Most of the reference exposure studies observed the morbidity/mortality of individuals working in sterilization plants with direct, chronic exposure to high concentrations of ethylene oxide gas prior to changes in allowable environmental levels in 1985, and also formed the basis for the United States Environmental Protection Agency (EPA) and National Institute for Occupational Safety and Health (NIOSH) findings of cancer causation
Meta-analyses of more recent observational cohort studies performed in the 2000s and 2010s of sterilization workers directly exposed to ethylene oxide gas in the workplace do not support the association between ethylene oxide exposure and increased risk of lymphohematopoietic or breast cancers
The elimination half-life of ethylene oxide in humans is approximately 42 minutes – thus almost 90% of any ethylene oxide in a single exposure would be eliminated from the body in two hours
In order to gain FDA approval, testing swabs need to have demonstrated to meet tolerable contact limits of ethylene oxide residuals – experts claim that once packaged for a period of time and aerated prior to use, it is unlikely to contain any ethylene oxide residuals; corroborated by a study assessing the residuals on DNA swabs, finding no detectable levels of ethylene oxide on swabs 3 weeks after sterilization treatment
Badea, A; Groot, G; Hernandez-Ronquillo, L; Fox, L; Mueller, M. What are the risks associated with repeated exposure to Ethylene Oxide from ongoing use of the Abbott Panbio AG COVID-19 Nasal swabs? 2021 Nov 30. Document no.: EOC211126 RR. In: COVID-19 Rapid Evidence Reviews [Internet]. SK: SK COVID Evidence Support Team, c2021. 14 p. (CEST rapid review report).
The group designated in Saskatchewan as Clinically Extremely Vulnerable (CEV) is a heterogenous clinical population with factors that impair their immune response to differing degrees.
Very Limited evidence is currently available to assess the immune response following vaccination is selected clinical populations; no evidence is available to assess vaccine efficacy or effectiveness in these populations. The clinical relevance of measured immune response with respect to protection from disease is still uncertain.
In considering the immune response of the CEV population, it is recommended that the absolute difference in immune response between 1 and 2 doses be considered, as it is possible some patient groups will have lowered protection regardless of vaccine strategy.
In terms of clinical subgroups:
oOrgan transplantation recipients on immunosuppressive medication: solid organ transplant recipients receiving anti-metabolite maintenance immunosuppression therapy were less likely to develop an antibody response to an mRNA vaccine, compared to those receiving other types of therapies (37% vs 63%). In a study of 242 kidney transplant recipients on immunosuppressive therapy only 10.8% became seropositive at 28 days after a single dose of mRNA vaccine.
oCancer: A study of 151 elderly patients with solid and hematological malignancies and 54 healthy controls who received one or two doses of BNT162b2 (Pfizer-BioNTech) vaccine shows approximately 39% of solid cancer patients, 13% of hematological cancer patients, and 97% of healthy controls (p<0.0001) developed anti-S IgG 21 days following a single dose vaccine. However, response in solid cancer patients increased to 95% within 2 weeks of the second dose at 21 days.
oOther immunocompromising conditions (e.g., auto-immune disorders and therapy): some level of immunity is generated with vaccination; however, what this means clinically is unknown. It seems that ensuring the dosing is properly timed around biologic therapy is important.
Azizian, A; Lee, S; Shumilak, G; Groot, G; Reeder, B; Miller, L; Howell-Spooner, B. What are the risks or benefits of extended intervals between doses of COVID-19 vaccines compared to recommended dosing in extremely vulnerable populations? 2021 Apr 20, Document no.: EOC210302 RR. In: COVID-19 Rapid Evidence Reviews [Internet]. SK: SK COVID Evidence Support Team, c2021. 15 p. (CEST rapid review report).
