Executive Summary

In any disaster or other crisis, how you react depends largely on how well prepared you are. Over the years, ECRI has witnessed a number of catastrophic events—such as outbreaks of severe acute respiratory syndrome (SARS) and Ebola—and has learned lessons that are pertinent for dealing for current crises such as the 2020 COVID-19 coronavirus pandemic. While no two emergencies are the same, we can gain vital insights from previous events.

In a crisis, normal processes must often be modified to ensure that the best possible care is provided while ensuring the safety of patients and personnel despite limited resources. We have collected many ECRI publications that include preparation checklists, patient handling checklists, equipment lists, lists of alternative suppliers, recommendations for patient care equipment such as ventilators, and recommendations for infection control.

Who Should Read This

COVID-19 OUTBREAK PREPAREDNESS AND RESPONSE

This section provides links to ECRI resources—and a few outside sources—that healthcare organizations may find useful during the 2020 COVID-19 pandemic.

New member resource: Healthcare Recovery Center—COVID-19. As organizations assess, plan, and implement reopening strategies, ECRI's researchers, analysts, engineers, and clinicians are here to support you. Through our COVID-19 recovery center, ECRI provides members with open access to recovery-related guidance, tools, and resources. No matter your stage of recovery, we are proactively developing resources you need to make the safest decisions.  

Visit our free COVID-19 pages. In keeping with its mission to advance effective, evidence-based healthcare globally, ECRI is providing free public access to many of its COVID-19 resources. A special version of this Essentials page gives public access to a wide variety of Health Devices resources, including many of those on this page. And even more content is available for free on ECRI's COVID-19 Resource Center. No membership or other payment is required.

 

COVID-19 and Medical Devices: A Lab Webcast Series
This live-streamed lab webcast series features guidance from ECRI experts and others on device-related issues that are arising as a result of the COVID-19 crisis. Join these webcasts from our lab live—with an opportunity to ask questions of our experts—or view recordings of previous webcasts.

Past topics:

COVID-19 Reports from Health Devices Alerts

Members can search Health Devices Alerts for the latest reports related to the COVID-19 pandemic. Alerts are being added to that site on a regular basis.  

From CDC: Interim Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed Coronavirus Disease 2019 (COVID-19) in Healthcare Settings

The U.S. Centers for Disease Control and Prevention (CDC) has issued interim recommendations to address the COVID-19 coronavirus outbreak. Key concepts in CDC's guidance are (1) limit how germs can enter the facility, (2) isolate symptomatic patients as soon as possible, and (3) protect healthcare personnel.
 

New Technologies or Technology Applications

ECRI's live-streamed lab webcasts:

  • Rapid Telehealth Adoption to Provide Routine Clinical Care during COVID-19 (7/1/2020)
  • Telehealth—Patient Monitoring in the Age of COVID-19 (6/17/2020)

Telepresence Carts: Key Purchasing Considerations
Telepresence carts are mobile workstations that allow telemedicine to be brought directly to the patient. By enabling remote examination, diagnosis, and monitoring, telepresence carts can help to protect clinical personnel and conserve PPE during the COVID-19 pandemic. Learn what capabilities you should think about when buying these carts, and find out who sells them.

Use of Unapproved Devices or New Applications for Existing Medical Devices to Address COVID-19 Shortages without an EUA May Jeopardize Patient or Staff Safety [ECRI Exclusive Hazard Report] (Health Devices Alerts Accession No. H0612)
The COVID-19 pandemic has created widespread shortages of key medical equipment and supplies. To address these shortages, healthcare facilities have been compelled to try nontraditional approaches, such as off-label use of existing devices, expansion of a device's indications for use, and use of new devices that have not been subjected to formal FDA premarket review. Recommendations are presented to help prevent harm and reduce liability when devices are used in this manner.

Emergency Preparedness Resources

Emergency Preparedness: Planning and Mitigation

Emergency preparedness includes planning, preparation, mitigation, response, and recovery. This guidance article discusses planning and mitigation. Organizations should take an all-hazards approach to planning for facility- and community-based natural and human-made disasters. Participation in annual community-based drill exercises is mandatory.

Emergency Preparedness Device List

A list of relevant equipment organized according to ECRI's Universal Medical Device Nomenclature System (UMDNS) device terms.
 

Lessons from SARS

Though on a much smaller scale than the 2020 COVID-19 pandemic, the 2003 epidemic of severe acute respiratory syndrome (SARS) was a public health crisis worldwide. Dealing with that outbreak provided vital lessons in how hospitals should protect against, and cope with, disasters involving airborne pathogens.

Preparation Is the Best Protection

Learn what part the healthcare facility, its surrounding community, clinicians, and facilities and clinical engineering staff can play in preparing for an outbreak.
 

Lessons from Ebola

In 2014 and 2015, an outbreak of the Ebola virus spread from Guinea to seven more countries, killing over 10,000 people. ECRI's Ebola-related publications at that time placed a heavy emphasis on preparedness.

