;56(4):382-8. Epub 2010 Jun 3.
PMID: 20605259 [PubMed – indexed for MEDLINE]

Free Full Text Article from Ann Emerg Med with links to Free Full Text PDF download

[2] RAD-57 Pulse Oximeter Performance – Study measures device’s readings comared with lab measurement
JEMS Street Science
by Keith Wesley, MD, FACEP and Marshall J. Washick, BAS, NREMT-P
Tuesday, February 15, 2011
Article

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Comments

  1. YOU ARE SOOO WRONG THE RAD57 SAVED MY ENTIRE FAMILY’S LIVES BY INDICATED A CO READING AND SENDING US ALL TO THE HOSPITAL TO HAVE BLOOD GASES DRAWN ALSO INDICATED HIGH CO LEVELS

    THE RAD 57 SAVED OUR LIVES, IF I WERE YOU I WOULD CONCENTRATE ON THE POSITIVES OF THE UNIT NO OTHER WAY WOULD THE EMT’S HAVE EVER KNOWN ABOUT OUR CO POISIONING

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