Evaluation Background: Continuous Positive Airway Pressure (CPAP) Units

Ratings: Continuous Positive Airway Pressure Units  Click the device names below to view our complete findings for each model. Products are listed alphabetically by supplier. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​
Model	Rating	Where Marketed	Performance	Safety	Workflow	Patient Experience	Interoperability	Cybersecurity	Maintenance	User Experience	Cost of Ownership (Estimated) over Five Years
Metran JPAP Last updated 12/2019		Australia, Hong Kong, Israel, Japan, Jordan, Thailand, various European countries (not available in U.S.)	Good	Good	Excellent	Excellent	Not evaluated	Good	Good	Not evaluated	Good;                         $2,400/$1,500 with/without Hummax QE humidification system*
Philips Respironics DreamStation Last updated 6/2020		Worldwide	Good	Good	Excellent	Excellent	Not evaluated	Good	Good	Not evaluated	Good; $1,800**
ResMed AirSense 10 Last updated 6/2020		Worldwide	Good	Good	Excellent	Excellent	Not evaluated	To be determined	Good	Not evaluated	Good; $2,000**
Resvent iBreeze 20A Last updated 12/2019		Africa, Asia, Europe, Latin America, the Middle East, Oceania (not available in U.S.)	Good	Good	Excellent	Excellent	Not evaluated	Good	Good	Not evaluated	Good; $1,300***
Xiaoniu AS100A Last updated 12/2019		Australia, Chile, China, Greece, India, Thailand, Tunisia (not available in U.S.)	Good	Good	Good	Excellent	Not evaluated	Good	Good	Not evaluated	Good; $1,200***
* Based on prices for Hong Kong, a major market for the product; converted to U.S. dollars. ** Based on prices for the United States, a major market for the product. *** Based on prices for China, a major market for the product; converted to U.S. dollars.  ​ ​ ​ ​ ​ ​ ​ ​ ​

Evaluation Background: High-Flow Oxygen Therapy Units​

Ratings: High-Flow Oxygen Therapy Units Click the device names below to view our complete findings for each model. Products are listed alphabetically by​ supplier. Learn about our five-star rating system.​​​​​​
Model​	Rating	Where Marketed	Performance	Safety	Workflow	Patient Experience	Interoperability	Cybersecurity	Maintenance	User Experience	Cost of Ownership (Estimated) over Five Years
Fisher & Payke​l Airvo 2 Last updated 12/2021		Worldwide	Good	Fair	Excellent	Good	Good	Good	Good	Not evaluated	Good; $15,200
​​​​Micomme Medical OH-70C Last updated 8/202​3	​	​Africa, Asia, Canada, Europe, Oceania, South America, UK (not available in US)​​	​Good	Fair​	Good​	Good​	​Not evaluated	​Not evaluated	​Excellent	​​Not evaluated	​Good; $14,000 ​​Based on prices for Malaysia, one of the markets for the product.​
Vapotherm Precision Flow Plus Last updated 12/2021		Worldwide	Good	Excellent	Excellent	Good	Excellent	Good​	Good	Not evaluated	Good; $23,300

Evaluation Background: Respiratory Assistance Helmets

Ventilator Safety Issues

Exploring the Evidence and Devices Designed to​ Prevent Ventilator-Associated Pne​​umonia (Webcast: 2022 Oct 26)

​View a recordin​g of our October 2022 lab webcast, which covers current strategies to reduce ventilator-associated pneumonia (VAP), the evidence supporting use of subglottic drainage to prevent VAP, and ECRI's hands-on lab testing of subglottic drainage technology. ​

Safe Cleaning and Disinfection of Ventilators: ECRI's Recommendations

The cleaning and disinfection recommendations provided for different ventilators are inconsistent from one vendor to the next, which may cause confusion about what measures are necessary to keep patients safe. Here's what ECRI recommends.

Using Ventilator Technology to Avoid Ventilator-Associated Events

Outdated ventilation protocols and failure to use current ventilator capabilities can lead to preventable patient harm.

