FDA Advisory Panel Recommends Approval of the SEDASYS(R) System

[ProRealDoc]

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If you were thinking about making a living pushing propofol at GI endoscopy suites, earning 300K,working 7-3pm, weekends off and 10 weeks of vacation (AKA 'lifestyler), I suggest you rethink your strategy.

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Panel Votes in Favor of Use by Physician/Nurse Teams to Deliver Minimal-to-Moderate Propofol Sedation

CINCINNATI, May 28 /PRNewswire/ -- Ethicon Endo-Surgery today announced that the Anesthesiology and Respiratory Therapy Devices Advisory Committee of the U.S. Food and Drug Administration (FDA) voted in favor of approval of the SEDASYS(R) System for use by physician/nurse teams to administer minimal-to-moderate propofol sedation during screening and diagnostic procedures for colorectal cancer (colonoscopy) and the upper gastrointestinal tract (EGD). The SEDASYS(R) System, the first computer-assisted personalized sedation (CAPS) system, integrates drug delivery and patient monitoring to enable propofol sedation personalized to each patient's needs.

The Anesthesiology and Respiratory Therapy Devices Advisory Committee voted 8 to 2 in favor of approval. Conditions of approval recommended by the Panel included that the SEDASYS(R) System only be used in adult patients age 70 and under, a comprehensive training program, definition of the sedation delivery team and a post-approval study. The final decision regarding approval of the device is made by the FDA.



"There is strong clinical support that the SEDASYS(R) System reduces the risk of over-sedation, which may help make sedation more predictable and reliable for physician/nurse teams," said Kenneth Sumner, Ph.D., Vice President, Clinical and Regulatory Affairs, Ethicon Endo-Surgery, Inc. "We look forward to continuing discussions with the FDA during the regulatory review process."


The Advisory Committee reviewed results from a recent pivotal trial, which were included in the company's Pre-Market Approval (PMA) application for the SEDASYS(R) System. In the study, patients who received sedation with the SEDASYS(R) System experienced fewer and less significant oxygen desaturation events, a clinical sign of over-sedation, than patients sedated with the current standard of care drugs -- benzodiazepines and opioids.


The SEDASYS(R) System automatically detects and responds to signs of over-sedation (oxygen desaturation and low respiratory rate/apnea), guided by continual monitoring and recording of critical patient vital signs, including oxygen saturation, respiratory rate, heart rate, blood pressure, end-tidal carbon dioxide and patient responsiveness.


Propofol (also known as DIPRIVAN(R)) is considered by physicians to be a preferred sedative due to its rapid onset and quick, clear-headed recovery, which enables patients to promptly return to normal activities following a colonoscopy or EGD procedure. Current propofol labeling states only persons trained in the administration of general anesthesia should administer the drug. In the majority of practice settings, gastroenterologists do not have broad access to anesthesiologists.


About the SEDASYS(R) System
The SEDASYS(R) System is the first computer-assisted personalized sedation (CAPS) system designed for physician/nurse teams to provide minimal-to-moderate sedation levels with propofol. By integrating drug delivery and patient monitoring, the SEDASYS(R) System enables physician/nurse teams to deliver personalized sedation. It automatically detects and responds to signs of over-sedation (oxygen desaturation and low respiratory rate/apnea) by stopping or reducing delivery of propofol, increasing oxygen delivery and automatically instructing patients to take a deep breath. The device is currently an investigational device limited by U.S. law to investigational use only.


About Ethicon Endo-Surgery
Ethicon Endo-Surgery, a Johnson & Johnson company, develops and markets advanced medical devices for minimally invasive and open surgical procedures, focusing on procedure-enabling devices for the interventional diagnosis and treatment of conditions in general and bariatric surgery, as well as gastrointestinal health, gynecology and surgical oncology. More information can be found at www.ethiconendo.com.




(C)2009 Ethicon Endo-Surgery


SEDASYS(R) is a trademark of Ethicon Endo-Surgery.


DIPRIVAN(R) is a registered trademark of the AstraZeneca group of companies.




