Issuance of authorization for sample collection in an at-home environment has the potential to increase testing capacity throughout the US while reducing exposure risk to healthcare providers. The latest EUA (issued for Everlywell COVID-19 Test Home Collection Kit) allows for the collection and shipment of a nasal swab sample from the user to CLIA certified  labs (Fulgent and Assurance) for molecular diagnostic testing. The test kit is provided with the nasal swab and a sample tube with transport medium as well as identification and shipping materials. Accompanying kit materials, authorized labeling is provided including instructions for use (registration, collection, preparation, and shipping), the EUA summary, and the receiving and processing operating procedure.

 


 

At-Home Collection

Issuance of authorization for sample collection in an at-home environment has the potential to increase testing capacity throughout the US while reducing exposure risk to healthcare providers. The latest EUA (issued for Everlywell COVID-19 Test Home Collection Kit) allows for the collection and shipment of a nasal swab sample from the user to CLIA certified  labs (Fulgent and Assurance) for molecular diagnostic testing. The test kit is provided with the nasal swab and a sample tube with transport medium as well as identification and shipping materials. Accompanying kit materials, authorized labeling is provided including instructions for use (registration, collection, preparation, and shipping), the EUA summary, and the receiving and processing operating procedure.

Tests are to be distributed by prescription only through a third-party physician network, the Physician Wellness Network (PWN). PWN provides oversight and interpretation for Everlywell’s COVID-19 questionnaire (included in authorized labeling, but not distributed). The EUA Summary provided with the kit informs eligibility of the patients and the standard procedure for receipt and processing as well as performance testing and validation for the collection and diagnostic testing. Individuals with positive results will be contacted through telephone and mail. Outreach is to include counseling on next steps and telehealth with a physician or HCP.

Previously, FDA authorized at-home collection for LabCorp’s Pixel nasal swab collection kit and Rutgers University saliva sample collection. Saliva samples are sent back to Rutgers Clinical Genomics Laboratory which had previously been issued an EUA for saliva sample molecular testing. As the only lab authorized for saliva testing, all samples will be tested there. Collection kits are distributed by prescription in conjunction with a physician network partnered with the University. Everlywell and LabCorp utilize the same physician network, PWNHealth, for prescription and results interpretation and consultation, and sample collection method. Registration and identification of samples follow similar chains of custody, while LabCorp uses its own designated labs for testing (e.g. Center for Esoteric Testing).

Reviewing the authorizations, it is clear that control measures for samples are to be more stringent for at-home sample collection and require medical oversight for prescription, results, and consultation. Sample collection requires registration, identification, and inspection of the specimens. The availability of networks to supply this support may prove to be a large barrier in extensive at-home testing. Additionally, designating labs for sample testing could be burdensome, with results being delayed depending on the volume of samples.

As of 30 April 2020, LabCorp’s Pixel test is being distributed by prescription with no upfront cost to the consumer, with reimbursement being distributed by insurance or federal funding. Everlywell has not begun distribution. The saliva sample kit authorized is manufactured by Spectrum and has been distributed to test sites for use under HCP supervision. Saliva test kits with telehealth consultation to be sent to the Rutgers lab are currently being promoted by several distributors. As at-home testing expands, support from health networks and designated, authorized CLIA labs will be required to grow with distribution.

NOTE: Residents in MD, NJ, NY, or RI are not able to use at-home collection due to state regulations.

 


 

Infusion Pump

The infusion pump and accessories letter of authorization published 13 May 2020 is similar to the ventilator and ventilator component letter, providing requirements for EUA request and a list of authorized devices as an appendix. The infusion pump and accessory letter refines the guidance published on policy and EUA issuance from April 2020. The letter has excluded some product codes from the infusion pump accessory table applicable for emergency use authorization and clarified that, because of the shortage and use of infusion pumps throughout healthcare facilities, use cannot be limited to only COVID-19 conditions.

