Face masks and other PPE

In Australia, face masks for the prevention of disease transmission are considered by the TGA to be a medical device, and therefore must meet TGA Standards to be approved for sale. There are broadly three types recognised by the TGA. Technically, ‘masks’ refers to surgical masks which are the looser, commonly used masks designed for fluid protection, while ‘respirator’ is the correct term for P2/N95 and similar products that provide respiratory protection by filtering inhaled air.

1. Surgical Masks (single use surgical or medical) – disposable – fluid resistance and bacterial filtration efficiency. Designed mainly to prevent the emission of larger droplets. Typically blue on the outside, white on the inside. Recommended to be worn for up to 4 hours before disposal. Subdivided into Assigned Protection Factor (APF) of either P1, P2 or P3 – higher is better. Generally widely available.

2. Standard Respirators – single use – disposable – form a tight seal around the face – block microorganisms and submicron airborne particulate materials. Labelled with the efficiency to which they have been tested – e.g.

a. P2 (Australian standard) / N95 (US standard) are very similar apart from slight differences in certification requirements. They both must capture at least 94% of particles in the penetrating size range. Surgical P2/N95 are fluid resistant; Non-surgical P2/N95 are not.

b. The Korean KF94 and Chinese KN95s are similar, though not identical, alternatives.

c. Generally available at pharmacies and hardware stores.

d. Optometrists providing direct patient care to individuals with suspected or confirmed COVID-19, or in zones with a high risk of transmission, should wear P2/N95 standard respirators.

3. Surgical Respirators – single use – as for respirators but are fluid resistant. Intended for performing surgery, aerosol generation of body fluids, or caring for confirmed COVID-19 patients. If a surgical respirator is required but not available, standard P2/N95 respirators can also be used in combination with a surgical mask or face shield to provide fluid resistance.

At least one study, published in the JAMA, has found that respirators with head ties performed better than those with ear loops.

The omicron variant is highly aerosolised – very tiny particles that float in the air. While the official Australian health advice hasn’t changed, a growing number of medical experts say people, especially healthcare workers in higher risk settings, should be proactive in upgrading their protection to the N95/P2 level, with fit checking (see below), for optimal protection.

Note: Other masks, such as cloth face masks, dust masks, home-made masks, scarfs, bandanas, and masks with valves, are allowed for sale in Australia but are not regulated by the TGA, and the advertising & packaging may not make any claims about any protection from viruses. These products do not provide adequate protection against airborne COVID-19.

Mask effectiveness table. Lisa M Brosseau, Author provided

Notes relating to the table:

1. These numbers are not bright lines between safe and unsafe, but rather meant to illustrate the differences between cloth face coverings, surgical masks and respirators.
2. People should not rely on these exact times to protect themselves, but should limit the amount of time they spend in enclosed spaces with many potential sources.
3. The baseline time of 15 minutes for an infectious dose with no protection is not based on any science and could be shorter or longer, depending on the number of sources, size of the room, source’s activities (talking, singing, etc.), nature of ventilation, etc.  CDC says that the 15 min could be spread out over the course of a day. Exposure (and dose) depend on the concentration of infectious particles in the air and the time spent inhaling those particles. This table only illustrates the impact of time.

Fit checking is the critical process that ensures the mask or respirator fits snugly and is correctly sealed around your face to minimise the number of particles that can pass the filter. It should be performed every time you don your mask/respirator.

Queensland and NSW have provided visual guides, and South Australia Health has produced a video, showing how to apply and remove (don & doff) and perform a fit check. (The D95 is SA’s locally produced version of the N95). Singapore’s Ministry of Health has also produced a short video showing donning and fit checking of an N95 with head straps rather than ear loops.

Different people have different nose & face shapes, so it’s well worth trialling different types & brands of masks, and make a note of which ones seem to fit the best and feel the most comfortable. If the part of the mask immediately in front of your mouth ‘pops’ in & out a little as you breathe, it’s probably a good fit.

Facial hair such as beards and moustaches can prevent a good seal – worth considering especially if you are going to be working in a high risk environment. The NSW ACI has a good summary document, and the US CDC has produced an infographic showing the effects of various facial hair styles upon the seal. If you have facial hair and work in a high risk setting then it’s worth considering the benefits of being clean shaven

A mask that fits closely & tightly, especially around the nose & upper cheeks, is less likely to fog up your glasses. Generally since the P2/N95 masks fit more tightly, they should be better for fogging problems, especially after having been fit checked and adjusted.

Various anti-fog treatments are available from Australia suppliers. Optometry Australia does not endorse one particular brand, but colleagues & industry forums can provide recommendations.

Both surgical masks and standard respirators (P2/N95) are intended to be single-use. They can be safely and comfortably worn for up to 4 hours without being removed unless damaged, soiled or contaminated.

According to the TGA, re-use of a face mask or respirator that has approval only for single use requires reprocessing, a validated process carried out in the controlled manner. For more information, refer to the TGA’s information page on re-use and reprocessing here. If you’d like to read some non-TGA approved expert opinions on mask re-use, see these reports from the Smithsonian Magazine and the National Academies of Science.

Compared to reusable cloth masks, which are no longer recommended, respirators (which are not washable) cost more and are likely to have a greater environmental impact. However the costs of prevention need to be compared to the burden of costs and waste materials produced by a single person requiring hospitalisation due to COVID-19. In Australia, the cost incurred in providing an intensive care bed is estimated to be over $4000 per day.

Unfortunately face masks and respirators cannot be recycled, due to the fact that they contain plastics in their structure (although an ABC news story describes a possible mask recycling scheme in Taiwan). Dispose of face masks & respirators in the general rubbish bin – in a sealed bag to avoid the possibility of someone else touching it. Before disposal, snip the ear loops, just in case the mask ends up in the environment and entangles wildlife.