Confusion Surrounding Ventilator Cleaning and Disinfection Requirements Can Lead to Cross-Contamination (Hazard #7—2023 Top 10 Health Technology Hazards)

Ventilator reprocessing instructions are sometimes incomplete or confusing. Lack of clarity about which steps are required, and when, increases the risk of infectious disease transmission. We present our disinfection recommendations, and challenge manufacturers to improve their instructions.

Improperly Set Ventilator Alarms Put Patients at Risk for Hypoxic Brain Injury or Death (Hazard #4—Top 10 Health Technology Hazards for 2019)

Ventilator patients are at risk if the device's alarms are not tailored to the patient's respiratory parameters. Breathing circuit leaks, disconnections, and other failures associated with consumable components can lead to harm if not identified promptly.

Missed Ventilator Alarms Can Lead to Patient Harm (Hazard #3—Top 10 Health Technology Hazards For 2017)

Ventilator alarm management challenges complicate efforts to prevent patient harm resulting from missed alarms. Ventilators deliver life-sustaining therapy, and a missed alarm could be deadly. Our recommendations can help you overcome these challenges.

Failure to Appropriately Operate Intensive Care Ventilators Can Result in Preventable Ventilator-Induced Lung Injuries (Hazard #9—Top 10 Health Technology Hazards for 2016)

Inappropriate patient ventilation can cause ventilator-induced lung injury (VILI), particularly in intensive care patients, and may lead to patient death. Lung-protective strategies have been developed, and advanced ventilator modes and features are available. Too often, however, these existing techniques and tools are not used to their full advantage, and best practices and device capabilities are not always assessed and adopted when warranted.

Unsafe Ventilator Alarm Management Practices

One of the most common safety concerns with ventilators has to do with alarm management. Most ventilator models allow clinicians to set alarm limits well outside reasonable clinical ranges, and some devices allow clinicians to disable some or many alarms completely without any indication on the main screen. We consider both these practices to be hazardous.  

Coping with Respiratory Equipment Shortages 

Inadequate Emergency Stockpiles Could Disrupt Patient Care during a Public Health Emergency (Hazard #4—2022 Top 10 Health Technology Hazards)

If the equipment and supplies in an emergency stockpile are inappropriate, missing, expired, or otherwise insufficient, care may be disrupted during a crisis, potentially causing patient harm. Careful attention is required to keep stockpiles ready for use when needed.

Ventilators Obtained from Storage, Unknown Sources, or Accelerated Manufacturing Require Inspection before Patient Use [ECRI Exclusive Hazard Report] (ECRI Alerts Accession No. H0624)
In responding to the COVID-19 pandemic, hospitals may require an influx of ventilators from multiple sources and in unknown conditions. In many instances, such equipment has failed incoming inspections, highlighting the importance of conducting acceptance checks on any incoming ventilators before placing them into service. Recommended steps are outlined.

Philips—Respironics E30 Ventilators: ECRI Assessment of Emergency Use Authorization Device [ECRI Exclusive Special Report] (ECRI Alerts Accession No. S0404)
Philips has received an Emergency Use Authorization (EUA) from FDA to temporarily sell the E30 ventilator to provide invasive and noninvasive ventilatory support for appropriate individuals with respiratory insufficiency during the COVID-19 pandemic. The limitations of the E30 compared to an ICU ventilator are described, along with ECRI's concerns.

Ventilators on FDA Emergency Use Authorization List: Hospitals Should Seek Clarity on Post-EUA Status Before Purchasing [ECRI Exclusive Special Report] (ECRI Alerts Accession No. S0399)
Healthcare facilities that are using ventilatory support devices that have been cleared by FDA for use only during the COVID-19 pandemic under an Emergency Use Authorization (EUA) need to be aware that continued use of the devices outside the special exemption provided by the EUA could expose the hospital to liability and/or action by accreditors or payers. Recommendations for navigating this issue are presented.

Shortages of Intensive Care Ventilators—Strategies for Mitigation [ECRI Exclusive Special Report] (ECRI Alerts Accession No. S0398)
Hospitals may experience shortages of intensive care ventilators during the COVID-19 pandemic. ECRI summarizes its recommendations for maximizing your supply and identifying and deploying alternatives.

