Monday, December 10, 2007

Has NAEMSE gone too far?

I was doing my daily search of EMS news recently and found a press release on from Masimo touting how the the National Association of EMS Educators made a critical medical announcement:

NAEMSE Letter to Members Warns of Critical and Fatal Implications of Missing the Diagnosis of Carbon Monoxide Poisoning

IRVINE, CA - Masimo (NASDAQ: MASI), the inventor of Pulse CO-Oximetry and Read-Through Motion and Low Perfusion pulse oximetry, today announced the National Association of EMS Educators (NAEMSE) has issued guidance to all its members advocating carbon monoxide screenings for patients presenting with any of the signs and symptoms of carbon monoxide poisoning or suspected exposure. In addition, the organization is advocating enhanced carbon monoxide training programs for all EMS professionals to help improve outcomes and save lives.

In a letter to its membership issued earlier this month, NAEMSE said failing to diagnose carbon monoxide (CO) poisoning during the emergency response efforts may lead to poor pre-hospital decisions, including failure to transport, failure to transport to an appropriate facility, failure to properly treat and failure of the emergency department to diagnose. The consequence of misdiagnosis can often result in returning the patient to a poisoned environment, possibly leading to a fatal outcome. Recognizing that CO poisoning-the most common form of poisoning in the United States-is notoriously difficult to detect, NAEMSE said improved screening and implementation of proper carbon monoxide EMS training programs "can no doubt lead to improved outcomes for patients and potentially save many lives."

Too often, even the most skilled first responders can miss the chance to treat carbon monoxide poisoning early because until now there hasn't been a fast, accurate and noninvasive way to detect elevated levels of CO in the blood. However, with the Masimo Rainbow SET Rad-57 Pulse CO-Oximeter, EMS professionals can easily detect carbon monoxide poisoning on the spot in just seconds with the push of a button, allowing for prompt and possibly life-saving treatment. In addition, Rad-57 can also limit the likelihood of long-term cardiac and neurological damage that can result from non-fatal exposures.

"We see first hand the overwhelming and immediate need for carbon monoxide screening during the first response stage and the importance of standardized carbon monoxide training protocols for EMS professionals as a matter of public safety," said NAEMSE President Angel Burba.

NAEMSE will soon have a new online training program available to all its members, free of charge, on their website The program-consisting of four carbon monoxide modules developed by Dr. Bryan Bledsoe and approved by top EMS physicians and professionals-covers the physiological dangers of CO poisoning, its signs and symptoms, as well as noninvasive methods for on-scene detection of CO in the blood. The modules include downloadable student workbooks, instructor manuals and PowerPoint slides for classroom presentation. Dr. Bryan Bledsoe is an emergency physician, highly regarded as one of the premier educators in the EMS field, and the leading author of numerous EMS textbooks.

Joe E. Kiani, Chairman and CEO of Masimo stated, "NAEMSE's recommendations for proper EMS training and field screening of carbon monoxide poisoning represents an important milestone in the establishment of new protocols for emergency responsiveness and improved public safety. If implemented nationwide, these recommendations will help reduce morbidity and mortality from unsuspected cases of carbon monoxide poisoning."

Coincidentally, NAEMSE's website welcomes Masimo as a new platinum corporate sponsor. Does anyone smell a pay-off? Can you guess who funded the development of the educational materials on the NAEMSE site? Does anyone actually think that someone at NAEMSE wrote that letter? It smells of being written by Masimo and copied onto NAEMSE letterhead--letterhead quoted on sites like (sponsored by Masimo) and healthcare as shameless Masimo ads.

Perhaps most disturbing is the between the lines implication that CO-oximetry may have a routine use to catch those sneaky non-diagnosed cases of CO poisoning.

Remember when we were all incensed when the AHA pushed Amiodarone after the manufacturer built them a new auditorium? How is this any different? And why would MASIMO do this with NAEMSE? Couldn't they get any clinical associations (e.g. NAEMSP, ACEP) to jump on with this sales pitch?

As a matter of fact, letters in Annals of Emergency Medicine are clearly divided on carbon monoxide poisoning and the role of these devices and act as a good representation of the fact that more research and technology improvement is needed.

O'Malley (O’Malley GF. Non-invasive carbon monoxide measurement is not accurate. Ann Emerg Med. 2006;48:477–478) stated:
We prospectively non-invasively measured COhgb on every ED patient. By the end of the second day of the study, we identified 5 false positive pulse co-oximeter readings. Every patient with an elevated COhgb level as described by the pulse co-oximeter had normal serum COhgb as measured with the blood test (100% false positive). The ED staff became distrustful of the pulse co-oximeter and lost interest in recording COhgb readings on every ED patient. We officially stopped the study after recording COhgb non-invasively on 328 patients and identifying 5 false positive COhgb readings

Suner, (Non-Invasive Screening for Carbon Monoxide Toxicity in the Emergency Department is Valuable Selim Suner , Robert Partridge , Andrew Sucov , Kerlen Chee , Jonathan Valente , Gregory Jay Annals of Emergency Medicine- 2007 May (Vol. 49, Issue 5, Pages 718-719) replied in a subsequent letter:
...To discredit a new technology based on 5 cases in a study which was stopped after 2 days is premature. Screening tests will have false positive results. Although confirming false positive results by performing venous co-oximetry has costs associated with it, identifying occult cases of carbon monoxide toxicity may prevent significant morbidity and mortality. With new technology in the field of medicine, frequently there is initial skepticism and growing pains. Similar complaints were evident when pulse-oximetry was first introduced in health care to measure oxy-hemoglobin concentration. It took months if not years before this technology was accepted. Now it is an indispensable tool in our diagnostic armamentarium and arguably a fifth vital sign. It is too early to determine the precise use of pulse CO-oximetry technology in the ED. The scientific community will weigh the data as it becomes available in the literature.

The take-home point in this case isn't in the statistical or research dispute. The issue is clearly stated in the last two sentences of Sumer's letter:
It is too early to determine the precise use of pulse CO-oximetry technology in the ED. The scientific community will weigh the data as it becomes available in the literature.

In short, it's not time yet.

In a position paper, "Critical Issues in the Management of Adult Patients Presenting to the Emergency Department with Acute Carbon Monoxide Poisoning," (October, 2007) the American College of Emergency Physicians states that there were 491 accidental deaths from carbon monoxide poisoning in 1998. Non-fatal poisonings were estimated at 15,000 - 40,000 with an acknowledgment that numbers may be higher because of misdiagnosis.

This post is getting long. Look at the references listed here. Make your own decisions. Here is the Dan Limmer position paper as a conclusion:

1. Masimo appears to have funded every study, education curriculum and press release out there.
2. NAEMSE went too far in issuing the press release and recommendations. I'm OK with the curriculum--generally and as a resource for educators--but am opposed to any statements or veiled implications making CO-oximetry a standard of care at this time. I believe this endorsement timed with platinum sponsorship by Masimo takes credibility away from NAEMSE as a national leadership organization.
3. I question the need for every agency to run out and buy a $4,000 device at this time. It is clearly not a standard of care. The scope of carbon monoxide poisoning cases as noted above does not warrant this designation.
4. In firefighter rehab and suspected carbon monoxide cases it may be useful (duh!) and we didn't need fanfare and press releases to tell us this. Firefighters deserve the best of care. In this area CO-oximetry may be useful and warrant recommendation.
5. The technology is in its infancy and will likely improve to be more reliable. At this time any implication that routine screening of patients is necessary or even suggested is nonsense and may in fact cause unnecessary transport and additional invasive testing.

The end.

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