Anyone have PureFlow Dyalisate fail lab tests?

[silverhead]

Our center has a very strict lab head who does not trust the Pureflow system and wants sterile samples of the Dyalisate, We supplied a sample and they say it failed after a 48 hour bacterial test, made a new batch and the center nurse came out to take the sample this time, to insure complete sterility, just got word that this one failed the test again, so we have been hanging bags and will have to continue until at least Tuesday when they want me to put in a new PurePak and make a batch and take them a sample, then wait a few days until the tests come back, so at least another week on the bags. Anyone else have this problem?........
Tom

[Adam_W]

From what I understand, only the bags are sterile dialyisate, and the Pureflow makes "ultrapure" dialysate, but not sterile. I was told in training that if I get a blood leak alarm and it fails the hemastix test, that I can only give my blood back if I'm using bags, because the Pureflow's dialysate is not sterile. I believe the dialysate used by full-sized machines is also "ultrapure" and not sterile.

Adam

[silverhead]

I sure am going to be demanding some answers on Tuesday, We both want this system to work, it definitely beats going to the center, but Man, these constants hassles and problems do nothing for the stress levels we have been going through.......

[jbeany]

I vaguely remember the NxStage trainer saying that as well - that it was ultrapure, and nearly sterile, but not good enough for the FDA to label it sterile.  I think you need to contact NxStage - your lab tech may be expecting a level of purity that the machine is not capable of.

[silverhead]

Sharon and I have been talking this over since these latest problems, we feel that this Tech needs to learn more about the workings of the PureFlow and Cycler, the fact that there is a blood leak detector to warn of a problem, and also the fact that the last two test samples were taken on day three of the PureFlow cycle, which means they had less than a day to complete all the tests before the 72 hour limit for the Dyalisate had been reached we feel is significant .  They tell us it passes the initial test, but fails the 48 hour test, the 48 hour one tell me that it has been well past it's useful life anyway, so should not be considered as far as I'm concerned......
Also wondering about the fact that they supply a sterile container to collect the sample, but it has to be exposed to the air to get the sample, and they most certainly let more air into the sample while testing, the Dyalisate bags and the PureFlow system are "closed", no air gets to the solution, so no chance for Bacteria to grow, Right?

[Black]

I agree that you need to contact NxStage ASAP, and as jbeany said the tech doesn't know enough about how the Pure Flow works to keep the solution clear of contamination growth.

In March the water in our Pure Flow, while we were in Miami, was being run through a food grade water hose connected to an outdoor faucet in a campground!!!  At home the water is from our well.  Neither of those situations would be acceptable for any other system on the market.  The NxStage Pure Flow has it's own disinfection system and removing the solution from the machine removes it from that system!

The problem appears to be the ignorance of the people at your center, not the NxStage system.  Please contact NxStage ASAP and tell them what is going on.  I do not want an ignorant person starting something about the NxStage system not being safe because the solution is  not "sterile" after they take it out of the system.

[silverhead]

Thanks so much for the replies, We have an appointment with the Home Nurses (who are on our side) at noon tomorrow, hopefully we can include this Head Tech and get some answers, especially if we can make a conference call to NxStage during the meeting.....
Tom

[JerseyGirl]

Whoa, Tiger!  A chief tech with high standards is better than one than doesn't have any!  You can't blame the person for being careful.  Us health care providers can't catch a break sometimes - damned if we do and damned if we don't.  Maybe the guy is new and isn't familiar with bacterial cultures.  Look, they failed twice.  Wouldn't you prefer being cautious?  Maybe the incoming water filter needs to be changed.   I imagine you'd have a canary if the dialyzor developed bacterial sepsis if the staff let it go.  Dialysate itself is not sterile = that is why there is an acceptable colony count range. I am not sure how you collect the samples from the NxStage - is there a port to draw it out via syringe or do you take them from the dialysate connectors?   If the bacterial colony count after 48 hours on the LAL is higher than the acceptable range twice - there could be a few errors - sample collection, incoming water micron filter, etc.   

[silverhead]

No, I do not blame him for being careful, what I have is a problem with him not being familiar with the NxStage system, his not understanding that taking a sample from the "chicken foot" fitting through the air and into a sterile jar, The samples pass the standards for the "immediate"  bacterial tests, but apparently just barely fail the 48 hour test  both these tests were collected near the end of the 72 hour permissible life, running the 48 hour tests after that time has expired  is beyond the limits. I believe he does not understand that the Dyalisate is NOT a sterile solution, but ultra pure, has caused some of these problems with him. I am ultra sensitive to Sharon's well being and will not knowingly expose her to possible harm from Bacteria or anything to influence her well being, but am really sick and tired of hanging bags and not having the use of the PureFlow for over a week, because of someones ignorance about a new system he has never seen before.
Tom

[Black]

I totally agree with Tom.   