Deploying Anesthesia Machines as ICU Ventilators

• ECRI's live-streamed lab webcast "Planning Considerations for Deploying Anesthesia Machines as ICU Ventilators" (4/7/2020), available here: Addressing Ventilator Shortages during the COVID-19 Pandemic
• COVID-19 Q&A: Considerations for Deploying Anesthesia Machines as ICU Ventilators
  One of the top recommendations for addressing ICU ventilator shortages experienced in COVID-19 hotspots is to make use of any available anesthesia systems that might be sitting idle. We address some of the key questions that were raised during ECRI's April 7, 2020, lab webcast about such deployments.
• Anesthesia Units Can Be Repurposed to Provide Ventilatory Support for Critically Ill Patients, as Long as Precautions Are Taken [ECRI Exclusive Special Report] (ECRI Alerts Accession No. S0397)
  Anesthesia units can be used to supplement a hospital's fleet of intensive care ventilators, as long as appropriate steps are taken. Technical considerations and safety recommendations are detailed.

Ventilating Multiple Patients with a Single Ventilator

• ECRI's live-streamed lab webcast "Strategies to Mitigate Ventilator Shortages" (4/1/2020), available here: Addressing Ventilator Shortages during the COVID-19 Pandemic
• Use of One Ventilator to Mechanically Ventilate Two or More Patients Simultaneously Presents Risks [ECRI Exclusive Hazard Report] (ECRI Alerts Accession No. H0574)
  The use of one ventilator to treat two or more patients via adapters has been proposed as one way to address ventilator shortages related to a surge of COVID-19 patients. While this may be technically feasible, there are numerous risks and complications involved in the process. Technical considerations and ECRI's recommendations are discussed.

Respiratory Assist Helmets—An Alternative Treatment Option? (Webcast: 2021 Jan 13)

Part of ECRI's "COVID-19 and Medical Devices" lab webcast series, our January 13, 2021, webcast focuses on the use of respiratory assist helmets for supplying supplemental oxygen and reducing the need for a full ventilator in COVID-19 patients suffering from acute respiratory distress syndrome. View the session recording, including live Q&A, plus supplementary materials.

Use of Consumer-Grade Obstructive Sleep Apnea Devices May Supplement Ventilator Supply during Shortage [ECRI Exclusive Hazard Report] (ECRI Alerts Accession No. H0587)

Under appropriate conditions, devices intended for obstructive sleep apnea may be used as a temporary measure for low-acuity patients while respiratory care devices cleare​​​d for other preferred therapies are in a critical shortage. Device requirements and patient selection considerations are discussed.

Automatic Gas-Powered Resuscitators: What Is Their Role in Mass Critical Care?

Although automatic gas-powered resuscitators may seem like a wise choice for ventilating patients in mass critical care scenarios, ECRI recommends against stockpiling the devices for this purpose. Find out why in our Evaluation.

Other Respiratory Safety Topics

In June 2021, Philips Respironics announced a recall that affected millions of their CPAP patients. While waiting for Philips to provid​​​e a full solution, patients are seeking solutions from sometimes questionable sources. View a recording of our June 23, 2022, live webcast that provides recommendations for helping your patients.  

High-Flow Oxygen Therapy Devices May Not Alert Clinicians of a Disconnect; Physical and Physiological Monitoring Is Recommended to Avoid Potential Complications [ECRI Exclusive Hazard Report] (ECRI Alerts Accession No. H0725)

High-flow oxygen therapy (HFOT) devices are effective as an initial support strategy for patients with acute respiratory failure and/or hypoxemia. But they do not have specific circuit "disconnect" monitoring and therefore may not alert clinicians during an accidental disconnection. Patients can suffer serious injury or death if their supplemental oxygen is less than prescribed or is stopped or interrupted.

Ventilators

User Survey Results

We surveyed users of intensive care ventilators about their opinions of current models, including ease of use, performance, and reliability, plus the average number of annual repairs they experience and how often they inspect the devices.

• Intensive Care Ventilators
• Transport Ventilators

Mechanical Ventilation: Understanding Key Terms and Concepts

This article presents a standardized vocabulary for mechanical ventilation that has been developed and is maintained by Robert Chatburn. This material is ©2015 by Mandu Press, Ltd., and is used with permission.

