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) 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: mmcpeck@westmedinc.com
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) 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: mmcpeck@westmedinc.com