FDA approval for nocturnal txs

I had wondered if NxStage is close to being FDA approved for nocturnal txs, but learned they are only now entering into trials, so assume approval will not take place anytime soon. I also learned that none of the other model machines that are used for nocturnal txs are FDA approved for this purpose- the physician must prescribe the txs “off label”. Can someone explain what this means for a nephrologist or dialysis corporation as far as their liability and costs?

The FDA regulates what can be marketed and how but the actual practice of Medicine is directed by doctors and is left to their judgment. Here is a link to a Word document (here is a link to a PDF version on HDC) that outlines what was discussed at a June 2005 meeting of the Gastroenterology and Urology devices panel of the FDA’s medical devices advisory committee.

These documents provide a background to understand what is being discussed and what a device would have to address to get FDA approval to be marketed as a nocturnal device. Here is a review of the meeting by an industry newsletter (PDF link) with a bit of information about what was discussed:

FDA Panel Discusses Nocturnal Hemodialysis Devices
On June 8, FDA’s Gastroenterology & Urology Devices Panel discussed future draft guidance on premarket requirements for nocturnal hemodialysis devices. Nocturnal hemodialysis is administered without medical personnel supervision, as compared to traditional hemodialysis. The panel stressed the importance of considering human factors and the sufficiency of alarms for reducing the risk of user error due to greater patient responsibility for treatment. One member of the panel maintained the risk of disconnection presents the most serious problem with nocturnal dialysis, highlighting the need for additional safeguards over and above those for traditional hemodialysis. While devices have been used off-label for overnight use in the home, a hemodialysis device has not been specifically indicated for nocturnal use.

The question the FDA seems to be addressing is what safety and usability features would a machine have to have in order to be marketed as a Home Nocturnal machine.

As far as liability and law suits - someone can always sue someone for just about anything but generally lawsuits having to do with off label use of drugs involve the marketing of off label usage by the medication manufacturer.

It is my impression that the dialysis machine manufacturers are careful about not marketing their devices as nocturnal home dialysis machines but they do explain that their machines have been used successfully for extended treatments and that dialyzors often choose to do their extended treatments at night and very often they fall asleep.

Here is a link to wikipedia’s article on Off Label use of drugs (it should be written to say drugs and devices).

There are not additional costs per se of providing extended dialysis other than supplemental alarm devices and perhaps additional dialysate costs depending on which system. The liability isn’t really any different than using a device on label - if a unit sent someone home for conventional dialysis who was not able to safely dialyze there would be no decrease in liability because the machine is approved for home conventional dialysis.

[QUOTE=Bill Peckham;15332]The FDA regulates what can be marketed and how but the actual practice of Medicine is directed by doctors and is left to their judgment. Here is a link to a Word document (here is a link to a PDF version on HDC) that outlines what was discussed at a June 2005 meeting of the Gastroenterology and Urology devices panel of the FDA’s medical devices advisory committee.

These documents provide a background to understand what is being discussed and what a device would have to address to get FDA approval to be marketed as a nocturnal device. Here is a review of the meeting by an industry newsletter (PDF link) with a bit of information about what was discussed:
The question the FDA seems to be addressing is what safety and usability features would a machine have to have in order to be marketed as a Home Nocturnal machine.

As far as liability and law suits - someone can always sue someone for just about anything but generally lawsuits having to do with off label use of drugs involve the marketing of off label usage by the medication manufacturer.

It is my impression that the dialysis machine manufacturers are careful about not marketing their devices as nocturnal home dialysis machines but they do explain that their machines have been used successfully for extended treatments and that dialyzors often choose to do their extended treatments at night and very often they fall asleep.

Here is a link to wikipedia’s article on Off Label use of drugs (it should be written to say drugs and devices).

There are not additional costs per se of providing extended dialysis other than supplemental alarm devices and perhaps additional dialysate costs depending on which system. The liability isn’t really any different than using a device on label - if a unit sent someone home for conventional dialysis who was not able to safely dialyze there would be no decrease in liability because the machine is approved for home conventional dialysis.[/QUOTE]

Anyone knows that if a patient went home to do nocturnal, but was not trained sufficiently, it could be an accident waiting to happen. The training is essential, but once trained, if the patient uses strict care, he will be safe. So, what is there that the FDA has to figure out to approve nocturnal txs? Are machines used for SDD txs approved by the FDA, because most of the same safety measures apply? It’s not the length of the tx or whether the patient is asleep or awake that is the danger- it’s the competency of the training and the patient’s diligence to adhere to it that makes for safe txs.

Re my question on physician or corp liability, I meant do they see nocturnal therapy as something they do not wish to take on as it could hit them too hard in the pocket if there is an incident, or are they more than covered? Or, is it that they fear it will hurt their reputation if a patient gets hurt or dies at home, because patients routinely get hurt in-center right under a nurse’s care, so why would it be any different at home?