vyaire Medical
Vyaire Avea Ventilator Series
Mechanical Ventilation Cleaning, Disinfecting and Sterilization Recommendations March 2020
Cleaning, Disinfecting and Sterilization Recommendations
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Informational Bulletin IMPORTANT INFORMATION – PLEASE READ AND KEEP
Mechanical ventilation cleaning, disinfecting and sterilization recommendations Date: March 13, 2020 Background With the heightened awareness and concern of the recent Coronavirus disease (COVID-19) outbreaks, we have been requested to reinforce our cleaning, disinfecting and sterilization recommendations for Vyaire Medical ventilation products. These recommendations are distilled from the product literature (e.g. operator’s manuals) and are aligned with the Center for Disease Control (CDC) guidelines. Centers for Disease Control (CDC) Recommendation With increasing concerns over the recent Coronavirus disease (COVID-19) outbreaks, Vyaire Medical is reinforcing the Centers for Disease Control (CDC) recommendation of following the manufacturer’s guidelines for cleaning, disinfecting and sterilization of medical equipment. To that that end, this serves as a restatement of cleaning guidelines (as published in the Operator’s Manuals) for Vyaire Medical mechanical ventilation products. Implement Environmental Infection Control of Dedicated Medical Equipment • Dedicated medical equipment should be used when caring for patients with known or suspected COVID-19 o All non-dedicated, non-disposable medical equipment used for patient care should be cleaned and disinfected according to manufacturer’s instructions and facility policies • Ensure that environmental cleaning and disinfection procedures are followed consistently and correctly • Routine cleaning and disinfection procedures (e.g., using cleaners and water to pre-clean surfaces prior to applying an EPA-registered, hospital-grade disinfectant to frequently touched surfaces or objects for appropriate contact times as indicated on the product’s label) are appropriate for SARS-CoV-2 in healthcare settings, including those patient-care areas in which aerosol-generating procedures are performed o Refer to List Nexternal icon on the EPA website for EPA-registered disinfectants that have qualified under EPA’s emerging viral pathogens program for use against SARS-CoV-2 (COVID-19) Page 1 of 5
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• •
Management of laundry, food service utensils, and medical waste should also be performed in accordance with routine procedures Additional information about recommended practices for terminal cleaning of rooms and PPE to be worn by environmental services personnel is available in the Healthcare Infection Prevention and Control FAQs for COVID-19
The following tables contains recommended cleaning methods of Vyaire ventilation products. Please refer to the appropriate Operator’s Manual or contact Vyaire Technical Support for more information. Technical Product Support: 800-231-2466 Europe, Middle East, Africa, LATAM: Email: [email protected] Hotline: +49-931-4972-393 Asia Pacific, Japan, ANZ: Email: [email protected] China: Email: [email protected] Hotline: +86-400-878-8885 • • • •
Avea™, Bird™, VELA™, bellavista™, fabian™ ventilators * [email protected] EnVe ® and ReVel™ ventilators* [email protected] HFOV 3100A/B and Infant Flow™ SiPAP ventilators * [email protected] LTV ventilators* [email protected]
*Not all products may be available in all regions.