I expect everyone involved with Mike's care to be very careful.  Actually, we are more careful than the center staff -- we buy individually wrapped gauze pads to put directly over his buttonholes, instead of the bulk pack which is no longer sterile once opened (one sterile pad directly over the buttonhole and three "non-sterile" on top of that) - we use extra care when washing with the antibacterial soap, high pressure faucet and longer scrub time - we often, when we deem necessary, use the liquid hand sanitizer, instead of the non-sterile gloves the center provides - we use "Sureseals" on his arterial buttonhole instead of the regular band-aids they provide. 

So, it's not a matter of not wanting to "careful", it's that I strongly object to an uneducated and ignorant lab tech second guessing a system which has been proven safe, and subjecting it to tests which do not accurately reflect the actual condition of the solution.

[Hawkeye]

Not knowing the NxStage system I can only tell you what I know of the whole process of dialysate from a Fresenius Technical standpoint.  I can guarantee that the dialysate for a NxStage is not sterile, but then again neither is the dialysate for a full size dialysis machine.  The solution in the bags that are premade should be sterile since it can be produced in a sterile environment.  To be honest I don't know how they can get away with only having a filter system and not having a water treatment system of some type that better cleans the water of contaminants before it makes the dialysate.  The technical staff at a regular center has to do bacteria sampling on a portion of the machines on a monthly basis and if a machine does not pass a 48 hr bacteria test that machine has to be removed from service.  A PM (preventative maintenance - filters, orings, etc replaced) would be done on that machine and it would be disinfected using a 1:100 bleach solution.  A new test would then be drawn and if it comes back with good results after 48 hrs the machine would be put back in service.  Unless you have a really high level of bacteria in your water you will always pass the 24 hr test.  The thing you have to remember is that dialysate is almost 90% water.  A normal person drinks roughly 10-14 Liters of water a week whereas an average dialysis patients blood is exposed to 360 Liters or more per week depending on their treatment length.  That is about 25 times more water that is in contact with your blood instead of just being digested.  If there are high levels of bacteria you could make yourself VERY sick with uncontrollable shaking, chills, fever, nausea/vomiting and low blood pressure otherwise known as a Pyrogenic Reaction. 

There are a few things that can be done to make sure the sample is drawn "clean". 

1. Make sure that the sample cup has a lid that is secure before taking the sample. 
2. Unless the container comes in its own individual sterile bag remember that if the lid is loose or not on at all the container may be contaminated.
3. Do not handle a sample cup unless you are wearing gloves.
4. If at all possible wipe down the area you will be taking the sample from with an alcohol pad and give it 10 min to completely dry before taking the sample.
5. If at all possible open the port that you will be taking the sample form and let it run into a bucket for a few min so you are getting a better representation of the actual sample.
6. While taking the sample always wear a facemask and clean gloves.
7. Never remove the sticker off the top of the sample cup if there if a sticker.  Underneath that sticker is a needle covered by rubber to keep it as clean as possible before the sample is drawn from the container.
7. Make sure that unless it is being processed right away that the sample is kept refridgerated.  A warm sample will start growing bacteria and the sample is then useless.  If someone else is picking the sample up store it in a clean ziplock baggy in your fridge (helps keep contaminants off the sample cup).  If you are bringing it to them buy a insulated lunch bag and a freezer pack to keep it cold while in transport.  Once again I would put the sample cup in a clean ziptop baggy to help keep things clean.  Once at the center they should be putting the sample in their own fridge to keep things cool till it's ready to send of to the lab.

I know this post was a bit long, and I'm sure what you are going through can be extremely frustrating so hopefully this helps get you clean samples.

[Black]

Not knowing the NxStage system ... To be honest I don't know how they can get away with only having a filter system and not having a water treatment system of some type that better cleans the water of contaminants before it makes the dialysate.   ...

That is one of the breakthrough technologies which makes the NxStage system so great.  There is an outside filter which removes large particles.  It occasionally needs to be removed and flushed.  Inside the Pure Flow, is a "Purification PAK" which cleans the water of contaminates before it makes the dialysate.  The Purification PAKs last several weeks and the Pure Flow tells you when it needs to be changed. IF I remember correctly, in addition to physical filtration,  it uses ultra-violet light somewhere in the process to kill organisms which may be introduced with the household tap water.

[Hawkeye]

That is one of the breakthrough technologies which makes the NxStage system so great.  There is an outside filter which removes large particles.  It occasionally needs to be removed and flushed.  Inside the Pure Flow, is a "Purification PAK" which cleans the water of contaminates before it makes the dialysate.  The Purification PAKs last several weeks and the Pure Flow tells you when it needs to be changed. IF I remember correctly, in addition to physical filtration,  it uses ultra-violet light somewhere in the process to kill organisms which may be introduced with the household tap water.

