Vaccines are the one of the most important resources to protect the public’s health, so naturally they are one of the most strictly regulated products in the healthcare industry. The Vaccines For Children (VFC) program goes above and beyond to guarantee the proper handling and storage of vaccines, ensuring they are provided to children whose families may not be able to afford them.
To validate that VFC providers are protecting patients and vaccine inventory, the CDC requires that every vaccine storage unit must have a specific type of temperature monitoring device (TMD) called a digital data logger (DDL). However, the DDL must meet the following requirements:
• Detachable probe that best reflects vaccine temperatures (e.g., a probe buffered with glycol, glass beads, sand, or Teflon®);
• Alarm for out-of-range temperatures;
• Low-battery indicator;
• Current, minimum, and maximum temperature display;
• Recommended uncertainty of +/-0 .5° C (+/-1° F);
• Logging interval (or reading rate) that can be programmed by the user to measure and record temperatures at least every 30 minutes.
In 2018, the CDC released the following additional requirements:
• Use of DDLs for each vaccine storage unit and each transport unit (emergency or non-emergency);
• Maintain primary and back-up DDLs that meet CDC requirements;
• Check and record storage unit minimum and maximum temperatures at the start of each workday.
The MadgeTech 4 Software comes standard with the VTMS providing detailed graphs and data tables to track long-term data and generate comprehensive reports for regulators. For added security, MadgeTech 4 Secure Software is also available for compliance with 21 CFR Part 11. The VTMS is also compatible with the MadgeTech Cloud giving users instant access to real-time data from any location, on any smartphone, tablet or internet enabled device.