Powered Air-Purifying Respirator (PAPR) use for prevention of highly infectious viral disease in healthcare workers

IMG_1132

Link to the Dental Elf

There has been a considerable amount of literature developed over the Coronavirus CoV-2 pandemic regarding the dental profession, aerosol generating procedures (AGP), airborne spread of the virus and the need for enhanced personal protective equipment (PPE).Though there is evidence that dental AGPs cause significant environmental contamination there is very little evidence linking this to direct infection of staff or patients (HPS, 2020).

To reduce the potential risk of infection via the airborne route most national and international regulations (Clarkson et al., 2020) require that dental teams wear Face Filtering Piece level respiratory protection (FFP2/FFP3) in addition to standard PPE when performing AGPs. Following the SARS-Cov-1 outbreak in Toronto, Canada, powered air-purifying respirators (PAPRs) superseded the use of FFP respirators in the respiratory PPE protocols (Peng et al., 2003) however there is no mention of their existence as an alternative to FFP3 respirator in the PPE guidance from the Office of the Chief Dental Officer (England) (OCDO, 2020). This review is important due to limited information available regarding the practical efficacy between FFP2/FFP3 and PAPRs in the clinical environment.

Methods

This systematic review was reported according to the standards for the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA), and the protocol was prospectively registered with the International Register of Systematic Reviews (PROSPERO). Searches were undertaken using the electronic databases: Medline; Embase; Cochrane Library (Cochrane Database of Systematic Reviews and CENTRAL). Grey literature was sought through: Google Scholar, OpenGrey, and GreyNet. Searches were repeated up to June 2020, and only English language studies were included.

Studies were screened by two reviewers. Risk of bias in randomized controlled studies was assessed using the Cochrane Risk of Bias tool, and the ROBINS-I (Risk of Bias in Non-randomized Studies of Interventions) tool to assess the risk of bias in non-randomized studies. Quality of evidence was classified according to Grading of Recommendations, Assessment, Development and Evaluation (GRADE). Due to the heterogeneity of the small number of studies a narrative review was undertaken.

Results

  • 10 studies fulfilled the inclusion criteria out of a total of 690.
  • There was no difference in the primary endpoint of COVID-19 infection in respective observational studies in the airway proceduralists utilizing PAPR versus other protective respiratory equipment.
  • Healthcare workers reported Improved comfort with regards to heat tolerance and visibility with PAPR technology.
  • Decreased effort was needed to maintain the work of breathing compared to conventional filtering face pieces.
  • Lower contamination rates of skin and clothing in simulation studies of participants utilising PAPRs.
  • Decrease in audibility and communication difficulties due to increased weight of the equipment and noise generated by positive airflow.

Conclusions

The authors concluded: –

Field observational studies do not indicate a difference in healthcare worker infection utilizing PAPR devices versus other compliant respiratory equipment. Greater heat tolerance accompanied by lower scores of mobility and audibility in PAPR were identified. Further pragmatic studies are needed in order to delineate actual effectiveness and provider satisfaction with PAPR technology.

Comments

This was a well conducted systematic review considering the limitation in the number of studies. Due to the global nature of the pandemic more papers could possibly have been identified if the authors had not restricted the language search. There would appear to be numerous advantages identified in this review regarding the use of PAPRs such as increased assigned protection factors (APF >25), inbuilt eye protection, reusable, they don’t need fit testing, improved heat tolerance and comfort if worn for longer than 1 hour, and they can be worn without limiting facial hair.

Limitations include challenges in verbal communication due to the hum of the motor, maintenance and battery life, decontamination after use, and cost. Given the lack of demonstrable advantage in terms of infection prevention, institutional decision makers may be applying a pragmatic choice to use FFP3 over PAPR respirators, however there may be considerable physical and financial advantage for health care workers and dental staff who are required to work for extended periods.

Links

Primary Paper

Use of Powered Air-Purifying Respirator (PAPR) by healthcare workers for preventing highly infectious viral diseases -a systematic review of evidence. Ana Licina, Andrew J Silvers, Rhonda Stuart. medRxiv 2020.07.14.20153288;

Review protocol on PROSPERO

Other references

CLARKSON, J., RICHARDS, D. & RAMSAY, C. 2020. Aerosol Generating Procedures and their Mitigation in International Dental Guidance Documents – A Rapid Review.

OCDO. 2020. Standard operating procedure Transition to recovery  first published 4th June.[Online].  Accessed 1st Aug 2020].

