Coronavirus Information for Healthcare Professionals | ResMed
Covid-19

COVID-19 resource center

Specific information for home medical equipment providers, respiratory therapists, sleep techs and other medical practitioners about the novel coronavirus, COVID-19.

 

Jump to: Respiratory care  |  Sleep apnea care  |  Sleep centers  |  Reimbursement  |  Helpful links

COVID-19 is evolving rapidly and we recommend using World Health Organization (WHO) guidelines as the initial point of reference for key decisions around patient care and workplace practices. We also encourage you to direct patients to ResMed.com/covid19 for safety information and FAQs that address common concerns.

And as our CEO, Mick Farrell put it: “Thank you to the front-line clinical heroes – many thousands of respiratory therapists, respiratory nurses, pulmonary and critical care medicine physicians, as well as hospital and clinical staff who set up our ventilators and masks for patients in need and deliver the lifesaving gift of breath. You are the superheroes of this COVID-19 crisis, and we salute you!"

Respiratory care

New training and resource page for COVID-19 related ventilation

We've created a resource page with specific product training, including setup and how-to information.

Clinical guidance

 

Emergency use authorizations
ResMed has received Emergency Use Authorization (EUA) from the FDA for use of certain ResMed devices to treat patients during the COVID-19 pandemic. Pursuant to the EUA, a fact sheet for healthcare providers has been issued to outline the significant known and potential risks, as well as benefits, associated with the emergency use of ventilators. The fact sheet for patients must be provided to patients using EUA ventilator devices and contains information to help them understand the risks and benefits associated with using ventilators for their treatment.

Download: Fact sheet for healthcare providers  |  Fact sheet for patients

 

Global clinical position statement
The information contained in these documents is current as of April 10, 2020 and is based on currently available information that will continue to change over time. The information in this guide, FAQs and product summary is believed to have a reasonable basis with respect to treatment. ResMed assumes no obligation to update the information in these guides, whether as a result of new information or future events.

Download: ResMed Ventilators and COVID-19  |  ResMed device specification table

 

FAQs

  • Can CPAPs be used as ventilators?

    CPAP devices are designed to provide only PAP (positive airway pressure) and would require significant rework to function as a ventilator. FDA guidance on March 22, 2020, signals to manufacturers of respiratory equipment that modifications to devices capable of providing modes of ventilation support that may be clinically applicable for COVID-19 patients can be considered if those modifications would not create undue risk for patients. To be clear, the FDA guidance does not signal that CPAPs can be used – as is – to treat the respiratory symptoms of COVID-19. The FDA still requires those potential modifications be made in a manner that is consistent with existing safety, quality, and manufacturing standards applicable to our devices.

    Converting in-market CPAPs to support more advanced modes of ventilation requires careful assessment to ensure risk is acceptable, and must meet labeling requirements to be set forth by the FDA. We’re currently exploring options for achieving this. Meanwhile, we’re taking every safe measure to maximize production of ResMed ventilators and bilevel devices that are more suited to the care of COVID-19 patients.

    For ResMed's position on modifications to CPAP machines, read here.

  • What types of ventilators does ResMed provide to North American markets and what are their indications for use?

    ResMed manufactures Astral™, a life support ventilator with invasive and non-invasive capabilities and Stellar™, a non-life support ventilator with invasive and non-invasive capabilities. Additionally, we manufacture bilevel devices including Lumis™ Tx, AirCurve™ 10 ST, and AirCurve 10 ST-A. These devices are indicated for hospital and home use. As the number of COVID-19 patients increases, and care is delivered outside of the hospital, our battery-operated devices will be useful.

  • Are you increasing production capacity for ventilators?

    Our primary focus is to maximize the availability of ventilators and other respiratory support devices for the patients that need them most. We’re looking to double or triple the output of ventilators, and scale up ventilation mask production more than tenfold.

  • What does ResMed recommend regarding the use of Anti-Bacterial (AB) filters with ventilation devices? How often should these filters be changed? Should these filters be used on the device inlet and outlet?

