Is anyone currently using the Baby K machine for SDD or SNHD txs? Would like to know what you think of it as far as the amount of time involved setting up, maintenance issues and how pleased you are with the technical service?
It’s my understanding that the K@Home (otherwise known as the Baby K) machine is off the market for now.
That would be temporary, Jane–Fresenius needs to get a home approval from the FDA for it, but that process is likely underway. Fresenius also bought Renal Solutions, which has the Allient Sorbent machine and is doing testing right now to get home approval for it. The Allient Sorbent uses just 6 liters of water to make dialysate using a multi-layered cartridge, and doesn’t need any special wiring. So, that will make it much easier for folks to set up at home–even if they have well water or rent an apartment.
How is it that the Baby K could be on the market and then off the market? I am interested to understand more about how FDA approvals work. Someone explained to me that the machine companies run trials, and at the end of the trials, the FDA decides if their machine will get approval. But what does the word approval mean? Because I have also read that the FDA does not approve machines.
Is the Baby K going through a trial for SDD or SNHD? Same with the Allient Sorbent- which modality/s will it be trialed for? I think I read it took NxStage about 18 months to get FDA approval for SDD and now they are trying to do the same thing for nocturnal. My interest at the current time is a machine that will be approved for nocturnal. And I am trying to find out how the 300 programs that are offering nocturnal txs are doing it if no machine has FDA approval for nocturnal. I’ve heard that they simply do so by nephs writing the machines off-label. The question I want to know is, why would some nephs do this, while others won’t touch it with a 10 foot pole? Who assumes the liability- nephs, corporations, nurses? Or could patients be signing something freeing them from liabilty?
The FDA approves medical devices (e.g., dialysis machines) and drugs–that’s its job. The FDA does not approve types of HD therapy. That’s the doctors’ job.
The Baby K was on the market–approved by the FDA–for years. When the Aksys PHD machine was designed as a home-only machine, they had to jump through an additional hoop: a study of the machine in the home to be sure it was safe. So, that machine got a home dialysis approval.
Having one machine with a home dialysis approval raised the bar for other home HD machines. So, when the NxStage System One machine came on the market (for use in acute dialysis–and at home), they did a home study to get both regular approval and home approval. The Allient Sorbent machine by Renal Solutions is doing the same.
Probably Fresenius thought the Baby K was “grandfathered” in, because it had been on the market prior to the Aksys PHD. Apparently the FDA disagreed, so now they may jump through that hoop. I have no idea if they are looking at the Baby K for daily or nocturnal in particular–the issue is home.
No machine is “FDA-approved” for nocturnal. It is not up to the FDA to approve a therapy. We had a whole thread on this already (that you started), so I’m not going to address it again here–nothing has changed since then that I know of. http://forums.homedialysis.org/showthread.php?t=1740
Went to the thread- I take in so much info each day that I completely forgot I even started a previous thread or what was covered there lol. Ok I see what you are saying here- the FDA does approve machines and does give approvals for home use, but leaves the HD modality up to nephrologists. Now this is the part I am confused about as I was told by my home program nurses that NxStage is FDA approved for SDD, but not SNHD. Other patients on the net are saying the same thing- their clinics will not allow them to use it for SNHD txs. until the FDA approval for nocturnal takes place. When I asked NxStage about this, I was told that they are currently doing a trial to try to get SNHD approval, just as they previously did to get FDA approval of SDD. So, this seems to be different from what you have said.
My nurses’ contention is that the corp feels it is unsafe to use a machine off-label, and the nurses feel their licenses would certainly be at risk if they did. So, what I am trying to find out is, then why are there currently 300 nocturnal programs? The patients I know who are using NxStage nocturnally at home are all in non-profits.
That is pretty funny! One of those days? 
When I asked NxStage about this, I was told that they are currently doing a trial to try to get SNHD approval, just as they previously did to get FDA approval of SDD. So, this seems to be different from what you have said.
Not exactly. Right now, there is no such thing as a machine “FDA-approved” for nocturnal, but NxStage is trying to get an approval for what they are calling “extended hours” dialysis. If they succeed, they raise the bar again, and since the FDA seems to not want to grandfather in other machines, everyone else will have to jump through a NEW hoop. Keeping folks on their toes–NxStage is very good at that! 
