Correct use of appropriate personal protective equipment (PPE) is part of any respiratory protection program to help reduce exposure to dangerous airborne particles including SARS-CoV-2, however some PPE items are not regulated medical devices and aren’t appropriate for use in clinical settings.

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Introduction

Australian COVID-19 infections are rising substantially,¹ and many health and aged care workers have or will be exposed to the virus at work or in the community.² Health and aged care workers are at higher risk of COVID-19 infection than many members of the wider community.³

While vaccination is one of the best protections against the worst impacts of COVID-19,^4-6 without adequate protection via best practice use of personal protective equipment (PPE), frontline staff can become infected, sick, and die due to exposure to the SARS-CoV-2 virus. Exposure of staff to infection also puts patients, colleagues, families, and the wider community at risk as workers can transmit infection from workplaces to community settings.

To be safe and effective, staff who work with people with suspected or confirmed COVID-19 must correctly use the right type and right size of PPE.⁷ This means that workplaces must be able to provide their staff with suitable PPE supplies and guidance. If staff use the wrong type or size of PPE, then they, their patients, and others are at risk.

In the same way that there are different brands and types of clothes, PPE is also made by a variety of manufacturers in a range of types. As with clothes, not every item of PPE is suitable to wear in every situation. For example; N95 and P2 respirators are also worn by people who work in manufacturing and by tradespeople. These items are still considered PPE but are not suitable for use by staff in clinical/medical contexts as the ‘N95/P2’ rating relates to general Australian standards not associated with therapeutic use. Such items are not ‘medical devices’ and are therefore not required to meet standards designed to guarantee the integrity of the respirators for use in clinical settings.

Regulation of clinical PPE

In Australia, the Therapeutic Goods Administration (TGA) regulates PPE for use in clinical contexts including but not limited to respirators, face masks, aprons, gloves, goggles, gowns and visors. Medical devices must be intended by the supplier/sponsor; ‘to be used for the prevention of the transmission of disease between persons, including where that intention may be ascertained from the articles being represented as suitable for use in surgery, or clinical, medical or other health services.’⁸

Personal protective equipment that is regulated by the TGA needs to be included in the Australian Register of Therapeutic Goods (ARTG) before it can be legally supplied in Australia. The ARTG’s register can be searched by the public to confirm whether or not a particular item is approved.

There are also items of PPE that do not meet the TGA’s definition of a medical device and so are not included in the ARTG but can still be used to prevent the spread of infection. Due to the sharp increase in the demand and supply for PPE since the start of the pandemic a large number of new PPE has been added to the ARTG or imported but not included. Further, from 22 March 2020 until 31 January 2021, an emergency exemption was in place to support the Australian Government to add to Australia’s PPE stockpile by facilitating access to certain necessary items of PPE.

The TGA is also undertaking a ‘post-market review’ of face masks and respirators that have been included in the ARTG due to concerns that some items have been wrongly included in the register and do not meet current legislative requirements for medical devices and that some items do not perform as intended or are counterfeit or fraudulent. Here, it appears that some respirators manufactured in China may not provide an adequate face seal due to the atypical use of ear-loops, and that some Chinese manufactured respirators may be counterfeit. You should not use items you believe may be fraudulent or that makes therapeutic claims but is not listed in the ARTG.

Some items of PPE that are listed on the ARTG may be packaged with a loose-leaf information sheet stating that that item should not be used for medical/therapeutic use. It is recommended that users should consider the evidence and information about the intended purpose of the product provided by the manufacturer to determine if items should be used in clinical settings. Importantly, the ARTG may include items of PPE that while intended to prevent disease transmission in non-clinical settings, are not suitable for medical use. Recently, some Chinese manufactured PPE has appeared in Australia with loose-leaf flyers stating that the items are ‘not for medical use’ (or similar wording). This is due to Chinese government requirements regarding export and does not necessarily mean the item is not a ‘medical device’ in line with Australian requirements and the item may still meet the TGA’s standards for quality and performance. The TGA has published a useful table to help users interpret labelling and claims of PPE to determine whether ARTG regulation should apply.

