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View Full Version : Vibralung® Acoustical Percussor receives FDA 510(k) Clearance



mmcpeck
06-18-2014, 09:42 PM
Hi everyone,

I don't want to be overly commercial and will keep this as brief as possible, but I just wanted to announce that Westmed, Inc. received FDA 510(k) clearance to market for its Vibralung® Acoustical Percussor on May 23, 2014. The official press releases will occur soon and the product launch will take place in late summer. The Westmed website is being modernized and updated and the new web site will also be relaunched soon along with a comprehensive family of web pages devoted to the Vibralung. I'll make an announcement when those sites are up and running.

The operating theory of the Vibralung Acoustical Percussor is to vibrate the "column" of air in the tracheobronchial tract, using sound waves, which also vibrates the different airways and the mucus at their specific Resonant Frequencies (RFs). This is called "sympathetic resonance," and a good real-world example is when a car pulls up next to yours with its stereo system pumping out at such extremely high volume that it causes your car to rattle and vibrate. This is what is accomplished in the lungs during therapy with the Vibralung.

In short, the Vibralung Acoustical Percussor is an acoustic airway clearance device that applies sound waves directly to the airway opening through a mouthpiece during both inspiration and exhalation while the subject is breathing normally. A veterinary version has been in use for many years to clear the lungs of race horses and now Westmed has developed a version of that device that is suitable for humans. The sound waves that are generated include "random noise" between 5 and 1,200 Hz plus 3 different modes of sequential tone pulses that are applied in different frequency ranges during a 10 minute timed treatment session: Low 5 - 200 Hz, Medium 5 - 600 Hz, and High 5 - 1,200 Hz. Simultaneous aerosol therapy can also be given via the Westmed Circulaire II high-efficiency aerosol drug delivery system.

The device consists of 2 components: an ergonomically shaped Hand-Held Transducer (HHT) connected with a tiny wire to a small, portable battery-operated Treatment Control Unit (TCU).

The reason for the different ranges and sequential frequency progression during the treatment is because each airway segment has its own RF, determined in part by its length and diameter. Treating the lung with a single frequency is likely to be effective on some airways but bypass many others that have different sizes and therefore different RFs. Treating the lung with a progression that includes hundreds of discrete frequencies will eventually expose virtually the entire airway system to acoustic vibration at some point during the treatment.

We will make additional announcements in the future and will also formally communicate with the CFF as the launch date becomes set. So please watch for the announcements this summer and stay tuned for further information.

Thank you for allowing me this brief announcement.

Mike

Michael McPeck, RRT FAARC
Director of Clinical Education
Westmed, Inc.
Tucson, AZ

Liza
06-19-2014, 08:26 PM
Sounds like the Frequencer to me. How is this different or is it not?

politicaljules
06-20-2014, 01:19 AM
This is GREAT news. I think my daughter would benefit greatly from this device. Waiting to hear more...

UsualSuspect
06-20-2014, 08:19 PM
It looks much different than The Frequencer according to this article I found:
http://www.pharmacy.arizona.edu/features/alumni-donors/unusual-device-may-aid-cystic-fibrosis-patients

UsualSuspect
06-20-2014, 08:21 PM
Is there anybody on this forum who got to try it in Arizona? It'd be great to have some feedback.

ecsnut
06-21-2014, 12:35 PM
Hi there...as interesting as this is...I have a problem with companies coming on this site and soliciting. I do not see any other companies coming to give their information...just saying. I would have appreciated a link to check out...but this is our site. ECS

Joe2007
06-21-2014, 04:02 PM
Hi there...as interesting as this is...I have a problem with companies coming on this site and soliciting. I do not see any other companies coming to give their information...just saying. I would have appreciated a link to check out...but this is our site. ECS

i welcome their announcement. This sounds like a legitimate beneficial and FDA approved device. I have not seen announcements about it elsewhere. Probably took time and money to get through approval process. It's not like some snake oil pitch like negative ionized water which has appeared on this board.

politicaljules
06-24-2014, 10:12 AM
I have been following the Vibralung device for awhile now, and I welcome their announcement here as well. I saw that it uses sound waves that break up the mucus, and can help people who do not understand the need, or the correct way to huff cough during the vest and breathing treatments. My kid has an intellectual disability, and it is hard teaching her to cough correctly. This device is supposed to help with that, as well as break up the mucus.

As I understand it, certain sound wave frequencies are very effective at breaking up mucus, and this device directs the sound waves into the airways rather than through the chest wall.

