Testing devices for COVID-19: Test swabs safety and effectiveness guidance

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Background

COVID-19 is an infectious disease caused by the SARS-CoV-2 coronavirus. The World Health Organization declared a global pandemic in March 2020. The Minister of Health signed the Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 on March 18, 2020. The interim order (IO) allows us to quickly address large-scale public health emergencies, such as through faster authorization of medical devices for COVID-19.

This guidance document presents the criteria for safety and effectiveness that apply to test swabs used for COVID-19 sampling. It also provides guidance on how to meet these criteria in an application under the IO pathway.

Diagnostic testing is a key element in both:

A test swab may be used to collect a sample for either Polymerase Chain Reaction (PCR) laboratory testing or point-of-care testing. Point-of-care testing can be done directly in a hospital or doctor's office.

Once the sample has been taken, the swab is either placed:

Swabs may be packaged in a variety of virus transport media (VTM). Specifications for individual VTMs are beyond the scope of this document.

Swabs play a role in the accuracy of COVID-19 diagnostic testing. For example, false negatives can occur in PCR tests if:

Test swabs that are not safe and effective may cause or lead to harm. For example:

Swab manufacturers are encouraged to submit evidence of safety and effectiveness for IO authorization.

We are processing applications as quickly as possible. To avoid delays, please ensure you have completed your application properly. Please see our guidance document for more information on how to prepare applications submitted under this IO.

Medical Devices Regulations (MDR) classification

In the Canadian regulatory framework, Class I devices present the lowest potential risk and Class IV the highest. Swabs are classified according to their labelling and intended use.

For example, if a swab is labelled for nasopharyngeal (NP) or oropharyngeal (OP) use only, it is classified as a Class I medical device. See Classification Rule 2(2) of the MDR.

If a swab is not solely for use in oral or nasal cavities or its use is not explicitly stated, it is classified as a Class II device. See Rule 2(1). These swabs may be used to collect tissue samples (for example, to test for chlamydia or ureaplasma) from other body orifices. This use is associated with greater risk.

Under Rule 2:

Regulatory pathways for COVID-19 devices

Manufacturers of Class I swabs may seek authorization to import and sell their products under either:

Health Canada is encouraging a sub-group of swab manufacturers to use the IO authorization pathway for Class I swabs, especially if they are:

IO applications for swabs should include the following information.

Device description

The device description should include:

Quality manufacturing

Manufacturers must either:

Design verification

Provide swab design verification (bench testing) data in a summary report. It should show that the essential minimum design characteristics are met. These data should be based on test samples representative of finished swabs that have been sterilized before bench testing.

Dimensions

Swabs should have minimum length specifications and minimum and maximum head diameter specifications in order to be safe and effective:

Flexibility

Swab flexibility is assessed through:

Manufacturers may describe the test performed, the number of samples and provide a summary of the results.

Strength and breakpoint (failure)

To limit the potential for patient harm, the minimum breakpoint distance should be about 8 cm to 9 cm from the nasopharynx. However, no breaks or fractures should occur following reasonable manipulation.

Applicants should submit a rationale for the design of the breakpoint distance from the swab tip. It should demonstrate that the breakpoint length can be accommodated by commercially available swab/media tubes.

Surface properties

The swab surface should be free of:

Injection molded swabs should not have any burrs, flashing or sharp edges.

Design validation

Provide swab validation (performance) data in a summary report that demonstrate the swab:

These data should be based on test samples representative of finished swabs that have undergone sterilization before testing.

Comparable sample acquisition to a control and PCR compatibility

The test swab cycle threshold (Ct) recovery values (RT-PCR) should be statistically comparable to those from a commercially available swab control using SARS-CoV-2 (or a scientifically justified surrogate).

Pass/fail criteria

Values ≥2Cts should indicate significantly less efficient ribonucleic acid collection and/or elution.

