ARCHIVED Authorized medical devices for uses related to COVID-19: List of medical devices for expanded use in relation to COVID-19 (2023-09-15 – 2024-01-02)

Cepheid Xpertxpress Test Device (IO 312836)

Xpertxpress SARS-CoV-2 is a rapid molecular in vitro diagnostic test that is performed on the GeneXpert Dx and GeneXpert Infinity systems that currently utilizes nasopharyngeal swab, nasal wash, and aspirate specimens under its existing authorization. Through a clinical trail and a limit of detection study, the performance of the device met Health Canada's requirements for expanded use authorization. In addition to the existing authorized sample types, the gargle and spit sample type is authorized for use with the Xpertxpress SARS-CoV-2 rapid molecular test.

In order to collect gargle and spit samples, the instructions provided by the BC Ministry of Health and Centre for Disease Control should be followed, namely:

1. The patient should be instructed not to eat, drink (even water), chew gum, brush teeth, vape or smoke for at least one hour before the test. This might affect the test results.
2. The patient should be provided a container of salt water (5mL sterile 0.9% saline) and instructed to take all the salt water into their mouth without swallowing it.
3. The patient should be instructed to swish for 5 seconds, then gargle for 5 seconds, then repeat each action twice more in order, for a total time of 30 seconds (swish 5s, gargle 5s, swish 5s, gargle 5s, swish 5s, gargle 5s). To gargle, the patient should be instructed to tip their head back, move the water to the back of their throat, open their mouth and make the "ahh" sound. They should not swallow the water at any point.
4. The patient should then be instructed to spit the water into the designated sample collection container, which should then be appropriately sealed and labeled.

Further instructions are available on the BC website for children and youth (EN and FR) and adults (EN and FR) as well as video demonstrations that are also available in American Sign Language.

Collected samples are stable for up to 5 days at 4 degrees C and up to 48 hours at room temperature. Specimens should be transported refrigerated (ice packs in insulated containers) to avoid exposure to higher temperatures if transportation delays are expected.

Expanded use (2021-04-15)

The samples used to validate the use of gargle and spit samples on the Cepheid XpertXpress SARS-CoV-2 test were collected in Fangye Cryogenic tubes with funnels (manufactured by TaiZhou Huangyan Fangye Technology Development Co. Ltd) using Sterile Saline Addipak^®0.9% (5 mL) (NPN 00598127, manufactured by Teleflex Medical, Research Triangle Park, NC, USA). The Starplex Scientific Leakbuster ™ Container (90 mL) (manufactured by Starplex Scientific, Etobicoke, Ontario, Canada) was used to collect the samples in combination with the Sterile Saline Addipak^®0.9% (5 mL) for clinical purposes. Both sample collection containers are considered appropriate for use with this type of sample.

The anticipated potential benefit of this expanded use during the pandemic is greater flexibility in the sample types that can be used with the Cepheid XpertXpress SARS-CoV-2 test. In addition, the gargle and spit sample collection method is less invasive than other sample types, improving the user experience of the test. Participants in the clinical analysis considered the gargle and spit sample collection to be significantly more acceptable than nasopharyngeal samples collected by healthcare professionals.

The potential risks are that users may collect samples inappropriately because the instructions for use related to this sample type are not supplied with the product. Further, information on potential interference by endogenous or exogenous substances has not been characterized for this sample type. Confirmatory testing using alternate samples should be considered when results do not concord with expectations based on clinical assessment or other considerations.

Additionally, there is a risk that users will seek clarification or additional information from Cepheid related to these sample types. Cepheid is not in a position to provide information about the collection or analysis of gargle and spit samples by the XpertXpress SARS-CoV-2 test. Such questions should be directed to Health Canada's Medical Devices Directorate at meddevices-instrumentsmed@hc-sc.gc.ca.

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, including pregnant women) in all hospital and all professional healthcare settings including patients receiving medical intervention/therapy for COVID-19. 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 real time Sensor glucose readings alone and instead should consider all the information on the results screen.

Expanded use (2021-02-23)

Additional Information for Pregnant Women:

The system is not intended to be used by pregnant women for self-management of diabetes. The system readings can only be used for pregnant women, to replace blood glucose testing, when used by healthcare professionals in hospital and professional healthcare settings. The system can replace blood glucose testing except in a few situations. These are the times when a blood glucose test should be performed before deciding what to do or what treatment decision to make as sensor readings may not accurately reflect blood glucose levels:

• Do a blood glucose test if you see the Check Blood Glucose symbol. The symbol means sensor glucose readings may not be accurate.
• Do a blood glucose test if you think the glucose readings are not correct or do not match how the patient feels. Do not ignore symptoms that may be due to low or high glucose.

Known and Potential Benefits:

The anticipated benefit of this expanded use during the pandemic is to allow for timely access to glucose measurements in these patients while minimizing person-to-person contact, reducing the risks of both patient infection and the spread of infection to health care workers, and conserving personal protective equipment.