It is a different kind of a device unlike one that is held onto the chest, like the Frequencer. Don't get me wrong, I liked the Frequencer a lot, but when I tried to get more information about it, I could never get them to call me back. I had an old brochure, and one number was disconnected, so I looked them up on the internet and tried to contact the Frequencer people, but was unsuccessful.

The only thing I could ascertain about the Frequncer is that it is a company in Canada, and very hard to get approval here in the states. I kinda gave up on it and thought that company was either very small, or not selling enough units to expand, or was not even going to continue in the Cf market.

However, when I first heard about the Vibralung, I contacted them by email, (I wanna say it was a year ago or so, but don't quote me on that), they wrote me back immediately saying they were still trying to get FDA approval. I was disappointed because I knew how the FDA worked, & I thought it would be many many years before I heard from them again. My hopes of sound wave technology helping my kid were dashed.

But now I am excited again, and I think this is great news. I really hope our family gets a chance to try it out very soon!

And if it works, it can be a device that will help people like my kid.

If it does not work, obviously it wont make it very far, but I think we should be open to new technology to help combat this disease that is attacking lungs, bodies, and shortening lives.

cfgf28
06-24-2014, 06:04 PM
Is this device the same as the metaneb? My fiance was just admitted for a tune up and they have him alternating the vest withe a machine called the metaneb and it is one that works when you are breathing in and out. The respiratory tech has him use it with hypertonic. He likes it better. The the vest and says it's faster but was told it hasn't been approved for home use yet..

Liza
06-24-2014, 06:06 PM
Thank you, Usual Suspect, for the link. I either missed that it was actually put in your mouth or it wasn't mentioned in the initial post.

This is quite interesting though. My first thoughts came after the video said that it takes 30 minutes to complete the therapy, wondering if there are breaks in treatment. I know my daughter would not be able to breath just through her mouth for half hour straight.

I think it's kinda good that they came on here to let the community know about this new FDA approved device. Sometimes, the word doesn't get out soon enough from clinics. Many of them get fixated on just one type of CPT and "everyone" should be doing that one kind. I speak from my girls having been seen at many different CF clinics, due to moving around in the military. Once the vest became popular, they were always asking us why we didn't use it, that we should use it, try it, try it, again and again at each different clinic. So, they tried it a few different times/ places before we finally said, no more.

I don't feel this was a sales pitch, just a FYI. I, myself, hadn't heard anything about this prospective new product. I think this was the perfect spot, Airway Clearance Technique. Now if they were posting repeatedly or in a different forum folder, that'd be def. wrong.

UsualSuspect
06-25-2014, 07:22 AM
Liza,

After reading the statement by Mr. McPeck again, it says the treatment sessions were 10 minutes. However, with vest therapy, the amount of time people spend doing it seems to be all over the map. What sounds really intriguing to me is the range of 5-1200Hz, and not having to manually position it.

mmcpeck
08-17-2014, 03:35 PM
The new web site for the Vibralung Acoustical Percussor is: vibralungACT.com (http://vibralungACT.com)


Mike

Michael McPeck, RRT FAARC
Director of Clinical Education
Westmed, Inc.
Tucson, AZ

Julieann Chassey
01-12-2015, 09:19 PM
My daughter just received this and we are just waiting for a phone consult to get going.
https://www.facebook.com/video.php?v=10152522276823204&l=189172852418113389

Rosie55
02-04-2015, 11:37 AM
This does remind me of the metaneb, which my daughter has used in the hospital and likes a lot! I'm just finding out about it, does anyone know if insurance is covering it? Or what it costs? I like the fact that it can be done simultaneously with aerosol therapy.

mmcpeck
02-04-2015, 12:07 PM
I will try to briefly answer your questions. Although all airway clearance devices vibrate the boundary between secretions and the airway surface, the mechanisms used to do so vary widely, thereby offering clinicians and patients many choices to find what works best for individuals. The Vibralung Acoustical Percussor differs from the MetaNeb in a number of ways. It does not require a powerful air compressor to operate by itself, without aerosol. However, when simultaneous aerosol therapy is desired, its optional Circulaire II aerosol delivery device can operate effectively from any air compressor because it uses a reservoir to conserve aerosol that would be wasted and allow it to be inhaled instead. The Vibralung effectively vibrates airways and secretions gently, with sound waves applied directly to the airways, rather than with forceful airway pressure spikes. Aerosol delivery is much better owing to the interface with the Circulaire II high-efficiency aerosol delivery system and the fact that aerosol particles are not accelerated and "slammed" into the back of the throat. Instead, the reservoir system delivers more drug in each breath. The Vibralung is battery-operated and extremely portable. Because it is relatively new, it is not yet widely covered by insurance although a number of patients have been successful at achieving coverage. As with all new devices, insurance coverage will improve over time. The Vibralung readily transitions from hospital to home. I hope you find this brief overview and information helpful. Please visit the Vibraung web site (http://www.vibralungACT.com) for further information.