Using approved PPE

To be used in clinical contexts, PPE must have been approved by the TGA and listed in the ARTG. Several tips can be useful:

• ARTG-listed and approved PPE must be supplied with English language labels, packaging, and instructions (other languages may also appear, but there needs to be English-language versions too).
• The name and address of the supplier/sponsor and the name of the manufacturer should be on the packaging or label.
• You can confirm whether the product is listed in the ARTG by searching by the name of the person or company that sponsored/supplied the product (product names are not listed in the ARTG).
• Make sure that the item is appropriate for the particular context or task it will be used for.
• Ensure you use the item as intended by the manufacturer by following the instructions for use.
• Examine the item and packaging for signs that it may be counterfeit/fake. Incorrect spelling or manufacturer name, faded packaging, and incorrect filters or materials can be giveaways).
• Always ensure that you follow proper fit testing and checking processes (see below) to make sure that your respirator fits properly with an adequate face seal.
• Always follow correct policies and processes for donning, using, doffing, and disposing of PPE.

Fit testing?

Fit testing is a formal process for enabling users to correctly identify and use the type and size of respirator/s that create an effective seal on their face.

Respirator fit testing is a formal component of an overall respiratory protection program and provides health and aged care workers with guidance for choosing the brand, model, and size of respirator which provides the best fit for each individual employee, as well as instructions for proper use.^9,10 Fit testing can be conducted using quantitative and qualitative approaches and should be conducted by a trained operator. Fit testing should occur each time a new brand, model, or size of respirator is used by an individual to ensure adequate fit.^11,12 Fit testing allows users to identify what respirators they can use to get a proper fit, so fit testing should also occur if a user’s facial characteristics have changed in a way that might impact fit.

Because fit testing is a formal process, to keep staff safe, it is the responsibility of employers to ensure that it takes place.

Fit checking?

Users must fit check their respirator every time they put one on. This is because even the right size and type of respiratory for an individual doesn’t automatically guarantee a good seal as soon as it is put on. Just like sizes and shapes of the same clothing item from the same brand can be slightly different, each respirator may be subtly different or need careful adjustment to fit properly.

Fit checking is component of respiratory protection programs and involves the user checking to ensure that a proper seal has been achieved on the face each time a respirator has been put on.¹¹⁵ This includes correcting positioning the respirator and straps, forming the nose bridge/clip of the respirator, and ensuring that facial hair is not present to interfere with the seal. Training in fit checking results in users achieving a better seal and should be performed each time a respirator is put on.¹³

Fit testing and checking are both important

If fit testing or checking reveals that a person cannot get an effective seal, then they should not be made to work in a setting that puts them at risk of infection. This is because a poorly fitting respirator is no more effective than a surgical mask.

An incorrectly sized or fitted respirator does not provide a safe, effective seal.^14,15 If the size and fit is wrong, virus particles can enter around the sides of the respirator which may then contaminate the inner surface of the mask or face or be inhaled. While the additional time and costs associated with fit testing can be a disincentive,¹⁶ the costs to health and safety posed by inadequate respiratory protection would outweigh these. Recent evidence suggests that lack of fit testing results in lower numbers of staff being able to achieve an effective seal.¹⁷ this means that workers with poorly fitting respirators may be put at risk or unable to work due to not being able to find a correctly fitting respirator. Fit testing as part of a respiratory protection program is effective in ensuring that almost all workers can identify a suitably fitting mask from a range of respirators.¹⁸

By ensuring that fit testing and checking are both formal parts of a workplace’s respiratory protection program, frontline workers, patients, and the community are kept safer from the risks of COVID-19-related infection, illness, and death.

Conclusion

Personal protective equipment is an important component of a workplace’s respiratory protection program and critical for protecting staff, patients, and the wider community from COVID-19 infection. With demand for PPE again increasing due to more widespread and rising COVID-19 case numbers and hospitalisations, accessing sufficient quantities of safe and effective PPE is vital in many health and aged care workplaces.

In clinical settings, staff should only use medical devices/PPE that has been approved by the TGA and listed on the ARTG. With a large number of new PPE manufacturers and imports, there are cases where inappropriate or fake/counterfeit PPE has either been mistakenly supplied to staff or listed on the ARTG. Staff should be aware that not all PPE is appropriate or legally allowed to be used in clinical contexts and ensure that they confirm that the PPE they are using is genuine and listed on the ARTG.

