Vibralung Cleaning & Care Instructions

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Westmed recommends that principles and practices related to cleaning and disinfection of nebulizers and related respiratory equipment, as published in the “Infection Prevention and Control Guidance for Cystic Fibrosis: 2013 Update,”1 be followed to the greatest extent possible by hospitals, durable medical equipment (DME) dealers and home-care patients when using the Westmed Vibralung Acoustical Percussor for airway clearance therapy. Accordingly, this document outlines cleaning and disinfection techniques for Westmed airway clearance and aerosol delivery products that are consistent with those guidelines.

Section I — Vibralung Parts Identification (referred to in subsequent cleaning instructions) 

 

1. Treatment Control Unit (TCU). The TCU is a reusable medical device that must be properly maintained to prevent infection, worsening of existing infection, or cross-infection.

2. Hand-Held Transducer (HHT). 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 in the hospital), or for 6 months in the home. It is supplied non-sterile and is not warranted against damage due to falls or misuse.

3. Patient Exchange Kit. The Patient Exchange Kit contains the disposable parts that interface the HHT to the patient’s mouth. These inexpensive parts may be discarded at intervals as short as every 24 hours, if desired.

4. Optional Circulaire II or Circulaire II Hybrid Aerosol Drug Delivery System. The Circulaire II or Circulaire II Hybrid is a high-efficiency aerosol drug delivery system that may be used in conjunction with the Vibralung Acoustical Percussor to provide concomitant aerosol therapy with isotonic saline, hypertonic saline or specific nebulizer solutions.

Section II — Instructions for Cleaning & Disinfection in the Hospital

1. Treatment Control Unit (TCU)

In general, the TCU should undergo surface disinfection:

  • ideally, after each treatment
  • after the last treatment of the treatment day
  • if it should become contaminated with sputum or bodily fluids
  • when it is moved from one patient to another

Surface disinfection technique for the TCU.  Clean all external surfaces of the TCU with a hospital-approved pre-moistened germicidal wipe or cloth product containing dimethyl-benzyl-ammonium chloride and/or dimethyl-ethylbenzyl-ammonium chloride (for example, CaviWipes,™ Super Sani Cloth® Germicidal Wipes, Clorox® Disinfecting Wipes, Lysol® Wipes or equivalent). Note: Clorox® Disinfecting Wipes do not contain sodium hypochlorite (bleach).Wipe surface to be disinfected, i.e., the TCU. Be sure to allow the appropriate contact time as specified by the product’s instructions; use enough wipes for treated surface to remain visibly wet for at least 4 minutes. Take care that liquid does not enter the case of the TCU at the seams or at the two electrical ports (battery charger and HHT) on the side of the TCU. The control buttons on the faceplate are sealed against moisture entry. Allow surface to air-dry completely before handling again.

2. Hand-Held Transducer (HHT)

In general, the HHT should undergo surface disinfection:

  • ideally, after each treatment
  • after the last treatment of the treatment day
  • if it should become contaminated with sputum or bodily fluids

Westmed recommends that the HHT undergo surface disinfection after each treatment. In addition, if the device should become contaminated with sputum or bodily fluids, it should be disinfected immediately. The disposable cone that attaches to the HHT with a screw-on thread is designed with an internal diaphragm that will protect the speaker element of the HHT in the event that a patient expectorates sputum directly through the mouthpiece. When the device is discontinued from use on a patient, the entire HHT should be immediately discarded as it is labeled as a single-patient use device for the hospital.

Surface disinfection technique for the HHT.  Clean all external surfaces of the HHT with a hospital-approved pre-moistened germicidal wipe or cloth product containing dimethyl-benzyl-ammonium chloride and/or dimethyl-ethylbenzyl-ammonium chloride (for example, CaviWipes,™ Super Sani Cloth® Germicidal Wipes, Clorox® Disinfecting Wipes, Lysol® Wipes or equivalent). Wipe surface to be disinfected, i.e., the handle and casing of the HHT. Take care not to contact the speaker as it may be punctured. Be sure to allow the appropriate contact time as specified by the product’s instructions; use enough wipes for treated surface to remain visibly wet for at least 4 minutes. Allow surface to air-dry completely before handling again.

3. Daily Change Kit

The #9640 Patient Exchange Kit contains one each of the following disposable parts:

  • Cone
  • Standard Y-adapter (with inspiratory valve)
  • Aerosol Y-adapter (no inspiratory valve)
  • Variable Expiratory Resistor for PEP
  • Mouthpiece

When used for patients with Cystic Fibrosis, the Daily Change Kit is intended to be used for no more than a single day in the hospital. Optionally, if the hospital believes it to be warranted, the Daily Exchange Kit could be used once and then discarded.