CONTACTS: Media: Investor Relations: Kelly Leadem Stan Panasewicz Ethicon Endo-Surgery Johnson & Johnson 513-337-1006 732-524-2524 973-713-6927 Wendy Dougherty Louise Mehrotra Ethicon Endo-Surgery Johnson & Johnson 513-337-8281 732-524-6491 513- 293-0254

______________________________________________________________

The ASA tried to block this and the two anesthesiologists sitting on the FDA panel voted against it but it was not enough.

http://www.asahq.org/Washington/ASACommentsFDASEDASYS51409.pdf

 

[Jeff05]

so what happens when the patient is obstructed and desats. the machine decreases or shuts off the propofol, but you still need an airway expert there.
what happens is the patient becomes disinhibited and you have to deepen the anesthetic.
what happens when there is a laryngospasm?

does it know that if the sat is 84% with a crappy pleth that the monitor is inaccurate. i don't have end tidal readings many times during EGDs (side capno nc is on).

light sedation with propofol is BS. may as well give 2 of midaz. the whole point is to appropriately sedate individuals for colonoscopy or EGD, which in my book requires heavy sedation.

this machine is a useless POC. a CRNA with a basic infusion pump is already better. i can already predict multiple respiratory events with this thing/not enough sedation.

next.

If you were thinking about making a living pushing propofol at GI endoscopy suites, making 300K,working 7-3pm, weekends off and 10 weeks of vacation (AKA 'lifestyler), I suggest you rethink your strategy.

_______________________________________________________________




Panel Votes in Favor of Use by Physician/Nurse Teams to Deliver Minimal-to-Moderate Propofol Sedation

CINCINNATI, May 28 /PRNewswire/ -- Ethicon Endo-Surgery today announced that the Anesthesiology and Respiratory Therapy Devices Advisory Committee of the U.S. Food and Drug Administration (FDA) voted in favor of approval of the SEDASYS(R) System for use by physician/nurse teams to administer minimal-to-moderate propofol sedation during screening and diagnostic procedures for colorectal cancer (colonoscopy) and the upper gastrointestinal tract (EGD). The SEDASYS(R) System, the first computer-assisted personalized sedation (CAPS) system, integrates drug delivery and patient monitoring to enable propofol sedation personalized to each patient's needs.

The Anesthesiology and Respiratory Therapy Devices Advisory Committee voted 8 to 2 in favor of approval. Conditions of approval recommended by the Panel included that the SEDASYS(R) System only be used in adult patients age 70 and under, a comprehensive training program, definition of the sedation delivery team and a post-approval study. The final decision regarding approval of the device is made by the FDA.



"There is strong clinical support that the SEDASYS(R) System reduces the risk of over-sedation, which may help make sedation more predictable and reliable for physician/nurse teams," said Kenneth Sumner, Ph.D., Vice President, Clinical and Regulatory Affairs, Ethicon Endo-Surgery, Inc. "We look forward to continuing discussions with the FDA during the regulatory review process."


The Advisory Committee reviewed results from a recent pivotal trial, which were included in the company's Pre-Market Approval (PMA) application for the SEDASYS(R) System. In the study, patients who received sedation with the SEDASYS(R) System experienced fewer and less significant oxygen desaturation events, a clinical sign of over-sedation, than patients sedated with the current standard of care drugs -- benzodiazepines and opioids.


The SEDASYS(R) System automatically detects and responds to signs of over-sedation (oxygen desaturation and low respiratory rate/apnea), guided by continual monitoring and recording of critical patient vital signs, including oxygen saturation, respiratory rate, heart rate, blood pressure, end-tidal carbon dioxide and patient responsiveness.


Propofol (also known as DIPRIVAN(R)) is considered by physicians to be a preferred sedative due to its rapid onset and quick, clear-headed recovery, which enables patients to promptly return to normal activities following a colonoscopy or EGD procedure. Current propofol labeling states only persons trained in the administration of general anesthesia should administer the drug. In the majority of practice settings, gastroenterologists do not have broad access to anesthesiologists.


About the SEDASYS(R) System
The SEDASYS(R) System is the first computer-assisted personalized sedation (CAPS) system designed for physician/nurse teams to provide minimal-to-moderate sedation levels with propofol. By integrating drug delivery and patient monitoring, the SEDASYS(R) System enables physician/nurse teams to deliver personalized sedation. It automatically detects and responds to signs of over-sedation (oxygen desaturation and low respiratory rate/apnea) by stopping or reducing delivery of propofol, increasing oxygen delivery and automatically instructing patients to take a deep breath. The device is currently an investigational device limited by U.S. law to investigational use only.


About Ethicon Endo-Surgery
Ethicon Endo-Surgery, a Johnson & Johnson company, develops and markets advanced medical devices for minimally invasive and open surgical procedures, focusing on procedure-enabling devices for the interventional diagnosis and treatment of conditions in general and bariatric surgery, as well as gastrointestinal health, gynecology and surgical oncology. More information can be found at www.ethiconendo.com.