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For Global Distribution. ©2020 Vyaire. Vyaire, the Vyaire logo and all other trademarks or registered trademarks are property of Vyaire Medical, Inc., or one of its affiliates. VYR-GBL-2000085
Vyaire Products AVEA
EnVe / ReVel
LTV
VELA
Exterior (including cables)
10% chlorine bleach5
Control III4 1% chlorine bleach1, 5
2% glutaraldehyde1, 4 1% chlorine bleach1, 5
1% chlorine bleach1, 5
Infant hot wire flow sensors
Autoclave3 Cidex4
n/a
n/a
n/a
Capnostat®
10% chlorine bleach5
n/a
n/a
10% chlorine bleach5
Reusable Capnostat Adaptors (see #2 below)
Autoclave3 (adult adaptor only) 10% chlorine bleach
n/a
n/a
Reusable water trap (see #2 below)
Autoclave
n/a
n/a
n/a
Use disposable circuit Autoclave3 Cidex4 ETO
Use disposable circuit Autoclave3 Cidex4
Reusable patient circuit (see #2 below)
Use disposable circuit Autoclave3 Cidex4
n/a
Autoclave3 (adult adaptor only) 10% chlorine bleach5
Autoclave3 Do not soak; limit temperature to 275°F (135°C)
Use disposable filtered water trap
Replace
Replace
Exhalation valve body (see #2 below)
n/a
Autoclave3 Cidex Plus 284
n/a
Autoclave3
Exhalation flow sensor (see #2 below)
n/a
n/a
n/a
Autoclave3
Exhalation diaphragm (see #2 below)
n/a
n/a
n/a
Autoclave3
Reusable filters (see #2 below)
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For Global Distribution. ©2020 Vyaire. Vyaire, the Vyaire logo and all other trademarks or registered trademarks are property of Vyaire Medical, Inc., or one of its affiliates. VYR-GBL-2000085
Vyaire Products, continued 3100 A & B
SiPAP
bellavista
fabian
Blenders
1% chlorine bleach1, 5
CaviWipes surface disinfecting wipes, 10% chlorine bleach and 5% hydrogen peroxide
CaviWipes surface disinfecting wipes
10% chlorine bleach5 ETO
n/a
n/a
n/a
Autoclave3
n/a
n/a
n/a
n/a
n/a
n/a
Reusable Capnostat Adaptors (see #2 below)
n/a
n/a
n/a
n/a
n/a
Reusable water trap (see #2 below)
n/a
n/a
n/a
n/a
n/a
Reusable patient circuit (see #2 below)
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
Exhalation valve body (see #2 below)
n/a
n/a
Autoclave3
Autoclave3
n/a
Exhalation flow sensor (see #2 below)
n/a
n/a
n/a
n/a
n/a
Exhalation diaphragm (see #2 below)
n/a
n/a
Autoclave3
n/a
n/a
Exterior (including cables)
Infant hot wire flow sensors
1% chlorine bleach1, 5 Do not allow chemicals to come into contact with driver diaphragm
Capnostat®
Reusable filters (see #2 below)
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For Global Distribution. ©2020 Vyaire. Vyaire, the Vyaire logo and all other trademarks or registered trademarks are property of Vyaire Medical, Inc., or one of its affiliates. VYR-GBL-2000085
Notes: 1. Although not stated in the Operator’s Manual, this method may be used when no other options are available. The weaker bleach solutions (1%) will require more time to disinfect (see note #5) 2. CDC recommends using disposable components when possible. 3. General autoclave guidelines (follow instruction in device Operators, or the exhalation valve IFU) a. Steam Autoclave: maximum temperature 138˚C (280˚F), minimum temperature 132˚C (270˚F) for a maximum of 18 minutes and a minimum of 15 minutes. b. Vacuum Steam Autoclave: Three pre-condition pulses (vacuum pulses). Sterilizer vacuum target set to 10- 26 psig. Dwell at 132 - 138˚C (270 to 280˚F) for 4 to 8 minutes. c. Reusable circuits: 20 psig, 135˚C (275˚F), moist heat for seven minutes (or) 0 PSIG (gravity) 135˚C (275˚F), moist heat for 15 minutes 4. Glutaraldehyde (Cidex products): Follow device Operator’s Manual and disinfectant instructions for use. 5. Allow all surfaces to air-dry thoroughly after disinfecting (to increase the contact time with the chlorine, surfaces should remain damp for at least 10 minutes). 6. General considerations for cleaning medical devices: Consult the equipment’s Operator’s Manual for specific cleaning instructions. Never: spray liquids in or on the device; immerse the device in liquids; or use abrasive cleaners.
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26125 N. Riverwoods Blvd. Mettawa, IL 60045
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For Global Distribution. ©2020 Vyaire. Vyaire, the Vyaire logo and all other trademarks or registered trademarks are property of Vyaire Medical, Inc., or one of its affiliates. VYR-GBL-2000085