Known and Potential Risks:

• The effect of common medications on FreeStyle Libre glucose readings was assessed in relation to the general population and not specific to the pregnant population. Medications commonly prescribed during pregnancy may have not been evaluated and their interference with FreeStyle Libre system is therefore unknown.
• CGMs may be subject to interferences that may generate falsely high and falsely low glucose readings. Known interferences for FreeStyle Libre system include a positive bias due to high doses of 1000mg of ascorbic acid (Vitamin C) which may cause users to miss a low glucose event, and a slight negative bias when taking salicylic acid (used in some pain relievers such as aspirin). Other reducing drugs / compounds may also interfere.
• CGM readings can vary depending on the patient's glucose levels. The FreeStyle Libre clinical study* in pregnant women was compared to self-monitoring of blood glucose. In the study, women with experience of pre-eclampsia were excluded from the study, and women in their first trimester were not included in the study. Also, the study did not assess the accuracy of the Glucose Trend Arrow versus actual blood glucose rate of change.

*Scott, Eleanor M., et al. Accuracy, User Acceptability, and Safety Evaluation for the FreeStyle Libre Flash Glucose Monitoring System When Used by Pregnant Women with Diabetes. Diabetes Technology & Therapeutics, 20.3 (2018):180-188

• The system Low Glucose and High Glucose Message thresholds of 3.9 mmol/L and 13.3 mmol/L are not optimised for pregnant women with diabetes (who have stricter glycemic control guidelines than the non-pregnant population).
• The system has not been evaluated for use in patients with hypoglycaemic unawareness and will not automatically alert you of a hypoglycaemic event without you scanning your sensor. For example, the system does not have an alarm that can alert or wake you when you are sleeping in the case of low glucose.

Supplemental Labeling: Additional information for Pregnant Women During COVID-19 Pandemic, Shipper Insert, Rev C

Bravo Autoclave

BRAVO 17V and

BRAVO 21V

(Licence No.: 79049)

Device identifiers:
M7A310011
M7A310011-R
M7A310012
M7A310013
M7A310013-L
M7A310013-R
M7A310014
M7A310014-L
M7A310014-R
M7A320011
M7A320011-R
M7A320012
M7A320012-L
M7A320012-R
M7A320013
M7A320013-L
M7A320013-R
M7A320014
M7A320014-L
M7A320014-R

To provide decontamination solutions for compatible N95 respirators during the SARS-CoV-2 coronavirus pandemic.

Expanded use (2021-02-21)

The Bravo Autoclaves are not compatible for:

• Respirators that are the molded/cup style,
• Respirators that have exhalation valves or
• Non-NIOSH approved disposable filtering facepiece respirators manufactured in China and authorized under the US Emergency Use Authorization (EUA).

There are no safety or effectiveness issues with regards to the expanded use of this device. The anticipated potential benefits of the expanded use during the pandemic include increased availability of safe and effective respirators for use, reducing respirator supply needs. There are no known additional risks with the expanded use of the device.

Additional labelling has been developed by the company, in keeping with other respirator reprocessing devices, which includes the following:

• Information Sheets for Healthcare Facilities and for Healthcare Personnel on the safe and effective reprocessing steps to be followed that are specific to their device and the models to be reprocessed
• Fact Sheet for Healthcare on how to collect and mark reprocessed respirators and conduct checks following respirator reprocessing to ensure their appropriateness for use.

Angiographic syringes

(Licence No.: 98999)

Device identifiers:

• CS0001
• CS0003
• CS0005

The syringes used together with hypodermic needles are intended to inject the drug for the patient or take out the blood from the patient.

Expanded use (2020-12-11)

There are no safety or effectiveness issues with regards to the expanded use. The anticipated potential benefits of this expanded use during the pandemic include availability and an additional safe and effective syringe for vaccine use. There are no known additional risks involved with the expanded use of this device.

No additional labelling is required for this use.

• Acute respiratory failure in the absence of cardiac failure or fluid overload
• Having diffuse alveolar damage (DAD) (HRCT findings)
• PaO2/FiO2 =< 300 mmHg

Expanded use (2020-04-20)

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)

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.

Expanded use (2020-04-24)

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

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

Expanded use (2020-04-24)

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

Expanded use (2020-04-25)

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]

Expanded use (2020-07-10)

In the general adult population, the Canadian Medical Device Licence for the Dexcom G6 Sensor labels it to be worn on the abdomen (belly). For pregnant women under this Interim Order Expanded Use, the Dexcom G6 Sensor is being authorized to be worn on the abdomen (belly) or back of the upper arm.

Patients are encouraged to speak to their care providers about using the remote glucose data sharing capabilities of the Dexcom G6 System, Dexcom Share App, and Dexcom CLARITY, to share their glucose data with their care providers in an effort to limit the necessity for direct contact between patients and their care providers during the pandemic.

The anticipated potential benefits of this expanded use during the pandemic, based on results of a clinical study of the Dexcom G6 System in pregnant women with diabetes mellitus, recommendations of Diabetes Canada and American Diabetes Association guidelines, and related clinical literature for use of continuous glucose monitoring in pregnant women are: reduced contact between patients and their care providers, thus limiting the potential spread of COVID-19, and; to help identify periods of hypoglycemia and hyperglycemia and help achieve glycemic targets.