    To help prevent cross-contamination, an AB filter placed on the inspiratory port is mandatory if the device will be used on multiple patients. Under some fault conditions, expired gas may be returned through the inspiratory port.

    We recommend the use of AB filters for use with all Astral, Stellar and Lumis Tx devices in a multi-patient scenario. The correct usage of these AB filters is described in the relevant ResMed clinical guides. Other AB filters can also be used per clinical guide instructions, including the performance of a learn circuit test.

    ResMed markets AB filters (SKU 24966), and HEPA filters (SKU 7075018). The specified filtration efficiency is:

    AB filters (SKU 24966)

    • BFE 99.999%
    • VFE 99.999%

    HEPA filters (SKU 7075018)

    • BFE 99.9999%
    • VFE 99.9999%

    As per the relevant ResMed clinical guide, filter specifications must comply with ISO 23328-1:2003 & ISO 23328-2:2002. Healthcare professionals will need to assess the frequency of filter replacement based on clinical guidelines and the filter manufacturer recommendations for the product.

  • If an Astral, Stellar or Lumis Tx device has been used without an AB filter, how can the device be disinfected between patients?

    p>To prevent the risk of cross-contamination, an AB filter placed on the inspiratory port is mandatory if the device will be used on multiple patients. Under some fault conditions, expired gas may be returned through the inspiratory port. WHO guidelines provide additional information on how to minimize cross-contamination of patients and healthcare workers when treating COVID-19 patients.

     

    If a device is used without an AB filter, it must be reprocessed using ResMed-labeled processes before reuse.

  • Which ResMed masks can be used to treat COVID-19 patients on ventilation?

    ResMed offers a variety of masks to support COVID-19 patients on ventilation. These include AirFit™ F20, AirTouch™ F20, AcuCare™ masks, and ResMed Hospital masks, among others. A complete list of compatible masks and device settings can be found here. Contact your sales representative to inquire about availability.

  • Can a device that has been used by a patient suspected of COVID-19 exposure be disinfected and reused by a new patient? For example, can devices that are part of loan or trial pools be safely used between patients, including those exposed to COVID-19? And can COVID-19 spread from contact with contaminated surfaces or objects?

    ResMed has established processes in place for validating device usage between patients in a multi-patient environment. These processes align with the recommendations set forth by the World Health Organization (WHO). ResMed has consulted with field experts, hospitals, regulatory bodies and medical practitioners to ensure the safety of our patients, healthcare workers and personnel.

    According to the WHO, it may be possible for people to get COVID-19 by touching surfaces or objects that have the virus on them, and then touching their mouth, nose, or possibly their eyes, but this is not thought to be the main way the virus spreads.

    COVID-19 is a new virus, however, the Environmental Protection Agency (EPA) found that enveloped viruses of this type are fragile and susceptible to common disinfection methods. This reinforces the need to follow existing cleaning and disinfection processes set forth in ResMed clinical guides, user guides and service guides.

    We’ve received inquiries about whether or not a ResMed device’s internal air path has the potential for contamination. We’re continually reviewing available information to understand this risk, so that we can help ensure the safety of ResMed frontline personnel, healthcare workers and patients using loan pool or fleet devices. Based on the behaviors of this virus, and its ability to spread, ResMed has assessed the risk of cross-infection for homecare devices and determined it to be improbable based on the following:

    • The difficulty of contamination reaching the interior of the device against positive air pressure
    • The ability of COVID-19 to remain viable on a surface in that environment
    • The ability of the virus to become mobilized and infect a second patient
  • How should staff in retail outlets, equipment suppliers and service centers handle used devices that are being returned or are already returned? Is additional Personal Protective Equipment (PPE) required?

    All devices returned from a patient to a ResMed facility are treated as contaminated, regardless of whether a virus or bacterial contamination has been identified (including COVID-19). These devices are contained in a specific location when received and isolated from clean devices in the area. Devices can then be reprocessed for reuse or repair by following the cleaning and disinfection procedures set forth in ResMed clinical guides. Some facilities have implemented a wait time before handling and processing returned devices for servicing.

