Authorized medical devices for uses related to COVID-19: List of medical devices for expanded use

Medical devices on this list have an expanded indication for use or intended use related to COVID-19. Diagnostic, treatment, mitigation or prevention claims are based on known evidence as outlined in section 13 of the interim order for importing and selling medical devices.

We are updating this list when new expanded uses are identified.

Medical devices on this list are granted an expanded indication for use or intended use, to include COVID-19 related diagnostic, treatment, mitigation or prevention claims based on known evidence.

List of medical devices for expanded use in relation to the COVID-19 pandemic
Medical device or COVID-19 medical device Expanded use Supplementary Information Date
(YYYY-MM-DD)
Toraymyxin (Pmx-20r)
(Licence No.: 63404)
When TORAYMYXIN is used for COVID-19 patients, indications are as follows:
  • Acute respiratory failure in the absence of cardiac failure or fluid overload
  • Having diffuse alveolar damage (DAD) (HRCT findings)
  • PaO2/FiO2 =< 300 mmHg

Limited data from published cases of TORAYMYXIN used for acute respiratory distress due to viral pneumonia and acute exacerbation of interstitial pneumonia suggest that TORAYMYXIN Therapy may:

  • Help reduce the magnitude of cytokine storm syndrome
  • Improve PaO2/FiO2
  • Improve hemodynamics

Additional Warnings and Precautions:

  • Drug level monitoring should be performed when utilizing this technique. Medication doses may need to be adjusted to account for undesired losses.

Addendum to Instructions for Use of TORAYMYXIN (PMX cartridge) as a COVID-19 Medical Device:

  • Rev. 2020- 04-20R-ENG (CAN-COVID-19)
2020-04-20

Hemosphere Advanced Monitoring System

(Licence No.: 99253)

The HemoSphere advanced monitoring platform is intended to be used by qualified personnel or trained clinicians in a critical care environment for monitoring of hemodynamic parameters in patients undergoing treatment, including for sepsis, acute respiratory distress syndrome (ARDS), or COVID-19, in a hospital setting.

Safety and effectiveness was supported by literature studies, clinical guidelines, and acceptable marketing history in Canada and globally.

Additional Warnings and Precautions:

N/A

Addendum to Instructions for Use:

Version EW-CAN-IO-1.0, original 2019-09-10

2020-04-24

Freestyle Libre Flash Glucose Monitoring System

(Licence No.: 99351)

The FreeStyle Libre Flash Glucose Monitoring System Reader (“Reader”)/FreeStyle LibreLink app (“App”) when used with a FreeStyle Libre Flash Glucose Monitoring System Sensor (“Sensor”) is indicated for measuring interstitial fluid glucose levels in adults aged 18 years and older (with or without diabetes) in all hospital and all professional healthcare settings including patients receiving medical intervention/therapy for COVID-19. In home setting, FreeStyle Libre system is indicated for measuring interstitial fluid glucose levels in adults aged 18 years and older with diabetes. The Reader/App and Sensor are designed to replace blood glucose testing in the self-management of diabetes, including dosing of insulin. Treatment decisions should not be based on realtime Sensor glucose readings alone and instead should consider all the information on the results screen

Safety and Effectivenes: Supported by a review of the published literature regarding the use of the system in hospitalized patients (both critically ill and non-critically ill populations), and sensory accuracy performance testing with risk assessment which provided assurance that the benefit of reduced patient contact and reduced usage of personal protective equipment outweighs the risks associated with potential suboptimal sensor accuracy in hospitalized patients.

Additional Warnings and Precautions:

Hospitals should consider whether they have the resources and expertise necessary to adequately implement Continuous Glucose Monitoring (CGM) system use in their facility and provide appropriate training to healthcare providers.

The FreeStyle Libre system is to be used in patients to perform glucose scans by themselves or with the aid of caregivers or healthcare professionals.

CGM glucose results are less accurate than blood glucose results obtained using traditional testing methods (e.g., lab glucose, blood glucose meters) in hospital settings. Users should consider all CGM glucose information (e.g., trend) along with individual glucose values, and interpret CGM results in the context of the full clinical picture.

CGMs may be subject to interferences that may generate falsely high and falsely low glucose readings. Levels of interference depend on drug concentration; substances that may not significantly interfere in non-hospitalized patients may interfere when used in the hospital setting because of higher dose levels. Most drugs used in hospital or critical care settings have not been evaluated and their interference with CGMs is unknown. Known interferences for FreeStyle Libre system include a positive bias due to high doses of ascorbic acid (Vitamin C) and a slight negative bias when taking salicylic acid (used in some pain relievers such as aspirin). Other reducing drugs / compounds may also interfere.

Addendum to Instructions for Use:

Additional information for Hospitalized Patients During COVID-19 Pandemic, Shipper Insert, 2020

2020-04-24

Dexcom G6 Continuous Glucose Monitoring System (Licence No.: 102449) The Dexcom G6 Continuous Glucose Monitor may be used in hospital to monitor critically ill patients.

Safety and Effectiveness:

It is hoped that the use of real time continuous glucose monitoring devices, such as the Dexcom CGM system, will help reduce personal protective equipment (PPE) usage and hospital staff exposure during the current COVID-19 pandemic.

Expanded use was supported by literature on the use of continuous glucose monitoring in hospitalized or critical care settings as well as recent article related to glycemic characteristics and clinical outcomes of COVID-19 patients Hospitalized in the United States.

Additional Warnings and Precautions:

Continuous glucose readings do have interpersonal variability and have not been tested on COVID-19 related patients.

Hospitals should continue to use their existing protocols to manage and treat patient glucose levels. Real time CGM can be used to provide remote monitoring and glucose trends to aid in glucose management and medical decision making.

CGM glucose results can be less accurate than blood glucose results obtained using traditional testing methods (e.g., lab glucose, blood glucose meters). Users should consider all CGM glucose information (e.g., trend) along with individual glucose values and interpret CGM results in the context of the full clinical picture.

CGMs may be subject to interferences that may generate falsely high and falsely low glucose readings. Levels of interference depend on drug concentration; substances that may not significantly interfere in non-hospitalized patients may interfere when used in the hospital setting because of higher dose levels. Most drugs used in hospital or critical care settings have not been evaluated and their interference with CGMs is unknown. Based on its structure, it is unlikely hydroxychloroquine would interfere with Dexcom CGM. Known interferences vary by CGM brand and can include:

  • Acetaminophen2
  • Ascorbic acid,
  • Hydroxyurea,
  • Other reducing drugs/ compounds.

Poor peripheral blood perfusion may cause inaccurate sensor readings. CGM results should be interpreted considering accompanying patient conditions and medications. Other clinical conditions may also cause inaccurate readings.

Dexcom G6 CGM System has not been tested in MRI/CT/Diathermy situations.

Remove CGM prior to MRI/CT/Diathermy tests. See, Dexcom’s “Using Your G6” guide for warnings and precautions.

Addendum to Instructions for Use:

Fact Sheet for Healthcare Providers: Use of Dexcom Continuous Glucose Monitoring Systems During the COVID-19 Pandemic [Doc. Ref.: LBL018932]

2020-04-25
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