Ebola Preparedness Survey: Results and Commentary

Here are responses to our survey asking hospitals to assess the status of their Ebola preparedness planning. Find out what challenges facilities have encountered in selecting equipment that might be needed to treat an Ebola patient.

Webinar: Ebola: Medical Device and Personal Protective Equipment Preparedness

With so much for hospitals to manage related to Ebola preparedness, efforts to manage the details of technology may get lost in the shuffle. This 90-minute interactive webinar, which took place in December 2014, gave an overview of Ebola equipment preparedness.

Checklist: Equipment-Related Preparedness for Ebola

If your hospital has to treat patients with Ebola, there are a host of equipment-related issues to address to keep your staff and patients safe. Here's a look at the most important ones.
 

Evaluations of COVID-19-Related Products

ECRI is evaluating a number of novel products, or new applications for existing products, that have emerged in response to the COVID-19 pandemic. Note that our findings apply only within the context of the current crisis, and that these Evaluations are conducted rapidly and thus may not be as conclusive as our standard Evaluations.

UV Decontamination of N95 Respirators

COVID-19 Evaluation Background: UV Solutions for Contingency and Crisis Decontamination of N95 Respirators

During the COVID-19 pandemic, new solutions have been proposed for UV decontamination of N95 filtering facepiece respirators (FFRs). Here's background on these devices. We review how the technology is used, what factors we test for, which product specs are important, and more.

COVID-19 Evaluation Ratings: UV Solutions for Contingency and Crisis Decontamination of N95 Respirators

Click the device name below to view our complete findings. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​

Model               Overall Judgment                           Where Marketed   Performance Safety Workflow Patient Experience Interoperability Cybersecurity Maintenance User Experience Cost of Ownership (Estimated) over One Year
Star Chamber
Last updated June 2020

Effective choice for rapid UV decontamination of FFRs but, as tested, lacked certain necessary safety features. (Some concerns have been addressed since our testing.) As a DIY product, overall safety and durability depend on the quality of each build.WorldwideGoodConcernsGoodNot evaluatedNot evaluatedNot evaluatedConcernsNot evaluated$1,400                     

 

 

SUPPLIES AND ACCESSORIES—PERSONAL PROTECTIVE EQUIPMENT (PPE)

Considerations for Respirators

Note that some of the resources included in the "Addressing Shortages" and "Alternative Suppliers" sections, below, likewise apply to respirators.

ECRI's live-streamed lab webcasts:

  • N95 Respirators—New Guidance for Addressing Shortages (4/15/20)
  • Safe Respirator Usage When Supplies Are Short (3/25/20)

Strategies for Addressing Expected or Known Shortages of Powered Air-Purifying Respirators and Accessories [ECRI Exclusive Hazard Report] (Health Devices Alerts Accession No. H0609)
The COVID-19 patient surge has contributed to a worldwide shortage of powered air-purifying respirators (PAPRs) and PAPR accessories (e.g., filters, breathing tubes, facepieces/helmets/hoods). Guidance is offered for conserving and optimizing supplies, obtaining new supplies, and identifying alternatives.

COVID-19 Q&A: Addressing N95 Respirator Shortages
Recommendations for addressing N95 respirator shortages have evolved as the COVID-19 pandemic has progressed. We answer key questions raised during ECRI's March 25 and April 15, 2020, lab webcasts on the topic, covering guidance from CDC and WHO, decontamination and reuse options, and considerations for importing of equivalent N95 masks.

Strategies for Addressing Expected or Known N95 Respirator Shortages [ECRI Exclusive Hazard Report] (Health Devices Alerts Accession No. H0577)
Increased N95 respirator use during a COVID-19 patient surge may exceed the available supply, resulting in shortages at the healthcare facility. Guidance is offered for calculating expected usage, modifying care practices, and identifying alternatives to help protect healthcare workers during the surge.

Disinfection of N95 Respirators: UV Light May Be Considered For Limited Reuse Situations [ECRI Exclusive User Experience Network] (Health Devices Alerts Accession No. S0394)
Extended use and reuse of single-use N95 respirators may increase healthcare worker exposure to pathogens, as compared to using new N95 respirators for each patient interaction. When faced with shortages, however, facilities may attempt to decontaminate single-use N95 respirators using various methods, including UV disinfection. Technical considerations and risks associated with the use of UV disinfection, along with ECRI's recommendations, are discussed.

MaxAir CAPR System (Syntech International) for Preventing Infectious Agent Transmission

The MaxAir CAPR (Controlled Air-Purifying Respirator) System is a loose-fit, powered air-purifying respirator (PAPR) intended to be worn (e.g., by healthcare workers) to prevent transmission of infectious agents (e.g., anthrax, bacterial meningitis, influenza, tuberculosis) to patients or medical staff. 