EUA issuance will add the manufacturer to “Appendix A” of the published letter of authorization. Candidate devices are still those not currently cleared or approved by the FDA, and those that have been cleared but have been modified to improve capabilities in response to COVID-19 (e.g. remote control/monitoring, cross compatibility, etc., further info INSERT LINK TO PREVIOUS INFUSION PUMP PAGE). Changes that would normally trigger a premarket notification may achieve expedited authorization through an EUA. For the duration of the declared emergency, FDA enforcement discretion policy has stated it will not require premarket notifications for changes to improve capabilities without increasing undue risk. Change control and documentation measures should remain in place for modifications to devices. EUA requests may be made for these changes by manufacturers potentially aiding marketing and future regulatory strategy. Devices with marketing authorization in a different regulatory jurisdiction are still open for EUA issuance as well. The request and issuance requirements under Section II of the published letter align with those laid out in the April guidance. This publication updates the product code applicability and streamlines the information for EUA issuance.

 


 

PPE – Protective Barrier Enclosures

Authorization for emergency use has been granted for protective barrier enclosures for use by HCPs when caring or performing medical procedures on patients known or suspected to have COVID-19 in healthcare settings. Barriers may prevent HCP exposure to pathogenic airborne particulates by providing an extra layer of protection in addition to PPE. Compliance with scope and conditions of authorization allow for marketing and distribution of protective barriers without further FDA interaction.

A protective barrier enclosure is a transparent device designed to cover a patient’s head and upper body that incorporates one or more ports through which the HCP’s hands are passed to perform medical procedures. Protective barriers do not include fans, air filters, or other features and does not create negative pressure. Enclosures may be used by HCPs in procedures such as airway management (e.g. intubation, extubation, etc.) or aerosol generating procedures. Protective barrier enclosures are not intended to replace PPE but add an additional layer of protection in situations where there is a greater risk of exposure to SARS-CoV-2. Enclosures may be single-use or for multiple-use with disinfection agent and procedure information provided with the product.

Following other blanket EUAs, such as for face masks and face shields, requirements and conditions of authorization are listed in the letter. Authorized labeling with the directions for use, intended use, body contacting materials, precautions, and fact sheets for patients and HCPs is to be included for distribution. Requirements for record retention and regulatory status (i.e. not FDA cleared/approved) is in place, as with all EUAs issued.

Authorization for emergency use has been granted for protective barrier enclosures for use by HCPs when caring or performing medical procedures on patients known or suspected to have COVID-19 in healthcare settings. Barriers may prevent HCP exposure to pathogenic airborne particulates by providing an extra layer of protection in addition to PPE. Compliance with scope and conditions of authorization allow for marketing and distribution of protective barriers without further FDA interaction.

A protective barrier enclosure is a transparent device designed to cover a patient’s head and upper body that incorporates one or more ports through which the HCP’s hands are passed to perform medical procedures. Protective barriers do not include fans, air filters, or other features and does not create negative pressure. Enclosures may be used by HCPs in procedures such as airway management (e.g. intubation, extubation, etc.) or aerosol generating procedures. Protective barrier enclosures are not intended to replace PPE but add an additional layer of protection in situations where there is a greater risk of exposure to SARS-CoV-2. Enclosures may be single-use or for multiple-use with disinfection agent and procedure information provided with the product.

Following other blanket EUAs, such as for face masks and face shields, requirements and conditions of authorization are listed in the letter. Authorized labeling with the directions for use, intended use, body contacting materials, precautions, and fact sheets for patients and HCPs is to be included for distribution. Requirements for record retention and regulatory status (i.e. not FDA cleared/approved) is in place, as with all EUAs issued.

 


 

Comunale Patient Isolation Transport Unit (PITU)

There is a shortage of FDA cleared or approved devices for isolation and transport of patients with suspected or confirmed diagnosis of COVID-19. Negative pressure rooms for isolation are also at reduced capacity in outbreak areas. Use of PITU allows for immediate, temporary isolation for patients and reduces the need of prepared rooms for transportation before admission to a space with appropriate biosafety level.

An EUA was issued 8 May 2020 for the Comunale Patient Isolation Transport Unit. This unit is comprised of disposable vinyl walls and filters around a reusable frame and motors that attach to standard hospital beds or gurneys creating a negative pressure enclosure similar to an Airborne Infection Isolation Room. Glove ports are provided on the side walls for patient interaction. The frame is adjustable and large enough to allow the patient to sit up and perform activities from the bed or gurney. As with other EUAs, the labeling has been authorized and includes the fact sheets for patients and HCPs as well as user manuals and operations guide.

In conjunction with the Protective Barrier Enclosure EUA and the previously issued PPE EUAs, FDA demonstrates a continued attempt to provide a device market and regulatory space to reduce disease spread within healthcare facilities as much as possible during this emergency declaration.

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