Surface disinfection technique for the Daily Exchange Kit.  Clean all external surfaces of the Cone, Y-adapter, Variable Expiratory Resistor and Mouthpiece with a pre- moistened alcohol pad or wipe after each treatment. Place on a clean surface, such as a fresh, dry paper towel, and allowed to air dry. Remove from the HHT and discard all component parts of the Daily Exchange Kit after the last treatment of the day.

4. Optional Circulaire II or Circulaire II Hybrid Aerosol Drug Delivery System

After each treatment, the VixOne nebulizer should be removed from the manifold of the Circulaire device and cleaned and disinfected according to hospital policy. Alternately, the residual medication should be discarded, and the nebulizer rinsed out with sterile water and placed on a fresh, dry paper towel and allowed to air dry.

At the end of the treatment day, the VixOne nebulizer should be removed from the manifold of the Circulaire device after each treatment and the residual medication discarded. Next, the external parts of the Circulaire system, including the mouthpiece, should be wiped with a pre-moistened alcohol pad or wipe and set aside to dry.

The VixOne nebulizer parts should be disinfected using one of the following cold methods approved by the CFF:

a. Soak in 70% isopropyl alcohol for 5 minutes
b. Soak in 3% hydrogen peroxide for 30 minutes

Then, rinse off the cold-method disinfectant using sterile or ≦0.2 micron filtered water, not tap water. Then place the rinsed parts on a fresh, dry paper towel and allow to air dry, taking care to not contaminate the inside parts of the nebulizer while moving them.

Alternately, the entire Circulaire II system can be discarded and replaced on a daily basis, as long as the VixOne nebulizer is properly cleaned in between treatments and discard at the end of the treatment day.

Section III — Instructions for Cleaning & Disinfection in the Home

1. Treatment Control Unit (TCU)

Westmed recommends that the TCU undergo surface disinfection after every treatment.

Surface disinfection technique for the TCU.  Clean all external surfaces of the TCU with a hospital-approved pre-moistened germicidal wipe or cloth product containing dimethyl-benzyl-ammonium chloride and/or dimethyl-ethylbenzyl-ammonium chloride (for example, CaviWipes,™ Super Sani Cloth® Germicidal Wipes, Clorox® Disinfecting Wipes, Lysol® Wipes or equivalent). Note: Clorox® Disinfecting Wipes do not contain sodium hypochlorite (bleach).

Wipe surface to be disinfected, i.e., the TCU. Be sure to allow the appropriate contact time as specified by the product’s instructions; use enough wipes for treated surface to remain visibly wet for at least 4 minutes. Take care that liquid does not enter the case of the TCU at the seams or at the two electrical ports (battery charger and HHT) on the side of the TCU. The control buttons on the faceplate are sealed against moisture entry. Allow surface to air-dry completely before handling again.

2. Hand-Held Transducer (HHT)

The HHT is a single-patient use disposable device that is designed to be used for 6 months in the home. It is supplied non-sterile and is not warranted against damage due to falls or misuse. In general, Westmed recommends that the HHT should undergo surface disinfection after each treatment, at the same time as the TCU is being disinfected.

Surface disinfection technique for the HHT.  Clean all external surfaces of the HHT with a pre-moistened germicidal wipe or cloth product containing dimethyl-benzyl-ammonium chloride and/or dimethyl-ethylbenzyl-ammonium chloride, such as but not limited to, Clorox® Disinfecting Wipes or equivalent product. Note: Clorox® Disinfecting Wipes do not contain sodium hypochlorite (bleach).

Wipe surface to be disinfected, i.e., the HHT. Be sure to allow the appropriate contact time as specified by the product’s instructions; use enough wipes for treated surface to remain visibly wet for at least 4 minutes. Take care not to contact the speaker forcibly as doing so may puncture it. Let surface dry.

3. Daily Change Kit

The #9640 Patient Exchange Kit contains one each of the following disposable parts:

  • Cone
  • Standard Y-adapter (with inspiratory valve)
  • Aerosol Y-adapter (no inspiratory valve)
  • Variable Expiratory Resistor for PEP
  • Mouthpiece

When used for patients with Cystic Fibrosis at home, the Daily Change Kit, while intended to be used for no more than a single day in the hospital, may be used for a single day or multiple days, up to one week, in the home, provided that it is appropriately cleaned after each treatment.

Surface disinfection technique for the Daily Exchange Kit.   Clean all external surfaces of the Cone, Y-adapter, Variable Expiratory Resistor and Mouthpiece with a pre- moistened alcohol pad or wipe after each treatment. Place on a clean surface, such as a fresh, dry paper towel, and allow to air dry. Remove from the HHT and discard all component parts of the Daily Exchange Kit after the last treatment of the day.

Alternately, the Cone, Y-adapter, Variable Expiratory Resistor and Mouthpiece can be cleaned according to the instructions for the VixOne nebulizer listed below.

4. Optional Circulaire II or Circulaire II Hybrid Aerosol Drug Delivery System

The Circulaire II or Circulaire II Hybrid is a high-efficiency aerosol drug delivery system that may be used in conjunction with the Vibralung Acoustical Percussor to provide concomitant aerosol therapy with isotonic saline, hypertonic saline or specific nebulizer solutions.