 

Addressing Shortages

Note that resources focusing specifically on respirators are listed in the preceding section.

Use of Novel Intubation Boxes Does Not Reduce the Need for Appropriate PPE and Intubation Precautions [ECRI Exclusive Hazard Report] (Health Devices Alerts Accession No. H0598)
In the face of PPE shortages, healthcare workers have sometimes been compelled to improvise protective barrier enclosures (e.g., intubation boxes) for use during high-risk procedures such as intubation. ECRI recommends that such barrier enclosures be considered only as a means of additional protection, not as a substitute for wearing standard PPE.

Strategies to Conserve Existing Supplies of Personal Protective Equipment [ECRI Exclusive Special Report] (Health Devices Alerts Accession No. S0400)
Inefficient use of existing PPE supplies can cause hospitals to burn through their current stockpiles at a faster rate and quicken shortages. Recommendations are offered for conserving existing PPE supplies so that protective equipment is available for the most essential patient care activities.

Strategies for the Use of Homemade Facemasks [ECRI Exclusive Hazard Report] (Health Devices Alerts Accession No. H0597)
Increased facemask use by healthcare workers and the general public during the COVID-19 patient surge will likely exceed the available supply, resulting in shortages at many healthcare facilities. Recommendations are offered for conserving supplies, selecting appropriate designs for expected activities, ensuring a proper fit, and cleaning masks appropriately.

Strategies for Addressing Expected or Known Eye Protection Shortages [ECRI Exclusive Hazard Report] (Health Devices Alerts Accession No. H0584)
Patient surges associated with COVID-19 have led to a worldwide shortage of eye protection. Increased usage of eye protection when treating such patients will likely result in shortages at many healthcare facilities. Guidance is offered for conserving and optimizing supplies, as well as for identifying alternatives.

Strategies for Addressing Expected or Known Facemask Shortages [ECRI Exclusive Hazard Report] (Health Devices Alerts Accession No. H0591)
The COVID-19 patient surge has contributed to a worldwide shortage of facemasks, such as the surgical masks used to protect healthcare personnel from respiratory droplets. Guidance is offered for conserving and optimizing supplies, as well as for identifying alternatives.

Strategies for Addressing Expected Glove Shortages [ECRI Exclusive Hazard Report] (Health Devices Alerts Accession No. H0586)
Patient surges associated with COVID-19 are expected to lead to a shortage of gloves used as a method of broad barrier protection for healthcare personnel. Guidance is offered for conserving and optimizing supplies, as well as for identifying alternatives.

Strategies to Combat Inadequate Supplies of Isolation Gowns [ECRI Exclusive Hazard Report] (Health Devices Alerts Accession No. H0578)
Increased isolation gown utilization to treat suspected and confirmed COVID-19 patients may exceed the available supply of gowns, resulting in shortages at some healthcare organizations. Guidance is offered for conserving and optimizing isolation gown supplies, as well as for identifying alternatives.
 

Alternative Suppliers

Outbreaks like the COVID-19 pandemic can put a severe strain on healthcare supply chains, forcing hospitals to look for alternate suppliers of certain PPE, such as goggles, masks, and gowns.

Personal Protective Equipment Supply Equivalents

This proprietary database (updated June 24, 2020) provides the best matches for the three most popular brands of exam gloves, face shields, isolation gowns, air-purifying respirators (e.g., N95, PAPRs), safety eyewear, shoe covers, and surgical masks based on key performance indicators (KPIs) and functional equivalence.

Nontraditional PPE Suppliers (Domestic and International)

ECRI is collaborating with The Association for Health Care Resource & Materials Management (AHRMM) to provide lists of nontraditional suppliers offering PPE supplies. In the collaboration, AHRMM is tracking nontraditional domestic suppliers, and ECRI is tracking nontraditional international suppliers. The combined effort and solution will help providers vet non-traditional suppliers and provide assurance that they have been assessed by each organization.

Alternate Supplier List: Personal Protective Equipment

This is a comprehensive directory of go-to sources to supplement the usual suppliers. It is organized by equipment type: respirators, shoe covers, masks, etc.
 

SUPPLIES AND ACCESSORIES—OTHER

3-D Printed Test Swabs Manufactured without Proper Validation Procedures Can Harm Health Care Providers and Patients [ECRI Exclusive Hazard Report] (Health Devices Alerts Accession No. H0621)
Swabs that were 3D printed and manufactured without following proper validation procedures may not perform as intended. Defective or damaged swabs may result in inaccurate results, potentially causing errors in treatment plans and putting patients and staff at unnecessary risk. Recommendations are presented for identifying reliable sources for 3D printed products, as well as for designing or manufacturing such products.

SARS-CoV-2 Test Kits--Product Equivalents
This proprietary database (updated June 17, 2020) includes a list of identified SARS-CoV-2 tests on the market with confirmation of availability and whether a supplier is accepting new customers.

