Update from Boston

[Anonymous]

http://www.mass.gov/eohhs/docs/borim/physicians/pca-notifications/robot-assisted-surgery.pdf

 

[Anonymous]

http://www.mass.gov/eohhs/docs/borim/physicians/pca-notifications/robot-assisted-surgery.pdf

I wonder if MAUDE reporting goes back to 1980s? I'm willing to bet there were similar or worse outcomes/injuries/learning curve related adverse events when laparoscopic surgery was evolving.

Everything noted in the report posted above are valid concerns, and terrible to hear. But they could and do happen every day in open/lap surgery.

Just bc it happens during robotic surgery, it is demonized as if it has never happened in the past. All of these risks are openly discussed and reviewed with patients prior to surgery (no matter what modality that surgeon is using).

 

[Anonymous]

I wonder if MAUDE reporting goes back to 1980s? I'm willing to bet there were similar or worse outcomes/injuries/learning curve related adverse events when laparoscopic surgery was evolving.

Everything noted in the report posted above are valid concerns, and terrible to hear. But they could and do happen every day in open/lap surgery.

Just bc it happens during robotic surgery, it is demonized as if it has never happened in the past. All of these risks are openly discussed and reviewed with patients prior to surgery (no matter what modality that surgeon is using).

There's something fundamentally wrong when 1000s of patients need to be guinea pigs in order for a physician to achieve some sort of learning curve for every new technology that comes out each year. That's bad engineering. I thought robotic surgery was supposed to be 'intuitive'?

 

[Anonymous]

I wonder if MAUDE reporting goes back to 1980s? I'm willing to bet there were similar or worse outcomes/injuries/learning curve related adverse events when laparoscopic surgery was evolving.

Everything noted in the report posted above are valid concerns, and terrible to hear. But they could and do happen every day in open/lap surgery.

Just bc it happens during robotic surgery, it is demonized as if it has never happened in the past. All of these risks are openly discussed and reviewed with patients prior to surgery (no matter what modality that surgeon is using).

Valid point. However, it's pretty clear that there were a lot of misinformed patients and poorly trained surgeons mixed in with the bad outcomes. Intuitive's downfall will be the overstated marketing claims and high-pressure sales tactics that are currently being documented.

 

[Anonymous]

I wonder if MAUDE reporting goes back to 1980s? I'm willing to bet there were similar or worse outcomes/injuries/learning curve related adverse events when laparoscopic surgery was evolving.

Everything noted in the report posted above are valid concerns, and terrible to hear. But they could and do happen every day in open/lap surgery.

Just bc it happens during robotic surgery, it is demonized as if it has never happened in the past. All of these risks are openly discussed and reviewed with patients prior to surgery (no matter what modality that surgeon is using).

I would like to know what the FDA actually does anymore. For medical devices, you're supposed to show testing that proves SAFETY. There shouldnt be surprises when products are launched.

 

[Anonymous]

This is all just a distraction. The robot is safe. When I was at ISI, best practices in attaining competency with the system were always encouraged and clearly communicated to the surgeons, and the hospitals for that matter. It's not ISI's business to dictate to healthcare providers whether someone is knowledgable enough to safely use the machine on a patient. ISI will provide direction and support, but it's up to the providers whether or not to follow through with implementing proper checks and balances in regards to a surgeon implementing the robot.

We've all dealt with the "cowboys" who think they have it all figured out and do exactly the bare minimum required by the hospital (which opted for rather loose robotic credentialing standards, instead of taking ISI's guidance) and then completely botch their first unsupervised case.

ISI's business is to engineer, sell, and support an enabling medical device that in the right hands with the proper training, provides a better minimally-invasive surgical procedure for patients in many cases. They are in no way qualified (and make no claims to be either) to determine a surgeon's credentials or to dictate the proper treatment of the patient.

If a finger should be pointed at anyone, it should be at the physicians who are "experimenting" on patients without knowing how to use the system and the hospitals that allow it. -- And this is coming from someone who was fired from the company, heartless bastards...

 

[Anonymous]

Have you been hurt, injured or experienced a bad outcome due to an Intuitive Robotic procedure? You may be entitled to compensation from damages arising out of the aggressive over use of this modality. A recent finding from the FDA found Intuitive Surgical illegally and aggressively marketed the use of it's product outside of it's FDA indication.

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[Anonymous]

This is all just a distraction. The robot is safe. When I was at ISI, best practices in attaining competency with the system were always encouraged and clearly communicated to the surgeons, and the hospitals for that matter. It's not ISI's business to dictate to healthcare providers whether someone is knowledgable enough to safely use the machine on a patient. ISI will provide direction and support, but it's up to the providers whether or not to follow through with implementing proper checks and balances in regards to a surgeon implementing the robot.

We've all dealt with the "cowboys" who think they have it all figured out and do exactly the bare minimum required by the hospital (which opted for rather loose robotic credentialing standards, instead of taking ISI's guidance) and then completely botch their first unsupervised case.

ISI's business is to engineer, sell, and support an enabling medical device that in the right hands with the proper training, provides a better minimally-invasive surgical procedure for patients in many cases. They are in no way qualified (and make no claims to be either) to determine a surgeon's credentials or to dictate the proper treatment of the patient.

If a finger should be pointed at anyone, it should be at the physicians who are "experimenting" on patients without knowing how to use the system and the hospitals that allow it. -- And this is coming from someone who was fired from the company, heartless bastards...

Well, sorry to hear you got sacked, but im sure you are better off.

That said, there is significant resposibility on the company/reps to deny MDs access to products that they well know are not in the most competent hands. Yes, ISI is responsible to its shareholders first. Unfortunately, the short term win of driving bad usage will be a long term loss for shareholders, patients and providers. This tech, in the propper hands for appropriate procedures, can actually provide a clinical benefit. But ISI f*cked it royally with over selling, empty promises, inflated claims and high pressure sales tactics. You put revenue ahead of patient outcomes. That will only last so long.

 

[Anonymous]

Well, sorry to hear you got sacked, but im sure you are better off.

That said, there is significant resposibility on the company/reps to deny MDs access to products that they well know are not in the most competent hands. Yes, ISI is responsible to its shareholders first. Unfortunately, the short term win of driving bad usage will be a long term loss for shareholders, patients and providers. This tech, in the propper hands for appropriate procedures, can actually provide a clinical benefit. But ISI f*cked it royally with over selling, empty promises, inflated claims and high pressure sales tactics. You put revenue ahead of patient outcomes. That will only last so long.

I'll agree with you that some of ISI's sales tactics are questionable to say the least, however they are in no position to deny a surgeon from using the system to treat their patients as long as the hospital gives the ok.