Efento / Applications / Healthcare / Temperature monitoring for medicines and vaccines in health clinics According to the guidelines of the sanitary inspectorate, medicines and vaccines must be stored in refrigerators at a temperature of 2 -8°C. This is important because in medicinal products stored at the wrong temperature, active substances may decompose, which in themselves may be more toxic than the drug itself.
Efento Inspector is a solution dedicated for clinics and health centers to monitor the temperature in medical refrigerators. The system allows, among others, sending SMS / email alerts, generating automatic reports, sound alarming on exceeding thresholds and signaling power failure in the facility.
The role of the base station is performed by a smartphone with Android 4.4 and Bluetooth 4.0, running Efento Inspector application. One phone can support up to 20 sensors. The app enables the user to view the data in the form of a chart, configure SMS alarms and data export, send the data to specified email address.
Efento sensors measure temperature within -35°C to +70°C range, with accuracy up to 0.5°C. High-capacity batteries ensure min. 2-year maintenance-free operation period. The measurements are wirelessly transmitted to the base station. Efento sensors are available in two versions, with an external probe and without it.
The sensors are calibrated by an accredited laboratory that compares the readings from the sensors with reference thermometers. The calibration is performed at 5°C, the optimum temperature for storing vaccines.
The loggers are accurate and reliable, durable and easy to maintain.
Secure software with encrypted connections – proven in over 300 large installations with up to 1000 sensors.
The solution complies with the legal requirements of the GxP, HACCP guidelines, FDA 21 CFR Part 11, GMP, the manufacturer provides materials for validation.
Easy and self-installation, the sensor is ready to use right out of the box. System configuration will take less than 15 minutes.
Manufacturer’s warranty 2 years.
Each sensor sends temperature readings to the base station that records and stores them. The base station can store measurements from any period of time, and you can restore them at any time.
You can check the temperature remotely at any time. After sending an SMS to the base station you will receive a return SMS with the current temperature measurements from all sensors.
The system allows you to set the lower and upper temperature thresholds. If the temperature exceeds one of the thresholds, the systems sends alarm SMSes to listed phone numbers or alarm emails addressed to defined recipients. In both cases, the number of the recipients is not limited.
The application sends an alert in the case of power outage (when the base station – smartphone – switches to battery power) and when one of the sensors stops sending data to the base station. Such notification will also be sent on resumption of power supply. This way, the system notifies you of power failures in the building.
Different users of the system can receive alerts resulting from different reasons. For example, person A gets a notice only in the case of exceeding temperature thresholds, and person B only in the event of loss of power or communication with a sensor.
At any time, you can generate a report with measurement data. The application allows you to export data from any period of time, in PDF format (print-ready) or in CSV format (data in tabular form, with the possibility of processing in MS Excel, OpenOffice Calc etc).
Why to generate reports manually? The application can do it for you automatically. Enter your email address and select how often you want to receive the report (once a day, once a week, once a month), and the application does the rest – all the temperature measurements you will receive by email, in the required format and with the chosen frequency.
The base station application allows you to visualize data in the form of charts from any period of time. The graphs are marked with upper and lower alarm thresholds, so you can quickly see if the temperature does not exceed specified values.
If the temperature exceeds a threshold, the application will start an audible alarm. The screen of the smartphone lights up and you hear alarm sound. The alarm continues until it is deactivated. Additionally, the application allows you to set a reminder – if the temperature has not returned to a safe range, the alarm will start again after a preset period of time (15 min, 30 min, 60 min).
The entire configuration of the temperature monitoring system is performed from the base station. You do not need to connect any device to your computer, install drivers or download software. Using the app, just search the sensors, set required alarm thresholds, add phone numbers for SMS alerts and start to monitor the temperature. The system is designed so that it can be configured by anybody.
Some functions of the app (e.g. removing sensors from the list) can be protected with a password. This guarantees that unauthorized people are not able to change the configuration of the system, settings etc.
The requirements for surveillance and record-keeping systems used in storage and handling of medicines and vaccines are part of the pharmacovigilance system of a country, so they depend on national regulations.
Here are examples of the most important and typical requirements that can be found in such regulations, each with the way of fulfillment in Efento system:
“The equipment used to control or monitor the environment for storing medicinal products should be calibrated at certain intervals on the basis of risk assessment and reliability. Calibration of the equipment should be performed in accordance with national or international standards of measurement. (…)”
Efento sensors are provided with calibration certificates issued by an independent accredited laboratory.
“Appropriate alarm systems must warn on deviations from specified storage conditions. Alarm levels should be properly adjusted, and alarm systems should be regularly tested to ensure proper functionality.“
Efento system alerts the user(s) on exceeding alarm thresholds via SMSes. The user can configure the thresholds according to requirements for a given medicinal product.
“The measurement data should be secured by physical or electronic methods and protected against accidental or unauthorized changes. Backup copies of the data should be retained for the period specified in national legislation, in a separate secure location.”
Key functions of the Efento system (e.g. removing sensors from the list) can be protected with a password. The user should backup and protect the measurement data in compliance with national regulations.
Regulations require that refrigerated vaccines also be subject to temperature monitoring on saturdays and sundays. The system alerts you of deviations from the storage conditions. and archiving of measurement data.
In accordance with applicable regulations, hospitals require constant monitoring of parameters such as temperature in medical refrigerators.
Using the Efento solution allows to inform hospital staff via SMS or email in the event of an emergency (e.g. sudden increase or decrease in temperature in a vaccine fridge).
According to the regulations, vaccines should be stored in refrigerators, which are subject to temperature monitoring with alarms warning of deviations from the storage conditions.
Drugs and vaccines should be stored in refrigerators, which are subject to temperature monitoring with alerts warning of deviations from the storage conditions.
In accordance with the recommendations of the World Health Organization (WHO) and the Summary of Product Characteristics (SmPC), all vaccines should be transported and stored in stable temperature conditions between +2°C and +8°C. Installing Efento temperature monitoring system in refrigerators allows remote control and supervision of vaccines.