Coronavirus Support Product Equivalents

This proprietary database (updated June 24, 2020) provides the best matches for the three most popular air clearance units, breathing circuits, dialysis catheters, disinfecting wipes, HME filters, IV extension sets, IV solutions, and universal transfer media based on key performance indicators (KPIs) and functional equivalence.

3-D Printed Objects Manufactured without Following Proper Validation Procedures Can Harm Healthcare Providers and Patients [ECRI Exclusive Hazard Report] (Health Devices Alerts Accession No. H0603)
Healthcare facilities may be compelled during the COVID-19 pandemic to use 3D printed products that have not been validated to be safe and effective. The use of untested product designs or failure to adhere to current good manufacturing practices could lead to harm. Recommendations for reducing the risk are discussed.

COVID-19 Emergency Response: Oxygen Supply Considerations [ECRI Exclusive User Experience Network] (Health Devices Alerts Accession No. S0396)
COVID-19 treatments are associated with high oxygen consumption. The increased demand for oxygen can lead to depleted oxygen supplies, reduced oxygen pressures, and other challenges. Guidance is offered for addressing oxygen shortages, minimizing waste, and locating alternate supplies.
 

PATIENT CARE EQUIPMENT—Ventilators

Following are a few resources to help organizations address challenges related to the use of mechanical ventilators. Refer to Ventilators: The Essentials for our complete collection of resources on ventilators, including product Evaluations and ratings, selection and purchasing guidance, safety information, and help in understanding the technology. Also see the Equipment Servicing and Maintenance section, below, for ventilator-related guidance.
 

Coping with Shortages 

Ventilators Obtained from Storage, Unknown Sources, or Accelerated Manufacturing Require Inspection before Patient Use [ECRI Exclusive Hazard Report] (Health Devices 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] (Health Devices 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] (Health Devices 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] (Health Devices 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

Evaluations

Evaluation Background: Intensive Care Ventilators
Here's background for our Evaluations of intensive care ventilators. We present our ratings and review how the technology is used, what factors we test for, which product specs are important, and more.

Evaluation Background: Transport Ventilators for Intrahospital Use
Here's background for our Evaluations of transport ventilators used for intrahospital transport. We present our product ratings and review how the technology is used, what factors we test for, which product specs are important, and more.

Evaluation: Portable/Transport Ventilators
Portable ventilators often have advanced features rivaling full-size units. But sometimes a simpler design is better. This article will help you find a model that meets your needs.
 

General Technology Guidance

Ventilators in Isolation Rooms May Fail to Alert Clinicians of Critical Alarm Conditions [ECRI Exclusive Hazard Report] (Health Devices Alerts Accession No. H0625)

Unique conditions during the COVID-19 pandemic make it more likely that ventilator alarms won't be heard—for example, ventilator patients require isolation with room doors closed, staff are limiting the number of entries into the room, or staff may not be familiar with alarm sounds and indicators on models not typically used in their area. Respiratory administrative and clinical recommendations are provided.

Mechanical Ventilation of SARS Patients
ECRI recommends that breathing-circuit filters be incorporated in the exhalation limb of any ventilator used on a patient with SARS, since the virus can be carried by droplets that exit from the limb. In this article, we review the issues behind our recommendations and describe steps hospitals can take to prevent any adverse effects on ventilation.

Mechanical Ventilation: Understanding Key Terms and Concepts
Definitions of ventilation terms derived from Robert Chatburn's standardized vocabulary for mechanical ventilation. (Reproduced with permission.)

Using Ventilator Technology to Avoid Ventilator-Associated Events
Outdated ventilation protocols and failure to use current ventilator capabilities can lead to preventable patient harm.

Unsafe Ventilator Alarm Management Practices
Many ventilator models allow their alarms to be effectively disabled. While clinicians may be tempted to do this to reduce alarm fatigue, we consider it an unsafe practice that should be discouraged.

Mechanical Ventilation: Manufacturer-Specific Terminology for Ventilation Modes and Features
To help buyers and users compare intensive care ventilators from different manufacturers, we use the Chatburn Taxonomy to classify the ventilation modes available on various models.

International Organization for Standardization (ISO) Standards for Critical Care Ventilators
Two International Organization for Standardization (ISO) standards relating to respiratory care are part of ECRI's requirements when evaluating critical care ventilators. Here's a quick look at the standards.

Safety Summary: Ventilators
We present a capsule look at three fundamental ventilator safety topics—ventilator alarms, staff training, and verifying ventilator performance—and briefly describe how you can address them.

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.
 

PATIENT CARE EQUIPMENT—GENERAL RESPIRATORY CARE

CPAP Units and Similar Technologies

Evaluation Background: Continuous Positive Airway Pressure (CPAP) Units

Here's background for our Evaluations of CPAP units. We present our product ratings and review how the technology is used, what factors we test for, which product specs are important, and more.

