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Regulatory Compliance Mesa Monitoring’s continuous monitoring (CM) solutions are designed to safeguard valuable products and vital assets, facilitate regulatory compliance, and enhance overall enterprise quality assurance. Determining the most appropriate regulations and parameters under which to maintain your continuous monitoring system can be a daunting task. The regulations can be specific to the piece of equipment being monitored, the type of facility or the product/items themselves.Navigating this sea of regulations is no easy task for those responsible for continuous monitoring, however Mesa Monitoring has compiled a listing of quality assurance standards and the recommended system set points for a continuous monitoring system below. | Application / Appliance Type | Standard | Reference Temperature Range | Temperature Range Set in Automated Monitoring System | | Food Refrigerator | FDA Food Code 3-501.16-19 | 2° – 5°C (35° to 41°F) | 2° to 5°C
1st alert 30 min | | Food Freezer | Title 22 CCR: Acute Care, Item 25 | -18°C (0°F) or below | -30° to -10°C
1st alert 30 min | | Medication Refrigerator | USP Quality Review: Storage Definitions; Title 22, CCR | 1° to 8°C (36° to 46°F) | 2° to 8°C
1st alert 30 min | | Medication Freezer | USP Quality Review: Storage Definitions; Title 22, CCR | -20° to -10°C (-4° to 14°F) or other freezer temperature range recommended by the drug manufacturer | -30° to -10°C
1st alert 30 min | | Specimen Refrigerator – | College of American Pathologists: 2007 Laboratory Inspection Checklist | 1° to 8°C (33° to 46°F) | 2° to 8°C
1st alert 60 min | | Breast Milk Refrigerator | Centers for Disease Control | 2° to 8°C (35.6° to 46.4°F) | 2° to 8°C
1st alert 15 min | | Breast Milk Freezer | Centers for Disease Control | -30° to -10°C (-22.0° to 14°F) | -30° to -10°C
1st alert 15 min | | Tissue Refrigerator | Joint Commission Standard PC.17.10 | -17.5° to -15°C (0.4° to 4°F) | Product and usage dependent | | Tissue Freezer | Joint Commission Standard PC.17.10 | -40°F (-40°C) | Product and usage dependent | | Blanket Warmer | Facility SOP | Not to exceed 43°C (110°F) | 38° to 43°C
1st alert 60 min | | Fluid Warmer | USP Quality Review: Storage Definitions | 30° to 40°C (86° to 104°F); 72 hour limit | 30° to 40°C
1st alert 60 min | | Contrast Warmer | Manufacturer Package Insert: Omnipaque and Visipaque | 15° to 30°C (59° to 86°F ) | 18° to 27°C
1st alert 60 min | | Vaccine Management | Centers for Disease Control | 2° to 8°C (35.6° to 46.4°F) | 2° to 8°C for refrigerated vaccines
1st alert 30 min | | POCT Test Supplies | Manufacturer’s Recommendations | 18° to 30°C (64° to 86°F) | 18° to 27°C
1st alert 60 min | | Blood Bank | FDA and AABB the Standards for Blood Banks and Transfusion Services (27th Edition) | 1.5° to 5.5°C (34.7° to 41.2°F) | 1.5° to 5.5°C
1st alert 5 min or less | | Platelets | FDA and AABB the Standards for Blood Banks and Transfusion Services (27th Edition) | 20.0° to 24.0°C (68.0° to 75.2°F) | 20.0° to 24.0°C
1st alert 15 min or less |
If you would like clarification, guidance or a consultation with our continuous monitoring team, please contact us today! |
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