4 Ways to Ensure Compliance with Vaccine Temperature Monitoring
Marathon Products’ DDLs are properly calibrated and highly accurate, with alarm and display features to enable continuous recording of temperatures.
Key Takeaways:
- Digital data loggers (DDLs) must be carefully calibrated for data recording in the required conditions
- DDLs should provide the lowest possible accuracy variance
- Alarms must be part of the logging device function to alert users to temperature excursions
Vaccines are subject to regulations. The Centers for Disease Control (CDC) has become even more stringent on vaccine compliance, so it’s vital that pharmaceuticals fully abide by set governmental requirements to ensure vaccines are safe and effective to avoid risks or even penalties. The CDC is even stricter when implementing its Vaccines for Children (VFC) Program.
The VCF Program is a “federally funded program that provides vaccines at no cost to children who might not otherwise be vaccinated because of inability to pay. The CDC buys vaccines at a discounted rate for distribution to registered VFC providers.”
Proper temperature: A critical requirement for vaccine efficacy
Vaccine efficacy has come under great scrutiny after a report by the U.S. Department of Health and Human Services (HHS) led to concerns about vaccine safety, especially regarding children’s vaccines.
One key requirement for a safe and effective vaccine is that it is kept at the proper temperature. Vaccine temperatures are critical to their successful use. Monitoring this factor can make the difference between saving lives or costing pharmaceutical manufacturers wasted time and money. Digital data loggers are the devices recommended for temperature monitoring.
What’s a digital data dogger?
Also called “continuous temperature monitoring devices (TMD),” a DDL is an electronic device that uses an external sensor probe to continuously read and record environmental parameters. DDLs are used in medical environments to provide accurate reports on vaccine temperatures over a period of time.
For VFC Program compliance, a data logger must have certain features, as detailed in this guide.
How to ensure data logging for VFC Program compliance
The following are four ways to ensure VFC Program compliance for your DDLs.
1. DDLs must be carefully calibrated
DDLs are primarily used for medicine or when safety regulations are paramount. That’s why it’s critical to be so cautious about calibrations – it’s literally a matter of life and death.
A DDL temperature or humidity calibration involves comparing a data logger against another device already calibrated for a specific parameter. The reference device is an accurate piece of equipment regularly inspected by an accredited entity.
During calibration, the two instruments are left running for a set period. If the two measurements vary at the end, remedial work is performed, including adjustment, repair, or replacement of the data logger.
To be VFC Program compliant, a data logger must be discretely calibrated in an ISO 17025 accredited laboratory that holds an ILAC MRA recognition.
The certificate of calibration testing must be valid and current and will clearly show the serial number, model number, and measurement results as evidence that the device passed the calibration test.
2. DDLs should provide the lowest possible accuracy variance
Accuracy of measurement refers to the proximity of agreement between the results of a measurement and the absolute value. The accuracy of a data logger can change over time. Several factors cause this change, including contamination, mishandling, damage, and drift of a sensor, among others.
Common risks of inaccurate data loggers include disparate data, data storage limitations, and missed alarms during a network failure. To ensure compliance with the VFC Program, your DDLs should provide the lowest possible accuracy variance – +/-0.5 °C.
A well-maintained digital data logger provides the highest accuracy. Here are tips to help maintain your data logger for maximum benefits and accuracy:
- Keep the DDL safe between use: A vital practice to help prevent DDL damage and unseen safety hazards. Data loggers should be kept in appropriate environments while in storage or transport.
- Safe battery storage: DDL batteries should be stored separately to avoid short-circuiting. Leaving DDL batteries in bundles or in a way where they come into contact with each other is extremely risky. They may short-circuit and cause damage or even fire hazards.
- Only use DDLs for their intended purpose and tolerance: Different types of DDLs are made for specific purposes and should not be used for any application other than what they were initially designed for, and by trained personnel.
- Regular checks and calibration: Data loggers should be regularly checked, calibrated, and re-calibrated against reference standards to ensure the highest levels of accuracy.
3. Ensure the data loggers are functional
One of the requirements of VCF Program-compliant data loggers is an alarm to sound an alert if temperatures fall or rise outside set limits. DDLs support an array of alarm capabilities for local and remote notifications. Typically, the data logger is linked to a local high and low alarm and can be programmed to send alerts to staff on duty via auto-dialer or SMS/email-enabled devices.
The alarm will sound or show a visual excursion when an alert is sent that indicates an out-of-range temperature. Staff must respond to the alarm immediately and act accordingly. The alarm feature helps achieve another condition for vaccine safety – continuous monitoring.
A VFC Program-compliant DDL should continuously record events and temperature with a logging interval of 10 or fewer minutes and must have at least a 4,000-point data storage minimum.
4. Visual display requirements
This requirement means the DDL has a clear visual display of current, minimum, and maximum temperatures. The DDL visual display should also show real-time battery level, alarm status, network connectivity status, device settings, and more.
A quality display for data loggers has a high resolution, wide viewing angle, high contrast ratio, and vibrant brightness levels. These features should be adjustable.
Modern DDL thermometers come with an LCD and have LED indicators to alert you when the temperature is out of range.
Following these guidelines helps to ensure you’re in compliance with the VFC Program, which is critical for your digital data loggers. Here’s why.
The risk factor: Why you must ensure compliance
The VFC Program has put immense pressure on vaccine coordinators, distributors, and administering doctors and healthcare facilities. Storage and transit temperature requirements for the VFC Program far exceed the ordinary refrigeration capabilities. This has dramatically transformed the global vaccines cold chain.
Temperature variations for vaccines in storage or in transit mean children could receive spoiled or inactive doses that will not protect them against diseases. This could lead to unnecessary illness or death. It could also lead to legal actions and result in major financial loss.
Prevention requires strict temperature control, and monitoring protocols are critical within the cold chain. A VFC Program-compliant DDL is vital to ensure temperature variations are kept in check.
We’re here to help you
With over 30 years of industry experience, Marathon Products is a leading manufacturer and distributor of precision environmental monitoring devices for temperature, humidity, and vibration for the healthcare industries, including vaccine transportation.
Our DDLs are VFC Program compliant. The DDLs are properly calibrated and highly accurate with alarm and display features to enable continuous recording of temperatures. Do you want to avoid pain and losses? Don’t ship without us!
We supply solutions to fit every budget, so contact us at web-inquiry@marathonproducts.com or call 510-562-6450 for more information!