The 2008 Baby K has not been approved for Nocturnal Dialysis, yet, it is used for this procedure each and every single day of the year. On the other hand, DaVita claims that NxStage is not approved for Nocturnal or Extended Treatments. Yet, if FDA approval is soooo important, why are they using 2008 K for Nocturnal when it is NOT approved by the FDA??? Someone is talking out of both sides of their mouth.
DaVita uses the Baby K for home nocturnal?
The idea that that a dialysis machine needs a separate indication for home nocturnal is new - 2005 I think was the first time I heard that it was being discussed and I read this document
Yes, they do, as far as I am aware. I know they have not discontinued it for Nocturnal use.
My reader says that the file was damaged, which could mean anything.
Just as NxStage is prescribed for nocturnal off-label, the Baby K can be done so too.
Last I heard from Fresenius, the K@Home will likely be available this summer.
As I understood it, when the FDA told Fresenius it needed to go through the approval process to use the K@Home in patients’ homes, they could continue to use the machines they had in use, but couldn’t put into use any new machines.
Any provider who prescribes a device off label is taking a risk. If a patient had a problem with a device that was being used off label, it’s possible that the patient or his/her family would seek legal action against the doctor who prescribed it, and the facility and manufacturer that provided it. Some providers may be more wary of legal liability than others, which might explain why some do one thing and others don’t. Although reimbursement plays into what patients have access to so far as treatment choices and machines, I doubt providers are denying certain machines because they are evil or to be mean to patients.
My clinic let me start Nxstage extended…as they call it… but I needed to sign a contract…a waiver form… I also looked at the Baby K as its offer here for nocturnal, but this machine is hooked up to a computer monitoring service and I would need to hook up at a certain time every night so they could monitor me… I didnt go for the baby K because of the restricked time element and the fact that I could not take the machine with me… Like Nxstage I can go many places with my machine… I am the first in my area to start Extended… and worked on this for months… I hope that when my clinic is sold to Divita in the next few months, they would make me stop doing extended with Nxstage… we will see… If they do and offer the baby K instead… I will quit Extended and back to day time dialysis… ( really I was already doing nocturnal but it was only for 4.5 hours… I would get up at 2:30 am and get off the machine…) ( my nurse at first told me that I couldnt do this… she said that I couldnt sleep while on the machine… My reply was … I see lots of people who sleep during the day on their machines and you have them right here in your clinic… she agreed and nothing more was said…LOL )
Anyway… Even with the short time Dialysis that I did, I feel so much better than in center… and I am sure I will feel better now with extended…but I feel pretty darn good now… its like I am not sick at all…Loving Nxstage…