Important regulatory considerations for the supply of medical gowns: Guidance to industry
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Important regulatory considerations for the supply of medical gowns: Guidance to industry

Oct 06, 2023

On February 22, 2023, Health Canada introduced the Regulations Amending the Medical Devices Regulations (Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19). These Regulations accelerate access to COVID-19 medical devices that have an urgent public health need in Canada. They also make it possible to continue to import and sell COVID-19 medical devices authorized under the interim order. Health Canada will be updating the content of this page soon. For more information, please refer to the notice on Amendments to Medical Devices Regulations to continue importation and sale of COVID-19 medical devices and guidance on Medical devices for use in relation to COVID-19.

The purpose of this document is to provide regulatory information with regard to medical gowns.

In Canada, all medical gowns are Class I medical devices. Medical devices are classified into four groups (Class I, II, III and IV) based on their risk to health and safety. Class I devices present the lowest potential risk (e.g., gauze bandages), while Class IV devices present the largest potential risk (e.g. pacemakers). Health Canada licenses all Class II, III and IV medical devices imported, advertised and sold in Canada.

An establishment license is required for the importation or sale of Class I medical devices. Unlike the higher risk Class II-IV medical devices, there is no pre-market review for Class I and these devices are not subject to the quality management system requirements under the Medical Devices Regulations and thereby do not require an audit under the Medical Device Single Audit Program. Class I devices can be manufactured by companies that hold a Medical Device Establishment Licence (MDEL). Medical gown manufacturers authorized in Canada are listed in the Medical Devices Establishment Licence Listing database.

Information on how to obtain a Medical Device Establishment Licence for medical gowns

Canada is also speeding up the importation and sale of medical devices used to diagnose, treat, mitigate or prevent COVID-19.

To submit an application for authorization under the Interim Order, contact the Medical Devices Directorate at [email protected].

For information about the licensing or authorization of medical devices in Canada, contact the Medical Devices Directorate at [email protected].

Companies that need an MDEL application fast-tracked should:

For more information, refer to Guidance on Medical Device Establishment Licensing (GUI-0016).

Manufacturers, importers and distributors that hold an MDEL, may be able to import gowns with non-compliant labelling into Canada. Examples include:

To import these gowns, manufacturers and importers should:

Medical gowns are used in a variety of health care settings, such as Emergency Departments, Intensive Care Units, and clinics. An appropriate type of gown is selected within the context of the setting and needs of health care professionals and patients.

There are two main types of medical gowns: isolation gowns and surgical gowns. They are both Class I medical devices. It is important to note that the product names of gowns are not standardized. These products may also be called procedural gowns, operating room gowns, or non-surgical gowns.

The Government of Canada encourages manufacturers to consider the use of recycled fibres/fabrics, recyclable and/or sustainable components in the development of medical gowns.

Regardless of how the product is named, the product labeling describes the intended use, and it is necessary to identify the desired level of protection based on the level of risk.

There are four levels of risk that can be broken down into two categories: Low Risk (Level 1 and Level 2) and High Risk (Level 3 and Level 4):

Isolation gowns

Isolation gowns are protective apparel used to protect the clothing of health care professionals, visitors, and patients from the transfer of microorganisms and body fluids in patient isolation situations.

Surgical gowns

Surgical gowns are sterile textile gowns worn by health care professionals who are performing activities in a sterile environment.

The section below describe the international standards recognized by Health Canada. There are standards for both the material integrity of gowns, as well as for the protective nature they provide.

These are standards that relate specifically to the integrity of the material used to make gowns including tear resistance, seam strength, lint generation, evaporative resistance, and water vapor transmission. Health Canada accepts conformance with the American Society for Testing and Materials (ASTM) F2407 which is an umbrella document that covers the following standards:

The standards listed below describe barrier performance with respect to penetration by liquids or liquid-borne pathogens. This ensures the prevention of transmission of pathogens and is intended for use in health care facilities.

Health Canada recognizes the following standards (summarized in the below table):

The World Health Organization also recognizes the EU Personal Protective Equipment (PPE) Regulation 2016/425 and EU MDD Directive 93/42/EEC for single use gowns.

Moderate water resistance (resistant to water spray and some resistance to water penetration under constant contact with increasing pressure)

AATCC 42 - Water penetration ≤ 1.0 g

Medical gowns may be disposable or reusable.

It is not recommended to use expired disposable medical gowns without confirming that they are still fluid resistant according to AATCC Test Method 42 for gowns of level 1, 2 and 3, or AATCC Test Method 127 for gowns of level 2 and 3.

Reusable (washable) medical gowns may be cleaned after each use and safely reused. Reusable gowns are required to meet manufacturer's instructions with respect to sterility and laundering requirements for healthcare settings. This includes the number of times gowns can be laundered to maintain performance, safety, and effectiveness. If there is no date available on the gown label or packaging to indicate a manufacturer-designed shelf life, facilities should contact the manufacturer.

Reusable gowns can be used beyond their recommended life span provided they are free of damage. Expired gowns should be visibly inspected for damage prior to use. Indications of damage may include odours or noticeable/heavy soiling, staining, or spotting (for example, signs of mould).

Expired gowns, whether disposable or reusable, can also be used for training and demonstration purposes in cases where protective barriers are not needed.

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gowns with non-compliant labelling Medical devices for exceptional importation and sale request form COVID-19 medical device Exceptional importation and sale notification form Table 1. Risk levels and gown classification Lower risk Level 1 Standard performance Level 2 Higher risk Level 3 High performance