Penn Medicine App Promotes More Rapid Weaning from Mechanical Ventilation and Sedation—An Award-Winning Initiative

Penn Medicine (Philadelphia, PA) was named the winner of ECRI's 13th Health Devices Achievement Award for its development of a dashboard and clinician alert system that uses EHR data to promote more rapid ventilator weaning and reduced sedation.

Medical Gas Systems

Troubleshooting Oxygen Delivery Problems

Since some patients require delivery of a precise concentration of oxygen from medical gas systems, ensuring that the proper concentrations are delivered is important. This article helps identify and resolve a number of problems that can occur.

Checklist for Identifying Medical Gas System Problems

We provide a brief checklist for clinicians, facilities staff, and engineering staff on what to do if problems arise with medical gas delivery.

Medical Gase​s and Their Uses

Learn the appropriate uses for the two main classes of medical gases, namely patient medical gases and medical support gases.

Medical Suction Devices​​​

Medical Suct​​​ion Devices: Using Them Safely and Effectively​

​Medical suction is essential and used universally across the patient care continuum. Learn the factors that affect the quality of suction and read our recommendations for using suction devices effectively and safely.

Ventilators

International Organization for Standardization (ISO) Standards for Critical Care Ventilators

A key requirement for all intensive care ventilators evaluated by ECRI is compliance with International Organization for Standardization (ISO) standard ISO 80601-2-12:2011, Medical Electrical Equipment—Particular Requirements for Basic Safety and Essential Performance of Critical Care Ventilators, and the accompanying ISO 80601-2-55:2011, Medical Electrical Equipment—Particular Requirements for the Basic Safety and Essential Performance of Respiratory Gas Monitors. These standards include requirements ECRI considers necessary to ensure both safety and performance for intensive care use.

Mechanical Ventilation: Manufacturer-Specific Terminology for Ventilation Modes and Features

In order to compare ventilation capabilities from different manufacturers that use dissimilar terminology, ECRI has adopted a generic nomenclature or taxonomy. All modes of the three models that we evaluated in December 2015—the Draeger Evita Infinity V500, Hamilton Medical G5, and Maquet Servo-i—are defined per this taxonomy and presented in a table to facilitate cross-referencing and comparison among the different devices. Identical modes among different ventilators can be easily identified, as can the availability or unavailability of particular modes.

Estimating Cost of Ownership for Intensive Care Ventilators

Estimating total cost of ownership of critical care ventilators requires not only capital equipment costs, but ongoing operational and maintenance costs. Assessing these costs involves formulating assumptions for ventilator utilization, physician practices, patient populations, infection control protocols, and maintenance practices. This article reports the results of a cost-of-ownership analysis of intensive care ventilators conducted by ECRI for a member hospital. The methods used to conduct the analysis and the results are reported.

Advanced Ventilation Features: What's Available and How to Make a Smart Purchase

Many of today's intensive care ventilators have similar core functionality. As a result, advanced ventilation modes and features are becoming more important as differentiating factors for purchasers, especially given the emphasis placed on them by vendors during the selection process. This article is intended to help hospitals critically analyze quotations for intensive care ventilators and make smarter, more cost-effective choices regarding the advanced features that are available.

Device Comparison Guide Charts

Access charts listing the specifications of each model side by side for quick comparison. Device Comparison Guide is available to members of the Device Evaluation Plus and Capital Guide programs.

• Breathing Circuits, Ventilator
• High-Flow Oxygen Therapy Units
• Masks, Air-Oxygen, Positive Airway Pressure Unit 
• Positive Airway Pressure Units, Noninvasive
• Resuscitators, Cardiac
• Resuscitators, Pulmonary, Manual
• Ventilators, Intensive Care
• Ventilators, Transport
• Ventilators, Sub-Acute/Home Care
• Ventilators, Intensive Care, High-Frequency

Market Intelligence Reports

Get rapid-access market intelligence on cardiac mapping systems, interest in various vendors and models, comparison of key features, service and support information, pricing, typical discounts, and more. (Market Intelligence reports are available to Capital Guide program members.)

• High-Frequency Ventilators
• Intensive Care Ventilators
• MRI-Compatible ICU Ventilators
• Portable Transport Ventilators​