Medical & Healthcare
Complete Five-Year “No-Touch” Refrigeration Compliance
Onformant delivers the industry’s only five-year no-touch medical monitoring solution.
8 year sensor battery life
Five-year NIST compliance certificate
Electronic NIST certificate storage
Reduced nuisance alarms
Auto-generated reports
Predictive failure of refrigerators and freezers
Key Features & Benefits
NIST Calibration Built-In
Five-year calibration certificates stored directly in the system
Certificates tied to refrigeration devices—no manual tracking
±0.3°C accuracy with only 0.02°C annual drift
Predictive Refrigeration Failure (Optional Add-On)
AI-driven electrical monitoring of compressor health
Detects cooling inefficiencies before temperature rises
Hours of advance warning before product loss
Goes beyond standard monitoring, which only alerts after failure
Ultra-Reliable Sensors
Competitors: 3–6 month battery life
Onformant: 8–10 years of battery life
Five years of continuous monitoring—no maintenance required
Intelligent Alerting System
Hierarchal email & SMS alerts for critical events
Smart filtering reduces nuisance alarms
Ensures staff act only when truly necessary
Advanced Monitoring & Reporting
Tracks refrigeration temperatures, ambient conditions, and humidity
Cloud-based, encrypted medical monitoring platform
Automated compliance reports + unlimited searchable history
Audit-ready documentation for FDA, CDC, and HACCP standards
Lifetime Warranty & Service Model
Hardware, software, and support included in subscription
Free replacements and lifetime upgrades
No upfront cost—subscription covers everything
Long-term data storage
Why Choose Onformant Medical Monitoring?
Unlike traditional monitoring systems, Onformant is a complete compliance solution. By combining NIST-certified calibration, predictive analytics, and ultra-long sensor life, we take compliance out of your hands and deliver peace of mind.
Eliminates manual compliance logs & certificate management
Protects valuable vaccines, medications, and biologics
Saves staff time with automated reporting & alerts
Prevents costly refrigeration failures with predictive monitoring
Remove NIST headaches with auto-managed certificates
True no-touch system with unmatched accuracy and reliability
NIST & Temperature Monitoring in Healthcare
Learn more about our NIST certification and how it ensures the highest standards of accuracy and compliance.
Why NIST Matters for Hospitals:
Medicines and vaccines must be stored at precise temperatures (often 2–8 °C for refrigerated vaccines, or below −20 °C for frozen).
Regulators like the CDC, FDA, and WHO require calibrated monitoring equipment to ensure accuracy.
NIST provides the traceability standards for calibration — this ensures that the thermometer or data logger used in a hospital has a documented, unbroken chain of comparisons back to a national reference standard.
NIST-Traceable Calibration:
Hospitals typically use digital data loggers (DDLs) or specialized medical-grade thermometers.
These must be NIST-traceable, meaning:
The device has been calibrated by an accredited laboratory.
The calibration is documented with a certificate.
The accuracy is traceable back to NIST’s national measurement standards.
Certificates usually specify the date of calibration, test results, and next due date for recalibration.
The Certification / Compliance Process for Hospitals:
Step 1 – Select Equipment
Hospitals must use NIST-traceable thermometers or data loggers.
CDC’s Vaccine Storage and Handling Toolkit requires continuous monitoring with buffered probes (to simulate vaccine conditions).
Step 2 – Calibration by an Accredited Lab
Devices are sent to a calibration laboratory that is ISO/IEC 17025 accredited.
These labs follow NIST standards and issue a Calibration Certificate that states NIST traceability.
Step 3 – Documentation & Recordkeeping
Hospitals must maintain:
Calibration certificates.
Logs of continuous temperature monitoring.
Records of corrective actions if excursions occur.
Step 4 – Regular Recalibration
Typically every 1–2 years, depending on manufacturer and CDC/FDA requirements.
Some facilities rotate devices so one can be recalibrated while another is in use.
Step 5 – Compliance Verification
During inspections (e.g., CDC Vaccines for Children program or Joint Commission audits), hospitals must show:
Proof that devices are NIST-traceable.
Temperature logs (usually 24/7 with backup systems).
Evidence of corrective actions for out-of-range events.
Related Standards & Regulations:
NIST Handbook 150 – sets calibration lab accreditation requirements.
CDC Vaccine Storage & Handling Toolkit – mandates NIST-traceable calibrated thermometers.
FDA 21 CFR Part 11 – governs electronic records/logging systems.
WHO PQS Standards – for international vaccine storage compliance.
Summary for Hospitals:
Hospitals don’t get “NIST certified.” Instead, their temperature monitoring devices must be NIST-traceable.
Compliance involves:
Using calibrated, NIST-traceable data loggers.
Keeping calibration certificates.
Maintaining temperature logs.
Recalibrating on schedule.
This process ensures patient safety, regulatory compliance, and eligibility for federal vaccine programs.