    The WHO has issued interim guidance on the use of PPE for healthcare professionals. ResMed recommends facilities and homecare providers identify their needs based on the recommendations for PPE set forth by the WHO.

  • If a device is received that has been used on a patient with suspected COVID-19, how should the device be handled by staff? (i.e. retail outlet staff, DME/HME staff and service center staff)

    As previously described, staff should handle and process returned devices per existing procedures. Our recommendation is not to dispose of returned devices, but to reprocess them in accordance with ResMed reprocessing procedures.

  • Are ResMed products “Made in China” safe?

    Yes, all Chinese-made components for ResMed products are safe for use, and all components received at a ResMed manufacturing facility go through rigorous safety, cleanliness, and quality checks before manufacturing – processes designed to safeguard against such health threats as COVID-19.


 

Sleep apnea care


We’ve curated a variety of content to help you continue providing much-needed care for patients during this time of social distancing and limited in-person interaction.

Learn more about virtual care

 

Check out our podcast
COVID-19 has forever changed how the sleep industry delivers patient care – today, tomorrow and well into the future. We’re here to help. Listen to ResMed discuss digital health solutions, and best practices for remote CPAP setups and patient management in a new podcast from HME Business.

 

Patient education and support

Sleep apnea treatment overview > Includes 10 steps to better sleep and better health for recently diagnosed patients.
Sleep apnea tests and diagnosis > How to get tested for sleep apnea, plus understanding your test options and results.
Snoring and sleep apnea video gallery > Real patients share their experiences about sleep apnea symptoms and how they got diagnosed.
Starting CPAP therapy video gallery > Tips from patients and experts on starting CPAP therapy and the benefits it can provide.
CPAP equipment: The complete system > Share this interactive page to help patients understand how their CPAP equipment works to treat sleep apnea.
Sleep blog > Articles to help patients better understand sleep health, sleep apnea and CPAP therapy.
How to start CPAP therapy: the complete guide > Downloadable patient guide with key information for the start of your sleep apnea treatment journey.
myAir™ > One of the best and easiest ways to help patients stay on track with their therapy. Encourage patients to create a myAir account and download the app to access their nightly sleep score, track their progress and receive personalized coaching tips.
Cleaning CPAP equipment > Top tips and videos for patients on cleaning and maintaining their CPAP equipment.
COVID-19 diagnosis information guide > In the event of COVID-19 diagnosis, read the American Thoracic Society’s tips on daily mask cleaning. Their informational guide includes additional information and resources on COVID-19 diagnosis and PAP therapy usage. Please refer to your specific ResMed User Guide for specific step-by-step instructions on cleaning your device and mask.

 

ResMed product information

ApneaLink™ Air product training > Access training videos, reference guides and webinars on using our home sleep testing device.
ResMed masks > Helps patients learn more about mask options at or prior to setup.
ResMed CPAP machines > Educates patients on PAP therapy devices and how the latest in sleep device technology can help them get a good night’s sleep.
ResMed sleep product manuals > Patients and providers can quickly view user guides through this product manual resource library.
Cleaning CPAP equipment > Outlines the importance of properly cleaning CPAP equipment on a regular basis including the mask, air tubing and humidifier tub.
Replacing CPAP supplies and equipment > Explains the importance of regular CPAP part replacement, when to order supplies and more.
ResMed YouTube channel > Contains a wide range of video content – including instructional and maintenance videos.

FAQs

  • Dropship and remote setups

    Can I utilize a shipping/delivery service to drop-ship ResMed products?
    Yes. Use of a shipping or delivery service to drop-ship product is approved by CMS. Additionally, in the absence of in-person setup instruction, suppliers may also use non-public facing communication to provide instruction on the proper use and care of equipment. You can find more information through CMS here and here. State laws may vary, so we encourage you to consult your state regulatory guidance.

