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Vapotherm pulled by CDC???

According to our attending, there has been some sort of bacteria found in certain filters for Vapotherm, so the units have been pulled.

Has anyone else heard about this?? We were just starting to take off with using it!

Gompers, BSN, RN

Specializes in NICU.

I hope they fix everything soon. I love Vapotherm, it's amazing!

The Fisher Prikel (sp?) version of it is very very similar, but the tubing is not nearly as long and flexible plus there aren't back-up alarms if it gets disconnected. Our babies seem to be having more apnea on it, too. When I listen to their chests, the airflow doesn't seem as strong as Vapotherm at the same pressure.

Still beats CPAP though!

I just heard about this recently as well. I hope the problem gets resolved quickly because Vapotherm is a wonderful device and so much better for the babies and for the nurses as well :)

Sweden

Specializes in NICU, Med/Surg. Has 10 years experience.

Hi

We have just tried Vapotherm for a few months and we loved it. Now we are not allowed to use it because there has been a few cases in us where the pressure has gone up so high that the babies eardrums actually broke!

There is no pressure valve protection to keep it from going off to high! :o

We are hoping the company can fix that so we can use it again....

Anna

I was told our vapotherms were pulled by the company,(not CDC) because they have 'discovered' there is no way to properly sterilize/clean them.

Our RT Manager told us that they were being pulled because of the growth of Staph and studies have shown they cause NEC. Not sure about the last one, maybe the amount of air in the belly?? I hope they get the problems ironed out, we like it too.

Our RT Manager told us that they were being pulled because of the growth of Staph and studies have shown they cause NEC. Not sure about the last one, maybe the amount of air in the belly?? I hope they get the problems ironed out, we like it too.

Oddly enough we saw an increase in NEC after we stopped using it because we would put kids on NIMV instead.

Gompers, BSN, RN

Specializes in NICU.

Our RT Manager told us that they were being pulled because of the growth of Staph and studies have shown they cause NEC. Not sure about the last one, maybe the amount of air in the belly?? I hope they get the problems ironed out, we like it too.

We had a lot of babies' bellies blowing up when we first started using it. You always have to have an NG or OG open to gravity at all times to vent the stomach. We usually put them on their tummies, too, and between that and the NG/OG open to gravity, we stopped having problems with big bellies. Even if the baby is taking all feedings PO, you still need to drop a tube for decompression.

Over the past year, since we've been exclusively using Vapotherm instead of CPAP, we've noticed a drop in acuity on our unit. The babies are just plain old doing better. Smaller and smaller babies are tolerating early extubation, and larger preemies are doing wonderful when given Curosurf and immediately pulling the ET and starting Vapotherm. We've never had this level of success with CPAP. The amount of infections, both NEC and staph, hasn't seemed to change.

The Fisher Prikel (sp?) that we are using now is pretty comparable. I still like Vapotherm better because it has back-up alarms. I suppose if Vapotherm never figures it out, at least we have something. Now, if the FP gets recalled, we're going to go bananas!!!!

Dawngloves I've been trying to PM you, but your box is full. Thanks!

Somei

Specializes in NICU, ICU,. Has 13 years experience.

based on the letter we received from vapotherm," several hospitals, reported to cdc and fda, have indicated that some vapotherm devices are colonized by ralstonia spp. the source of contamination is not known, but testing is ongoing. we are therefore recommending that all vapotherm devices be removed from operation as soon as clinically and reasonably possbile..."

our unit has followed the recommendation and have discontinued use of vapotherm until futher notice :o . vapotherm is indeed a godsend! we miss the comfort it provided our babies as opposed to cpap. our unit was the first in the nation to send a baby home on vapotherm, (the story was posted on the vapotherm website).

i am currently researching for an alternative. thus far i have come across a product by smiths medical "aquinoox" which is also a high flow humidificaiton system. i have emailed smiths medical asking if this product has been approved for neonatal use, i have not yet received a response. i do plan on calling the company today and will keep everyone posted.

pip

walkingrock, ADN

Specializes in Retired NICU. Has 41 years experience.

