An FDA dispute panel will hear an appeal from Ethicon Endo-Surgery this month.
Ethicon Endo-Surgery is the manufacturer of the Sedasys computer-assisted sedation system. They will appeal the denial of its pre-market approval application before an FDA dispute resolution panel.
The Sedasys device is intended to replace an anesthesiologist or CRNA when IV anesthesia is performed. It is for delivering intravenous propofol, better known of late as Milk of Michael Jackson.
It lets gastroenterologists and their nurses administer propofol during colonoscopy and endoscopy without an anesthesia provider present. As might be expected, the anesthesia community is up in arms.
Anyone who can read the label on a bottle of propofol knows better. The only folks that should be giving propofol are anesthesiologists, or CRNA’s and AA’s under their direction.
I have a suggestion. Why not seek out Conrad Murray’s endorsement? He sure is going to need the money. When the judge rules on damages in the MJ case, it could top 100 million.
Just re-brand the Sedasys as the Conrad Murray Home Propofol Infuser. Rent it out to Hollywood types for $150,000 per month and kick the good doctor back 10%. Label it Not for Human Use, and you won’t even need FDA approval.