I would like to know how clinics that offer nocturnal txs do so. I know this has been answered in posts in the past, but I am taking this to my clinic, so am hoping to get some current replies in this thread that I can share with them. Here’s some questions I have:
I have read that none of the existing machines are FDA approved for nocturnal length txs- is this accurate?
If the machines are not FDA approved, how are clinics offering nocturnal txs?
Whose liability is at risk if a nocturnal patient gets hurt?
Re NxStage, this co. will not answer any questions on nocturnal from nurse trainers, so where would nurse trainers get support to run patients nocturnally?
Is it possible to find out which clinics in the country offer nocturnal txs on NxStage?
I’m not sure it’s accurate to say that the FDA has not approved any machines for “nocturnal-length” treatments. As far as I’m aware, any machine currently on the market could be used for a 7 or 8-hour treatment that is done during the day. The issue comes in when nocturnal treatments are done at night while folks (and presumably home HD partners) are sleeping. The FDA has not yet looked at any machines for this specific purpose yet. It is certainly our fervent hope that when and if they do, that they will take into consideration a safety record that dates back 40 years–and compare it to the known risks that occur each year in dialysis centers where patients are “supervised” and yet incidents still occur.
If the machines are not FDA approved, how are clinics offering nocturnal txs?
At this point in time, the issue is not whether a machine is FDA approved for nocturnal treatments–none of them are. The issue is whether machines are FDA approved for home, which requires studies in addition to those needed to just get a machine on the market. The Renal Solutions Allient Sorbent machine, for example, is undergoing this research right now. It will be very flexible as to treatment length once it is available for home use–which can be handy for switching between short daily and long nocturnal.
Whose liability is at risk if a nocturnal patient gets hurt?
I can’t tell you how much I hate this question. Since when is someone else always at fault if someone gets hurt? I fell and broke my ankle last summer because my daughter was cleaning the kitchen floor and I ran across it. Should I sue her? My homeowner’s insurance? Myself? Each year, tens of thousands of U.S. in-center dialyzers die from any number of causes, including things like infections that could have been prevented, needles that fell out so folks bled to death, etc. Do they all sue? (A few do, no doubt, and some have good reason for it). Still, sometimes accidents just happen, and adults who choose to do home therapies do take on some responsibility. IMHO, that doesn’t include a built-in right to sue someone if something goes wrong. But then, you can probably tell that you’ve hit a hot button. Beth and I have done some searching and not found any incidences of any programs getting sued over someone getting hurt doing nocturnal HHD (or other HHD). But there have been plenty of lawsuits related to in-center care. If a center is worrying about its liability re: nocturnal, it is looking in the wrong place.
Re NxStage, this co. will not answer any questions on nocturnal from nurse trainers, so where would nurse trainers get support to run patients nocturnally?
I would presume that this is pretty much a simple matter of adding a heparin pump and figuring out the fluid goal/time, but maybe Bill P or someone else who does this could address that question.
Is it possible to find out which clinics in the country offer nocturnal txs on NxStage?
Dori,
Thank you for your answers, but what I mainly need to know is what the liability issues are. Apparently, some professionals think there is risk to their license if patients do nocturnal length txs while they are asleep at night. As you said, you and Beth couldn’t even find a case where a home hemo patients of any modality had sued. First of all, whose liability is on the line if a patient gets hurt on a SDD tx and sues? Secondly, how is it any different if a patient gets hurt on a night time nocturnal tx?
If I am understanding you correctly, machines are not FDA approved for particular length txs or if the patient is sleeping or awake- the machine is simply approved for home txs. So, someone has to be liable if a patient gets hurt. My question is, who is that- the machine co., the nephrologist, the nurses? And how is the liability different for in-center vs home txs? I am trying to understand why some clinics offer SDD and SNHD while others will only offer SDD, but not SNHD as far as liability is concerned.
