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Advice on surgical masks and gowns during COVID-19
Information for health professionals
The demand for surgical masks, surgical and isolation gowns, and surgical suits may overtake the supply available to healthcare organisations during the COVID-19 pandemic. In response to this increased demand, the Department of Health including the Therapeutic Goods Administration (TGA) and the Office of Health Protection (OHP) has prepared the following information to assist healthcare organisations as they update their operating procedures during the outbreak.
For surgical masks, gloves and gowns, the OHP and TGA suggest that health professionals follow the recommendations below, based on the supply needs of their healthcare organisations.
- Be aware that shortages may occur and plan accordingly in a composed manner.
- Masks, gloves and gowns intended by the manufacturer for use in an Australian hospital setting should be included on the Australian Register of Therapeutic Goods (ARTG). It is advised that you source your supplies bearing this in mind.
- Masks, gloves and gowns not intended by the manufacturer for use in a hospital or clinical setting are not required to be included in the ARTG, even if they are used in a hospital or clinical setting.
- Use masks, gloves and gowns according to labelling/Instructions for Use (IFU).
- Follow your healthcare facilities' infection control policies around the use of masks, gloves and gowns.
Supply needs in health care organisations
Supply levels are categorised at three levels:
- Standard conventional supply levels: supply levels are adequate to provide patient care without any change in routine practice.
- Contingency supply levels: limited supply levels may change patient care, but may not have a significant impact on patient care and healthcare provider safety.
- Crisis supply levels: may need to be considered if surgical mask or gown demand exceeds the supply.
While standard conventional supply levels or contingency supply levels are available, all IFU instructions should be adhered to, such as single use and clinical guidelines and protocols.
Recommendations for crisis supply levels
Although the following recommendations for gowns, gloves and masks do not comply with the IFU for these items, they can be considered where there is no other alternative.
It should be noted that the efficacy of gowns, gloves and masks cannot be assured when used after their expiry date, but should be used where there is no alternative.
While not recommended, where there is low supply and/or high demand, masks can be used past their shelf life if:
- the straps are intact;
- there are no signs of visible damage; and
- they can be fit tested.
Where there is high demand and/or limited access to surgical masks, healthcare facilities could consider allowing healthcare professionals to continue wearing the same mask between treating patients with the same diagnosis or infectious disease.
The use of masks should be prioritised for aerosol-generating procedures. These include but are not limited to suctioning and nebuliser treatments (currently nebulising medication is not recommended due to aerosolisation risk).
The TGA is aware of recently identified issues with some filtering face piece respirators (FFRs) which claim compliance as KN95 respirators against the Chinese national standard for Respiratory Protection, GB 2626.
There are concerns they may not provide consistent and adequate respiratory protection based on testing conducted by National Institute for Occupational Safety and Health (NIOSH) - National Personal Protective Technology Laboratory (NPPTL) of the Centers for Disease Control and Prevention (CDC).
The TGA is currently undertaking a post-market review of all filtering face piece respirators (FFRs) and facemasks that are included in the Australian Register of Therapeutic Goods (ARTG). Further information is available on the post market review of face masks page.
While not recommended, where there is low supply and/or high demand, gowns could be used as follows in crisis response measures:
- Expired sterile surgical gowns may be used as single use isolation gowns as they provide a physical barrier for isolation care.
- Healthcare providers may continue to wear the same gown between treating patients with the same diagnosis or infectious disease, such as COVID-19, providing they are being cared for in a confined area. If there are other concomitant infections present, such as C. difficile or MRSA, wearing the same gown between treating patients is not an appropriate action.
- Cloth gowns may be used where they are able to be re-processed as isolation protective equipment.
- Aprons should be worn underneath gowns which are not fluid resistant.
Gloves should continue to be worn for patient care activities along with strict adherence to the organisation's hand hygiene and infection control policies.
Under the Therapeutic Goods (Declared Goods) Order 2019 the following products are declared to not be therapeutic goods:
Non-sterile protective or safety apparel or equipment when used:
- in the home; or
- for occupational or recreational use.
This means that non-sterile PPE including masks, gowns and gloves that do not make any therapeutic claims are regulated as general consumer items and do not need to be included in the Australian Register of Therapeutic Goods (ARTG) before they can be supplied.
PPE including masks, gowns and gloves that are presented or claim to be for therapeutic use, such as surgical or examination masks intended to reduce or prevent the transmission of disease or micro-organisms (such as bacteria or viruses), meet the definition of a medical device. These products are regulated by the TGA under the Therapeutic Goods Act 1989 and will need to be included in the ARTG before they can be supplied.
