NxStage Question

Discussions for Patients, Family, and Friends HD For Patients
1

I believe I will be giving the NxStage machine a try in the next few weeks and if my clearances are good will be switching from the Fresenius. I remember someone posting recently that NxStage has a new high flux dialyzer. My question is: What is it called, or what is its number so I can be sure I am getting the new setup.

For those who wonder I am hoping to change for the faster set up and clean up and for the ability to travel.

Thanks

Cathy
home hemo 9/04
PKD

PS my clinic is opening another new home unit in Milpitas CA. They are getting a lot of new patients. They already have clinics in Modesto, San Jose, San Carlos and Emeryville.

2

Interesting Cathy. Does this mean that NxStage will support self-dialyzers?

3

Sadly no, my sister has agreed to train, really only emergency as I will still do everything myself.

I think it is ridiculous that the manufacturers set limits like needing a helper, they refuse to allow us the opportunity to make our own choices in spite of my willingness to sign any kind of waiver requested.

Cathy

4

Since experienced NxStage users are capable of doing everything themselves, don’t you think that it is primarily for safety/law suit protection for the company, and secondarily for the safety of the users? Accidents and emergencies though rare, do happen. Therefore, the company really has no choice but to stipulate that the user have an experienced “helper” present. (They may suspect that some patients will on occasion be alone while on their machines because they are so well designed.)

5

don’t you think that it is primarily for safety/law suit protection for the company, and secondarily for the safety of the users? Accidents and emergencies though rare, do happen. Therefore, the company really has no choice but to stipulate that the user have an experienced “helper” present.

As I said I am more than willing to sign any kind of waiver so, no, I don’t think it has to do with law suit protection. Accidents and emergencies happen true, people die even with helpers. There has never been a death (and yes I’ve searched and searched) with someone doing self dialysis, and there are quite a few.

As I’ve said many times before, when you have a healthy dialysis person, who doesn’t have problems and knows what to do if she did, I do not believe there is an increased risk of doing self dialysis. I mean really, those doing nocturnal have their helper sleep through dialysis often in another room, those doing short daily with helpers seldom have their helpers in the room while doing dialysis. The only real risk I see is a heart attack or stroke happening during dialysis, and to be honest these things could happen off dialysis I don’t see dialysis increasing the risk and if you are alone most of the time then why insist on someone being there for dialysis.

I am not advocating self home dialysis for patients who are not generally in good health and well trained, or anyone who has problems on dialysis, although generally I think people have less problems on home dialysis simply because you are in control of your treatment and and immediately take steps if you feel your b/p dropping or cramping begins.

So NO, I do not think they have to insist a helper be available. Personally I think diabetes is a very dangerous disease, so maybe no one should be allowed to treat their diabetes unless they have a helper since low and high blood sugars are so dangerous. Of course no manufacturer of glucose testing machines or pumps or anything has ever insisted on this, so why do the dialysis machine manufacturers have a right to insist on this, it should be up to the clinic, doctor and patient, I do not believe the manufacturers legally have a right to do this, but don’t feel like challenging it in court right now.

Cathy
self home hemo 9/04, never a problem
PKD
looking to switch to NxStage but must inconvience my sister in order to do so

6

NxStage’s inHouse dialyzer has always been a highFlux, but just recently they’ve updated their high-flux dialyzer to have better clearance than the previous one that was being used…

On the other hand, NxStage System One has another cartridge option that lets you use other dialyzers…If you look at my site’s gallery you can see a pic there of the cartridge…

NxStage Gallery!

Btw, your reffering to WellBound right?

Anyway, hope all goes well for you and I’m sure your gonna enjoy it as much as I do…
:wink:

7

Yes, Gus but is that the only one they now sell or do I have to specifically request the higher clearance dialyzer??

Yes I am talking about Wellbound. It will be tough for me as I love my clinic, but the new one will be significantly closer (I think) so I might change to the new one when it opens next year. Since we both love our clinics I’m guessing they will hire more very knowledgeable and nice staff.

Cathy

8

As I said I am more than willing to sign any kind of waiver so, no, I don’t think it has to do with law suit protection.

One of the reasons why dialysis machine makers say you need a helper when you do home hemodialysis is because the FDA won’t approve any hemodialysis machine without the manufacturer saying that. If you want to advocate with someone about who might be a good self-dialysis patient and who might not, I think it would be the FDA that you need to convince.

I also think that you have to convince dialysis corporations, doctors and nurses. Having worked for years in dialysis, liability IS a huge concern, especially for doctors and dialysis clinics/corporations. Personally, I think many clinics worry about liability much more than they need too. However, in their minds, even if you sign a waiver, a relative might sue for negligence. Even if the suit was found to be without merit, it would cost money for legal fees to get it to that point. And if it wasn’t thrown out, to defend against such a suit would be expensive and time consuming for doctors, nurses, and administrative staff.

I know some patients that dialyze alone. I know others that would be able to do it if their clinics would let them. And I know some that need a helper there because they can’t do it all themselves or they want that added security. Personally, I think patients for most part know their limitations and those that think they could do it alone probably could. Accidents and even deaths happen in dialysis clinics where patients are always under nursing supervision.