PENG, P. W., WONG, D. T., BEVAN, D. & GARDAM, M. 2003. Infection control and anesthesia: lessons learned from the Toronto SARS outbreak. Canadian Journal of Anesthesia, 50, 989-997.

HPS 2020. SBAR: Assessing the evidence base for medical procedures which create a higher risk of respiratory infection transmission from patient to healthcare worker.

Aerosol generating procedures (AGPs) and their mitigation in international guidelines: Fallow time

330px-Dental_aerosols

Link to Dental Elf

Bottom line

The recommendations for  fallow time in dental practice following an AGP appears almost random in its application across half of international guidelines. Its basic idea appears to be centred on a single precautionary principle based on simulation studies that are only weakly supported by evidence. Policy makers will need to take a more balanced approach when assessing the benefits and harms fallow time creates.

Introduction

With the publication of, ‘Aerosol Generating Procedures and their Mitigation in International Dental Guidance Documents – A Rapid Review’ by the  COVID-19 Dental Services Evidence Review (CoDER) Working Group (Clarkson et al., 2020) it was interesting to note their finding regarding fallow time for non Covid-19 patients:

  • 48% of the guidelines recommend having a fallow period.
  • The amount of time recommended varied (2-180 mins) between guidelines and also within guidelines, depending on environmental mitigation.
  • None of the fallow period recommendations referenced any scientific evidence.

The fallow period is the ‘time necessary for clearance of infectious aerosols after a procedure before decontamination of the surgery can begin’ (FGDP, 2020), and this has caused considerable discussion/stress amongst the dentist returning to practice after lockdown in the UK (BAPD, 2020, Heffernan, 2020).

The fallow times following an AGP for both Covid-19 negative patients and Covid-19 positive patients are presented in Figure 1 and Table 2 using the data from the CoDER rapid review:

Figure 1. Stacked bar chart representing fallow times for both Covid negative and positive patients

Fallow times

Since the fallow times are not normally distributed the median value was utilised and the 95% confidence limit approximated according to Hill (Hill, 1987).

Table 1. Median fallow time

Aerosol generating procedure Median Fallow time (mins)
Non Covid-19 patient 15 (95% CI: 15 to 30)
Covid-19 positive patient 20 (95% CI: 10 to 60)

Much of the theory around the need for fallow time is based on the aerosol transmission of the Coronavirus SARS-CoV-2 and the need to allow the aerosol to settle or be physically removed from the room via ventilation or filtration. Initially the WHO supported the idea that spread was predominantly caused by large droplets and contact (WHO, 2020a) but under increased lobbying from the scientific community to include airborne transmission as a significant factor (Morawska and Milton, 2020) the WHO amended their position (WHO, 2020b) on the 9th July.

The evidence for airborne transmission of Coronavirus SARS-CoV-2 is uncertain and mostly based on mathematical modelling (Buonanno et al., 2020) but where there has been limited observational data Hota and co-workers concluded that the virus was not well transmitted by the airborne route compared to measles, SARS-1 or Tuberculosis  (Hota et al., 2020).

The reason there is no strong scientific evidence for fallow time and airborne transmission is possibly because it is based on two conceptual arguments:

The Precautionary Principle (PP)

The precautionary principle (PP) states that if an action or policy has a suspected risk of causing severe harm to the public domain (affecting general health or the environment globally), the action should not be taken in the absence of scientific near-certainty about its safety. Under these conditions, the burden of proof about absence of harm falls on those proposing an action, not those opposing it (Taleb et al., 2020). The confusion at the moment is that the PP has been reversed and the action is evidence-based ‘normal/enhanced PPE and cross infection policy’ rather than the imposition of untested application of ‘fallow time’ in general practice.

The Independent Action Hypothesis (IAH)

The IAH states that each virion has an equal, non-zero probability of causing a fatal infection especially where airborne spread via small droplets (5μm) is the proposed method of transmission (Stadnytskyi et al., 2020). The reality of the IAH is that evidence supporting this theory is oversimplified and indirect, based mainly on small sample studies of moth larvae, and tobacco mosaic virus (Zwart et al., 2009, Cornforth et al., 2015).

Discussion

The main problem for anyone challenging the PP and IAH is having to prove a ‘near certainty of safety’ when there are many confounding factors in play, and the application of a ‘non-zero’ probability of a single inhaled virus causing death results in an ill-defined probability of risk (Taleb et al., 2020). Unfortunately, once the PP was been invoked designing challenge studies to create the scientific proof that the action is safe can be unethical in humans or experimentally impossible due to the effect of low viral prevalence in the community on statistical power.