The potential risks, based on the available information, are:

• The effect of common medications on the Dexcom G6 glucose readings was assessed in relation to the general population and not specific to the pregnant population. Medications commonly prescribed during pregnancy may not been evaluated and their interference with the Dexcom G6 is therefore unknown;
• With the Dexcom G6, you can take a standard or maximum acetaminophen dose of 1 gram (1,000mg) every 6 hours. Taking higher than the maximum dose of acetaminophen (e.g. > 1 gram every 6 hours in adults) may affect the G6 readings and make them look higher than they really are.
• CGM readings can vary depending on the patient's glucose levels. The Dexcom G6 clinical study in pregnant women included limited reference glucose measurements in both level 1 and level 2 hypoglycemia or hyperglycemia ranges. CGM readings are typically less accurate during the first day of sensor wear. The Dexcom G6 was not tested against reference glucose measurements on the first day of sensor wear in pregnant women.

Medtronic Enlite Sensor and compatible devices:

Enlite Glucose Sensor (Licence No.: 90691)

iPro 2 Continuous Glucose Monitoring (CGM) System (Licence No.: 85706)

Minilink Real Time Transmitter (Licence No.: 73839)

Paradigm Insulin Infusion Pump (Licence No.: 62859)

Guardian Link Transmitter (Licence No.: 97803)
Minimed 630G (Licence No.: 97802)

Expanded use (2020-07-10)

Patients are encouraged to speak to their care providers about using the Carelink software to share their glucose data with their care providers in an effort to limit the necessity for direct contact between patients and their care providers during the pandemic.

The anticipated potential benefits of this expanded use during the pandemic, based on results of the CONCEPTT randomised controlled trial, recommendations of Diabetes Canada and American Diabetes Association guidelines, and related clinical literature for use of continuous glucose monitoring in pregnant women are: reduced contact between patients and their care providers, thus limiting the potential spread of COVID-19, and; to help identify periods of hypoglycemia and hyperglycemia and help achieve glycemic targets.

The potential risks, based on the available information, are:

• Taking medications with acetaminophen while wearing the Enlite Sensor may falsely raise your sensor glucose readings. The level of inaccuracy depends on the amount of acetaminophen active in your body and may be different for each person.
• The effect of common medications on the Enlite Sensor glucose readings was assessed in relation to the general population and not specific to the pregnant population. Medications commonly prescribed during pregnancy may not have been evaluated and their interference with the Enlite Sensor is therefore unknown.
• To the best of Health Canada's knowledge, the accuracy of the Enlite Sensor versus a blood glucose reference method has not been studied in pregnant women.

The Panbio™ COVID-19 Ag Rapid Test Device is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal swabs from individuals who are suspected of COVID-19 by their healthcare provider. As an alternative to nasopharyngeal swabs, the test is also authorized to be used with the following foam nasal swabs:

FOAM SWAB Nasal (COVID-19 AG) (Jiangsu Changfeng Medical Industry Co., Ltd.)

FOAM SWAB Nasal (COVID-19 AG) (Noble Biosciences Inc.) (Item code SS-2W)

FOAM SWAB Nasal (COVID-19 AG) (MRC)

Expanded use (2021-02-16)

The instructions for use provided with the Panbio^TM COVID-19 Ag Rapid Test Device includes instructions for collecting a nasopharyngeal swab only. Users should not follow those sample collection instructions while using a foam nasal swab as this could cause discomfort, pain, or potentially injury. Appropriate nasal swab sample collection instructions and training must be provided to users who will employ the test with authorized nasal swabs instead of nasopharyngeal swabs.

The anticipated potential benefit of this expanded use during the pandemic is greater user acceptability of the test when paired with nasal swab collection procedures rather than nasopharyngeal swab collection procedures.

The potential risks are that users may inappropriately follow the instructions provided with the test kit for collection of a nasopharyngeal sample while using a nasal swab. The risk associated with this is that the patient may experience discomfort, pain, or potentially injury. This risk must be mitigated by ensuring that anyone who will use this test with nasal swabs is appropriately instructed in nasal swab sample collection technique. Additionally, the test has been validated for use only with the listed foam nasal swabs. The use of other nasal swabs has not been validated with this test at this time.

Instructions for Use for Dolphin Neurostim (NS) applied as a vagal nerve stimulator (VNS) is authorized for emergency use in the acute treatment of adult patients with known or suspected COVID-19. Intended for those:

• who are experiencing exacerbation of longhaul symptoms and/or asthma-related dyspnea and reduced airflow and
• for whom approved drug therapies are not tolerated or provide insufficient symptom relief as assessed by their health care provider.

Using non-invasive VNS applied to the auricular branch of the vagus nerve (ABVN) during the COVID-19 pandemic can help with symptom relief.

Expanded use (2022-04-01)