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Catalyst Protective Barrier Enclosure

Catalyst Protective Barrier Enclosure
Catalyst Protective Barrier Enclosure
Catalyst Protective Barrier Enclosure
Catalyst Protective Barrier Enclosure
Catalyst Protective Barrier Enclosure
Catalyst Protective Barrier Enclosure
Catalyst Protective Barrier Enclosure
Catalyst Protective Barrier Enclosure
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⚠️ Read the Warning Below

EMERGENCY USE AUTHORIZATION BY THE FDA - This Protective Barrier Enclosure has been authorized by the FDA for sale via an EUA for use during the period of shortage caused by the COVID-19 pandemic.

PHYSICAL BARRIER TO PROTECT HEALTHCARE PROVIDERS - Designed to be used by Healthcare Providers (HCPs)* when caring for or performing medical procedures on patients who are known or suspected to have COVID-19. It reduces risk to healthcare workers that are directly exposed during high risk medical procedures when airborne transmission may happen from Aerosol-Generating Procedures*. *See Note 1 & 2

UNHINDERED VISION AND EASY ACCESS TO PATIENT - Made with transparent materials to provide a clear, unobstructed view of the procedure field, the device covers the patient’s head and upper body. The Protective Barrier Enclosure incorporates 2 ports through which the HCP’s hands are passed to perform medical procedures*.

CUSTOMIZABLE DESIGN - The Catalyst Protective Barrier Enclosure can be adapted in a range of ways to suit the requirements. Push in the side flaps to allow for additional assistance in the procedure. Add protective sleeves and a disposable drape to close the space around the HCP's arms or the patient’s chest to lessen the possibility of contamination through this space. This will reduce surface contamination of the surrounding area from airborne particulates.

CLEANABLE AND REUSABLE – The Catalyst Protective Barrier Enclosure should be thoroughly cleaned and disinfected after each use and is compatible with EPA-registered hospital disinfectants from the EPA List. See Note 5

FLATPACK DESIGN FOR EASY STORAGE - Unlike other protective barrier enclosures, this unique patent-pending flatpack design allows hospitals and medical facilities to keep multiple units in storage while taking up minimal space.

LIGHT AND EASY TO MANEUVER - Made with light flexible polyethylene terephthalate (PETE) and designed with built-in handles, the Catalyst Protective Barrier Enclosure can be easily lifted and maneuvered by healthcare workers. It is designed to accommodate large and small body types.

EASY TO ASSEMBLE - Using simple intuitive instructions, each unit can be assembled in a matter of minutes. The Catalyst Protective Barrier Enclosure is designed so it can be easily disassembled after use.

QUALITY CONTROL - The protective barrier enclosure is manufactured in an FDA registered facility that has quality systems that meet FDA 21 CFR Part 820 standard and authorized by the FDA for sale via an Emergency Use Authorization.


    Specifications


    WARNING

    • This Protective Barrier Enclosure helps protect against certain particles. Misuse may result in sickness or death. For proper use, read these User Instructions. Not intended for individual resale. This CATALYST® Protective Barrier Enclosure has not been FDA cleared or approved. This Protective Barrier Enclosure has been authorized by FDA under an Emergency Use Act. This respirator is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of PPE under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
    • This Protective Barrier Enclosure helps protect against certain particles. Misuse may result in sickness or death. For proper use, read these User Instructions. Not intended for individual resale. This CATALYST® Protective Barrier Enclosure has not been FDA cleared or approved. This Protective Barrier Enclosure has been authorized by FDA under an Emergency Use Act. This respirator is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of PPE under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.