Michael McPeck, RRT FAARC
Director of Clinical Education
Westmed, Inc. Tucson, AZ
www.vibralungACT.com (http://www.vibralungACT.com)

believingjesus
03-02-2015, 11:05 AM
Does anyone know anything about the Vibralung percussor? Is anyone getting it approved through insurance especially if you already have a Vest system? I have tried to click on the links but they do not work! Mmcpeck - your links do NOT work. I was wondering the cost and also the size as it sounds portable. We have the Vest (the newer smaller version) and the Flutter Valve. We really need something smaller that will pass through customs easily as my son has to fly internationally with his job.

Also: (The Flutter Valve is small but really is not effective at least for my son).

charliej5
03-02-2015, 02:40 PM
Is anyone on here using the Vibralung, and if so, what successes/failures have been experienced?

believingjesus
03-03-2015, 09:03 PM
I too would like to know if anyone is using the Vibralung? Can it be sterilized between uses? Is it effective like the Vest? I was looking for something portable and this is and is also small (battery-operated). If anyone knows about this I would appreciate your input. I have called the number and visited but am confused about if it can be cleaned properly. Also does insurance cover any of it if you already have a vest?

wpierson7
03-04-2015, 04:09 PM
believingjesus: I came here to gain info and joined the board just to answer your question. My dad just received the device earlier today. The nurse who provided training said the mouth piece only needs to be sterilized about once a week. I believe she said to use peroxide or alcohol. There is another detachable part that only needs to be rinsed off with water if saliva or mucus happens to get on it. I think that can be done as needed. She stated that studies showed no significant difference in effectiveness between the vest and Vibralung. However, the Vibralung is apparently much easier to use and maintain. I don't have an answer to your last question, but she did state that every device she has issued thus far has been approved. The company is starting people on 30-day trials before submitting to insurance. My dad has only taken one treatment since receiving it this morning, so I'm not sure how effective it is for him yet. Hopefully this info helped!

believingjesus
03-04-2015, 06:24 PM
Thank you wpierson! I really wanted to hear from someone who is using it so I appreciate your response. Can you please keep us posted as to how it is working since he just got it? I called but the representative is no where near where we live and I didn't want them to have to travel to show me the device and then I decide not to get it. I didn't feel comfortable just looking at it online as the representative suggested. He also told me it retails for $4,000 but if insurance would not pay they could sell for $2,000 so it is a lot of money. I really have difficulty with how they say to clean it. I know that maybe it is standard but it says you can clean with Clorox wipes and that makes me nervous as I know wipes have been found to sometimes contain bacteria that was unknown when it is sold but later found after people have used them. I also am unsure about only cleaning the mouthpiece once a week as the representative also told me over the phone. Does your dad have cystic fibrosis? I just feel so more comfortable being able to boil things for sterilization. I really do like the Vibralung though as it looks like it would really work effectively and would be portable and small. Please keep me updated about how it is going. I really appreciate you logging on and letting me know about the Vibralung! Thanks so much!

wpierson7
03-04-2015, 06:54 PM
No problem! We live in Arizona, where the company that sells the product is based. The nurse was able to drive up to Phoenix from Tucson. She told us that the device costs $2K as well (if insurance refuses to pay), and that they have a payment plan. The mouthpiece appears to be made of plastic; similar to the type found on nebulizer machines. I am uncertain if it can be boiled. My dad does not have cystic fibrosis - he has COPD. But his pulmonary doctor thinks the device could be useful. The nurse who provided the training repeatedly mentioned that we could easily send it back without charge if it did not work out. So it may be worth it to you to give it a shot. I'll keep you updated!

LittleLab4CF
03-05-2015, 03:39 AM
I need to hurry up. Last year two products I was developing suddenly hit the market which meant I was at least a year behind. Vibralung or something acoustic to replace the pelting of a vest has been something I hit on about six months ago.

In a former life I was doing digital signal processing professionally and digital media was a rarity. I met my wife who was my boss then. She took a two year contract to write digital modeling software for another company and the software could model any middle ear to a concert hall design.