I’m not sure there is any logical accounting for the actions of attorneys, Jane. Their job is to reduce exposure to risk. Unfortunately, they mostly fail to realize that there is virtually always more risk in-center than at home, and it may or may not be possible to change their minds based on data. Any liability coverage would need to be held by the dialysis center and the doctor just as it would be for ANY other dialysis patient.
What makes you so certain that liability is even the reason for some centers to offer short daily but not nocturnal treatments? In the U.S., short daily seems to be a stepping-stone to nocturnal, at least in WellBound’s experience. So, it makes sense that there would be more daily than nocturnal programs.
Also, in a “breastfeeding vs. bottlefeeding” sense, there is a specific machine for daily, while nocturnal can be done with any machine. So, there is much more marketing going on around daily than nocturnal therapies. More people know about daily, so there are more programs. This may or may not change over time, but no-one has ever told me that liability is an issue for offering or not offering nocturnal vs. daily–and folks tell me lots of things.
Well, with all “noctural” dialysis being performed off label I think the bottom line would be that the clinic/nephrologist who has decided to order it would be the point person/people. The reason I say this is until the FDA approves any machine for nocturnal use they would be able to point out that their labeling does not include nocturnal applications.
[QUOTE=Dori Schatell;15572]I’m not sure there is any logical accounting for the actions of attorneys, Jane. Their job is to reduce exposure to risk. Unfortunately, they mostly fail to realize that there is virtually always more risk in-center than at home, and it may or may not be possible to change their minds based on data. Any liability coverage would need to be held by the dialysis center and the doctor just as it would be for ANY other dialysis patient.
What makes you so certain that liability is even the reason for some centers to offer short daily but not nocturnal treatments? In the U.S., short daily seems to be a stepping-stone to nocturnal, at least in WellBound’s experience. So, it makes sense that there would be more daily than nocturnal programs.
Also, in a “breastfeeding vs. bottlefeeding” sense, there is a specific machine for daily, while nocturnal can be done with any machine. So, there is much more marketing going on around daily than nocturnal therapies. More people know about daily, so there are more programs. This may or may not change over time, but no-one has ever told me that liability is an issue for offering or not offering nocturnal vs. daily–and folks tell me lots of things.[/QUOTE]
Dori,
I had the opportunity to speak with some nurse professionals re their concerns/fears in re to SNHD. Not knowing enough about this home modality, they have the concept that SNHD is risky because it is not FDA approved and it is not safe as the patient is asleep, so they feel the liability would be greater and their license would be at risk if the patient got hurt. Is the nurse’s license at risk when a home patient is hurt?
I’m surprised no one has told you what these nurses told me. They were adamant that they felt their license was on the line when it came to SNHD and the co. didn’t want the risk. So, would it be then the companies that do offer SNHD are more squared away on the facts and willing to take the risk as they do not see it as anymore a risk than in-center?
Do you and Beth ever counsel clinics on starting SDD programs including SNHD? Or do you know of any existing programs I can contact who would share with me their philosophy on offering both SDD and SNHD, or would they only speak with nurse professionals?
Unregistered, once any product or medication is approved by the FDA, it can be used for any purpose by a prescribing doctor. (It CANNOT, however, be PROMOTED for off-label use). As long as such use is reasonable and customary–which would be fairly easy to argue given the tremendous growth in these programs–I don’t think anyone would be at any greater liability for prescribing nocturnal than standard HD.
If anything, IMHO, there is a preponderance of evidence suggesting that standard in-center HD is a poorer therapy with worse outcomes. It is certainly “usual and customary,” but that doesn’t make it good.