    DESCRIPTION

    • The Catalyst Protective Barrier Enclosure acts as a physical barrier between healthcare workers and potentially infectious patients. It is designed to provide a disposable protective barrier that reduces risk to healthcare workers that are directly exposed during high-risk Aerosol-Generating Procedures. With the Catalyst Protective Barrier Enclosure, doctors and nurses can perform these procedures in a safe and controlled manner by reducing their exposure to certain airborne contaminants. The Catalyst Protective Barrier Enclosure is designed to be lightweight and disposable while allowing for efficient storage and easy assembly.
    • The Catalyst Protective Barrier Enclosure acts as a physical barrier between healthcare workers and potentially infectious patients. It is designed to provide a disposable protective barrier that reduces risk to healthcare workers that are directly exposed during high-risk Aerosol-Generating Procedures. With the Catalyst Protective Barrier Enclosure, doctors and nurses can perform these procedures in a safe and controlled manner by reducing their exposure to certain airborne contaminants. The Catalyst Protective Barrier Enclosure is designed to be lightweight and disposable while allowing for efficient storage and easy assembly.


    FEATURES

    • Flatpack design allows for efficient shipping and storage
    • Clear and practical assembly instructions make it possible to assemble without expertise of prior experience
    • Carefully designed edges create handles for easy positioning and stabilization
    • Made from light material that is easily maneuvered by one person
    • Can be easily adapted to have additional entry points
    • Flatpack design allows for efficient shipping and storage
    • Clear and practical assembly instructions make it possible to assemble without expertise of prior experience
    • Carefully designed edges create handles for easy positioning and stabilization
    • Made from light material that is easily maneuvered by one person
    • Can be easily adapted to have additional entry points

    MATERIAL

      • Polyethylene terephthalate (PETE)

      • Acrylic

      • Polyester

      • Coated release paper

    • Polyethylene terephthalate (PETE)

    • Acrylic

    • Polyester

    • Coated release paper

    DIMENSIONS

      • L: 26.8" (68,07cm)
      • D: 15.75" (40,01cm)
      • H: 23.2" (58,92cm)
    • L: 26.8" (68,07cm)
    • D: 15.75" (40,01cm)
    • H: 23.2" (58,92cm)

    NOTES

    • Note 1: For this EUA, HCP refers to practitioners, including physicians, nurses, pharmacists, dentists, respiratory therapists, physical therapists, technologists, or any other practitioners or allied health professionals that have a role in using a device for human use.

    • Note 2: While COVID-19 is primarily spread via droplet transmission, certain Aerosol Generating Procedures may increase risk to medical personal via airborne transmission. These procedures include: These procedures may include: open suctioning of airways, sputum induction, cardiopulmonary resuscitation, endotracheal intubation and extubation, non-invasive ventilation (e.g., BiPAP, CPAP), bronchoscopy, and manual ventilation. Source: CDC 

    • Note 3: It does not include fans, air filters, or other features and is not intended to generate negative pressure. This is used as a physical barrier by HCPs in situations including, but not limited to, airway management (e.g., intubation, extubation, and suctioning of airways) and any aerosol generating procedures (e.g., nebulizer treatments, manipulation of oxygen mask or Bilevel Positive Airway Pressure (BiPAP) mask) to provide an additional layer of barrier protection in addition to Personal Protective Equipment (PPE) against airborne particles or droplets from the patients. These products should be removed if they impede a HCP’s ability to care for a patient or impede the HCP’s ability to perform a medical procedure on a patient. Source: FDA 

    • Note 4: AGPs should ideally be performed in a negative pressure isolation room with a limited number of people, who wear a well-fitted respirator, visor or goggles, long-sleeved impermeable protective gown, and gloves, there may be a shortage of respirators or other PPE and this enclosure is designed to help reduce exposure to healthcare professionals by creating an enclosure around the patient. Source: CDC

    • Note 5: June TBD list & blurb text in foot note citing EPA www.epa.gov/pesticide-registration/list-n-disinfectants-use-against-sars-cov-2 & also Kampf article on COVID & need full disclaimers about disinfectant risks for mixing bleach, risks for skin exposure, add back additional hospital disinfectants that show efficacy from Kampf as long as we do confirmatory testing via immersion if compatibility data is not available].
    • Note 1: For this EUA, HCP refers to practitioners, including physicians, nurses, pharmacists, dentists, respiratory therapists, physical therapists, technologists, or any other practitioners or allied health professionals that have a role in using a device for human use.