I began by running tests on a variety of mucus and mucus like material directly vibrating a plate the mucus is stuck to. Certain frequencies will cause the mucus to literally fly off the vibrating plates. No vibration pattern caused it to adhere better. The concept of air vibrating with and through breathing is compelling. The whistle like flutterer causes stops and starts in breathing and sort of works on a limited but similar basis to Vibralung. It hopefully accomplishes the same results as a vest only better and easier. There are sympathetic frequencies that could virtually atomize mucus and phlegm.

Best of luck, we'll be waiting,

LL

mmcpeck
03-05-2015, 08:45 AM
Hi all - I received an email from this message board that there were follow up questions from a number of you. I have been preoccupied with conducting some all-day training sessions this week but should have some time later today to read all the questions and provide answers. We appreciate your interest in the Vibralung Acoustical Percussor and want you to be informed. By the way, the "believingjesus," our web site was in maintenance mode over the past weekend, and I suspect that's when you were unable to access it. But it is up and running now, and we are getting ready to update it soon with new cleaning instructions, testimonials we have received, and other information. That could happen in about another week and I will post here when the changes have been made. I'll be back later with answers to all your questions. Thank you.

Michael McPeck, RRT FAARC
Director, Clinical Education
Westmed, Inc.
Tucson AZ
[email protected]
vibralungACT.com
westmedinc.com

believingjesus
03-05-2015, 10:29 AM
Little Lab - that is so cool that you were working on that before! Do you really feel it is better than the Vest? I would really love for my son to have one but when I read the instructions on cleaning it talks about using wipes or soap and water in parts and to be sure not to get it in the crevices. This makes me believe that bacteria could get in the crevices or stay on the part that just says to use Clorox wipes or soap and water. I honestly know soap and water are not sufficient to kill most bacteria people with CF culture. Unless I am missing something, which is highly possible - :o -, I feel they should have fixed this problem before they manufactured it if they were aiming to help people with lung diseases like cystic fibrosis.

wpierson - I didn't notice last night that you had replied, sorry! I appreciate you letting us know since your dad actually has this device. I really hope it works well for him. I am sure it is an excellent device, I am just unsure about the sterilization for people with cf because of the various bacteria that is in the lungs of most people with cf. I didn't know that they would let you try it on a trial period. That is super for your dad but again makes me question the sterilization if they could then let someone use it with cf and then let someone else use it??? I'm just super paranoid about everything so this is natural for me. I appreciate you keeping us updated as to how it is working for him! Thanks so much!

LittleLab4CF
03-06-2015, 02:53 AM
When I looked at the pictures of the Vibralung, I was somewhat surprised that the acoustic driver, the speakers if you will, are integrated into the mouthpiece. The concept of using sound inside the airways and lung is fantastic, and it sounds like it has been tried when the technology wasn't as advanced, which is a good thing usually. The sound can be percussive just like the pummeling action of a vest without having to pass through the body and lung tissue to get to the mucus. In effect the percussion or whatever vibration pattern is impressed into our airways hits the mucus first instead of last. Far less trauma should be one major result because it is in direct contact with the mucus and airway surfaces.

In theory, with what my wife and I know about acoustic modeling we know that a resonant frequency for our thick, sticky mucus and phlegm is possible to hit. When resonance has mucus gyrating, it can be literally atomized and nothing would be easier to expectorate.

Although it was one of the more mysterious and oddly reported stories Nicola Tesla pioneered resonant frequency and reportedly did substantial damage to the steel beamed building housing his laboratory. Tesla had a toaster sized box bolted to an I beam and it was oscillating everything from the beams to the bricks. The story breaks down at a point where the infernal machine was stuck on maximum and Tesla was found beating his equipment with a sledgehammer, yada, yada... The point is that sympathetic vibration and acoustic resonance delivered in the form of a percussive pulse has the potential for more effective and possibly pleasant variety of frequencies to literally jiggle the mucus off of whatever it's stuck to. Impressing energy in the form of friction into the tiniest amount of mucus heats and thins mucus. Potentially with an acoustic model of the lungs for each person, extracted from a chest CT, percussive pulse patterns could hit specific mucus densities and the internal structures in the lungs with specific diameters.

Obviously I am excited about the technology, I really have experimented with mucus and its response to sound frequencies. There is tremendous potential in computerized, sensor monitored acoustic therapy. Everyone who knows the issues behind sterilization and the company will solve it. If there is an issue with cleaning or anything reasonably fixable, 99.9% of the work has been done. As a guess.

