Personal protective equipment against COVID-19: Medical gowns
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.
On this page
- Importance of medical gowns
- Medical gowns distributed and sold in Canada
- Conserving the use of gowns in healthcare settings when supplies are limited
Importance of medical gowns
Long-sleeved medical gowns are essential for health care providers during the COVID-19 outbreak. As a personal protective equipment (PPE), they help protect health care providers against respiratory droplets and to slow the spread of the disease in Canada.
Health care providers use medical gowns in a variety of settings, including emergency departments, intensive care units and medical clinics.
There are 2 types of gowns:
Sometimes they’re labelled as:
- procedural gowns
- non-surgical gowns
- operating room gowns
Regardless of the name used, the label will indicate the intended use for the gown.
Isolation gowns protect the clothing of health care providers. They also protect visitors and patients because they prevent the transfer of microorganisms and body fluids in patient isolation situations.
Surgical gowns are sterile textile gowns. Health care providers wear these gowns when they are working in a sterile environment.
Medical gowns distributed and sold in Canada
In Canada, all medical gowns are classified as Class I medical devices. Class I devices present the lowest potential risk and are subject to the Medical Devices Regulations. Despite their classification as low risk, medical gowns serve an important function. Pathogens are unable to penetrate the material, which protects both the wearer and the patient.
Health Canada recognizes 3 standards for medical gowns:
- Canadian Standards Association - CSA Z314
- American National Standards Institute and Association of the Advancement of Medical Instrumentation - ANSI/AAMI PB70
- European Standards - EN 13795
Medical gowns distributed and sold in Canada are grouped by category and level of risk:
- low risk
- level 1 – minimal risk; used for standard precautions and simple procedures
- level 2 – low risk; used for minimally invasive surgery
- high risk
- level 3 – moderate risk; used for open gastrointestinal surgeries
- level 4 – high risk; used for open cardiovascular and trauma procedures
Companies with a medical device establishment licence (MDEL) can import and distribute medical gowns.
The COVID-19 pandemic has created an unprecedented demand for medical gowns. To meet the demand, Health Canada is:
- easing approvals of medical devices through an Interim Order,
- under the IO, manufacturers can apply to import or sell their medical device
- allowing medical gowns that haven’t been approved or don’t meet labelling requirements to be imported and sold
- fast-tracking the MDEL application process for companies that want to manufacture, import or distribute medical gowns
A guidance on medical gowns outlines how manufacturers, importers and distributors that hold an MDEL can import medical gowns with non-compliant labelling or that aren't approved for use in Canada. The guidance also provides information on the use of expired gowns.
Under the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19, manufacturers and importers are to report medical gown shortages.
Conserving the use of gowns in healthcare settings when supplies are limited
An isolation gown is an item of personal protective equipment (PPE) used by all healthcare workers (HCWs) in all healthcare settings, including acute care, long-term care, ambulatory care and home care. For example:
- HCWs include personal support workers, orderlies, nurses, doctors, etc.
- other critical staff and volunteers working in those settings such as housekeeping staff may also require PPE for certain activities
Wearing a gown helps protect the HCW's clothing and forearms while caring for a patient with an infection such as COVID-19.
Isolation gowns can be reusable or disposable. They should have long-sleeves, cover the body front and back from the neck to the thighs, overlap in the back, fasten at the neck and back and be easy to put on and take off. All HCWs require training on how to put on properly and take off PPE safely, including the isolation gown.
If a shortage of isolation gowns might occur in a healthcare setting, the following strategies should be considered:
- save existing supplies of gowns by decreasing the need for their use, such as:
- placing a physical barrier between HCWs and individuals at screening points
- reducing, postponing or cancelling non-essential procedures that may require a gown
- bundling of activities to reduce the need to change a gown
- increase the frequency of laundering of reusable gowns
- use other types of gowns such as:
- operating room (or surgical) gowns
- change uniforms more frequently
- use expired disposable gowns for training of HCWs
- identify other apparel or combination of apparel that could provide similar protection, including:
- laboratory coats
- sleeve covers
- if no alternatives are available, then, after discussions with staff, the use of expired gowns that are physically intact and show no visible wear could be considered in the strategies to address a shortage
Other apparel such as coveralls, laboratory coats and aprons are not normally used by HCWs when caring for patients. It is important to train HCWs on how to put on and safely take off these apparel, to minimize the risk of self-contamination.
Coveralls (reusable or disposable) provide full body protection. They open at the front and can cover the head and feet as well. They are more complicated to put on and take off and sizing may be an issue for some HCWs. They might have to be worn in combination with an apron if the clothing is not fully protected at the front.
Laboratory (lab) coats (reusable or disposable) provide a cover over clothing similar to a gown, except that they open in the front and may not be as long as a gown. Gloves may not fit well over the cuff of the lab coat, possibly exposing the wrist. Sizing may also be an issue for some HCWs. For example:
- to increase effectiveness, lab coats should be buttoned up
- lab coats may need to be worn in combination with other items, such as an apron
Aprons (reusable or disposable) provide protection to the front of the body. They can tie at the neck or have an overhead strap. This type increases the chance of touching the face and self-contaminating when taking them off. They can be long-sleeved or without sleeves and can be made of different kinds of material, such as plastic or fabric. Aprons should be used in combination with other apparel, such as a lab coat and sleeve covers, since aprons may not cover the back and arms.
Sleeve covers protect the forearms and are available in different kinds of material. Sleeve covers need to be used in combination with other apparel such as aprons.
Learn more about technical specifications and risk levels for gowns.
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