Clinical feasibility and suitability simulation

Manufacturers should submit either:

Clinical test report

The clinical test report should describe the use of the proposed finished swab (sterilized) in a minimum of 30 patients who have tested positive for SARS-CoV-2 or a scientifically justified surrogate virus. The test should be conducted by trained health care professionals. It should compare the proposed swab against a flocked swab commercially available in Canada with respect to:

Clinical testing considerations

For more information on collecting, handling and testing COVID-19 specimens, please refer to the Centers for Disease Control and Prevention (CDC) Interim Guidelines for Collecting, Handling and Testing Clinical Specimens for COVID-19.

Previous clinical data

Previously obtained clinical data may be submitted instead of clinical testing. Those data should demonstrate the safe and effective use of a swab of identical design and materials in human subjects. The proposed swab should be compared against a flocked swab commercially available in Canada with respect to:

Sterility

Provide sterilization validation data in a summary report. It should demonstrate that the chosen sterilization method will achieve a minimum sterility assurance level (SAL) of 10-6 for the proposed swab, using an appropriate biological indicator (BI) organism (see below).

If the swab is sterilized using an ethylene oxide (EtO) method, you should demonstrate that EtO and ethylene chlorohydrin (ECH) residuals meet the tolerable contact limits (TCL) specified in ISO 10993-7. Commonly used swab materials, compatible sterilization methods and appropriate biological indicators are described below.

Sterilization Method
Swab Materials EtO
(for example, ISO 11135)
Gamma Irradiation
(ISO 11137)
Polystyrene handle, polyester bicomponent fiber tipFootnote * X
(for example, Puritan 25-3316-H/U)
Not applicable
Polystyrene handle, nylon flocked fiber tipFootnote * X
(for example, Copan 503CS01)
X
(for example, BD 220252)
Footnote *

The CDC provides guidance on the types of swabs that should be used for optimal specimen collection for PCR testing. Swabs made of polyester (for example, Dacron), rayon or nylon-flocked are included. Cotton-tipped or calcium alginate swabs are not acceptable because residues in those materials inhibit the PCR reaction.

Return to footnote * referrer

Appropriate BI

If ionizing radiation will be used to sterilize the swab:

Sterilization Process Spore (Indicator Organism)
Steam Geobacillus stearothermophilus
(formerly Bacillus stearothermophilus)
Dry heat Bacillus atrophaeus (formerly Bacillus subtilis var. niger)
Ethlylene oxide Bacillus atrophaeus (formerly Bacillus subtilis var. niger)
Hydrogen peroxide Geobacillus stearothermophilus
(formerly Bacillus stearothermophilus)

Source: U.S. Food and Drug Administration, "Biological Indicator (BI) Premarket Notification [510(k)] Submissions," October 2007. [Online].

Packaging validation

Provide packaging validation data in a summary report. It should demonstrate that the swab packaging system will maintain a sterile environment across the labelled shelf life (for example, ASTM F1980):

Test packaging samples should be representative of finished swab packages that have undergone sterilization before testing.

Biocompatibility

Provide biocompatibility data in a summary report. It should demonstrate compliance with biocompatibility tests recommended for devices in limited contact (≤24 hrs) with mucosal membranes (see ISO 10993-1). These include:

These data should be based on test samples representative of finished swabs that have undergone sterilization before testing.

Labelling

Swabs should be individually packaged and labelled. The application must include the swab label, which must include:

If swabs are not sterile but must be sterilized at the user facility, then the sterilization parameters and method should be clearly described in accompanying instructions for use documentation.

Post-market requirements

Within 10 days of becoming aware of an incident in Canada, all IO authorization holders must:

MDEL holders importing and/or selling swabs in Canada must follow the requirements set out under the MDR. This includes complaint handling, mandatory problem reporting and recall reporting.

While the IO does not have unique requirements related to recalls, any device authorized under thee IOis subject to the mandatory recall provisions under the Food and Drugs Act. Also, while the Minister has the ability to order a mandatory recall, manufacturers should proactively notify Health Canada if they become aware of the need to recall their COVID-19 medical device in Canada. The guide to the recall of medical devices provides guidance on how to conduct a recall in Canada.

Health Canada may engage in activities to assess compliance with the IO authorization and/or MDEL requirements and take immediate action when non-compliance is confirmed. This includes stopping the importation and sale of any products that are found to pose a risk to the health of Canadians.

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