LL

ethan508
03-06-2015, 07:49 AM
LL from your tests, what was the natural frequency range of phlegm? How does that compare to the natural frequency of the lungs?

believingjesus
03-06-2015, 08:38 AM
Little Lab - I appreciate your response on this as you are so knowledgeable about things and really put your all into it.

I understand that the company probably thought of this and all that, however, I did talk to a representative of the Vibralung and he basically said the same thing the website says - if mucus or sputum gets on a part of it then you just wipe with Clorox wipes or rinse with soap and water. Also wpierson who responded on this thread and already has one for his/her dad that has copd said the same thing that if sputum or mucus gets on a certain part then just rinse with soap and water. To me that is not adequate sterilization. When nebulizers have to be boiled for 10 minutes or placed in isopropyl alcohol for at least 5 minutes - I do not see how if mucus gets on a part of it that it would be safe to continue to use. This also brings to mind those spirometers or whatever they are called that a person with CF blows into to test their lung function when they go to clinic. I have questioned that before too and got an unsatisfactory response as to how that is sterilized.

I wish mmcpeck could respond to this thread as I suppose he is a representative of the company but I guess he is very busy. I would love to get a Vibralung but unless I can resolve how a device that is put in the mouth can be sterilized I will have to look at something else. To me, every person with CF should consider that before looking into a Vibralung. It sounds absolutely wonderful if it truly can be cleaned (sterilized).

Rosie55
03-07-2015, 09:31 AM
This is an excerpt from the website on cleaning. I have a 21 year old daughter with CF and I think this could work really well for her. I'm calling the company to set up a trial. From what I understand they will give you a 30 day trial and then assist with insurance or set up a payment plan. However I'm not really sure what it costs so I'm hoping to get all questions answered, including cleaning, when I call and they set us up for a trial. I'll share my experience.

"The HHT is a single-patient use disposable device that is designed to be used for the duration of a patient’s hospital stay, but not to exceed 30 days. It is supplied non-sterile.To clean the HHT, remove the Y-adapter, mouthpiece, variable expiratory resistor and screw-on cone. Remove Circulaire, if present. Clean the outside surface of the HHT and the transducer diaphragm with a pre-moistened germicidal wipe or cloth product containing dimethyl-benzyl-ammonium chloride and/or dimethyl-ethylbenzyl-ammonium chloride. Allow the appropriate contact time as specified by the product’s instructions. Allow the surface to dry before reassembling and using.Clean the Y-adapter, mouthpiece, variable expiratory resistor and screw-on cone with soap and water, rinse, and then disinfect the parts by soaking in alkyldimethyl-benzyl ammonium chloride for 10 minutes. Rinse with sterile water and allow the parts to air dry. Remove the nebulizer and clean according to the nebulizer care instructions."

believingjesus
03-07-2015, 11:34 AM
Thank you Rosie. If you could let me know how it goes for you I would really appreciate it. It really looks like a device that could really help. I wish someone from Vibralung could respond on this forum as to the sterilization. I am not worried about the outside components of the device, only the inside. I read something different than what you posted and I was pretty sure they were talking about the inside components and it said to use a Clorox wipe on that part. The Vibralung is $4,000 but if insurance does not cover it then they charge $2,000. I appreciate if you could share what you find out. Thanks so much!

Julieann Chassey
03-08-2015, 06:06 PM
My daughter has this and loves it. They will be using her response and feelings of what she thinks. We have seen a difference in the mucus moving around. I just saw they did tweets to it based on feedback and we are excited to see the difference.

mmcpeck
03-09-2015, 12:34 AM
I'm sorry to have not answered the questions so far. As I stated earlier, I have been involved in training sessions and some other activities this past week, and haven't had a spare moment to sit and respond. However, I am flying from Los Angeles to Long Island on Monday 3/9 and plan to use the flight time to answer all of your inquiries about the Vibralung and, particularly, its cleaning. Also, this coming week, I will be updating the web site to include information about the change that was made to the frequency generating software and the availability of a "change kit" that allows certain parts of the device to be discarded and replaced at appropriate intervals. More to follow.

Quick response to ethan508 - The lung doesn't have a single resonant, or natural, frequency. Instead, it has many. Each time airways branch into progressively smaller airways, each of those airway segments has a different length, diameter, resistance, compliance and other factors than the previous airways. This means that the frequency required to vibrate those airway segments keeps changing. Consequently, the Vibralung lung steps through a wide range of frequencies, from lower to higher, divided into 3 different ranges for convenience, in order to gradually vibrate all airways at or near their resonant frequency. The operating theory is that the gas in the airways is vibrated by the sound waves which, in turn, vibrate the airway structures by sympathetic resonance. This is the same reason your windows vibrate when you turn up your stereo too loud. The sound waves vibrate the air in the room which, in turn vibrates the windows by sympathetic resonance. When the airways vibrate, shear forces occur at the boundary between the mucus and the airway surface, just like when you cough effectively.