Vulnerable populations such as those experiencing homelessness are 20 times more likely to be hospitalised due to COVID-19, 10 times more likely to require intensive care for COVID-19 and 5 times more likely to die within 21 days of a positive test for COVID-19
Many organizations advocate for socially vulnerable populations to be considered priority populations due to their oftencomplex health needs and inability to fully execute best practices for infection prevention and control
Past experiences from Hepatitis vaccination (requiring 3 injections) and H1N1 pandemic influenza vaccination indicate that partnering with community organizations to provide vaccinations in shelters, community centers and other frequently accessed places along with education and access to known, trusted healthcare providers greatly increase the uptake of vaccination among socially vulnerable populations
Beyond sheltered populations experiencing homelessness, considerations for equitable vaccination programs for the general population should include plans for accessibility for all, including underserved geographic regions
Badea, A; Reeder, B; Hanson, L; Miller, L; Howell-Spooner, B. What are the vaccination strategies for vulnerable populations? 2021 Mar 12; Document no.: PH030401 RR. In: COVID-19 Rapid Evidence Reviews [Internet]. SK: SK COVID Evidence Support Team, c2020. 33 p. (CEST rapid review report)
Two congregate living situations were identified in the literature: those in correctional facilities and those with mental health issues.
People in correctional facilities are more susceptible to infection and have higher mortality rates due to COVID-19 than the general population. Managing outbreaks in facilities is difficult due to high levels of movement, the inability to physically distance, and limited personal protective equipment.
People with mental illness have higher risk of morbidity and mortality due to COVID-19. Severe mental illness is positively correlated with other environmental risk factors for contracting COVID-19, including living in crowded settings, homelessness, and institutionalization. Furthermore, those with mental illness find it difficult to adhere to changing public health or government guidelines around reducing the spread of COVID-19.
Fick, F; Groot, G; Young, C; Mueller, M. What evidence is available to inform vaccination planning in congregate living? 2021 Jan 15; Document no.: EOC011102 RR. In: COVID-19 Rapid Evidence Reviews [Internet]. SK: SK COVID Evidence Support Team, c2020. 23 p. (CEST rapid review report)
No scientific evidence was found to support limits of a specific number of visitors. The Newfoundland/Labrador visitor policy referred to evidence supporting restrictions to 6 contact persons including one designated support person and 5 visitors; however, supporting references were not provided (25; 4.1).
The majority of Canadian and international visitation or family presence policies differentiate between general visitors (those attending for social visits) and designated support persons (essential care providers involved in physical, psychosocial, behavioral, cultural, or language support).
Designated support persons are not limited in duration, timing, or frequency of access to resident (3, 7, 9, 11, 12, 14, 16, 24, 26).
The majority of policies limit the number of general visitors to 2 persons. These visits typically have to be scheduled and may be restricted if there is an outbreak, if the resident is COVID+, or if community transmission is high. General visitors are usually not restricted during end of life or other compassionate care reasons.
Although modeling data supports contact restrictions as an effective measure to reduce infection spread, contact restriction can be achieved with infection prevention and control measures of micro-distancing, including hand and respiratory hygiene, physical distancing, and mask use (49). Family presence in LTC can support efforts to reduce resident wandering, micro-distancing, and hand hygiene.
There continues to be no scientific evidence that family presence increases risk of infection spread into and throughout LTC homes (1, 2, 44, 46)
No evidence was found that examined adherence of family caregivers to IPAC practices. A self-report survey of visitors and staff in 87 LTC homes in Hong Kong found that visitors self-reported high compliance with most infection prevention measures despite only one quarter of homes providing education (50). Low knowledge was identified as a primary barrier for infection prevention for visitors.
Education materials have been developed in several jurisdictions for family caregivers regarding COVID-19 IPAC best practices (4, 6, 8, 28).
No evidence was found regarding the impact of staff or family caregiver education on COVID-19 infection or transmission in LTC homes.