    How is ResMed helping HMEs support patients unable to come in for setups?
    We’ll be creating additional tools to help size and set up patients remotely on specific masks. These will include an HME playbook with sizing guidelines to help providers size patients at home for remote setups as well as remote setup guides, which provide step-by-step instructions for getting started with ResMed AirSense 10, AirFit F20, AirFit N20, and AirFit P10.

  • Sleep devices

    Can CPAPs be used as ventilators?
    CPAP devices are designed to provide only PAP (positive airway pressure) and would require significant rework to function as a ventilator. FDA guidance on March 22, 2020, signals to manufacturers of respiratory equipment that modifications to devices capable of providing modes of ventilation support that may be clinically applicable for COVID-19 patients can be considered if those modifications would not create undue risk for patients. To be clear, the FDA guidance does not signal that CPAPs can be used – as is – to treat the respiratory symptoms of COVID-19. The FDA still requires those potential modifications be made in a manner that is consistent with existing safety, quality, and manufacturing standards applicable to our devices.

    Converting in-market CPAPs to support more advanced modes of ventilation requires careful assessment to ensure risk is acceptable, and must meet labeling requirements to be set forth by the FDA. We’re currently exploring options for achieving this. Meanwhile, we’re taking every safe measure to maximize production of ResMed ventilators and bilevel devices that are more suited to the care of COVID-19 patients.

    Can CPAP machines spread Coronavirus to bed partners?
    Latest info says non-invasive ventilation (delivered by a mask with air diffusers) has low risk of aerosolization, provided that there’s a good mask fit, patient isolation, and PPE for care providers. See more via the American Academy of Sleep Medicine: Coronavirus FAQs: CPAP tips for sleep apnea patients.

    If a sleep patient is diagnosed with COVID-19, will the virus remain in the device even after the patient has recovered? How should this patient’s CPAP device be treated? Can they continue to use this device after recovery?
    For patients who have recovered from COVID-19, there is currently limited data on the potential for reinfection. Patients should follow our cleaning procedures as outlined in ResMed user guides.

    If a device is received that has been used on a patient with suspected COVID-19, how should the device be handled by staff? (i.e. retail outlet staff, DME/HME staff and service center staff)
    As previously described, staff should handle and process returned devices per existing procedures. Our recommendation is not to dispose of returned devices, but to reprocess them in accordance with ResMed reprocessing procedures.

    Can an AB filter be used on a ResMed AirSense™ 10 or a ResMed S9™ device?
    Per our AirSense 10 and S9 clinical guides, AB filters can be used with these devices. Please note the instructions, specifications and limitations of these filters as described in their respective clinical guides.

    Example: AirSense 10 device:
    Antibacterial filters increase resistance in the air circuit and may affect the accuracy of displayed and delivered pressure, particularly at high flows. ResMed recommends using an antibacterial filter with a low impedance [e.g. 2 cm H2O (2 hPa) at 60 L/min], such as PALL (BB50T), Filter without Luer Port (4222/702) or the Filter with Side Port 24966 (4222/701). If using the Filter with Side Port, an Oxygen Connector Port is required.

    Are ResMed products “Made in China” safe?
    Yes, all components of ResMed products made in China are safe for use. All finished products sold outside China are built outside China, and all components received at a ResMed manufacturing facility (in Sydney or Singapore) go through rigorous safety, cleanliness, and quality checks before manufacturing – processes designed to safeguard against such health threats as COVID-19.

  • Masks

    With the shortage of personal protective equipment, can ResMed CPAP masks be used in lieu of N95 masks?
    ResMed masks have not been tested nor validated for use in combatting the spread of COVID-19; therefore wearing one for this purpose would be considered off-label usage. Modifying or altering the mask in any way would also be considered off-label.

    Does ResMed have enough mask systems and components available to meet current demand in the US and worldwide for new and existing patients?
    We’re taking every safe measure to maximize the production of masks, ventilators and other respiratory devices, while still ensuring the same quality, safety, good manufacturing practices, and top-level hygiene procedures at our manufacturing facilities worldwide. Please contact your ResMed sales representative for mask availability in your area.