Use of Consumer-Grade Obstructive Sleep Apnea Devices May Supplement Ventilator Supply during Shortage [ECRI Exclusive Hazard Report] (Health Devices 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.
 

Video Laryngoscopes

Strategies for Addressing Known or Expected Single-Use Video Laryngoscope Blade Shortages [ECRI Exclusive Hazard Report] (Health Devices Alerts Accession No. H0596)
Since many COVID-19 patients require intubation, hospitals that intubate with single-use video laryngoscopes are depleting their inventory of single-use video laryngoscope blades much faster than normal. Guidance is offered for optimizing supplies, as well as for identifying alternatives.

Evaluation Background: Video Laryngoscopes

Here's background for our Evaluations of video laryngoscopes. We present our product ratings and review how the technology is used, what factors we test for, which product specs are important, and more.

When to Consider Single-Use Laryngoscopes

Single-use (i.e., disposable) laryngoscopes can offer benefits beyond reducing infection risk. Learn how these systems can benefit your facility, and what trade-offs you may encounter.

 

Specialty Resuscitators

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.

 

PATIENT CARE EQUIPMENT—IMAGING TECHNOLOGIES

Magnetic Resonance Imaging Systems

N95 Respirator and Surgical Mask Precautions for COVID-19 Patients in the MRI Room [ECRI Exclusive Hazard Report] (Health Devices Alerts Accession No. H0590)
The presence of metal nose clips on N95 respirators (and similar devices) can cause problems in the MR environment. Respirators worn by patients, for example, can become hot enough to injure the patient or could create image artifacts. Recommendations for patients and staff are provided.

Procedure Precautions When Using MRI Imaging [ECRI Exclusive Hazard Report] (Health Devices Alerts Accession No. H0588)
Use of the MR suite for potentially infectious patients may lead to contamination of the scanner, coil, and/or room. Without proper precautions, the risk of cross-contamination affecting patients or staff is high. Recommendations for minimizing the risks are discussed.
 

Radiology Equipment

Procedure Recommendations for Use of Mobile X-Ray Devices [ECRI Exclusive Hazard Report] (Health Devices Alerts Accession No. H0585)
Mobile x-ray units used on contagious patients, as may occur in makeshift emergency rooms or triage areas, can become contaminated, putting patients and staff at risk from cross-contamination and reducing the availability of the unit during decontamination procedures. Recommendations for minimizing contamination risks are discussed.

Failure to Routinely Clean CT Scanner or Fixed Radiology Equipment Surfaces between Patients Could Intensify Community Spread of COVID-19 [ECRI Exclusive Hazard Report] (Health Devices Alerts Accession No. H0580)
Fixed radiology equipment like CT scanners may be used on contagious patients, creating the risk for cross-contamination (affecting patients or staff) if the equipment is not properly cleaned and disinfected between patients. Recommendations are detailed for minimizing the risks and managing the workflow impact of the decontamination requirements.
 

Ultrasound Scanners

Following are a few resources to help organizations make effective use of ultrasound scanners, with a special focus on point-of-care ultrasound (POCUS). Refer to Ultrasound: The Essentials for our complete collection of resources on ultrasound, including product Evaluations and ratings, selection and purchasing guidance, safety information, and help in understanding the technology.

ECRI's live-streamed lab webcast "Ultrasound in the Age of COVID-19: Guidance through the Recovery and Future Planning" (5/13/2020)

Disinfection Considerations

Point-of-Care Ultrasound Is Beneficial to Triage Patients for Suspected COVID-19; Safeguards Are Required [ECRI Exclusive Hazard Report] (Health Devices Alerts Accession No. H0573)

Inappropriate use of point-of-care ultrasound (POCUS) to triage patients with suspected COVID-19 can lead to cross-contamination if devices are not properly cleaned and disinfected, or misdiagnoses if clinicians are not qualified to perform POCUS for lung applications. Technical considerations and ECRI's recommendations are discussed.

Point-of-Care Ultrasound Scanners: An Introduction
Point-of-care ultrasound—in which the treating physician scans patients instead of sending them to an imaging specialist—can speed patient management decisions. Here's an intro to POC ultrasound and the portable scanners used for this purpose.

Evaluation Background: Cart-Based Point-of-Care Ultrasound Scanners

Here's background for our Evaluations of cart-based point-of-care ultrasound scanners. We present our product ratings and review how the technology is used, what factors we test for, which product specs are important, and more.

Evaluation Background: Handheld Point-of-Care Ultrasound Scanners

Learn about handheld ultrasound scanners, including our product ratings, how the devices are used, important factors in our testing, which specifications are important, and more.

Evaluation Background: Tablet-Style Point-of-Care Ultrasound Scanners

Here's background on tablet-style point-of-care ultrasound scanners, including our product ratings, how the technology is used, what factors we test for, which product specs are important, and more.
   

PATIENT CARE EQUIPMENT—OTHER

Dialysis Equipment

See ECRI's May 6, 2020, live-streamed lab webcast, Renal Replacement Therapy and COVID-19 Patients.
 