    • Note 2: While COVID-19 is primarily spread via droplet transmission, certain Aerosol Generating Procedures may increase risk to medical personal via airborne transmission. These procedures include: These procedures may include: open suctioning of airways, sputum induction, cardiopulmonary resuscitation, endotracheal intubation and extubation, non-invasive ventilation (e.g., BiPAP, CPAP), bronchoscopy, and manual ventilation. Source: CDC 

    • Note 3: It does not include fans, air filters, or other features and is not intended to generate negative pressure. This is used as a physical barrier by HCPs in situations including, but not limited to, airway management (e.g., intubation, extubation, and suctioning of airways) and any aerosol generating procedures (e.g., nebulizer treatments, manipulation of oxygen mask or Bilevel Positive Airway Pressure (BiPAP) mask) to provide an additional layer of barrier protection in addition to Personal Protective Equipment (PPE) against airborne particles or droplets from the patients. These products should be removed if they impede a HCP’s ability to care for a patient or impede the HCP’s ability to perform a medical procedure on a patient. Source: FDA 

    • Note 4: AGPs should ideally be performed in a negative pressure isolation room with a limited number of people, who wear a well-fitted respirator, visor or goggles, long-sleeved impermeable protective gown, and gloves, there may be a shortage of respirators or other PPE and this enclosure is designed to help reduce exposure to healthcare professionals by creating an enclosure around the patient. Source: CDC

    • Note 5: June TBD list & blurb text in foot note citing EPA www.epa.gov/pesticide-registration/list-n-disinfectants-use-against-sars-cov-2 & also Kampf article on COVID & need full disclaimers about disinfectant risks for mixing bleach, risks for skin exposure, add back additional hospital disinfectants that show efficacy from Kampf as long as we do confirmatory testing via immersion if compatibility data is not available].

       

       

      Documents
      • Information Sheet
      • User Instructions 


      Frequently Asked Questions

      ABOUT THIS PRODUCT

      HOW EFFECTIVE IS THE PROTECTIVE BARRIER ENCLOSURE 

        • Studies have shown that a protective barrier enclosure significantly limits the spread of droplets and aerosols that can be generated from a forceful cough or sneeze.

        • One such study from the New England Journal of Medicine tested the effectiveness of a protective barrier enclosure by replicating a patient’s cough with a balloon and fluorescent dye. Results found that the protective barrier enclosure limited the spread of dye droplets to the device, gown and gloves of the healthcare worker. Without the use of a protective barrier enclosure, dye was found on the healthcare worker’s gown, gloves, face mask, eye shield, hair, neck, ears, and shoes.

      IS THE PROTECTIVE BARRIER ENCLOSURE FDA APPROVED?

        • This CATALYST® Protective Barrier Enclosure has not been FDA cleared or approved. This Protective Barrier Enclosure has been authorized by FDA under an Emergency Use Act. This respirator is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of PPE under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

      WHEN AND WHERE SHOULD THE PROTECTIVE BARRIER ENCLOSURE BE USED? 

        • Intended for use in healthcare settings to prevent HCP exposure to pathogenic biological airborne particulates by providing an extra layer of barrier protection in addition to PPE.
        • Designed to provide protection for HCPs during Aerosol Generating Procedures
        • Aerosol Generating Procedures should ideally be performed in a negative pressure isolation room with a limited number of people.

      WHAT PPE SHOULD BE USED WHEN CARRYING OUT AEROSOL GENERATING PROCEDURES

        • This product is not intended to replace the need for PPE*. Based on available scientific evidence, FDA has concluded that the protective barrier enclosures may be an effective barrier device when used in addition to PPE when caring for or performing medical procedures on a patient who is known or suspected to have COVID-19 to prevent HCP exposure to pathogenic biological airborne particulates. See Note 3 & 4

         

         



        HOW TO USE

        HOW SHOULD I ASSEMBLE AND DISPOSE OF THE ENCLOSURE?


        Refer to instructions sheet for direction on assembly, disassembly and disposal