I don’t understand why we can’t just act like “adults”. Those of us who have chosen to do our own “self-dialysis” at home, with or without partners, have taken the responsibility for our own lives. Even if a machine malfunctions during a treatment, we should have the where-with-all to be able to get off ourselves, or with the aid of our “partner”. The same would be the case in a center if a machine, malfunctioned. In that case the tech or nuse are responsible. But by agreeing to “self-care”, we have relieved the center of that liability. It should be the same case with our “home” nurses. They are not present as we treat and should not have any culpability in case anything goes wrong. Hopefully, we’ve been trained properly, and if not, we should accept some of the blame. As adults, we have all had the opportunity to ask whatever questions we’ve wanted, and hopefully have gotten the appropriate answers. So whether you’re dialyzing on SDD or NHHD, you’ve take the riens in your own hands. And what’s the difference between dozing for an hour on SDD or sleeping through the night on NHHD? You’re still not awake in both cases.
I truly believe the MD is at far more risk than an RN, and have NEVER heard of either having any sort of licensing issues related to the practice of home vs. in-center HD. Paranoia abounds, however, especially among those who don’t know much about the therapies. We’ve been able to document more than 178% growth in nocturnal clinics in our database since 2004 (and we’re likely missing some). Do you really think that anyone would open such a program if it made them liable for patients’ problems at home, in our litigious society? Or that they hadn’t thought of it? I don’t think so.
I’m surprised no one has told you what these nurses told me. They were adamant that they felt their license was on the line when it came to SNHD and the co. didn’t want the risk. So, would it be then the companies that do offer SNHD are more squared away on the facts and willing to take the risk as they do not see it as anymore a risk than in-center?
That would be my guess. Also, nurses are invaluable to home HD programs–but they don’t necessarily tend to start them. Doctors do. So, I’m not sure that nurses are the right folks to talk to about this.
Do you and Beth ever counsel clinics on starting SDD programs including SNHD?
We’ve certainly both talked to folks who were thinking of starting programs, but mainly referred them to the consultants who keep a presence on our “Start a Program” page. As far as who might be willing to talk with you, you’d have to call and ask them.
My thinking is that certainly there is a way for those who start home programs, including nocturnal txs, to be protected or they wouldn’t be doing it. I am just trying to gather the facts of how this is accomplished, because I learned from these nurses that the thinking of the corp. is that SNHD is too much of a risk until it becomes FDA approved, and that in turn makes the nurses fear for their license if nocturnal was offered before it is FDA approved.
Yes, I would think that it is the MD who starts the programs, not nurses, but I don’t fully know who gives the go ahead when a corp. owns the clinic. The MD may want a program, but would think the corporation has to authorize home hemo programs. They might give SDD a try, but then fall back into the same rut of having something convenient and nocturnal then becomes the boogie man tx. It seems that until the whole mindset changes and everyone involved realizes that SDD is a superior tx and SNHD is even better, that clinics may take the step of offering SDD, but not SNHD. I do know that they’ve figured out that home txs of all types are more profitable than in-center txs. In my discussions with the professionals I am trying to dispel the myths.
I can see where the nursing professionals are coming from. It’s put on them to get a program going. They are already overworked. The machine companies will not offer support when it comes to nocturnal. This is brand new territory to them. They doubt their own ability to be of support to patients re the nocturnal modality that they are unfamiliar with. They have the mistaken idea that their license is on the line if a patient gets hurt. It would take some pretty confidant nurses to want to attempt more than SDD- even that is a big stride for them.
I guess my next step will be to try to contact some clinics that offer nocturnal and inquire how they got set up to do it. If anyone has any suggestions of who I can call that’s the direction I’m headed in.
Hey, Jane. I was pondering the phrase “FDA-approved” this morning, and perhaps that’s where some of the confusion lies. The converse of FDA-approved, in this case, is NOT “FDA-disapproved,” it’s really that the FDA has not yet chosen to even look at this area. But I’m getting the sense that folks are interpreting it as, “This is something the FDA does not approve of.” That’s not accurate and would lead to the sorts of fears you’ve described.
The FDA only has the jurisdiction to approve medications and medical devices–there’s not really a mechanism for them to approve treatment modalities themselves. So, there is actually not even a way for them to “approve nocturnal home hemo.”