Infusion Pumps

In addition to the resources below, also see ECRI's April 8, 2020, live-streamed lab webcast, Infusion Therapy—Conserving Supplies in the Age of COVID-19.

COVID-19 Q&A: Conserving Infusion Therapy Supplies

We answer key questions raised during ECRI's and ISMP's April 8, 2020, lab webcast on managing infusion therapy during the COVID-19 pandemic. Experts from the two organizations discussed strategies for conserving personal protective equipment (PPE) and infusion supplies and for optimizing infusion pump deployments.

Large-Volume Infusion Pump Administration Sets—Responding to Possible Availability Disruptions [ECRI Exclusive User Experience Network] (Health Devices Alerts Accession No. S0393)
Shortages of some infusion pump administration set configurations can necessitate exploring alternatives. The use of non-standard methods to deliver drugs may be required in the case of limited administration set availability, but the practice can increase the risk of medication errors. Safety considerations and ECRI's recommendations are discussed.

Large-Volume Infusion Pumps—Considerations When Used with Long Extension Sets outside Patient Rooms to Help Reduce Staff PPE Use [ECRI Exclusive User Experience Network] (Health Devices Alerts Accession No. S0392)
In some cases, infusion pumps can be used with extension sets that allow the pump to be placed outside the patient room as a temporary measure to protect the clinical personnel and conserve personal protective equipment (PPE) during the COVID-19 pandemic. Technical considerations and ECRI's recommendations are discussed. 
 

Physiologic Monitoring 

Home-Use SpO2: Considerations before Prescribing or Using Consumer-Grade Pulse Oximeters in the Home Care Environment [ECRI Exclusive Hazard Report] (Health Devices Alerts Accession No. H0619)
With limited resources to host patients during the COVID-19 pandemic, facilities may consider monitoring the oxygen levels of non-COVID patients at home using home-use SpO2. Additionally, consumers are showing interest in these devices. Without proper training, however, patients may receive misleading results or gain a false sense of security. Recommendations are presented to help determine when this technology can be useful, which models to select, and how to support proper use.
 

SURGICAL CONSIDERATIONS

Considerations for Endoscopy Procedures [ECRI Exclusive Hazard Report] (Health Devices Alerts Accession No. H0631)
Healthcare personnel may be exposed to SARS-CoV-2 while performing non-elective/emergent endoscopy procedures on confirmed and/or asymptomatic COVID-19 patients. Recommendations are provided for deciding whether procedures should be performed, for taking precautions before and during such procedures, and for completing proper cleaning afterward.

Strategies to Minimize Surgical Staff Exposure to COVID-19 [ECRI Exclusive Hazard Report] (Health Devices Alerts Accession No. H0614)
The risk that healthcare personnel could be exposed to SARS-CoV-2 while performing surgery on a COVID-19 patient requires that additional precautions be taken before, during, and after surgery. Appropriate practices to protect the surgical team and others are discussed.

Considerations for Smoke Evacuation during Non-Deferrable Surgery [ECRI Exclusive Hazard Report] (Health Devices Alerts Accession No. H0613)
While there are no relevant studies on transmission of the SARS-CoV-2 virus via surgical smoke, there is anecdotal evidence of similarly sized viral particles transmitting disease to surgical staff via smoke plume, causing concern. The lack of clinical evidence and concern for transmissivity of the virus warrants considering expanded use of surgical smoke evacuation. The recommendations in this report place an emphasis on diligence and best surgical practices in any situation, regardless of the current pandemic.
 

CLEANING AND DISINFECTION

Following are several resources to help organizations effectively clean and disinfect spaces and equipment. Refer to Infection Reduction Technologies: The Essentials for more resources on devices and systems designed to reduce healthcare-associated infections, including product Evaluations and ratings, purchasing guidance, and safety information.  
 

Products and Practices

In addition to the resources below, also see ECRI's live-streamed lab webcasts:

COVID-19 Q&A: Cleaning and Disinfection Practices during the COVID-19 Pandemic

We answer key questions raised during ECRI's April 29, 2020, lab webcast on cleaning and disinfection practices to prevent the spread of SARS-CoV-2 during the COVID-19 pandemic. ECRI's experts discussed recommended practices, as well as common mistakes to be avoided.

Systems for Disinfecting the General Public Are Ineffective and Hazardous [ECRI Exclusive Hazard Report] (Health Devices Alerts Accession No. H0618)
In some areas of the world, the COVID-19 pandemic has prompted an ineffective and hazardous practice of spraying disinfectants on people who are not wearing appropriate personal protective equipment (PPE). ECRI outlines its objection to this practice.