Ward, H; Tupper, S; Miller, L; Boden, C; Mueller, M. What is the evidence regarding limiting patient visitors in long-term care facilities to 2 or less, and how are other jurisdictions managing family caregivers? 2020 Dec 4; Document no.: LTC101501 RR. In: COVID-19 Rapid Evidence Reviews [Internet]. SK: SK COVID Evidence Support Team, c2020. 35 p. (CEST rapid review report)
Badea, A; Groot, G; Dalidowicz, M; Miller, L. What is the evidence to support the reprocessing and re-use of N95 respirators by healthcare workers? 2020 Nov 20; Document no.: PPE110201 RR. In: COVID-19 Rapid Evidence Reviews [Internet]. SK: SK COVID Evidence Support Team, c2020. 19 p. (CEST rapid review report)
An optimal surveillance strategy for COVID-19 infection in healthcare workers (HCWs) has yet to be determined.
Weekly screening of HCWs for infection through polymerase chain reaction (PCR) testing would reduce their contribution to SARS-CoV-2 transmission by approximately one quarter.
Any testing surveillance strategy should be in addition to other strategies already in place to identify symptomatic HCW.
Any strategy needs to take into consideration the availability of testing (i.e. feasibility) and the level of community transmission (i.e. the risk of asymptomatic HCWs entering the facility and spreading the virus).
HCWs could be categorized as high, medium, or low risk based upon their exposure to COVID-19 and the frequency of surveillance could be designed accordingly.
Newaz, S; Lee, S; Reeder, B; Groot, G; Young, C; Fox, L. What surveillance strategy is most effective for COVID-19 testing in healthcare workers? 2020 Nov 10; Document no.: EOC110401 RR. In: COVID-19 Rapid Evidence Reviews [Internet]. SK: SK COVID Evidence Support Team, c2020. 26 p. (CEST rapid review report)
· Overall, there is a lack of high quality evidence to support recommended pandemic preparedness strategies (checklist items) to prevent or mitigate respiratory infection outbreaks in LTC.
· In the absence of high-quality or mixed evidence to support strategies for pandemic preparedness, it is advisable to follow clinical practice guideline recommendations that have been based on expert opinion (key sources are identified in red). This is particularly the case for infection control interventions that are likely to have no negative impacts on LTC residents (e.g. hand hygiene, cough etiquette). Strategies that have a potential negative impact on LTC residents (e.g. visitor restrictions) must be handled with more flexibility and individual assessment to determine how infection control can be preserved while minimizing negative consequences for residents and families.
· Internationally recognized pandemic/outbreak preparedness checklists for LTC (e.g. CDC 2020, Buynder et al. 2017) share many similarities to the current SHA Annex R checklists.
· Consideration should be given to converting the checklist into a planner with accountabilities to demonstrate how each item is being addressed (similar to CDC 2020). Links can be embedded in the planner/checklist to more detailed information, such as the PPE burn calculator (CDC 2020), education/training materials (WHO 2020), and communication materials for families (CDC 2020, WHO 2020, Buynder et al. 2017).
· Consider the addition of specific detail to the SHA pandemic preparedness checklists on the date of the next pandemic plan/checklist review, contact names for local resource acquisition or assistance with staffing, tracking forms for dates of education/training with staff and residents, tracking of audits/observation of infection control practices, surge capacity planning items, and expanded items for communication (see attached recommendations from family caregivers of the Saskatchewan LTC Network).
· Discrepancies exist between reported (77-100%) and observed (25-63%) adherence to infection control practices, indicating a need for independent audits. Adherence rates improve with direct observation, frequent education reminders and prompts.
· Even when there is not an outbreak in a home, the pandemic response results in increased workload demands on staff due to infection control practices (e.g. PPE and hand hygiene), loss of family caregiver assistance with resident care, enhanced care needs of residents due to anxiety, increased communication with family caregivers and other members of the care team, monitoring and restricting resident movement in the home, enhanced cleaning, staff absenteeism, and education/training. Consideration is needed for a provincial process for evaluation of needs within individual homes, and allocation of additional human resources, disposable supplies, equipment, or funding to ensure that both infection control and usual care needs of residents are consistently met.
· Maintaining public confidence through communication is a defined infection control strategy. Communication strategies include individual communication between family members and staff, public communication strategies by individual facilities and provincially through dedicated pandemic information pertaining to LTC (e.g. dedicated LTC section on provincial websites).