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 III

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

Doc Wesley comments: . . . Examination of the data reveals that a significant number of RAD-57 readings were 0%. These results should have been excluded as a technical error because it’s unlikely to have a CO level of 0%, especially in a suburban/urban environment. To illustrate this, I took a RAD-57 and walked through my ambulance company going through administration, billing, operations and fleet. I performed 30 consecutive readings and never got a reading of 0%. Including these readings in the study creates an incorrect error rate.[1]

Should we assume that the zero readings would be ignored when this is used on real patients?

No. People would never do that.

The people using the RAD-57 in this study were trained by the people from Masimo. Could the researchers receive better training than that? Does Masimo suggest that their people do not know how to train people in the use of their equipment?

Is there any reason to believe that the non-zero numbers are accurate?

According to this chart from the original study with the area in red indicating the readings that were below 15% even though the blood level was above 15%. Some of these are low, but not zero. Even if we throw out the zero readings that were obtained by repeated measurements (all of the measurements in the study were repeated), we still have an inaccurate device.

The RAD-57 is not something to bet your life on.

Quick and easy-to-use—requires no user calibration and does not require patient cooperation or consciousness.[2]

Keep Firefighters Safe From CO Poisoning

> Have CO levels tested on the scene with the Masimo Rad-57.

• Just because firefighters don’t feel like they have CO poisoning doesn’t mean that they don’t have unsafe levels of carboxyhemoglobin (SpCO) in their bloodstream.

• That’s why rehab guidelines support the use of on-scene CO testing.6 To be safe, have SpCO levels tested with a Masimo Rad-57 before going back into the fire and during overhaul, even if firefighters think they’re okay.

> Get prompt on-scene treatment.

• Recognition is the key to immediate on-scene treatment. With early recognition, treatment for CO poisoning can begin immediately, which significantly reduces both immediate and long-term health risks.[3]

To be safe, have SpCO levels tested with a Masimo Rad-57 before going back into the fire and during overhaul, even if firefighters think they’re okay.

And if the reading is zero?

According to Dr. Wesley, that should be ignored and we should roll again until we come up with something that is not zero.

More likely is that firefighters will want to go back and fight fire, so they will insist that the the RAD-57 be applied over and over, until acceptable numbers come up.

The firefighters I know do not like to be told that they may not fight fire. They will claim, If the machine produces numbers that say it is OK to fight fire, why are those numbers any less reliable than the numbers that say, “Go to the hospital”?

And they would be right.

If we are not supposed to trust the zero readings, should we trust any of the other readings?

Come on small non-zero numbers! Poppa doesn’t want to go back and put on his shoes.

If the RAD-57 only reads zero, do we take the firefighter to the hospital?

In the real world, how many of these firefighters will have significant COHb levels that will not be recognized until later on.

Is there any reason to believe that the non-zero numbers are accurate?

No.

Maybe toxicity will become obvious while fighting the fire.

Maybe toxicity will become obvious during the driving home.

Maybe toxicity will become obvious during the autopsy.

To be continued in Bad Advice on Masimo’s RAD-57 – Part IV.

Footnotes:

[1] 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

[2] RAD-57
Masimo
Product information page

[3] RAD-57 for Fire/EMS
Masimo
Product information page

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Comments

  1. Is the SpCO feature on the LP15 in the same boat as this device?

  2. LP15 False positive CO readings

    The LP15 produces consistent false positive CO readings for certain individuals. The false readings were confirmed by blood analysis.

    I have asked Masimo what could cause consistent false readings; but have not received an adequate explanation.

    Has anyone else had experience with false positive CO readings from LP15s?

    Thanks.

    • You won’t get any adequate explanations from Masimo, because there simply aren’t any. Their devices are all entirely bogus, except for SP02 (02sat). Masimo continues to fraudulently and recklessly launch diagnostic parameters without any real clinical data to back them up. The only ‘clinical’ data they ever offer is either cooked up in their very own Masimo Laboratories, or by a 100% Masimo-financed operation, i.e. biased & manipulated.

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  1. […] 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. […]

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