Masimo Invests in Anesthesia Awareness Technology. Good Move? We Don't Think So.

Sounds like a knee-jerk reaction to Covidien buying Aspect.

As president of the Anesthesia Awareness Campaign, Inc., I would like to respond to this article. Realizing your website is titled MedGadgets, I consider brain activity monitoring technology much more than a gadget! In my opinion, brain function monitoring technology should be used in every general anesthesia surgery in this country. Please note that I am using the generic term, brain activity monitor, and not any specific brand.

Qouting from your article, I don't think your interpretation of the ASA's position as "the American Society of Anesthesiologists does not recommend the widespread use of brain function monitoring devices, such as BIS. The other problem, of course, is the devastating study published in the March, 2008 issue of the New England Journal of Medicine"

Indeed, the ASA's practice advisoryof 2005 leaves the use of brain activity monitoring "at the discretion of the individual practitioner." Use of brain activity monitoring has been increasing every day in the last five years. Many hospitals are rnow routinely using this technology as an adjunct to other techniques of monitoring depth of anesthesia, especially in TIVA anesthesia. Use of this technology can spare 100-200 general anesthesia surgery patients every day from the life-changing sequelae of traumatic instances of anesthesia awareness.

As for the "devastating"study in NEJM, namely Avidan, those who closley studied the methodology of this study have expressed their suspicions about the validity of the study due to the methodology used.

Open discussion and open minds on the subject of brain activity monitoring are the best way to give patients the best and safest care possible. Isn't that the goal?

Carol Weihrer
Anesthesia Awareness Campaign
www.anesthesiaawareness.com

As president of the Anesthesia Awareness Campaign, Inc., I would like to respond to this article. Realizing your website is titled MedGadgets, I consider brain activity monitoring technology much more than a gadget! In my opinion, brain function monitoring technology should be used in every general anesthesia surgery in this country. Please note that I am using the generic term, brain activity monitor, and not any specific brand.

Qouting from your article, I don't think your interpretation of the ASA's position as "the American Society of Anesthesiologists does not recommend the widespread use of brain function monitoring devices, such as BIS. The other problem, of course, is the devastating study published in the March, 2008 issue of the New England Journal of Medicine"

Indeed, the ASA's practice advisoryof 2005 leaves the use of brain activity monitoring "at the discretion of the individual practitioner." Use of brain activity monitoring has been increasing every day in the last five years. Many hospitals are rnow routinely using this technology as an adjunct to other techniques of monitoring depth of anesthesia, especially in TIVA anesthesia. Use of this technology can spare 100-200 general anesthesia surgery patients every day from the life-changing sequelae of traumatic instances of anesthesia awareness.

As for the "devastating"study in NEJM, namely Avidan, those who closley studied the methodology of this study have expressed their suspicions about the validity of the study due to the methodology used.

Open discussion and open minds on the subject of brain activity monitoring are the best way to give patients the best and safest care possible. Isn't that the goal?

Carol Weihrer
Anesthesia Awareness Campaign
www.anesthesiaawareness.com

The brain is the most important organ in the body and the most complex. To give up on the technology of brain monitoring just because Aspect focused on awareness and tried to correlate this to an index developed from an algorithm is like giving up on heart monitoring when we only had a stethoscope! The technology needs to be developed and I see Masimo's commitment to support research in this area as validating the importance of brain function monitoring in general and SEDLine's technology in particular.

I think Masimo's investment makes a great deal of sense. Their $3.5 million investment in SEDLine sounds like a great way to keep a stake in this business of brain function monitoring, without much at risk and it keeps competition viable in this space. The cortical brain electrical activity (EEG), as easily demonstrated by the SEDline, can be very informative in maintaining patient well being. Sleep patterns are easily recognizable. Adverse changes in the brain related to ischemia or hypoxia can be detected while still reversible. Seizure activity can be easily monitored, and for the patient requiring deep sedation or paralysis, there is no other technology to demonstrate depth of sedation, depth of anesthesia or demonstrate burst suppression.