All PPE must be correctly selected and used to be safe and effective, so both fit testing and checking is essential and correct protocols and processes should be followed regarding donning, using, doffing, and disposing of PPE.

References

1. Australian Government Department of Health. Coronavirus (COVID-19) case numbers and statistics [Online]. Australian Government Department of Health. 2022. Available: https://www.health.gov.au/health-alerts/covid-19/case-numbers-and-statistics (accessed 21 January 2022).

2. Australian Government Department of Health. COVID-19 outbreaks in Australian residential aged care facilities [Online]. Australian Government Department of Health. 2022. Available: https://www.health.gov.au/resources/collections/covid-19-outbreaks-in-australian-residential-aged-care-facilities (accessed 21 January 2022).

3. Nguyen LH, Drew DA, Graham MS, et al. Risk of COVID-19 among front-line health-care workers and the general community: a prospective cohort study. The Lancet Public Health 2020; 5(9): e475-e83.

4. V Shah AS, Gribben C, Bishop J, et al. Effect of vaccination on transmission of COVID-19: an observational study in healthcare workers and their households. medRxiv 2021: 2021.03.11.21253275.

5. Salo J, Hägg M, Kortelainen M, et al. The indirect effect of mRNA-based Covid-19 vaccination on unvaccinated household members. medRxiv 2021: 2021.05.27.21257896.

6. Harris RJ, Hall JA, Zaidi A, Andrews NJ, Dunbar JK, Dabrera G. Effect of Vaccination on Household Transmission of SARS-CoV-2 in England. New England Journal of Medicine 2021.

7. Peters MDJ, Marnie C, Butler A. Policies and procedures for personal protective equipment: Does inconsistency increase risk of contamination and infection? Int J Nurs Stud 2020; 109: 103653.

8. Therapeutic Goods Administration (TGA). Regulation of Personal Protective Equipment and COVID-19 [Online]. Therapeutic Goods Administration. 2021. Available: https://www.tga.gov.au/behind-news/regulation-personal-protective-equipment-and-covid-19.

9. Hines L, Rees E, Pavelchak N. Respiratory protection policies and practices among the health care workforce exposed to influenza in New York State: evaluating emergency preparedness for the next pandemic. Am J Infect Control 2014; 42(3): 240-5.

10. Clayton M, Vaughan N. Fit for purpose? The role of fit testing in respiratory protection. Ann Occup Hyg 2005; 49(7): 545-8.

11. Ciotti C, Pellissier G, Rabaud C, Lucet JC, Abiteboul D, Bouvet E. Effectiveness of respirator masks for healthcare workers, in France. Med Mal Infect 2012; 42(6): 264-9.

12. Winter S, Thomas JH, Stephens DP, Davis JS. Particulate face masks for protection against airborne pathogens – one size does not fit all: an observational study. Crit Care Resusc 2010; 12(1): 24-7.

13. Or P, Chung J, Wong T. Does training in performing a fit check enhance N95 respirator efficacy? Workplace Health Saf 2012; 60(12): 511-5.

14. Myong JP, Byun J, Cho Y, et al. The education and practice program for medical students with quantitative and qualitative fit test for respiratory protective equipment. Ind Health 2016; 54(2): 177-82.

15. Viscusi DJ, Bergman MS, Zhuang Z, Shaffer RE. Evaluation of the benefit of the user seal check on N95 filtering facepiece respirator fit. J Occup Environ Hyg 2012; 9(6): 408-16.

16. Hannum D, Cycan K, Jones L, et al. The effect of respirator training on the ability of healthcare workers to pass a qualitative fit test. Infect Control Hosp Epidemiol 1996; 17(10): 636-40.

17. Danyluk Q, Hon CY, Neudorf M, et al. Health care workers and respiratory protection: is the user seal check a surrogate for respirator fit-testing? J Occup Environ Hyg 2011; 8(5): 267-70.

18. Shaffer RE, Janssen LL. Selecting models for a respiratory protection program: what can we learn from the scientific literature? Am J Infect Control 2015; 43(2): 127-32.

Authors:
Micah DJ Peters PhD and Casey Marnie are at the National Policy Research Unit (Federal Office), Australian Nursing and Midwifery Federation (ANMF) and University of South Australia, Clinical and Health Sciences, Rosemary Bryant AO Research Centre.