Sounds interesting I may have to look into the operation of this system a little more.  UV lights are great at killing bacteria, but one thing to be careful of if the system does use UV is that the UV bulbs get replaced as required by the manufacturer.  If the bulb does not get replaced as it should you can actually create a super bug when it burns out.

[Black]

I may be wrong about the UV light, but if that is the case, then it will be changed frequently when the PAK is changed every 4 to 12 weeks.  The Pure Flow alerts when it is time to change the PAK

[Adam_W]

I may be wrong about the UV light, but if that is the case, then it will be changed frequently when the PAK is changed every 4 to 12 weeks.  The Pure Flow alerts when it is time to change the PAK

I believe the Pureflow will let you know when the UV light needs to be changed, which requires the whole control unit to be swapped out, and if the UV does burn out, I don't think the PF will let you make a new batch until it's changed.

Adam

[kidney4traci]

Wow, thanks for all the input, there is so much information here that I didn't know about!

[Black]

Spoke to one of the NxStage techs tonight and he said there are various physical filters, some of which filter down to particles which are measured in microns -- I think he said there are a total of 7 filters.  He listed them but I couldn't write fast enough and some of it I couldn't spell.  Then there are two ultraviolet lights in the Pure Flow cabinet, not the PAK, to kill anything which is left.

He advised getting the lab tech to draw the sample himself using sterile technique, immediately refrigerate the sample and keep it refrigerated for only a short time until they begin the test at the lab.  (Hawkeye, you got it almost word for word what he said.  )

The NxStage tech agreed that a conference call on this matter would be a good idea so they can educate the lab tech.  He was very nice and said they would be eager to spread the word about how safe and efficient their system is.

[Hawkeye]

I'm glad you got some answers from NxStage and hope this will resolve your issues.  Keep us posted.

[Black]

I'm glad you got some answers from NxStage and hope this will resolve your issues.  Keep us posted.

I wasn't the one having the issues with the lab tech, but I wanted to know the answers to post here in order to head off the speculation that NxStage Pure Flow does not produce high quality dialysate.  This revolutionary technology is still new to many people and I believe those of us lucky enough to be using it owe it to other patients to educate as many people as possible.

I look forward with eager anticipation to when it is announced that more than half of all dialysis patients are using NxStage equipment at home.  Since the present rate of kidney failure is increasing exponentially, in a very few years there will not be enough chairs in centers to handle all of the patients.  Many patients who want to travel to popular vacation spots are already finding that there are no empty chairs within convenient driving distance.  When it reaches the point that there is nowhere to do dialysis except at home, the centers will be pushing every patient possible out the door.  Congress may help with that as well, since I remember seeing that every home dialysis patients doing daily dialysis saves Medicare on average $25,000 annually.  Sure wish I had had the $$$ to buy NXTM when it was around $8.

[Hawkeye]

I wasn't the one having the issues with the lab tech, but I wanted to know the answers to post here in order to head off the speculation that NxStage Pure Flow does not produce high quality dialysate.

  got lost in the post and didn't look back to see who the original poster was.

[Black]

   No problem as it is sometimes hard to keep up with all of the posters in some of these busy and long threads.

[Bill Peckham]

CMS has issued new guidance to State surveyors regarding the PureFlow here: http://www.cms.hhs.gov/SurveyCertificationGenInfo/downloads/SCletter07-34.pdf I have read through once - it looks like there will be monthly testing and testing each time the PAK is changed - Hawkeye I'd be interested in your take - along with everyone else. My provider has had me using bags since April - I think this guidance supports their concerns while leaving a couple concerns undressed.

My take away is that water/dialysate purity is the hardest nut to crack when it comes to providing optimal dialysis in the home.

[silverhead]

I changed our "pak" and made a new batch, using all the care possible, We obtained a sample and delivered it to the clinic lab and heard back today that the sample passed all their tests and we can go back to using the PureFlow again. As an aside, in our talk with the home care nurses, they mentioned that one of the oldest in the nation dialysis centers, Northwest Kidney Foundation, was using the NxStage system, but only with bags, they have several issues with the Pureflow, I sent them an E-Mail today and received a prompt reply from the vice-president of clinical services, she stated that they were working with NxStage to address several items, among them was the lack of a back flow prevention device to prevent siphoning back of Dyalisate to the potable water system per state law. This was the only item she told me about, will try to find out any others that they have.....
Tom

[Bill Peckham]

The Northwest Kidney Centers is my provider. There is a Northwest Kidney Centers Foundation but it is the Centers that determines water treatment policy. This is a related thread on HDC http://forums.homedialysis.org/showthread.php?goto=newpost&t=1479

[JerseyGirl]

Thanks Bill for that CMS link.  I may not be a patient but you are my hero too.  Always a pleasure - I learn something new from you every day!