Corporations–DaVita and Fresenius–have been among the leaders in starting in-center and home nocturnal programs. They are notoriously litigation-shy. If there was a problem with nocturnal, they wouldn’t offer it.
Jane,
When we first started nocturnal home dialysis we used the Freni machine. We were and still are watched on the internet. We have hookups that allow observers to see what the machines are doing like alarming etc.
When we went to Nxstage we are also watched by observers. Right now there are only (4) of us I believe that are doing nocturnal Nxstage because of software capabilities only allowing 4 to a screen (window) Nxstage is supposed to be working on that. The rest of our Nxstagers (about 35) are running just like everyone else and doing 2-3.5 hrs a day. They have to do run sheets etc.
I have a run sheet that I report beggining and ending stuff like weight, BP Temp and weight and goal.
We are in upstate NY and the only center in our surrounding area that is doing either regular nocturnal, Nxstag or nocturnal nxstag.
Hope thid helps.
Pat
Wow what a thread. Thanks Jane for getting it going or restarted it.
There has been so much posted I would have Quote almost everyone post…
As to Davita doing nocturnal they might be letting folks do nocturnal on some machines. (Davita has a # of machines open to home hemo)But while I was with them they were not letting folks do nocturnal on Nxstage. I left Davita and hooked up with Wellspan out of York Pa. A small non profit, that is hooked to a host of other health modes. Hospital ETC.
AS to doing nocturnal on nxstage I’m doing and have been since 05/05/07. They are extra things a person must do to sleep good. Alarms on the hook up site etc. I can’t see going back to sdhh.
Yes this has been a very informative thread…wondering what Dr Agar would have to say about some of the questions posed here…perhaps Dori could ask him in Orlando… also looking forward to hearing about what Dr Mike Copland has to say about Home Hemodialysis here in Canada… and Dr Kliger’s progress report on the NIH study
[QUOTE=Pat Colongione;15586]Jane,
When we first started nocturnal home dialysis we used the Freni machine. We were and still are watched on the internet. We have hookups that allow observers to see what the machines are doing like alarming etc.
When we went to Nxstage we are also watched by observers. Right now there are only (4) of us I believe that are doing nocturnal Nxstage because of software capabilities only allowing 4 to a screen (window) Nxstage is supposed to be working on that. The rest of our Nxstagers (about 35) are running just like everyone else and doing 2-3.5 hrs a day. They have to do run sheets etc.
I have a run sheet that I report beggining and ending stuff like weight, BP Temp and weight and goal.
We are in upstate NY and the only center in our surrounding area that is doing either regular nocturnal, Nxstag or nocturnal nxstag.
Hope thid helps.
Pat[/QUOTE]
Pat,
Could you find out if your nurse trainer would be open to speaking with me to help me understand the liability issues of offering nocturnal txs? Is your clinic a for profit or non-profit, privately owned? Is your clinic involved in a trial using NxStage for home nocturnal txs?
Wow what a thread. Thanks Jane for getting it going or restarted it.
There has been so much posted I would have Quote almost everyone post…
As to Davita doing nocturnal they might be letting folks do nocturnal on some machines. (Davita has a # of machines open to home hemo)But while I was with them they were not letting folks do nocturnal on Nxstage. I left Davita and hooked up with Wellspan out of York Pa. A small non profit, that is hooked to a host of other health modes. Hospital ETC.
AS to doing nocturnal on nxstage I’m doing and have been since 05/05/07. They are extra things a person must do to sleep good. Alarms on the hook up site etc. I can’t see going back to sdhh.
BobOBrien[/QUOTE]
Your welcome, Bob. Same as I asked Pat, can you find out if your nurse trainer would be willing to speak with me about the liability issues of doing nocturnal on NxStage? Is your clinic involved in a trial using NxStage for home nocturnal txs? I am glad you have found your nitch with nocturnal txs and if I was given the opportunity to do nocturnal, I bet I wouldn’t want to go back to SDD either. SDD is a superior tx to in-center and I’m very grateful for it, but it’s a time robber in that it interferes with daytime or evening activities.
