Mesa Monitor: December 18, 2014

MesaMonitor

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 1^st alert 30 min
Food Freezer	Title 22 CCR: Acute Care, Item 25	-18°C (0°F) or below	-30° to -10°C 1^st 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 1^st 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 1^st 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 1^st alert 60 min
Breast Milk Refrigerator	Centers for Disease Control	2° to 8°C (35.6° to 46.4°F)	2° to 8°C 1^st alert 15 min
Breast Milk Freezer	Centers for Disease Control	-30° to -10°C (-22.0° to 14°F)	-30° to -10°C 1^st 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 1^st 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 1^st 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	C enters 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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Mesa Monitor: December 18, 2014

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Author: Mesa Labs

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