    Can a mask that has been used by a patient with suspected COVID-19 be disinfected and reused by a new patient?
    For multi-patient/multi-use masks, ResMed has established processes that are validated for use between patients in a multi-patient environment, and these align with the recommendations of the WHO. With the onset of COVID-19, we’ve consulted with experts, hospitals and medical practitioners to ensure that existing disinfection guidelines remain appropriate for the safety of our patients, health care workers and personnel. Please refer to the HCP mask support page for disinfection guidelines and other resources for specific ResMed masks.

    The ResMed Mask Guarantee program allocates a 30-day window for mask returns. What should be done if a patient can’t return their mask because of a stay-at-home request and/or quarantine due to COVID?
    During this time, we realize it may be difficult for patients to get in contact with their HME within the allotted 30-day period. Whether a patient reaches out before or after the 30-day period, ResMed will still honor all mask guarantees for those under a COVID-19 quarantine order or stay-at-home request.

    Can you determine mask selection based on a patient’s AHI?
    Each ResMed mask has been validated for patient use at different AHI pressure ranges. Please refer to specific mask user guides for more information.

    Will ResMed ReSupply services remain open to assist my patients during the “stay-at-home” mandate window?
    Yes. ResMed Resupply’s fully staffed call center and solutions operations teams are available to assist providers and their patients with full continuity of services for their replacement needs.

  • Home sleep testing

    Is the inside of the ApneaLink™ Air home sleep testing device clean and safe for MPMU in light of Covid-19?
    The Cleaning and Disinfection section of the ApneaLink Air Clinical Guide describes the validated materials and method for processing devices between patients. It is not necessary to clean the interior of the ApneaLink Air device. Based on the behavior of this virus, and its ability to spread, ResMed has assessed the risk of cross-infection for homecare devices and determined it to be improbable. This is based on:

    • The difficulty of contamination reaching the device interior
    • The ability of COVID-19 to remain viable on a surface in that environment
    • The ability of the virus to become mobilized and infect a second patient

    Does ResMed recommend using cannulas with inline filters on ApneaLink Air?
    We have not tested nor validated the use of in-line filters for ApneaLink Air.

    What is the bag cleaning and disinfection procedure for ApneaLink Air bags that have been returned and potentially used by patients?
    We recommend cleaning bag surfaces with a disposable cloth and mild detergent or alcohol disinfectant.

  • CMS guidelines

    What does the expansion of telehealth under the CMS 1135 waiver allow?
    Effective March 6, 2020, Medicare patients can receive a wider range of telehealth services from doctors without having to travel to a healthcare facility. A telehealth visit is acceptable for all in-person/face-to-face encounters for patients in all areas of the country, for all Durable, Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS). This replaces the requirement for the in-person visit as long as the emergency expansion remains in effect. While telehealth replaces the in-person visit, the coverage criteria must still be documented per the medical policies. A range of providers, such as doctors, nurse practitioners, clinical psychologists, and licensed clinical social workers can offer telehealth to their patients. For more, read CMS’ Telehealth Fact Sheet.


 

Sleep centers

Reopening procedures related to COVID-19

New resources for sleep centers, including product-specific training, titration and disinfection guides, and industry partner links.

ResMed clinical position statement

 

Current industry-wide recommendations for sleep laboratories in the US following COVID-19
US sleep laboratories can access this resource for current industry-wide recommendations following COVID-19. The information contained in this document is current as of June 24, 2020, and is based on currently available information that will continue to change over time. The information in this document with respect to treatment is believed to have a reasonable basis. ResMed assumes no obligation to update the information in this document, whether as a result of new information or future events.