One solution may be to rapidly assess the retrospective infection rates associated with the provision of dental care in those countries with extended fallow times and compare then to countries of similar demographics that do not have fallow time (Table 1). Policy makers may need to revise their current interpretation of the precautionary principle and IAH  based on the fact that in a pandemic situation there may be multiple interacting factors that can cause significantly more second and third order harm to the public domain than the virus itself.

 

Table 2. Countries with/without(bold) fallow time. ND – no data

Country Non Covid-19 Covid-19   Country Non Covid-19 Covid-19
Ireland 0 60 Burkina Faso ND ND
Poland 0 0 Canada ND 180
Bolivia 2 2 Chile ND ND
Philippines 5 5 Columbia ND ND
Dominican Republic 10 10 Costa Rica ND ND
Ecuador 10 10 Croatia ND ND
Brazil 15 15 Denmark ND ND
France 15 15 Finland ND 30
Italy 15 ND Greece ND ND
Morocco 15 15 Guatemala ND ND
Romania 15 15 Honduras ND ND
Spain 15 ND India ND ND
Switzerland 15 30 Kenya ND ND
Tunisia 15 ND Kosovo ND ND
UAE 20 ND Malaysia ND ND
Germany 30 30 Mexico ND ND
Malta 30 ND Mozambique ND ND
Ukraine 30 ND Myanmar ND ND
Estonia 45 ND Netherlands ND ND
Singapore 45 ND New Zealand ND 20
Argentina 60 60 Norway ND ND
Bulgaria 60 60 Panama ND ND
Montenegro 60 60 Peru ND ND
UK 60 60 Portugal ND ND
UK – NI 60 60 Slovakia ND ND
UK – Wales 60 60 Slovenia ND 10
China 90 ND South Africa ND ND
Paraguay 180 180 UK – Scotland ND ND
Australia ND ND Uruguay ND ND
Austria ND ND USA ND ND
Belgium ND ND Zimbabwe ND ND

 

References

BAPD. 2020. BAPD urges government to reconsider PPE requirements for dentistry [Online]. Dentistry. [Accessed 30th July 2020 ].

BUONANNO, G., STABILE, L. & MORAWSKA, L. 2020. Estimation of airborne viral emission: Quanta emission rate of SARS-CoV-2 for infection risk assessment. Environ Int, 141, 105794.

CLARKSON J, RAMSAY C, RICHARDS D, ROBERTSON C, & ACEVES-MARTINS M; on behalf of the CoDER Working Group (2020). Aerosol Generating Procedures and their Mitigation in International Dental Guidance Documents – A Rapid Review.

CORNFORTH, D. M., MATTHEWS, A., BROWN, S. P. & RAYMOND, B. 2015. Bacterial Cooperation Causes Systematic Errors in Pathogen Risk Assessment due to the Failure of the Independent Action Hypothesis. PLoS Pathog, 11, e1004775.

FGDP. 2020. Implications of COVID-19 for the safe management of general dental practice A practical guide [Online]. [Accessed 30th July 2020 ].

HEFFERNAN, M. 2020. Is a one hour fallow period really necessary for dentistry in England? [Online]. Dentistry. [Accessed 30th July 2020 ].

HILL, I. 1987. 95% Confidence limits for the median. Journal of Statistical Computation and Simulation, 28, 80-81.

HOTA, B., STEIN, B., LIN, M., TOMICH, A., SEGRETI, J. & WEINSTEIN, R. A. 2020. Estimate of airborne transmission of SARS-CoV-2 using real time tracking of health care workers.

MORAWSKA, L. & MILTON, D. K. 2020. It is time to address airborne transmission of COVID-19. Clin Infect Dis, 6,ciaa939.

STADNYTSKYI, V., BAX, C. E., BAX, A. & ANFINRUD, P. 2020. The airborne lifetime of small speech droplets and their potential importance in SARS-CoV-2 transmission. Proc Natl Acad Sci U S A, 117, 11875-11877.

TALEB, N., READ, R. & DOUADY, R. 2020. The Precautionary Principle (with Application to the Genetic Modification of Organisms).

WHO 2020a. Modes of transmission of virus causing COVID-19: implications for IPC precaution recommendations: scientific brief, 27 March 2020. World Health Organization.

WHO 2020b. Transmission of SARS-CoV-2: implications for infection prevention precautions 9th July. World Health Organization.

ZWART, M. P., HEMERIK, L., CORY, J. S., DE VISSER, J. A., BIANCHI, F. J., VAN OERS, M. M., VLAK, J. M., HOEKSTRA, R. F. & VAN DER WERF, W. 2009. An experimental test of the independent action hypothesis in virus-insect pathosystems. Proc Biol Sci, 276, 2233-42.