Michael McPeck, RRT FAARC
Director, Clinical Education
Westmed, Inc.
Tucson AZ
[email protected]
vibralungACT.com
westmedinc.com

charliej5
03-09-2015, 08:00 PM
I am a COPD victim. Like many others, I am plagued with sticky mucus which severely restricts my airway. I do have, however, an excellent aid - SSKI (Saturated Solution Potassium Iodide). I mix 3 mL with 3 mL of Ipratropium/Albuterol in my nebulizer about 4 times per day. Within 3-5 minutes I begin to expectorate the mucus and in 40-50 minutes I am breathing freely and comfortably.

This prescription item is manufactured by Upsher-Smith. I buy the 237 mL (8 ounce) bottle at Sam's at a cost of $105.00.

The uses are numerous. Here is a good link for overview: http://www.olaloa.com/the-healing-power-of-potassium-iodide-sski.html

I hope this is beneficial to some.

believingjesus
03-21-2015, 12:10 PM
MMCPeck: I thought you had said a few weeks ago that you would reply as to the cleaning of the Vibralung? I have been looking since then and have not seen a thing. I am sure I am not the only one. When you have a group of people that supposedly this device is made for that look on this forum and consider purchasing it - why wouldn't you address this? I know that it would take about 5 minutes to let us know about the INSIDE cleaning of this device as to whether it is adequate or not for CF and also it would give you an opportunity to promote your product. ???????

UsualSuspect
04-09-2015, 07:47 PM
Believingjesus,

I don't see any reason why the plastic pieces can't be soaked in isopropyl alcohol or hydrogen peroxide, the only 2 cold cleaning methods left that the CF Foundation still endorses to disinfect. From browsing the site, it'd be the clear plastic pieces in the box on the right:

http://westmedinc.com/wp-content/uploads/2014/07/VL-Parts-ID1.png

The Clorox wipes would simply be for the box and that hair dryer looking thing with the speaker that says HHT.

LisaGreene
04-10-2015, 02:58 PM
We have one for my two teens with CF. They share the base but each have their own mouthpieces. They love it. They use this WITH the vest (they use Smartvest) and when they travel (my daughter just returned from Hawaii for a week for spring break with another family), its SO easy. She soaked it in alcohol to clean it but when we are at home, we use a baby bottle sterilizer and it works just fine (nothing has melted yet). We boil everything usually so I understand the need for good cleaning and I feel okay about it with the sterilizer and the alcohol when traveling. It is a little loud, be aware of that, but I guess the vest is too.

I think that having a variety of airway clearance options are great. We also use the accapella (looking into the new Aerobika, too) as well as flutter and hand CPT. I like the Vibralung because it is a different kind of therapy, from the inside out. Its a great addition to our medical cabinet.

believingjesus
04-16-2015, 06:48 AM
One of the private messages I received late last night said that a person on this forum was told by a representative of the Vibralung company that they would charge them $3,200 for this device. They PM'd me to ask which representative I talked to at the Vibralung as I was told $2,000 if insurance did not pay. I feel the absolute need to post as this is not fair that one person would be told one thing and a different representative or possibly the same one would tell someone else another price. I was told by a representative of the Vibralung that if insurance did not cover this device that it would cost $2,000 - not the $4,000 the company is charging originally. That price should be the same one offered to ALL people. Also I was wanting to ask the people that have this device already and use it a question as UsualSuspect posted pics of this device. The part I was always worried about the sterilization was the HHT part. As UsualSuspect noted - in order to sterilize any part used in the mouth they would have to be boiled at least 10 minutes or sit in 70% Isopropyl Alcohol for at least 5 minutes. To me if you are using the HHT device on more than one person and mucus gets in the HHT part it can grow and then the next person to use it would also get that bacteria. So I do not understand the policy of the company to let everyone try this device for 30 days and if they do not like it they can return it. Makes me nervous for the next person who gets the device. I appreciate your explanation of cleaning MMCPeck but I just still don't understand how the HHT part is truly sterilized. My son is supposed to talk to his doctor about this device at his next appointment in May so I would still very much like to know. Thank you!