Download: Sleep centers and COVID-19

 

ResMed product information

ResMed S9™ VPAP™ Tx clinical guide > Downloadable guide that includes instructions on the S9 VPAP Tx, which provides CPAP and bilevel therapy, and is a component of the S9 VPAP Tx Lab System.
ResMed H5i™ disinfection guide > Downloadable guide that describes our recommended and validated cleaning and disinfection procedures for the ResMed H5i humidifier, and is intended for multi-patient use in a sleep lab, clinic, hospital or healthcare provider facility.
ResMed sleep lab titration guide > Downloadable guide to help you get started with the S9™ VPAP™ Tx Lab System, our sleep lab titration system.
ResMed ApneaLink™ Air product training > Access training videos, reference guides and webinars on using our home sleep testing device.
ResMed AirFit™ F20 disinfection and sterilization guide > Downloadable guide intended for multi-patient re-use of the AirFit F20 full face mask in a sleep lab, clinic or hospital.
ResMed AirFit™ F30 disinfection guide > Downloadable guide intended for multi-patient re-use of the AirFit F30 full face mask in a sleep lab, clinic or hospital.
ResMed AirFit™ F30i disinfection guide > Downloadable guide intended for multi-patient re-use of the AirFit F30i full face mask in a sleep lab, clinic or hospital.
ResMed product information guide > Downloadable guide that provides a complete overview of our products and services, including ResMed devices and accessories, masks and connected health solutions.

 

Industry partner links

AASM COVID-19 resources
AAST COVID-19 resources


 

Reimbursement

IMPORTANT: These FAQs bring together publicly available information as of April 3, 2020 from government sources on responses to the COVID-19 public health emergency (PHE) declared by the U.S. government and many states. The information presented here is being provided on an “as-is” basis with no express or implied warranty of any kind, and should be used only at your discretion and only after consulting with your own experts on reimbursement issues. Additionally, the guidance we have seen from official sources is that any exceptions by CMS and other agencies (e.g. the OIG) is temporary and will expire when the public emergency has ended. Therefore, all information is subject to change without notice. ResMed does not represent or warrant that any of the information being provided is true or correct. You agree to hold ResMed harmless in the event of any loss, damage, liabilities or claims arising from the use of any reimbursement information provided to you. Providers should consult their own payers, the U.S. Centers for Medicare & Medicaid Coronavirus waivers & flexibilities website, or their own counsel for legal advice on how CMS waivers & flexibilities apply to their business.

Verification is always the sole responsibility of the provider. ResMed does not commit to update information beyond the date set forth above.

FAQs

IMPORTANT: These FAQs bring together publicly available information as of April 3, 2020 from government sources on responses to the COVID-19 public health emergency (PHE) declared by the U.S. government and many states. The information presented here is being provided on an “as-is” basis with no express or implied warranty of any kind, and should be used only at your discretion and only after consulting with your own experts on reimbursement issues. Additionally, the guidance we have seen from official sources is that any exceptions by CMS and other agencies (e.g. the OIG) is temporary and will expire when the public emergency has ended. Therefore, all information is subject to change without notice. ResMed does not represent or warrant that any of the information being provided is true or correct. You agree to hold ResMed harmless in the event of any loss, damage, liabilities or claims arising from the use of any reimbursement information provided to you. Providers should consult their own payers, the U.S. Centers for Medicare & Medicaid Coronavirus waivers & flexibilities website, or their own counsel for legal advice on how CMS waivers & flexibilities apply to their business.

Verification is always the sole responsibility of the provider. ResMed does not commit to update information beyond the date set forth above.


 

Helpful links

Official information related to COVID-19 from relevant governmental agencies and industry partners.

WHO:

CDC:

Canada-specific

CMS: 

FDA:

AASM:

Commercial Payers:

SBA:

U.S. Department of the Treasury:

AARC

 

Disclaimer: This reimbursement information is being provided on an “as is” basis with no express or implied warranty of any kind, and should be used solely for your internal informational purposes only. Verification is always the responsibility of the provider/supplier. The information does not constitute professional or legal advice on reimbursement and should be used at your sole liability and discretion. All coding, coverage policies and reimbursement information is subject to change without notice. ResMed does not represent or warrant that any of the information being provided is true or correct and you agree to hold ResMed harmless in the event of any loss, damage, liabilities or claims arising from the use of the reimbursement information provided to you. Before filing any claims, it is the provider’s/supplier’s sole responsibility to verify current requirements and policies with the applicable payer.