Disinfectant Concentrations and Contact Times for EPA's List of Products Effective against Novel Coronavirus SARS-CoV-2, the Cause of COVID-19

This table lists disinfectant concentrations and contact times for EPA's List N, which covers antimicrobial products effective against novel coronavirus SARS-CoV-2. Manufacturers of reusable, noncritical medical devices and equipment may recommend the use of certain generic disinfectants (e.g., sodium hypochlorite) at certain concentrations. But List N does not specify disinfectant concentrations. Our list will help you ensure you're using an effective disinfectant at a sufficient concentration and contact time to kill SARS-CoV-2.

Routine and Terminal Cleaning of Suspected or Confirmed COVID-19 Patient Rooms [ECRI Exclusive Hazard Report] (Health Devices Alerts Accession No. H0595)

Temporary changes to cleaning policies, procedures, and personnel during the COVID-19 pandemic (e.g., to conserve PPE) can increase the risk of improper or ineffective cleaning. Recommendations are provided for reducing both the risk of staff exposure to the SARS-CoV-2 virus and the potential for cross-contamination of patient care equipment.

Evaluation Background: Disinfectant Wipes

Here's background for our Evaluations of disinfectant wipes. We present our findings and review how the products are constructed and used, what factors we test for, hospital interest in different vendors, and more.

How Much Does Surface Wetness Matter When Using Disinfectant Wipes?

There is controversy about whether surfaces must be kept visibly wet for the whole manufacturer-specified contact time when disinfectant wipes are used. Find out what we think and why.

How Improper Cleaning Can Damage Medical Equipment

Using the wrong cleaning solutions or methods can damage medical equipment. Find out how it happens and how you can avoid it. Also download our customizable Cleaning/Disinfectant Wipe Compatibility chart.

See also:

  • Cleaning and Disinfection without Appropriate Training May Result in Damage to Equipment [ECRI Exclusive Hazard Report] (Health Devices Alerts Accession No. H0627)
    Use of improper techniques for cleaning medical equipment, including failure to follow cleaning product or equipment manufacturer instructions, using excessive amounts of cleaning solutions, and incorrect rinsing procedures while cleaning equipment, may cause problems such as harmful residues remaining on surfaces, wetting of areas susceptible to fluid damage, and equipment failures. Recommendations for ensuring proper cleaning are provided.

Enhanced Environmental Disinfection Systems: Can They Help You Reduce Infection Rates? 

Environmental disinfection systems that use vaporized hydrogen peroxide, UV light, or other techniques to disinfect surfaces of patient rooms are intended to help reduce healthcare-associated infections. This 2011 introduction to three such technologies and systems summarizes the early evidence about their use.

Ensuring the Sterility of 3D Printed Objects

Small-volume manufacturing, now possible with 3D printing, has many potential applications in healthcare. However, sterilization concerns cannot be overlooked and must be addressed before 3D printed objects are used in some clinical settings.

Hand Hygiene Compliance Monitoring Methods: A Selection Guide

Methods for hand hygiene compliance monitoring (HHCM) include direct observation and the use of group-level, individual-level, or real-time location systems. We explain each HHCM method and provide guidance to select one that is appropriate for your facility.

Should You Install Clinical Copper Surfaces?

Is your facility considering the installation of copper-containing surfaces? Learn how copper-containing surfaces kill bacteria and the importance of cleaning these surfaces to maintain their antimicrobial efficacy.
 

UV Disinfection Technologies

In addition to the resources below, also see ECRI's March 18, 2020, live-streamed lab webcast, "Effective Use of UV Disinfection," available here: Cleaning and Disinfection Practices during the COVID-19 Pandemic.

Using UV Disinfection Safely and Effectively: Technology Challenges during the COVID-19 Pandemic

Learn about UV disinfection and its application against COVID-19 and the SARS-CoV-2 virus. We present ECRI's eight key points about the limitations and potential risks of UVC light.

UV Disinfection: Understanding Key Terms and Concepts

Get definitions of terms related to ultraviolet (UV) disinfection devices and procedures, as well as related concepts.

UV Room Disinfection

Countertop UV Disinfection Devices

 

EQUIPMENT SUPPORT AND FACILITIES MANAGEMENT

Guidance for Temporary Airborne Isolation of COVID-19 Patients Undergoing Aerosol-Generating Procedures [ECRI Exclusive Hazard Report] (Health Devices Alerts Accession No. H0617)
Airborne infection isolation rooms (AIIRs) are recommended for isolating suspected or confirmed COVID-19 patients during aerosol-generating procedures, but facilities may not have enough AIIRs available to meet the needs of COVID-19 patient surges. Alternatives for establishing temporary airborne patient isolation are discussed as a way to protect healthcare personnel from airborne infectious diseases.

Recommendations for Emergency Power Outlet Management at Peak Resource Use [ECRI Exclusive Special Report] (Health Devices Alerts Accession No. S0403)
Emergency measures implemented during the COVID-19 pandemic could lead to patient harm from power interruptions if emergency power is not managed carefully. Considerations include whether general care areas that are converted to function as intensive care units have a sufficient number of emergency power outlets, and how devices that are pressed into service for emergency life support will respond to power interruptions. Recommendations for nurses and for biomedical engineering/facilities staff are provided.