I like the SEDLine product because it provides an excellent image of bilateral EEG activity and that is like looking at a brain EKG! And, just because Aspect Medical's BIS technology has been available for many years doesn't mean they've gotten the formula right or even that they've found its most optimal uses. One reason that the BIS monitor has failed to gain a larger market share is that the BIS is prone to artifact such as muscle activity - the EMG frequency and the EEG frequencies overlap. SEDLine's core technology, with Masimo's financial backing to accelerate their R&D efforts, has an opportunity to overcome this.

Pulse oximetry was around for over 20 years before it was finally improved to monitor both extremes of the most active patients (high motion) and the sickest of patients (extremely low perfusion). And, guess who had the smarts to do it?....yep, Masimo! Masimo's involvement in SEDLine will help advance the technology and it will take off, and their very small investment could have huge pay-offs, both for Masimo, anesthesiologists and most of all the patients.

The future is in brain monitoring; we have only just scratched the surface! Masimo has taken a very futuristic and very much needed step into enhancing brain monitoring and improving patient care.
Personally, I feel that a smart investment to advance medicine is a win for us all. Healthy and sick patients alike stand to benefit from improved detection and diagnostic tools. And, if I'm the one on the operating table, I'd feel a lot better if a brain function monitor was used, but that's just me!

Mike Ramsay MD
Chairman Department of Anesthesiology
Baylor University Medical Center

Inspite of the rah-rah comments from the Masimo fanboys and industry sycophants, I agree fully with Medgadget assessment that this is a big goof-up for Masimo. EEG based awareness monitoring is a very expensive and often unreliable tool attempting to replace an anesthetist's experience and alertness. BIS and all its clones (Entropy, PSI, Sedline etc) have all failed to provide an unambiguous and reliable indicator, and I agree with Marc's assessment above that is just a commercial, knee-jerk reaction.

Mike Ramsay probably doesn't need to declare his affiliation with Masimo, because his fawning comments do that for him.

Dr. Ramsay,

Thank you for offering us your perspective. I would also like to add that if Masimo wants this technology to succeed, it needs to take a lesson from the computer industry, and go "open source" for the EEG algorithm that is used to calculate the consciousness level. There is simply no logical way of keeping the source code secret and asking clinicians to conduct clinical studies to evaluate this technology. It's like trying to evaluate the effectiveness of a black box. Releasing the code will go a long way: once clinicians understand how the algorithm works, it will help us to conduct clinical studies, and will make an acceptance of this technology much more palatable.

Michael Ostrovsky, MD
(also an anesthesiologist)

I beleive the BIS Monitor is one of, if not the most clinically tested and studied devices used in the Operating Room. Is it, or any other brain montioring device perfect? Of course not. Does it provide an additional piece of information that an anesthesia provider can use for titration purposes and an increased level of patient care and satisfaction? Of course. Brain monitoring has never been touted as a single tool to provide anesthesia to patients. In fact, any clinician relying solely on BIS or any other brain monitor to provide their care is dangerous and careless. While I completely agree that the Masimo investment is a knee jerk reaction to Covidien's acquisition, it's biggest hurdle will be to jump over the hurdles of doubt that Hospira covered the market with when they couldn't sell the device themselves. I for one hope this turns out well for Masimo as increased competition will only drive these devices to improve their capabilities.
For the comments that implied that brain monitoring devices are expensive? There are multiple studies out there that show a net cost of 5.55 per case to use these types of devices. Would you like to know your anesthesia provider has access to an additional piece of information regarding YOUR brain activity if you were undergoing a surgical procedure? Additional studies have shown that patients would be willing to pay 32.00 out of pocket to have the technology used during their cases.
For the comments of the clinical non effectiveness of these products - There are 3500+ published studies that beg to differ with your point.
Carol made some wonderful points above regarding this topic. Most folks that have actually read the NEJM article (very few have) are first, puzzled that the journal even published it, and second, notice the gaping holes in the study itself. Dr Avidan is definitely not a fan of this technology. So far though, he has only helped reinforce its' impact in the OR. He confirmed that these devices reduced the potential for awareness by 80% in high risk patients, as the industry has claimed from the beginning.
Let's be clear, there are very few, if any, devices that are 100% accurate being used in the operating room today. The best we can do is provide as much clinically relevent information for our care giver and assume their education and life experience will provide the rest. I for one would gladly accept an additional 5.55 to potentially improve my patient's outcomes.