Re-opening of dental services: A rapid review of international sources. Part II.

Separating the signal from the noise regarding masks.

Link to the Dental Elf

File:Face Masks used to prevent the spread of Coronavirus in ...

Bottom Line

As the number of clinical guidelines and standard operating procedures increases, we are seeing a reduction in consensus regarding a clear way forward in patient management. If we are going to take an evidence-based approach in a land devoid of direct evidence the policy makers are going to have to defer to the clinical expertise, and local knowledge of the profession in regards to the choice of PPE regarding Covid-19 negative patients requiring aerosol generating procedures.

Background

The recent ‘Cochrane Recommendations for the re-opening of dental services: a rapid review of international sources’ has been updated  on the 16th May to include a further 5 international guidelines. The document now reviews 17 guidance documents from 16 countries (France, Spain, Portugal, Austria, Switzerland, Belgium, Netherlands, Norway, Denmark, Malta, America CDC, America ADA, Canada, Australia, New Zealand, India). The common themes and the relevant recommendations were divided into 5 domains:

  1. Practice preparation and patient considerations.
  2. Personal protective equipment (PPE) for dental practice personnel.
  3. Management of the clinical room.
  4. Dental procedures.
  5. Post-operative cleaning/disinfection/waste management.

Methods

The data was extracted in a similar way to the previous review. The five domains have mostly remained the same with little change in domains 1, 3, 4, and 5. The exception being domain 2 (PPE for dental practice personnel). The domain almost doubled in size to 29 subgroups from the original 15, but at the same time there was a reduction in the consensus with the mean dropping from 58% to 30% (See Figure 1.).

Update_f1

As with the previous review I selected the subgroups that achieved to filter out the large number of subgroups with a low degree of consensus. In the original paper there were 10 subgroups that scored ≥ 50%, in the update this reduced to 7 which constitutes a 42% reduction in agreement considering the expansion of the domain. (See Figure 2).

Figure 2. Subgroups with greater than 50% consensus.

Update_f2

 

Looking at these subgroup headings there is a lot of duplication especially regarding the use of FFP2 and FFP3 masks and the infective status of the patient. To try and clarify this matter a subgroup analysis was undertaken (See Figure 3,).

Figure 3. Mask selection

update_f3

From this chart it was obvious that for Covid negative patients the consensus was for the use of surgical masks, and with Covid infective patients requiring an aerosol generating procedure (AGP) an FFP3 mask should be used. There was however a grey area around the use of a surgical mask combined with a face shield/visor, and an FFP2 mask for Covid negative patients requiring an AGP, the prevalence of asymptomatic patients being very low in the community (ONS, 2020). There was 41% (95% CI: 18% to 65%) agreement regarding the surgical masks, against 59% (95% CI: 35% to 82%) agreement for the use of an FFP2 mask, however as the sample size was small (n=17) the result was not statistically significant (p= 0.29).

Discussion

What can we conclude from the update? Due to the lack of hard evidence regarding the effectiveness of PPE in the real-world clinical environment the guidelines would appear to be based on opinion that ranges from the precautionary principle that all patients should be considered infective, to a more pragmatic approach based on the professions current cross infection strategies. In a perfect world we would like to see well  design randomised controlled studies to answer these questions, but this does not address the here-and-now of real-world dentistry. If we are going to follow the principles of evidence-based dentistry (Sackett et al., 1996) the clinicians are going have to make the decision of using surgical masks, or FFP2 masks  for AGPs based on individual clinical expertise, best available evidence, and their patients values and preferences rather than rigid guidelines that can’t adapt to local circumstances.

References

ONS. 2020. Coronavirus (COVID-19) Infection Survey pilot: England, 14 May 2020 [Online]. Available: https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/conditionsanddiseases/bulletins/coronaviruscovid19infectionsurveypilot/england14may2020 [Accessed].

SACKETT, D. L., ROSENBERG, W. M., GRAY, J. M., HAYNES, R. B. & RICHARDSON, W. S. 1996. Evidence based medicine: what it is and what it isn’t. British Medical Journal Publishing Group.

https://oralhealth.cochrane.org/news/recommendations-re-opening-dental-services-rapid-review-international-sources

Disclaimer:  The article has not been peer-reviewed; it should not replace individual clinical judgement, and the sources cited should be checked. The views expressed in this commentary represent the views of the author and not necessarily those of the host institution. The views are not a substitute for professional advice.