Medical Device Dust Filter Replacement Considerations during Pandemic [ECRI Exclusive User Experience Report] (Health Devices Alerts Accession No. S0405)
During servicing of medical device dust filters, particles that had been captured by the filter are likely to be released into the air. This report outlines precautions to take during routine exchange/cleaning of medical device dust filters to reduce the risk of spreading COVID-19.

Protecting against Infectious Disease Transmission during Equipment Maintenance

This article provides guidance for clinical engineering, respiratory therapy, and other personnel involved in maintaining potentially SARS-exposed equipment.

Selecting Respiratory Protection for Equipment Servicers and Other Hospital Personnel

This article addresses the advantages and limitations of the N95 respirator for respiratory protection against infectious diseases and offers recommendations for further protection.

Inspection and Preventive Maintenance (IPM) Procedures

 

IT CONCERNS

The U.S. Department of Homeland Security and other organizations have warned healthcare organizations that malicious actors may seize on opportunities created by the COVID-19 pandemic to initiate cyberattacks, including phishing campaigns and attempts to exploit remote access capabilities. Following are a few resources to help organizations deal with these threats. For additional guidance, including ECRI's recommendations for addressing various cybersecurity threats, see Cybersecurity: The Essentials

The Transfer of Loaned Equipment during the COVID-19 Response Could Lead to Breach of Sensitive Information [ECRI Exclusive Hazard Report] (Health Devices Alerts Accession No. H0616)
Devices used in a healthcare setting can contain sensitive information, including electronic protected health information (e-PHI) or network configuration information or credentials. When receiving or returning such devices, measures must be taken to prevent disclosures of (1) e-PHI (which could constitute a HIPAA violation) or (2) protected data that could be used as intelligence in targeted hacking attacks.

The Use of Loaned or Warehoused Devices during the COVID-19 Response Could Pose Security Risk [ECRI Exclusive Hazard Report] (Health Devices Alerts Accession No. H0615)
While responding to COVID-19-related surges, facilities may obtain devices from alternative sources, including loaned or warehoused devices. Such devices could have out-of-date firmware and may contain cybersecurity vulnerabilities (e.g., be infected with malware from a previous use). Recommendations are provided to reduce the risks of introducing potentially out-of-date or infected devices onto hospital networks.

Health Emergency Exploited by Phishing Campaigns [ECRI Exclusive Hazard Report] (Health Devices Alerts Accession No. H0570)
Malicious actors are exploiting the COVID-19 health emergency with targeted phishing e-mails falsely claiming to contain COVID-19-related content. Recommendations are presented to help facilities thwart attempts to compromise credentials or spread malware.

Expanded Work from Home Policies May Pose Increased Security Risks [ECRI Exclusive Hazard Report] (Health Devices Alerts Accession No. H0571)
The large number of employees working from home during the COVID-19 health emergency poses security risks, from employees being inexperienced with handling protected health information (PHI) from home to remote access systems being configured in a way that bypasses perimeter security controls. Steps to minimize the risks are discussed.

HHS Temporarily Allows Use of Consumer Audio or Video Chat Applications for Telemedicine Use [ECRI Exclusive User Experience Report] (Health Devices Alerts Accession No. S0390)
The removal of prohibitions against the use of consumer audio or video chat applications for telemedicine will require that healthcare facilities draft temporary technology-usage policies to accommodate telemedicine use and that they have a plan for rolling back those policies post crisis.

EHR Screening for Wuhan Novel Coronavirus (2019-nCoV) [ECRI Exclusive User Experience Network] (Health Devices Alerts Accession No. S0385)
If electronic health records (EHRs) are not configured to effectively screen patients for the 2019 novel coronavirus (SARS-CoV-2), staff may not be alerted to take the necessary isolation precautions. Recommendations for screening are outlined.

From the HSCC: Management Checklist for Teleworking Surge during COVID-19 Response (may not display properly in Internet Explorer)
A checklist and related resources from the Healthcare and Public Health Sector Coordinating Council intended to ensure that bandwidth and cybersecurity needs are met during a teleworking surge resulting from wide-scale public emergencies such as COVID-19.

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Resource List

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Topics and Metadata

Topics

Emergency Preparedness; Equipment and Facility Planning; Physician Preference Items

Caresetting

Ambulatory Care Center; Emergency Department; Hospital Inpatient; Hospital Outpatient; Trauma Center

Clinical Specialty

Critical Care; Infectious Disease; Pulmonary Medicine

Roles

Allied Health Personnel; Biomedical/Clinical Engineer; Clinical Practitioner; Infection Preventionist; Materials Manager/Procurement Manager; Patient Safety Officer; Regulator/Policy Maker; Risk Manager

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Guidance

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Product Catalog

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