Respiratory Assistance Helmets
Evaluation Background: Respiratory Assistance Helmets
Ratings: Respiratory Assistance HelmetsClick 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) |
Amron 8891 Series Last updated May 2021 |
| Worldwide | Good | Good | Good | Good | Not evaluated | Not evaluated | Covered under Workflow | Covered under Workflow | Excellent; $200 per device + $30 per use (product can be used for multiple patients) |
Intersurgical StarMed CaStar R Hood Last updated May 2021 |
| Worldwide | Good | Good | Excellent | Good | Not evaluated | Not evaluated | Covered under Workflow | Covered under Workflow | Fair; $260 (product is single-use) |
Lombardi Undersea Subsalve Oxygen Treatment Hood Last updated May 2021 |
| Worldwide | Good | Good | Excellent | Good | Not evaluated | Not evaluated | Covered under Workflow | Covered under Workflow | Good; $200 (product is single-use) |
Sea-Long PN 5404 Covid Helmet Kit C Last updated May 2021 |
Rating applies only when used with an external anti-asphyxia valve and external pressure-relief valve, and when IFU are closely followed so that the port on the patient's right is only used for inflow to prevent a flow obstruction. | Worldwide | Good | Fair | Good | Good | Not evaluated | Not evaluated | Covered under Workflow | Covered under Workflow | Excellent; $200 per device + $60 per use (product can be used for multiple patients) |
Oxygen Concentrators
Evaluation Background: Stationary and Portable Oxygen Concentrators
Ratings: Stationary Oxygen ConcentratorsClick 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 Three Years |
Canta Medical V8-WN-NS
Last updated 9/2022 |
| Asia; unable to confirm additional regions (not available in US) | Excellent | Good | Good | Good | Not evaluated | Not evaluated | Good | Not evaluated | ECRI databases do not have pricing for this model. |
Nidek Nuvo Lite Mark 5
Last updated 9/2022 |
| Worldwide | Good | Good | Good | Good | Not evaluated | Not evaluated | Good | Not evaluated | $650 (capital cost only) |
Philips EverFlo
Last updated 9/2022
Note: US sales of this product discontinued as of 1/25/2024
|
|
Worldwide (excluding US) | Good | Good | Good | Good | Not evaluated | Not evaluated | Good | Not evaluated | $750 (capital cost only) |
Respircare AO5W
Last updated 9/2022 |
| Africa, Asia, Australia and Oceania, Europe, Central and South America, UK (not available in US) | Good | Good | Good | Good | Not evaluated | Not evaluated | Good | Not evaluated | Good; $1,400 Based on general (not country-specific) pricing provided by Shenyang RMS Medical Tech
|
Subglottic Aspiration Devices
Evaluation Background: Subglottic Aspiration Devices
Ventilator Safety Issues
Exploring the Evidence and Devices Designed to Prevent Ventilator-Associated Pneumonia (Webcast: 2022 Oct 26)
View a recording 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
Ventilating Multiple Patients with a Single Ventilator
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 cleared 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 provide 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.
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 Gases 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 Suction 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.)