Our Vapotherm was pulled a couple of weeks ago for the potential staph problem also. We had no problems with it in our NICU and used it a lot, it worked amazingly well, it was almost like a miracle treatment (surfactant comes to mind in the same category...) we certainly hope it will be back, NCPAP isn't nearly as effective or easy to manage in our experience!

Gompers, BSN, RN

Specializes in NICU.

Our Vapotherm was pulled a couple of weeks ago for the potential staph problem also. We had no problems with it in our NICU and used it a lot, it worked amazingly well, it was almost like a miracle treatment (surfactant comes to mind in the same category...) we certainly hope it will be back, NCPAP isn't nearly as effective or easy to manage in our experience!

I wasn't a nurse yet when surfactant came along - but from what I hear, the experiened nurses on our unit are thinking the same thing. Our acuity is just getting lower and lower, it seems. We're a level III, and sometimes we'll have, say, 40 patients, with only 5 intubated and 20 on Vapotherm! We're seeing less BPD as well - much fewer kids getting Decadron because we're extubating before there is much damage. In the past two years, we've only had one baby trached for BPD, and that was a former 23-weeker. Very cool invention. The Fisher Packel version seems to be working okay in the meantime. Anything but CPAP!

I read the letter that our attending recieved from the company. They did a recall of the machines because a few hospitals found some bugs in them... starts with an R...Wish I could remember the name!!!!!

So they are looking for ways to sterilize them but Im sure it will probably end in bancruptcy :( I hope not, I love it!!

Gompers, BSN, RN

Specializes in NICU.

I read the letter that our attending recieved from the company. They did a recall of the machines because a few hospitals found some bugs in them... starts with an R...Wish I could remember the name!!!!!

So they are looking for ways to sterilize them but Im sure it will probably end in bancruptcy :( I hope not, I love it!!

Ralstonia ssp.

There is a press-release on their official website.

http://www.vtherm.com/about/news.asp?id=62

Our unit was absolutely against it and we never used it, the nurses were devastated since our sister hospital was using it and gave rave reviews, but the other night i saw that we have rigged our own set-up and we are capable of breaking it down and sterilizing it, also I think we don't use as much heat. Anyway we like the new set-up and hopefully we will see more popping up.

Gompers, BSN, RN

Specializes in NICU.

Our unit was absolutely against it and we never used it, the nurses were devastated since our sister hospital was using it and gave rave reviews, but the other night i saw that we have rigged our own set-up and we are capable of breaking it down and sterilizing it, also I think we don't use as much heat. Anyway we like the new set-up and hopefully we will see more popping up.

The heat is partly what makes it work so well. It's easier to breathe warm air than cold air. We now use the Fisher Paykel version, and it's even warmer than the Vapotherm. This system uses an inflatable cuff to force sterile water through a heater, and this is vaporized into tubing that is connected to the wall air and oxygen ports. We still like Vapotherm better, but until their sterilization situation improves, we are happy to have a very similar product.

Why was your unit "absolutely" against it? It's wonderful!

They were worried about infection, they were just concerned about how we were going to sterilize the setup. I have never seen it personally so I don't know what they are talking about. But this other set-up we are using seems similar to the vapo-therm or the one you mentioned. We are just so happy to have an alternative to CPAP. Now if we can just get rid of the nasal rated CPAP and that "hug n' snug"

After the Vapotherm was pulled here, someone in RT management jerryrigged a "high flow" cannula together with a concha heater to use in place of it. Some docs will use it, some won't. It was cleared for use by biomed and risk management, however some of the RTs and nurses are still uncomfortable. Just last week, a baby practically drowned from water spewing out of it. Anybody else using a makeshift Vapotherm?

One of the therapists told us yesterday the Vapotherm may be back in a couple of weeks. Anybody else heard this?

TiffyRN, ADN, BSN, PhD

Specializes in NICU. Has 27 years experience.

We are using a rigged-up high flow NC with a heater. I know I have seen these used on kids with flows up to 3-4L/min and I think I heard we are using them with flows up to 6L/min. I does tend to shoot water up to the kid. Fortunately it's usually when a nurse is providing care and she can suction it out but obvioulsy not a very ideal situation.

I haven't heard anything about Vapotherm coming back but I would SO welcome it back. We loved it where I work.

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