(C)2009 Ethicon Endo-Surgery


SEDASYS(R) is a trademark of Ethicon Endo-Surgery.


DIPRIVAN(R) is a registered trademark of the AstraZeneca group of companies.




CONTACTS: Media: Investor Relations: Kelly Leadem Stan Panasewicz Ethicon Endo-Surgery Johnson & Johnson 513-337-1006 732-524-2524 973-713-6927 Wendy Dougherty Louise Mehrotra Ethicon Endo-Surgery Johnson & Johnson 513-337-8281 732-524-6491 513- 293-0254

______________________________________________________________

The ASA tried to block this and the two anesthesiologists sitting on the FDA panel voted against it but it was not enough.

http://www.asahq.org/Washington/ASACommentsFDASEDASYS51409.pdf

 

[ProRealDoc]

so what happens when the patient is obstructed and desats. the machine decreases or shuts off the propofol, but you still need an airway expert there.
what happens is the patient becomes disinhibited and you have to deepen the anesthetic.
what happens when there is a laryngospasm?

does it know that if the sat is 84% with a crappy pleth that the monitor is inaccurate. i don't have end tidal readings many times during EGDs (side capno nc is on).

light sedation with propofol is BS. may as well give 2 of midaz. the whole point is to appropriately sedate individuals for colonoscopy or EGD, which in my book requires heavy sedation.

this machine is a useless POC. a CRNA with a basic infusion pump is already better. i can already predict multiple respiratory events with this thing/not enough sedation.

next.

My feelings exactly but do you think the GI docs care as long as they are pocketing the anesthetic fee?

 

[Taurus]

Is this the start of automation in anesthesia? How long before we see FDA approval of McSleepy?

 

[ProRealDoc]

Is this the start of automation in anesthesia? How long before we see FDA approval of McSleepy?

Hard to say but if airplanes can almost fly themselves I don't see why these machines could not be refined to put a few thousand CRNAs out of work.

 

[coprolalia]

Hard to say but if airplanes can almost fly themselves I don't see why these machines could not be refined to put a few thousand CRNAs out of work.

Agreed. But, those planes still have a pilot, don't they?

I think you're right about not having CRNAs doing these cases. It'll probably be one anesthesiologist pre-op'ing and getting the patient set-up, as well as being there in case the shtuff hits the fan.

And, if I recall correctly, the endoscopist doesn't get to pocket a separate "sedation" fee, by the way. Same rules apply when the anesthesiologist does the TEE as part of the total anesthetic. So, I don't know why there's such a huge incentive to do away with us.

-copro

 

[ProRealDoc]

Agreed. But, those planes still have a pilot, don't they?

I think you're right about not having CRNAs doing these cases. It'll probably be one anesthesiologist pre-op'ing and getting the patient set-up, as well as being there in case the shtuff hits the fan.

And, if I recall correctly, the endoscopist doesn't get to pocket a separate "sedation" fee, by the way. Same rules apply when the anesthesiologist does the TEE as part of the total anesthetic. So, I don't know why there's such a huge incentive to do away with us.

-copro

I said almost, although drones do. I think the anesthetic fee is bundled in the payment. Have to double check on that though,.

 

[tennisnr]

How much do one of these cost anyway and how many ppl can they handle?

 

[MDEntropy]

Forget about it.

This thing is only going to make a few people overconfident and less vigilant. A few people will get hurt thereby creating more work for humans.

Anesthesia is like no-limit texas hold'em. A computer just can't get the job done.

 

[ProRealDoc]

Forget about it.

This thing is only going to make a few people overconfident and less vigilant. A few people will get hurt thereby creating more work for humans.

Anesthesia is like no-limit texas hold'em. A computer just can't get the job done.

The gadget below may not replace the anesthesiologist as a physician but it may decrease the need for monitoring that we now rely on nurses for. I can envision an enterprising company like GE getting their hands on Macsleepy, refining it and marketing it as a system that can save millions of dollars on labor to the hospitals in the form of reduced need for anesthesia personnel. Think of the automated cashiers at the supermarket. The anesthesiologist will still be reponsible for airway management, invasive monitoring placement pre and postop management but won't have to rely on nurse anesthetists to sit in the room and pay them top dollar for charting vitals. That's the point. The ACT model of the future may bbe comprised of an anesthesiologist, AA and 8-10 MacSleepys.

