Evaluation of temperature stability among different types and grades of vaccine storage units: Data from continuous temperature monitoring devices |
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| Affiliation: | 1. Immunization Services Division, CDC, United States;2. Association of Schools and Programs of Public Health, United States;1. Department of Nursing and Midwifery, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa;2. Cochrane South Africa, South African Medical Research Council, Cape Town, South Africa;3. Independent Consultant, Pretoria, South Africa;4. Department of Global Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa;5. School of Public Leadership, Stellenbosch University, Cape Town, South Africa;6. Ikhwezi Township, Mthatha, Eastern Cape Province, South Africa;7. Division of Epidemiology and Biostatistics, School of Public Health and Family Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa;1. Palo Alto Medical Foundation Research Institute, 795 El Camino Real, Palo Alto, CA 94301, United States;2. Palo Alto Foundation Medical Group, 325 Distel Drive, Los Altos, CA 94022, United States;3. Palo Alto Medical Foundation, 325 Distel Drive, Los Altos, CA 94022, United States;1. Discipline of Paediatrics, School of Medicine, University of Adelaide, Australia;2. Department of Paediatrics, Dalhousie University, IWK Health Centre, Halifax, Canada;3. Department of Psychology, University of Guelph, Guelph and Pediatric Chronic Pain Program, McMaster Children’s Hospital, Hamilton, Ontario, Canada;4. Department of Essential Medicines and Health Products (EMP), World Health Organization, Genève, Switzerland;5. Division of Pediatric Infectious Diseases and Vaccinology, University of Basel Children''s Hospital, Basel, Switzerland;6. Expanded Programme on Immunization, World Health Organisation, Geneva, Switzerland;7. Regional Office Europe, World Health Organisation, Denmark;8. Clinical Evaluation Division, Vaccines/Blood Biologics and Genetic Therapies Directorate, Health Canada, Canada;1. Ministry of Health, Community Development, Gender, Elderly and Children, Dar es Salaam, Tanzania;2. East African Community Regional Centre of Excellence for Vaccines, Immunization and Health Supply Chain Management (EAC-RCEVIHSCM), Kigali, Rwanda;3. School of Business, University of Dar es Salaam, Tanzania;4. University of Mzumbe, Dar es Salaam, Tanzania;5. Muhimbili University of Health and Allied Sciences, Dar es-Salaam, Tanzania;1. Nexleaf Analytics, 1964 Westwood Blvd. Suite 410, Los Angeles, CA 90025, United States;2. Clinton Health Access Initiative, Yaounde, Cameroon;3. Expanded Programme on Immunization, Yaounde, Cameroon |
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| Abstract: | ObjectiveTo evaluate the ability of different types of vaccine storage units to maintain appropriate temperatures for the storage of vaccines and to characterize deviations from recommended temperatures.Data sourcesContinuous temperature monitoring devices, or digital data loggers, from vaccine providers who participated in a continuous temperature monitoring pilot project.Study designWe computed descriptive statistics on the percentage of runtime with an out-of-range temperature, or excursion, for different storage unit types (freezers and refrigerators) and for different storage unit grades (household-grade combination, household-grade stand alone, and purpose-built or pharmaceutical grade). We developed frequency histograms for the percentage of storage unit runtime outside of the normal range. We plotted the duration and temperature extrema for identified excursions. Analyses were stratified by storage unit type and grade.ResultsHousehold-grade combination units underperformed relative to household-grade stand-alone and purpose-built units. Among refrigerators, household-grade combination units operated in the normal temperature range an average of 98.9% of their observed runtime, which was lower than 99.4% (p value = 0.038) for household-grade stand-alone and 99.9% (p value < 0.001) for purpose-built units. Among freezers, household-grade combination units operated in the normal temperature range an average of 95.0% of their observed runtime, which was lower than 99.3% (p value < 0.001) for household-grade stand-alone units and 99.7% (p value < 0.001) for purpose-built units.ConclusionThese findings, in particular the underperformance of household-grade combination units relative to household-grade stand-alone and purpose-built units, support current CDC recommendations to avoid the use of household-grade combination storage units when possible. |
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| Keywords: | Vaccines Storage units Cold-chain Continuous temperature monitoring Digital data logger |
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