All optometrists should use equipment shields to reduce droplet transmission during close encounter patient examinations.

Some options for commercial products;

• Zeiss has a comprehensive guide to shields and other protective devices for use in your practice. See the website: https://www.zeiss.com/meditec/int/med-support-now.html for more details.
• Contact your slit lamp manufacturer.
• https://slitlampshield.com/  Australian designed and has large area and side wings: $80.
• https://www.guldenophthalmics.com/products/index.php/slit-lamp-breath-shield.html

All optometrists should use slit lamp shields to reduce droplet transmission during close encounter patient examinations.

Some options for commercial slit lamp shields;

• Current 1-05-2020 Zeiss are providing free universal slit lamp shields to practitioners worldwide including Australia which fit a variety of slit lamp makes and models: https://www.zeiss.com/meditec/int/med-support-now.html
• Contact your slit lamp manufacturer

Other universal shields:

• https://slitlampshield.com/ Australian designed and has large area and side wings: $80.
• https://www.guldenophthalmics.com/products/index.php/slit-lamp-breath-shield.html

Yes. Qld Member Helen Flohr passed on a helpful tip for creating a temporary breath shield by putting an empty sheet through the laminator and then cutting a hole for the slit lamp eye pieces. It is again larger than many conventional breath shields. Please be aware these may be more difficult to disinfect between patients than commercial shields.

Simply type ‘Surgical Mask’ or ‘P2 / N95 mask’ into your online search bar to see what is available.

Amidst a huge increase in demand the answer to this question changes daily but supply lines seem to be improving as many factories overseas and locally pivot to making PPE.  Online suppliers selling surgical masks as at 14 May 2020, still  have stock available from Australia for quick delivery.

It may be worth splitting orders with different suppliers (rather than putting all your eggs in one basket) as members are reporting some orders being cancelled and refunded or transit and shipping delays.  You may wish to consider P2 masks for yourself and staff and surgical masks for patients.

Here are some suppliers that have let us know that they have masks available, or we have been alerted that members have been successful in getting orders. Optometry Australia does not endorse, or have any corporate relationship with any of the following companies, nor guarantee quality or supply. If you know of any available suppliers (or are one) that should be added to this rapidly changing list, please let us know.

• Aviva & Mann Optical group has face masks arriving shortly
• ANSIC has surgical and N95 masks, many of which are TGA / FDA approved
• Kogan Australia has multiple sellers providing masks, many of which are TGA / FDA approved
• PPE Masks Australia has sanitiser plus surgical and N95 masks, many of which are TGA / FDA approved.  They have offered a discounted rate to OA members. You will need to enter a password: (staysafe) to enter site and at the checkout use your AHPRA number when registering and discount code OPTOM2020. Pricelist available here and guide to mask selection here.
• Space Tank has been a successful supplier for some members. An Australian based company in Coburg, Victoria, they make face masks

Professor Mary-Louise McLaws, a Professor of Epidemiology of Hospital Infection and Infectious Diseases Control at the University of New South Wales and a member of the World Health Organization (WHO) Health Emergencies Program Experts Advisory Panel for infection Prevention and Control Preparedness answered this issue with the following on the 9th of April 2020;

“No. The production of masks is complex, for example some masks are made up of polypropylene central layers that are charged to prevent penetration of particles and designed to fit the face to provide a seal to prevent small particles from entering the mask. Both N95 and surgical masks are lab tested to ensure they filter at least 95-98% of lab particles (referred to as the ‘most penetrating particle’).

It is understandable that people in places like New York City where the COVID-19 infection rate is very high are nervous and may resort to making their own masks. While a mask made out of cotton may provide a small amount of protection from droplets, it is incredibly important that this does not give people a false sense of security. If you want to wear a mask, remember it may not be hospital grade. If you wear a mask don’t forget to hand hygiene, avoid touching your face and apply social distancing as these simple actions are still the best ways to avoid being infected with COVID-19 even while wearing a non-hospital grade mask.”

 And the CDC on the 17^th of March 2020 in their release titled “Strategies for Optimising the supply of facemasks” stated;

“In settings where facemasks are not available, HCP might use homemade masks (e.g., bandana, scarf) for care of patients with COVID-19 as a last resort. However, homemade masks are not considered PPE, since their capability to protect HCP is unknown. Caution should be exercised when considering this option. Homemade masks should ideally be used in combination with a face shield that covers the entire front (that extends to the chin or below) and sides of the face.”

There have been multiple rumours about inadequate masks entering the Australian market, and deciding if a product is suitable for clinical use is challenging. The following is not an exhaustive list, but some recommendations include:

1. Look for TGA, FDA or CE certification where possible.  Please be aware the ‘China Export’ mark and  European standards logo “CE” look very similar.
   
2. Check how many layers do the surgical masks have?
3. Is it from Australian stock or being sent from overseas and what is the estimated delivery window (often months away)
4. Is it a reputable seller?
5. The ABC reported on the 1st of April 2020 that the Australian Border Force had seized up to 800,000 counterfeit or otherwise faulty masks
6. How fluid repellent is the mask? Halyard has this infographic to explain the different standard of masks (Note: Halyard does retail masks)
7. According to the Australian Department of Health “Safe Use of PPE”, The P2 mask is the Australian equivalent of the United States’ N95 mask. Both masks are designed with a high filtration capacity and essentially provide the same level of protection.
8. For in depth description of how masks were developed the American Centers for Disease Control and Prevention recently put out this extensive blog.