McSleepy: Automated Anesthesia System

Filed under: Anesthesiology

Canadian Researchers at McGill University in Montreal, Quebec and the McGill University Health Centre (MUHC) have developed an automated anesthetic system and believe they were the first in the world to perform a surgery with such a machine. The new system, named 'McSleepy' - in honor of the nicknames given to the doctors on the TV show 'Grey's Anatomy' - will administer drugs and monitor vital signs for patients undergoing surgery. So far, the system has been used during seven operations, and according to Dr. Thomas Hemmerling, principal developer for the system at McGill University, the preliminary results show that "...it is actually better in terms of stability of anesthesia than us at this point".

Think of "McSleepy" as a sort of humanoid anesthesiologist that thinks like an anesthesiologist, analyses biological information and constantly adapts its own behavior, even recognizing monitoring malfunction.
The anesthetic technique was used on a patient who underwent a partial nephrectomy, a procedure that removes a kidney tumor while leaving the non-cancerous part of the kidney intact, over a period of three hours and 30 minutes. To manipulate the various components of general anesthesia, the automated system measures three separate parameters displayed on a new Integrated monitor of anesthesia (IMATM): depth of hypnosis via EEG analysis, pain via a new pain score, called AnalgoscoreTM, and muscle relaxation via phonomyographyTM, all developed by ITAG. The system then administers the appropriate drugs using conventional infusion pumps, controlled by a laptop computer on which "McSleepy" is installed.
Using these three separate parameters and complex algorithms, the automated system calculates faster and more precisely than a human can the appropriate drug doses for any given moment of anesthesia. "McSleepy" assists the anesthesiologist in the same way an automatic transmission assists people when driving. As such, anesthesiologists can focus more on other aspects of direct patient care. An additional feature is that the system can communicate with personal digital assistants (PDAs), making distant monitoring and anesthetic control possible. In addition, this technology can be easily incorporated into modern medical teaching programs such as simulation centers and web-based learning platforms.
​

 

[Taurus]

Automation in anesthesia is inevitable. There's too much financial incentive for companies to develop them and for hospitals to deploy them. The question is why hasn't this happened sooner.

 

[ProRealDoc]

Automation in anesthesia is inevitable. There's too much financial incentive for companies to develop them and for hospitals to deploy them. The question is why hasn't this happened sooner.

macsleepy will never call in sick, won't have an attitude and won't ever need vacation or PTO.

 

[anesthesiadoc]

you guys haven't seen the prototypes for this pump? The patient's head gets pinned, (think neurosurgery cases) and when the end tidal CO2 is absent for more than 30 seconds, propofol infusion stops and the machine cranks the patient's head back to supply chin lift and relieve the obstruction. You have to recalibrate it every day, though. (Otherwise you get C-spine injuries.)

 

[ProRealDoc]

you guys haven't seen the prototypes for this pump? The patient's head gets pinned, (think neurosurgery cases) and when the end tidal CO2 is absent for more than 30 seconds, propofol infusion stops and the machine cranks the patient's head back to supply chin lift and relieve the obstruction. You have to recalibrate it every day, though. (Otherwise you get C-spine injuries.)

Which gadget are you referring to?

 

[Jeff05]

umm what we do is more difficult than checking out groceries. which, before the process was automated, was performed by junior high kids and trailer park dwellers.

certainly, there are parts of long stable cases that do not require our presence. however, we have NO WAY of PREDICTING which cases will absolutely go smoothly.

 

[ProRealDoc]

umm what we do is more difficult than checking out groceries. which, before the process was automated, was performed by junior high kids and trailer park dwellers.

certainly, there are parts of long stable cases that do not require our presence. however, we have NO WAY of PREDICTING which cases will absolutely go smoothly.

It was just an example to illustrate the idea that human tasks can be automated. Read my post again and see that I did not say it would replace anesthesiologists. I said it could replace folks who chart vital signs. Hell, I don't have to chart vitals signs now (we use EMR) and this technology is in its infancy.

 

[Taurus]

Automation in anesthesia doesn't mean the wholesale replacement of anesthesiologists or AA's/CRNA's. What it means to me is that you will need fewer people to do the tasks that a program can handle, ie, stool sitting and charting. So instead of 1 MD to 4 AA/CRNA ratios, you may see 1 MD to 1-2 AA/CRNA ratios.

 

[Bertelman]

Automation in anesthesia doesn't mean the wholesale replacement of anesthesiologists or AA's/CRNA's. What it means to me is that you will need fewer people to do the tasks that a program can handle, ie, stool sitting and charting. So instead of 1 MD to 4 AA/CRNA ratios, you may see 1 MD to 1-2 AA/CRNA ratios.

So with automation, there are more providers? Your ratio goes from 1:4 to 1:2.