[QUOTE=Dori Schatell;15585]Hey, Jane. I was pondering the phrase “FDA-approved” this morning, and perhaps that’s where some of the confusion lies. The converse of FDA-approved, in this case, is NOT “FDA-disapproved,” it’s really that the FDA has not yet chosen to even look at this area. But I’m getting the sense that folks are interpreting it as, “This is something the FDA does not approve of.” That’s not accurate and would lead to the sorts of fears you’ve described.
The FDA only has the jurisdiction to approve medications and medical devices–there’s not really a mechanism for them to approve treatment modalities themselves. So, there is actually not even a way for them to “approve nocturnal home hemo.”
Corporations–DaVita and Fresenius–have been among the leaders in starting in-center and home nocturnal programs. They are notoriously litigation-shy. If there was a problem with nocturnal, they wouldn’t offer it.[/QUOTE]
So then, does that mean that no machine is FDA approved for SDD txs either- just that machines are approved for home use with nephrologists deciding how long txs will run? Does DaVita and Fresenius offer nocturnal at home with NxStage or only with other make machines?
What it means is that each machine is separately approved by the FDA for in-center and/or home use. (Home use approval takes an extra study). The Aksys PHD was limited to treatments of a certain length, because the manufacturers included that limit when they submitted it to the FDA. So, it could only be used for short daily while it was on the market. Other machines aim to demonstrate flexibility in treatment times to the FDA, so they can be used for treatments of, say, 2-8 hours. I’m not sure what NxStage’s FDA submission said in that regard. The FDA has not addressed the issue of nocturnal treatments at ALL with any machine.
Fresenius does not use NxStage for the most part, because they make their own machines. DaVita uses Fresenius machines and NxStage. I don’t know if they use NxStage for nocturnal or not, since it needs a separate heparin pump. Northwest Kidney Centers apparently does let folks use NxStage for nocturnal, since Bill P is doing that.
[QUOTE=Dori Schatell;15593]What it means is that each machine is separately approved by the FDA for in-center and/or home use. (Home use approval takes an extra study). The Aksys PHD was limited to treatments of a certain length, because the manufacturers included that limit when they submitted it to the FDA. So, it could only be used for short daily while it was on the market. Other machines aim to demonstrate flexibility in treatment times to the FDA, so they can be used for treatments of, say, 2-8 hours. I’m not sure what NxStage’s FDA submission said in that regard. The FDA has not addressed the issue of nocturnal treatments at ALL with any machine.
Fresenius does not use NxStage for the most part, because they make their own machines. DaVita uses Fresenius machines and NxStage. I don’t know if they use NxStage for nocturnal or not, since it needs a separate heparin pump. Northwest Kidney Centers apparently does let folks use NxStage for nocturnal, since Bill P is doing that.[/QUOTE]
The following is from the FDA submission dated July 31, 2006:
>The NxStage System One is indicated for the treatment of
acute and chronic renal failure or fluid overload using
hemofiltration, hemodialysis, and/or ultrafiltration, in an acute
or chronic care facility. The System is also indicated for
hemodialysis with or without ultrafiltration in the home.
All treatments must be administered under physician’s
prescription, and must be observed by a trained and qualified
person, considered to be competent in the use of this device
by the prescribing physician.<
The submission does not seem to limit the use of the System One to a particular tx length.
I don’t think anyone at my center would be of any help. Some really don’t like the idea of home dialysis at all but since it is a job. And some who know of this site don’t trust what is posted here, they have told me not to take what I read here as being the truth, Sorry
Beth and I have done some searching and not found any incidences of any programs getting sued over someone getting hurt doing nocturnal HHD (or other HHD). But there have been