Also I wanted to add as an edit: I appreciate your time and patience MMCPeck. I am very interested in the Vibralung so that is why so many questions. If you could also let us all know what the price would be if insurance does not cover it as I was told one price and another person was told a different one. I really appreciate your time. Thank you so much!

lifeisgood729
04-17-2015, 10:53 AM
I was the person who contacted believingjesus about the price confusion, but i was able to speak to a sales rep at WestMed directly, and they straightened it out. I have met MMcPeck, and I don't believe there is anything unfair going on. I think it was just a miscommunication. This is a fairly new device, and so there might have been some confusion about pricing when they first released it? There are only two providers who are selling the device in the US, and I think they are both selling for $3200 if your insurance won't cover it.

I tried the device in my home and I think it would be a good addition to my airway clearance routine. I also like that it's small enough for travel, since I don't bring my Vest with me when I travel. I'm going to try to get the device covered by my insurance company. The mouthpiece has a sort of filter on it to stop mucus from going into the device, and it can be sterilized in alcohol. It's also a disposable piece, so you only use the mouthpiece for a while before you replace it.

If I get the device, I'll let you all know how I like it.

Martha
47 w/CF

believingjesus
04-17-2015, 11:09 AM
Martha: I'm glad you found out the final price if insurance did not cover. I was told $2,000 so I sure hope our insurance covers it when and if we get a prescription for it from the doctor as I can't really afford the extra $1,200. I appreciate you letting us know how it works for you. Maybe I just have to see the device up close to realize no mucus could get in the HHT? I still am not confident though because of that part but it sounds like a wonderful device that would really help. Thank you Lifeisgood!

Also Martha - thanks for the PM just now- I just saw it after I posted here. I hope it is covered for both of us. My insurance company had said at one time it would probably be covered somewhat if we get a prescription but they can not say for sure until it is submitted. Good luck to you!

ecsnut
04-17-2015, 04:47 PM
What if you don't have private insurance. Is it covered by Medicare or Medicaid or state funded insurance. Who is carrying it.

lifeisgood729
04-18-2015, 10:32 AM
I spoke to the owner of SleepRxonline, one of the two places carrying it. She said Medicare likely won't pay for it, because the billing code is listed as "miscellaneous" and Medicare doesn't usually pay those. I don't know about Medicaid. I have a secondary policy that she seems to think will pay for it. The good news is that she will do the work of filing for payment with the insurance company. I received a list of records I need to get from my doctor, as well as a letter of medical necessity, so she obviously knows how to go about trying to get the device covered.

I would recommend that anyone curious about the device contact the company directly for more information.

Martha

mmcpeck
04-18-2015, 11:23 AM
In the 7 months since the Vibralung Acoustical Percussor was released to the market there has been some "normal" price fluctuation. It was released with "introductory pricing" to encourage early sales and then subsequently prices were adjusted based upon the market, insurance considerations, manufacturing and distribution costs and other factors. This is how the medical device market often works. As with almost anything that can be purchased, prices will occasionally change. Another consideration is that medical device dealers and distributors may receive discount pricing based upon volume and then establish their own retail pricing for individual unit sales. In that way they may be able to offer some patients discounted pricing if insurance coverage is not available. However, Westmed does not control the retail price that distributors charge.


As with any new medical device, insurance coverage is not automatic and requires some time and determination to establish. It is also important to realize that the Vibralung Acoustical Percussor is indicated for many conditions other than cystic fibrosis and overall pricing and infection control procedures must also take these into account as well. Submission to Medicare for a billing code and reimbursement early in a new device's history, before it has had time to develop a track record and establish efficacy, could result in the assignment of such a low-paying code that it is unprofitable to market it. Thus, we have not done so yet.


As for cleaning, I am not sure where anyone would have gotten the idea that the Hand-held Transducer (HHT) would be used on more than one person. The Instructions for Use (IFU), available on the web site, certainly do not state that. That should never be the case. For inpatient hospital use, the HHT is "single-patient use," meaning that it is discarded at the end of hospitalization, or sooner if circumstances require it. It may undergo frequent surface cleaning with germicidal wipes and/or alcohol wipes as often as required by circumstances or hospital policy and disposable parts to connect it to the patient's airway (mouth) are provided and should be discarded and replaced as often an necessary for the particular infection control risk for each patient.