 

[MDEntropy]

I agree that automation is inevitable. I don't believe we have technology anywhere near capable of making the kind of complex decisions human make.

We have enough trouble automating 2-d still line ECG reading....and 2-d films, forget about it. This stuff is relatively easy. No moving parts. We will much more quickly be able to automate time consuming portions of many of the procedures humans take care of patients during before automating care of the patient.

We will much sooner see automated placement of intravenous and arterial lines and needles into the subarchnoid space.

Complex dynamics really trouble automation.

When you see a change in one of your many many monitors, before making an intervention, you routinely consider this change in the setting of other monitors and consider a number of fake outs that may be leading to bad information. You also consider real causes of the change/s that could require different interventions. Sometimes you do this in a matter of seconds and you do it in an 'automated' way.

First, we need all our monitors to give us correct information with six sigma accuracy. A reasonably awake patient can't clench their hand and cause your Massimo pulse oximeter to read 76% when their brain is seeing something different. The patient simply can not move their arm resulting in an artificial bp reading of 46/24. There can be no EKG interference do to procedural manipulation which causes a tracing consistent with V-tach.

When we do get there, to the point of having perfect monitors, then we will have to figure out how to deal with the hard stuff, like what is actually happening to the patient leading to the changes we see on our monitors. Creating perfect monitors is relatively simple from a relative perspective. We ain't got em.

Unfortunately, the computer is not even close to the human. When it gets close, our lives as humans will be vastly different in so many other areas. I suspect most people using this website will actually be long gone.

 

[Bertelman]

First, we need all our monitors to give us correct information with six sigma accuracy. A reasonably awake patient can't clench their hand and cause your Massimo to read 76% when their brain is seeing something different. The simply can't move their arm and get an artificial bp reading of 46/24. Their can be no EKG interference do to procedural manipulation which causes
a tracing consistent with V-tach.

Exactly. Bad info/improper action is thought to have been a factor in the Air France flight. Obviously, a pilot is much more reliant on monitors and electronic data than we are in a typical clinical scenario.

 

[Trisomy13]

Anesthesia, On!

 

[Licoricestick]

So with automation, there are more providers? Your ratio goes from 1:4 to 1:2.

I assume Taurus meant that they will still be looking after 4-5 patients at a time.

 

[sweetalkr]

well i think the FDA has nothing but the best intentions for patients. The FDA is not swayed politically, and makes fair and conscious decisions.

http://www.washingtonpost.com/ac2/wp-dyn/comments/display?contentID=AR2007042201551&start=221

http://www.chantix-legal.com/news/2009/01/21/fda-scientists-say-their-agency-is-corrupt-and-broken/

http://www.theepochtimes.com/n2/content/view/16742/

ok now i will be followed the rest of my life

 

[mountaingastro]

My feelings exactly but do you think the GI docs care as long as they are pocketing the anesthetic fee?

Copro and ProReal are correct. There is no mechanism allowing separate payment for the supervision of moderate sedation by the endoscopist. The sedation component of service is incorporated into nearly all endoscopy codes (which carry a "bullseye" designation in the CPT book). Additionally, there is no means for an endoscopist supervising deep sedation (my nurses give propofol under my direction) to be paid any more either, even though the moderate sedation definition specifically excludes deep sedation. Anesthesia codes cannot be used by the individual performing the procedure itself.

Unless insurers (Aetna has threatened to) create a means of compensating an endoscopist-facility for the additional costs incurred by the use of Sedasys that are over and above those of administering moderate sedation, it is difficult to imagine a lot of facilities electing to take the additional overhead hit.

While in some communities most or all endoscopy sedation is managed by anesthesiologists or CRNAs (typically in the east) this is not true in most of the country, where the endoscopists who have been supervising their own sedation since the inception of endoscopy continue to do so.

Some of us, where nurse practice acts permit it, are supervising the administration of propofol. From my point of view, it is not difficult to do so, and it can be done safely and effectively, provided that the endoscopist and the RN have undergone specific training in using the drug and managing deep sedation. We don't get paid anything more to do this than to supervise the administration of opioids-benzos, but to us it seems safer and more effective than traditional moderate sedation and more cost effective than bringing another physician (or CRNA) and thus another professional fee, in on every case.

Those of us using endoscopist-directed propofol now would have no incentive to adopt Sedasys, absent a new financial payment.

It is also hard to imagine a facility in which anesthesia providers currently provide deep sedation switching to Sedasys-managed moderate sedation (which is what the machine achieves), unless insurers become more aggressive in refusing to pay for anesthesia services for average-risk patients undergoing routine EGD and colonoscopy.