Facemasks that are specifically intended to be used to reduce the risk of transmission of pathogens between people in a health setting are required to be included on the ARTG prior to their importation and supply. All facemasks that are currently included on the ARTG are single use items that are not intended for reprocessing to make suitable for re-use. Facemasks cannot be guaranteed to have the same risk profile for children or people with facial hair.
- N95 respirators which are included on the ARTG are intended to be used in a health care setting. They are designed to form a very close seal around the nose and mouth, to protect the wearer from exposure to airborne particles, including pathogenic biological airborne particulates such as viruses and bacteria. N95 respirators have been tested for particulate filtration to ensure they remove a minimum of 95% solid and liquid aerosols that do not contain oil. They are a single use item.
- Surgical N95 respirators are of a similar structure and design to standard N95 respirators and therefore meet the same testing requirements to achieve a minimum 95% filtration against airborne particulates, but have also been tested for fluid resistance against penetration by synthetic blood under different pressures, such as may occur during certain high risk medical procedures.
- Surgical masks are single use, fluid-resistant, disposable, and loose-fitting protection devices that create a physical barrier between the mouth and nose of the wearer and the immediate environment but do not achieve a close seal to the wearer's face. When used, surgical masks should cover both the mouth and the nose, and be secured using the ear loops or ties at the back of the head. Surgical masks have different grades of filtration and are useful for blocking splashes and large particle droplets or sprays which may occur. They do not provide complete protection from germs and other small particle contaminants.
Surgical gowns are single use items intended for use in the operating room to protect operating room personnel from the transfer of body, fluids, micro-organisms and particulate material.
Single use isolation gowns are intended to protect either the patient, or healthcare providers and visitors from the transfer of infectious agents when they are in contact with each other. They must have long sleeves and cuffs that cover the wearer to the wrist.
To ensure these gowns fit correctly, they should cover the wearer from the neck to the knees and sleeves should finish at the wrists with cuffs. They should have enough overlap at the back that they do not separate when the person wearing them is sitting and come to below the knee.
Medical gloves are disposable and include examination gloves, sterile gloves and medical gloves for handling chemotherapy. Gloves are used during medical examinations and procedures to help prevent cross-contamination between healthcare providers and patients and vice versa, as well as from one patient to another.
The World Health Organisation (WHO) recommends, as a general policy, that examination gloves be powder free to avoid reactions with alcohol-based hand rubs used in healthcare facilities. If there are no other gloves available, powdered gloves should be used to maintain infection control standards.
Gloves should be used during all patient-care activities that may involve exposure to blood and all other body fluids (including contact with the mucous membrane and non-intact skin); during contact precautions; and outbreak situations. It is important to monitor the integrity of gloves and change them as soon as possible following appropriate hand hygiene measures.
All medical gloves are single-use items and, according to the WHO, there are no standardised, validated and affordable procedures for safe glove re-processing available.
Local hand hygiene policy should be followed before applying gloves and when removing or changing gloves. The wearing of gloves is not a substitute for hand hygiene. Gloves should be applied and removed following local policy and discarded appropriately.
A personal protective device in the form of eyewear/glasses with clear lenses intended to be used to shield the eyes of healthcare staff from blood and other body fluid splashes while performing a clinical or laboratory procedure. It is designed as uncorrected (non-prescription) or corrected (prescription) goggles or spectacles with lenses and side shields. The lenses and side shields offer additional physical barrier protection.
A transparent personal protective device intended to shield the face and eyes of a healthcare worker from unnecessary exposure from blood and other body fluid splashes while performing a clinical or laboratory procedure. Visors are suitable for use with prescription lenses and protective masks.
The use of petroleum-based hand creams or lotions following hand hygiene may affect the integrity of latex gloves.
For further information:
- Overview of how medical devices are regulated within Australia.
- Information about how to include medical devices (including in vitro diagnostic (IVD) medical devices).
- Therapeutic Goods (Declared Goods) Order 2019 declares particular goods or classes of goods to be therapeutic goods, or not to be therapeutic goods, for the purposes of the Act.
- For additional information relating to the regulation of face masks during the COVID-19 pandemic, see Face masks and respirators that are regulated by the TGA.
If you have questions around supply of masks or gowns please contact the Office of Health Protection at email@example.com.
If you wish to report any adverse events or suspected adverse events experienced with gowns or surgical masks contact: IRIS@health.gov.au
Note: this media release was first published on 23 March 2020, and was updated on 16 April 2020.