My nurses’ contention is that the corp feels it is unsafe to use a machine off-label, and the nurses feel their licenses would certainly be at risk if they did. So, what I am trying to find out is, then why are there currently 300 nocturnal programs? The patients I know who are using NxStage nocturnally at home are all in non-profits.
A.It is NOT off-label to use NxStage for nocturnal. It is also not ON label. Right now, there IS no label. Since it is NOT off-label, nobody’s license is at risk, IMHO. (Of course, my opinion counts for about what you just paid for it–I’m not an attorney, let alone a risk-averse corporate one). We are not aware of any lawsuits related to nocturnal dialysis at all, and certainly not to “off-label” use or licensure issues. (There are plenty of lawsuits related to in-center HD, though. Folks worrying about their licenses should look there!)
B. The current 300 nocturnal programs use whatever machines are already out there–mostly Baby K’s, or regular K’s, or BBraun Dialogs. (See A). There are both for-profit and non-profit nocturnal programs.
The problem is, nothing is going to convince corporate lawyers that ANYTHING is safe and free from risk. It’s amazing that they tolerate folks driving to and from dialysis (Who knows what could happen? Folks could pass out and cause a 42-car pile-up! We’d be liable!). The fact that there ARE 300 nocturnal programs should be a sign that it’s certainly possible, but some folks will just not look at signs. (They are probably causing 42-car pile-ups. ;-))
Sometimes I feel like I’m in that 42 car pile-up ARGH!!!.. since I can’t move ahead in my care until my clinic grants me permission to go to the optimum level with my txs. There’s nothing worse then feeling stuck or held back re one’s care. It’s like there’s a big carrot right in front of me, yet I can’t grab hold of it due to the usual corporate politics.
In fairness, I do see their point about liability issues. Whether problems with nocturnal txs are more likely to occur or not, anything is possible with dialysis txs. So, they have the right to protect their liability. But the point is, if there are 300 other nocturnal programs in this country, surely there are safeguards in place in order that these programs are free to operate.
I read recently of a patient who has been doing nocturnal txs. for 30 years! The technology has been around at least that long and patients like the one mentioned have flourished. So, I’m back to where I left off- the question is simply, HOW are the programs that are offering nocturnal doing it? And for that I will have to go to the horses’s mouth.
If you happen to run into anyone in such a program, please inquire for me. I am still trying to get some referrals on who to call. One person so far, who does nocturnal through a non-profit, has offered to put his nurse in touch with me. Like you said, nocturnal is not off-label and it’s not on-label- 300 clinics have found a way to offer it- my mission is to make contact with some clinics that are nocturnal proponents to see how they are able to offer it while other clinics consider nocturnal OFF LIMITS…
A brand new update says that Fresenius lost a patent battle with Baxter over the display on the 2008K (regular K) dialysis machines–which have an estimated 90% market share. Read all about it: http://www.renalbusiness.com/hotnews/fresenius-2008k-violates-baxter-patents.html
Wow, what a mess! What will happen to all the patients who are on the 2008K both in-center and at home? Will they be given any grace or will the machines be withdrawn immediately?
This case was in the U.S. District Court and decisions can be appealed. Apparently this is what Fresenius plans to do according to the last paragraph in the article:
Fresenius, however, said it will appeal the ruling and will develop a back-up design while the legal process continues so it can continue to sell the 2008K machine in 2009. The dialysis provider said it expects no major impact on its dialysis machine business. In the appeal, Fresenius is looking to reinstate a July 2006 jury decision that patent claims against its touch-screen interfaces for dialysis machines were found to be invalid. Fresenius also notes the fact that the U.S. Patent and Trademark Office rejected claims that the Baxter patents are invalid, which the company believes will bolster its chances to appeal.
Worse case scenario, Fresenius will have to pay a 10% royalty for any machines it sold from November 7, 2007 until it develops a new screen, which the article says Fresenius is working on now. The win is important to Baxter because Fresenius has 90% of the market in dialysis machines and it could mean lots of money to develop other products. Patent infringement lawsuits happen all the time. Sometimes companies win and sometimes companies lose. A loss typically means money exchanges hands. It doesn’t mean that machines will be removed from patients’ homes or from dialysis facilities where most of the Fresenius machines are used.