For home use, the HHT handle and speaker are likewise wiped down with germicidal wipes frequently, such as after each use. The speaker is protected from mucus contamination by a disposable/replaceable component called the "cone," which covers the speaker and isolates it by way of a thin film diaphragm that is permeable to sound waves but not to mucus or aerosols. If the cone should become internally contaminated, it will protect the speaker from contamination. The cone is disposable and can be replaced as necessary. The disposable components of the HHT (mouthpiece, Y-adapter, PEP resistor and cone exterior) can be wiped with alcohol wipes in between treatments in the hospital or completely discarded according to hospital policy and/or infection control risk level. In the home, these same parts can wiped down with alcohol pads in between treatments. They can also be washed with soap and water, rinsed, and then disinfected by soaking in either 70% isopropyl alcohol or hydrogen peroxide (as per CFF guidelines) and then rinsed with boiled (sterile) water that has cooled. Alternately, the disposable parts are available in a change kit to enable discarding used disposable components and replacing them with new clean parts from the change kit.


In order to keep costs as low as possible for all the markets applicable to the Vibralung, boilable/reusable plastic components have not been utilized at the present time. Instead, the focus has been on germicidal disinfection for hard surfaces of hardware plus less-expensive disposable plastic components for parts that connect to the airway. However, this could change as experience is developed over time and patient preferences and suggestions are evaluated.


The small, lightweight, battery-operated electronic controller (Treatment Control Unit, TCU) can be be wiped frequently with germicidal wipes inasmuch as it does not come in contact with the mouth. The TCU could conceivably be used with multiple patients, with surface disinfection in between, but they are affordable enough that most CF facilities should be able to acquire one for each isolation room.


In summary, the Vibralung Acoustical Percussor was designed with infection control consideration in mind for both home and hospital. That it why it is a two-piece unit:


● The one piece (TCU) that does not come into contact with mucus membranes is able to withstand repeated hard-surface germicidal disinfection.


● The part that is held in the hand (handle portion of the HHT),that does not come into contact with mucus membranes, is able to withstand repeated hard-surface germicidal disinfection.


● The parts that do come into contact with mucus membranes are fully disposable and replaceable, but can be wiped, or washed, or disinfected in between treatments, as required by individual circumstances.


I hope this sufficiently answers the questions about cost and cleaning. The best way to approach obtaining a Vibralung Acoustical Percussor is to first discuss it with your care team and refer them to the website (www.vibralungACT.com (http://westmedinc.com/vibralung/)) in the unusual event that they may not have already heard of it. It requires a prescription and minimal training.


Michael McPeck, RRT FAARC
Director, Clinical Education
Westmed, Inc.
Mobile: (516) 729-9989
E-mail: [email protected]

believingjesus
04-18-2015, 12:44 PM
MmcPeck: Thank you for your detailed explanation of the cleaning of the Vibralung. I really appreciate that. The only concern I personally ever had with this device was the cleaning of the HHT as I had read in the directions to clean with germicidal wipes if mucus happened to get in that part. If I understand correctly you explained that NO mucus could ever get past the "Cone" to the speaker or any other inside chamber of the HHT? I did not quite understand the part you stated that if the cone should become internally contaminated it will protect the speaker from contamination? I am just thinking of the internal part of the HHT. I appreciate your explanation of the cleaning and I understand everything but this part.

Also you stated that you do not know how anyone got the idea that the HHT would be used on more than one person. I was told by a representative that if we wanted we could try the Vibralung for 30 days and if we were not completely satisfied that we could return the device and not be charged for it. WPierson7 on this thread was also told the same thing. If there can be no contamination possible past the cone than there is nothing to worry about, right? That is my concern as some bacteria do not go away on their own and are very resistant and come from the mucus. I would not think the company would just throw away the device after a person may return it so that is another question. Also I noticed on this thread here that someone has two children using the same HHT but cleans the mouthpieces between uses. Is that okay to do when people with CF carry different bacteria in the lungs?

I hope our insurance covers it. Maybe if I saw the device in person I would not misunderstand what you are saying. I appreciate your very detailed explanation and I appreciate you coming to this forum and helping everyone with it.

wpierson7
08-22-2015, 05:39 PM
Hi guys. Just wanted to give a quick update on my dad's experience with the Vibralung. It's been almost six months, and I can honestly say it's been great! In fact, he hasn't been to the hospital one time since receiving it. This also means he's been able to avoid the high doses of steroids and antibiotics, which are always prescribed during flare-ups or pneumonia. He currently takes two treatments consecutively, two times a day. We were skeptical of the device initially because it takes a while after each treatment to see results. However, we have noticed a real improvement in his lung health over the past few months. If you have the opportunity to get one, I would recommend it.