9

Beth I do not think the FDA requires a helper for any dialysis machine. I’m not certain and it is always hard to prove a negative but there is this link:
http://www.fda.gov/fdac/departs/2002/402_upd.html
in this blurb the FDA notes that the Aksys PHD " … requires a prescription from a physician and training for the user" there is no mention about training a helper - “the user” requires training.

There is a continuum of helper involvement at all home programs. Some helpers are there to serve dinner, others take responsibility for all elements of the treatment - what exactly is a helper is an open question and I am not aware of an FDA definition. I would be surprised if the FDA has a policy on home hemodialysis helpers.

I, of course, agree with everything Cathy has written. But I felt compeled to post. I really would hate to see another canard about a government agency requiring a blanket policy get accepted as truth. I have noticed that when a policy can’t be rationally justified on medical grounds there is always a government agency to blame/point to – OSHA banning visitors or food for instance. And I have to note that every time a government agency is purported to be the reason behind a ban the secondary reason is “fear of lawsuits”.

Beth I know you want what is best and safe for we home dialyzers but I don’t think making this decision for people is justifiable. Like all blanket policies: bans against self dialyzers are a cop out. It’s easier to simply ban something than it is to honestly evaluate an individual’s abilities and treat individuals as individuals; adults as adults.

10

I don’t believe that OSHA has anything to do with food in clinics and I’ve never heard that OSHA bans visitors. It’s probably protection for the visitors to not be in the treatment area during put ons and take offs so they don’t get blood on them if something unforeseen happens.

I do know that the CDC does not prohibit food in dialysis clinics due to risk of spreading blood borne pathogens. This was the excuse for years…and some may still use it. I talked with Dr. Matt Arduino from the CDC and he debunked that myth for me. I believe food is prohibited for 2 primary reasons – 1) fear that a patient will choke on it and 2) the mess that it can make if someone is not careful which cause staff extra time to clean it up and could lead to bug problems if they don’t – Of course the same thing can be said about staff food messes.

To be honest, I don’t know that the FDA requires a partner and I hope I’m not perpetuating a myth. I have heard this from reps of machine makers when I’ve asked them why patients can’t dialyze alone. I’ve told them that the requirement to have a partner is a huge barrier for single people or those who don’t have a willing partner to overcome and I hate to see them relegated to in-center dialysis if they’re capable of doing home hemo.

Safety is an important issue, but I don’t disagree with Bill that blanket prohibitions due to paternalism should not keep someone who is capable of self-dialysis from proving his/her ability to his/her treatment team. I suspect blanket prohibitions are more likely to occur in larger entities than in smaller ones, but I could be wrong on that too.

11

Oh cool, WellBound has very nice looking clinics…the one in Modesto resembles some nice looking antique looking furniture, making you feel you at home and not in a clinic…

Leaving your old clinic is not easy but your in charge of your health and decisions, always look ahead and not back. You choose what’s best for you and believe me, I know how it feels as I also left my old clinic for a better future…the closer to home the better…

As for the new dialyzer, everyone using NxStage is already using it, so by the time you start your training you will already use it and any new machine updates along the way will also be part of the process.

Personally, I wouldn’t want to use a different dialyzer that you have to connect to the NxStage machine, that increases setup time…but if they need to they will do it…

P.S. Re-Self Care…No doubt about it but how many patients already do alone? Alot alot alot, its the shut up don’t ask policy…BUT the day that comes that an accident or something happens to you and your partner wasn’t around then there’s no liabiltiy for the clinic nor the manufacturers, its all you… :stuck_out_tongue:

12

Yes I’ve heard the food justifications too and Beth I appreciate your work debunking the CDC angle and then with the danger of cell phones. If the FDA has a home hemodialysis policy I think there would be a link to a reference and we’d have seen it by now but I could be wrong - our government has many surprising policies.

The food “issue” is a good example too because it was through personal experience that I figured out the “choking hazard” is over blown. Traveling through Europe and getting served a meal during every run let me know that some other dynamic was at work. I don’t know if it is large v. small entity, or it’s a kind of peer pressure - maybe medical directors go to national conferences and are teased for having units that allow eating.

I think your point about single individuals is very important. If more frequent hemo offers a benefit as measured by mortality what does it mean if 100 single people are dialyzing incenter 3x a week instead of dialyzing more frequently at home? Are these 100 people safer incenter? Healthier incenter? I think statistically one could say that the prohibition against self-dialysis cost lives.

13

I always thought the no food policies down there were officially to prevent hypotension, not choking - but really just to make things easier for the staff and cheaper in terms of cleaning, etc. Luckily, it was never a problem at the centre I went to. You can eat and drink whatever you want. I was even served a full hospital tray when I dialyzed at the hospital a few times. I even ate during dialysis while training. I don’t see what the problem with eating is, unless a person is clearly hypotensive all the time. Why would a person choke on dialysis anymore than at any other time?
Pierre