A position statement and practical guide to the use of particulate filtering facepiece (N95, FFP2, or equivalent) respirators for South African health care workers exposed to respiratory pathogens including M. tuberculosis and SARS-CoV-2

Executive summaryInitial recommendations for protecting health care workers (HCWs) against COVID-19 were based on an early and incomplete understanding of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) transmission; namely, that it occurred mainly via large respiratory droplets (>10 µm) that were inhaled into the nasopharynx, directly inoculated onto mucous membranes, deposited on the skin and transferred by direct contact, or transferred indirectly by infected fomites. There is now substantial evidence to show that transmission by aerosol (particles <10 µm that can remain suspended for hours before being inhaled) is likely the predominant mode, with skin- and fomite-based transmission thought to play a lesser role. Many international organisations have updated their personal protective equipment (PPE) guidelines accordingly. Because N95 or equivalent particulate filtering facepiece respirators (henceforth referred to as ‘respirators’) are more effective than surgical masks against bioaerosols, the World Health Organization, United States Centers for Disease Control and Prevention, and European Centre for Disease Control and Prevention all now recommend that HCWs wear a respirator when caring for individuals thought to have COVID-19. In South Africa, however, surgical masks are still recommended for the routine care of individuals with possible or confirmed COVID-19, with respirators reserved for so-called aerosol-generating procedures. In contrast, South African guidelines recommend the use of respirators for routine care of all individuals with possible or confirmed tuberculosis (TB), which is transmitted almost exclusively via aerosol.In health facilities in South Africa, TB and COVID-19 have similar presentations, may occur together, and often have overlapping risk factors and imaging characteristics. Distinguishing between TB and COVID-19 in individual patients is challenging without examination and investigation, both of which may entail prolonged exposure of HCWs to potentially infectious individuals. Symptom-based triage has limited utility in identifying risk: asymptomatic transmission of SARS-CoV-2 is well recognised, and a high proportion of individuals with pulmonary TB also may not have symptoms. The prevalence of undiagnosed respiratory disease is therefore likely to be significant in many general clinical areas (e.g., waiting areas). HCWs are known to be at higher risk of TB than the general population and thousands of HCWs have developed COVID-19 since the start of the pandemic. A proportion of South African HCWs are also HIV positive, placing them at increased risk of severe COVID-19 disease, hospital admission, and death.Improving infection prevention and control involves implementing a package of administrative, environmental, and personal protection measures, along with substantial reorganisation of systems, care processes, and guidelines to prioritise HCW and patient safety. While this will take time, it is unacceptable to expose HCWs to increased risk until such changes are made. We propose that the South African health system adopts a target of ‘zero harm’, aiming to completely eliminate transmission of respiratory pathogens to all individuals in every health care setting. Accordingly, in line with the precautionary principle, we recommend the use of high quality, fit-tested respirators by all frontline or non-frontline staff (clinical and non-clinical) during activities that involve contact or sharing air in indoor spaces with individuals who (i) have not yet been clinically evaluated or (ii) are thought or known to have TB and/or COVID-19, or other potentially harmful respiratory infections including influenza, measles, and varicella. We recognise that this will be challenging, not least due to global and national shortages of PPE. The National Department of Health’s policy for the regulation of respiratory protective equipment enables a robust framework for manufacture, assessment, and quality control and has been well supported by local manufacture and the South African Department of Trade, Industry and Competition. Manufacturers should explore adaptations to improve comfort of respirators and reduce barriers to communication. The wider use of respirators does not replace the need for structural changes to improve the safety of health facilities: persistent advocacy and research around potential systems change remain essential.

Creating A Validation Dataset to Test Record Linkage Algorithms in A Province-Wide South African Health Information Exchange

IntroductionIncreasing use of digital medical records creates disparate data resources for the same health care client population; and harnessing the benefits of real-time health data requires effective data linkage. A South African Health Information Exchange (HIE) collates and links routine health data from multiple sources, running daily updates through an automated ETL process. Many existing deterministic and probabilistic algorithms link person-level data using demographic identifiers, and can be combined in an optimised methodological pipeline. The performance of such pipelines must be validated against known matched pairs. The HIE uses current algorithms for record linkage, but methods that rely on similar spelling, name frequency and phonetic matching have been optimised for non-African names, and are not as effective. ObjectivesWe assessed common problems arising in the linkage process in the HIE, using this information to compile a curated representative African validation database for optimising existing and new linkage pipelines. ResultsUsing current linkage algorithms, we have identified the proportion of duplicates in the last five years, ranging from 25% in 2015 and stabilising at 10% by 2019. Common causes of duplicates across the whole database include mismatch in first name (37%), surname (17%), date of birth (13%), sex (8%) and South African Identification Number (0.2%). Complications from new-born naming and records of twins affect >8% of all records, and temporary health identifiers assigned at birth, during emergency response, and during poor connectivity of facilities to the provincial patient master index affect 2% of records. ConclusionsBased on these data, we have constructed a South African-specific, representative validation dataset that contains linkage pairs that represent placeholder phrases for newborns prior to naming (e.g. “baby of”), language variations; twins; character insertions, substitution and omissions in names with similar spellings; frequencies of names in the general population; and similar-sounding names.

A Proposed Regulatory Review Model to Support the South African Health Products Regulatory Authority to Become a More Efficient and Effective Agency

Background: National regulatory agencies of various sizes and maturity levels, including the South African Health Products Regulatory Authority (SAHPRA), have had to revise systems and re-engineer processes in order to adapt to the new regulatory environment and increase the effectiveness of regulatory operations. This study aimed to develop a new regulatory review model for improved regulatory performance, underpinned by the parameters of the World Health Organization Global Benchmarking Tool (WHO GBT) that support strengthening of regulatory systems. Methods: A new enhanced model for regulatory review, was developed based on the key recommendations from 6 studies, previously conducted by the authors, that were identified as fundamental elements in enhancing regulatory performance. The elements selected to define the new regulatory review model were endorsed through the integration of the parameters of the WHO GBT that, when embedded within regulatory systems, support enhanced regulatory performance. Results: Opportunities for improvement in regulatory performance were identified and include quality measures; monitoring and evaluating review times; a risk-based evaluation; transparency and communication; and training and education. An improved model for the South African regulatory review and benefit-risk (BR) assessment supported by quality decision-making was proposed as well as recommendations for the application of risk-stratification strategies, strengthening of reliance networks, reinforcing good regulatory practices (GRPs) and enhancing transparency. Conclusion: If implemented the proposed improved regulatory model may pave the way towards more efficient and transparent, streamlined review processes, coupled with increased consistency, evidence-based decision-making practices, reduced timelines and improved patients’ access to new medicines in South Africa.