FDA Reconsiders Approval of Personalized Sedation System

[ADMIN]

FDA Reconsiders Approval of Personalized Sedation System

The Federal Drug Administration has granted an appeal by Ethicon Endo-Surgery to reconsider approval of the Sedasys System, a computer-assisted personalized sedation system, according to a Gastroenterology & Endoscopy News report.

The FDA has granted such an appeal only once before, more than 20 years ago, according to the report.

The system would provide automated, minimal-to-moderate propofol sedation for patients undergoing colonoscopy and upper GI procedures. The device would also allow gastroenterologists and nurses to administer propofol without the supervision of an anesthesiologist.

Some experts have expressed concern about the safety of the device, saying the Sedasys system administers propofol in doses known to produce general anesthesia, not "minimal to moderate sedation" as advertised. Proponents say the device could cut costs associated with colonoscopies and upper GI procedures and that propofol is becoming the anesthesia of choice.

Read the Gastroenterology & Endoscopy News report on the Sedasys System. (http://www.gastroendonews.com/index.asp?section_id=409&show=dept&article_id=16317)

[mgreencrna]

Another time when money over safety talks. Someone has to die or become incapacitated before they stop the madness. What I don't get is, how does this system negate the nursing practice acts that prohibit non-anesthesia providers from administering propofol? The nurse will fill the system and is, "administering". Unless they split hairs and say that the nurse is merely the system's "assistant". I doubt the MD will fill the system. Any nurse involved with this system should be reported to the state's nursing board.

Mark


FDA Reconsiders Approval of Personalized Sedation System

The Federal Drug Administration has granted an appeal by Ethicon Endo-Surgery to reconsider approval of the Sedasys System, a computer-assisted personalized sedation system, according to a Gastroenterology & Endoscopy News report.

The FDA has granted such an appeal only once before, more than 20 years ago, according to the report.

The system would provide automated, minimal-to-moderate propofol sedation for patients undergoing colonoscopy and upper GI procedures. The device would also allow gastroenterologists and nurses to administer propofol without the supervision of an anesthesiologist.

Some experts have expressed concern about the safety of the device, saying the Sedasys system administers propofol in doses known to produce general anesthesia, not "minimal to moderate sedation" as advertised. Proponents say the device could cut costs associated with colonoscopies and upper GI procedures and that propofol is becoming the anesthesia of choice.

Read the Gastroenterology & Endoscopy News report on the Sedasys System. (http://www.gastroendonews.com/index.asp?section_id=409&show=dept&article_id=16317)

[ethernaut]

i can see it now. get a call from the endo unit for anesthesia to come and set up/trouble shoot/run the sedasys system. yea, makes complete economical and safety sense.

[jwk]

Another time when money over safety talks. Someone has to die or become incapacitated before they stop the madness. What I don't get is, how does this system negate the nursing practice acts that prohibit non-anesthesia providers from administering propofol? The nurse will fill the system and is, "administering". Unless they split hairs and say that the nurse is merely the system's "assistant". I doubt the MD will fill the system. Any nurse involved with this system should be reported to the state's nursing board.

MarkRemember that concept varies from state to state. I know in Georgia, RN's may not give propofol except by infusion to ventilated patients in the ICU. However, in other states, it's perfectly legal for RN's to give propofol by bolus, despite the black box warning from the manufacturer.

[SuperSleeper]

What about that bizzare pt that looks/acts like they'd take 200 to think about closing their eyes, but gets apneic at 30? Do little robot arms come out and mask the pt?

[sandmanpk]

"It automatically detects and responds to signs of oversedation (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". This is from the Sedasys people.

What happens when the machine "automatically" tells the patient to "take a deep breath", and the apneic patient stubbornly refuses to comply? Or that pesky 300# patient who just can't keep their damn airway open and uses a CPAP at home every night?

The nursey nurse will yellow her whites as the patient's sat drops to nothing. Oh, but it's okay. The machine will then "stop delivery of propofol", and magically make the patient pink and warm again.

[stanman1968]

The truth is that the sedation gravy train WILL end and sooner then later, I do a lot of it right now but I do not think it is a viable career choice for the long hall.

[Volatile42]

This is stupid! The GI docs pushing this are STUPID and should be ashamed of themselves. I cant imagine endo nurses managing a propofol drip on any given patient, much less leaving it to a machine. Wow.

[SuccsDrugs&Rocuron]

would love to see a "virtual jaw thrust" or a robot intubator~
can u imagine the insane cluster f*ck when the apneic pt starts to code, and no one is there to
handle the code & intubate the pt, there is no positive pressure/ambu-bags in room,
unfortunately, must be a ton of money $$$$ smoozing the FDA officials from the GI doc groups~
oh well, after the first person dies (and they will) maybe things will go back to a safe anesthetic delivered by CRNAs.

(they've already forgotten about poor Michael Jackson...)

propofol is not a benign "dream cream" or "milk of amnesia" but a powerful induction agent that deserves respect & human handling~