After each treatment, the Circulaire mouthpiece should be wiped with a pre-moistened alcohol pad or wipe. The VixOne nebulizer should be removed from the manifold of the Circulaire device, the residual medication discarded, and the nebulizer rinsed out with sterile water and placed on a fresh, dry paper towel and allowed to air dry.

At the end of the treatment day, the VixOne nebulizer should be removed from the manifold of the Circulaire device after each treatment and the residual medication discarded. Next, all remaining parts of the Circulaire system (including the reservoir ball and the VixOne nebulizer) should be disassembled and cleaned with dish soap and water. All parts except the nebulizer should be rinsed in tap water and placed on a fresh, dry paper towel and allowed to air dry. The reservoir ball may be stood upright on its flange for drainage and then laid on its side for air-drying.

The VixOne nebulizer parts should be disinfected using one of the following cold methods approved by the CFF:

a. Soak in 70% isopropyl alcohol for 5 minutes
b. Soak in 3% hydrogen peroxide for 30 minutes

Then, rinse off the cold-method disinfectant using sterile or ≦0.2 micron filtered water, not tap water. Then place the rinsed parts on a fresh, dry paper towel and allow to air dry, taking care to not contaminate the inside parts of the nebulizer while moving them.

If pre-packaged sterile or filter water is unavailable, use water that has boiled for 1 minute and allowed to cool to rinse off residual chemicals.

Important Note: The plastics used for the Vibralung Acoustical Percussor and Circulaire II aerosol delivery systems are not designed to withstand the high temperatures (~ 212° F / 100° C) associated with use of heat or steam disinfection methods (boiling, baby bottle sterilizers, or microwavable steam bags). Some or all of the parts may deform when exposed to these temperatures. However, the reusable VixOne nebulizer (purple cap and purple-tinted cup) may be placed in most household dishwashers without damage.

Guidance from the Cystic Fibrosis Foundation

The following information is extracted from the 2013 Update:¹

Care of Nebulizers in the Hospital

47. The CF Foundation recommends the following:

a. Nebulizers are for single-patient use only
b. Aseptic technique is always followed when handling the nebulizer and dispensing medications c. Single-dose vials of medication used in nebulizers are always preferred
d. Handheld disposable nebulizers are managed as follows:

i. After each use, rinse out residual volume with sterile water and wipe mask/mouthpiece with an alcohol pad
ii. Discard the nebulizer every 24 hours

e. Handheld reusable nebulizers (eg, home equipment) are managed as follows:

i. After each use, clean, disinfect, rinse with sterile water (if applicable, following cold disinfection method), and air dry away from sink
ii. After each use, the nebulizer can be reprocessed (eg, by steam sterilization) if the reprocessing is performed according to the manufacturer’s instructions and the CF Foundation recommendations for home care (rec. 59) and if the nebulizer can be returned to the patient in time for the next treatment

Source of supporting evidence: 2003 CF IP&C guideline, Category II; 2003 pneumonia guidelines, Category IB; 2008 sterilization and disinfection guidelines, Category IB
2013 CF IP&C guideline consensus: 100%
Sections in the text: III.D.2; IV.E.2

Nebulizers: Cleaning and Disinfecting

59. The CF Foundation recommends that the following steps be performed for nebulizers used in the home as soon as possible after each use:

a. Clean the nebulizer parts with dish detergent soap and water
b. Disinfect the nebulizer parts using one of the following methods:

Heat methods:

a. Place in boiling water and boil for 5 minutes
b. Place in a microwave-safe receptacle submerged in water and microwave for 5 minutes c. Use a dishwasher if the water is more than or equal to 70° C or 158° F for 30 minutes 
d. Use an electric steam sterilizer

Cold methods:

a. Soak in 70% isopropyl alcohol for 5 minutes
b. Soak in 3% hydrogen peroxide for 30 minutes

i. Rinse off the cold-method disinfectant using sterile water, not tap water; the final rinse must be with sterile or filtered (less than or equal to 0.2-micron filter) water
ii. Air dry the nebulizer parts before storage

Source of supporting evidence: 2003 CF IP&C guideline, Category II
2013 CF IP&C guideline consensus: 100%
Sections in the text: III.D.1; IV.E.3

60. The CF Foundation recommends that nebulizers used in the home should not be disinfected with acetic acid (vinegar), bleach solutions, or benzalkonium chloride (e.g., “Control III”).

2013 CF IP&C guideline consensus: 100%
Sections in the text: IV.E.3

References

1. Saiman L, et al (Committee Members). Cystic Fibrosis Foundation Guideline. Infection Prevention and Control Guidance for Cystic Fibrosis: 2013 Update. Infect Control Hosp Epidemiol 2013; 35 (Aug): S1-S67.

Online Manuals

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