With health care’s increasing reliance on wireless systems, the day is coming when all laboratory refrigeration equipment will need to be continuously and positively monitored, and deviations automatically tracked. As the technology matures and accreditation bodies revisit their existing guidelines and regulations, clinical laboratories have come to rely more on continuous, positive monitoring for all temperature sensitive materials.
Ultimately, positive temperature monitoring helps ensure the highest quality patient care through accurate results and shortened turnaround times by reducing the need to prepare additional reagents and perform unnecessary QC and calibrations. While there are distinct costs involved in employing dedicated, medical-grade refrigeration equipment, along with sophisticated and robust monitoring systems, to seamlessly maintain tight temperature ranges, these costs are counter balanced by the benefits of persistent, best-quality conditions for reagents, controls and calibrators, patient samples, and testing equipment, as well as the ultimate benefits to the patients.
The following is a sampling of key temperature monitoring systems now available. Please visit medlabmag.com/findit for a full listing of laboratory vendors and products.
Temperature Monitoring from Rees Scientific
Temperature monitoring systems from Rees Scientific can monitor the temperature of cold storage (refrigerators, freezers, and ultra-low freezers) from +1300°C to -196°C as well as parameters such as humidity, differential pressure, and more. Users may receive notification via interactive phone, text, and email. The system can be wired, Zigbee wireless, WiFi, or a hybrid. The system can be installed on the facility’s network or on the ReesCloud, and is easily expandable to fit the user’s needs, including considerations for regulatory requirements such as GxP, FDA, CDC, USP <797>, USP <800>, and others.
VersaTrak from Veracity Group Inc
VersaTrak from Veracity Group is a secure, easy-to-use, enterprise level solution designed to support a variety of departments within any hospital infrastructure. It offers system security that protects data from changes made by other departments by compartmentalizing access for each department, including military spec security user access protocols.
The system’s browser-based software is simple to use and maintain, provides updated traceability certificates, and its patented ANC (automatic node calibration) function performs an automatic, weekly self-audit. VersaTrak Mobile is accessible to offsite users and a variety of hardware options also are available, including WiFi and 900 MHz configurations with mix-and-match capabilities, and a variety of general purpose and laboratory-grade probes (temperature, humidity, pressure, CO2, and more). All products are NIST-traceable. VersaTrak also offers a mobile app enabling 24/7 system access.
Stat Temp from Health Care Logistics
Stat Temp from Health Care Logistics is a mobile friendly, WiFi-enabled temperature monitor offering unlimited readings with a user-selected logging rate from once-a-minute to once every 30 minutes. Portals can be created on the Stat Temp website and users can choose to view all units being monitored, or sort to groups by location. Compatible with 2.4 GHz WiFi networks, the unit can be added to the Stat Temp website so that the sensor will appear on the user portal when plugged into the monitor.
Cloud-based storage is unlimited and allows instant access to reports for process improvement, compliance, or inspection, and users can link any number of monitors to their portals. User-defined permissions can be set, based on shifts or roles. Real-time and user-defined alerts can be sent via text, email, or phone call with a forced acknowledgment function. The system uses a pass-through plug that inserts into the same wall outlet as the cooling unit and has a three-day battery backup. CDC compliant, Stat Temp provides min/max data for the previous 24 hours and has a temperature range of -20°C to 50°C (-4°F to 122°F). It includes one glycol sensor, but double sensor and room and air humidity sensor models also are available.
Temperature Monitoring Solutions from Hampshire Controls Corporation
Hampshire Controls’ fourth generation of single probe temperature monitors cover a range of -200°C to +400°C, each utilizing sensors optimized for the specified temperature range. Standard temperature monitors include audio and visual alarms, user-adjustable high and low set points, mute period, initial delay-to-alarm period, test alarm switch, 100-ohm RTD sensor with 10′ lead wire, and UL-listed power supply.
Optional features are passcode protected and include readout in degrees F, back-lit display, normally open (NO) or normally closed (NC) relay with programmable delay period, battery backup, 4 to 20mA output to building automation systems, voltage output, RS485 and digital output, Ethernet interface, input for door alarm switch, and custom programming and packaging for OEM applications.
PowerPath Temp from Emanate Wireless
The PowerPath Temp solution from Emanate Wireless aims to eliminate the loss of clinical inventory due to improper temperature storage. A slow response to a refrigerated storage failure event can result in costly product losses, and this solution is designed to eliminate the need for emergency response to refrigerator failure events by providing advanced warning before the failure occurs. By monitoring both the temperature and AC power draw of affiliated refrigeration devices and applying AI machine learning, the system detects anomalies such as a laboring compressors and failing defrosters before they cause a device failure, allowing for corrective maintenance or ample time to safely relocate the inventory. As a cloud-based system, it is easy to install and configure, and provides full compliance reporting and flexible alarming via email, text, pager, and/or voice call. PowerPath Temp can also be used to monitor both temperature and humidity for room-level compliance.
AssureTemp from EoScene Corporation
AssureTemp from EoScene is a compliance-driven temperature and humidity monitoring system designed for managing the strict compliance reporting and data retention requirements associated with high-value inventories, including reagents, vaccines, patient samples and specimens. Combining automated and manual data collection into a single application, the system helps to ensure that critical inventories are maintained at proper temperature and/or humidity levels.
AssureTemp provides the ability to demonstrate to regulators, program sponsors, and accreditation bodies that refrigerated elements are regularly monitored and that proper corrective actions are taken when measurements approach or deviate from required ranges. Simple to use, the system notifies staff of temperature issues according to the facility’s temperature management policy. Notifications can be escalated to multiple tiers if they go unaddressed, and real-time reporting and documentation provide a complete audit trail for remediation tracking and calibration management. Using existing IT infrastructure, installation is quick and easy. The monitoring hardware connects to a cloud-based application that records measurements at predefined intervals both locally and in the cloud, ensuring that readings are never missed or lost.
Sentinel Next from Sanguis Health/Argus Labs
Sentinel Next is a wireless environmental monitoring system that communicates directly to a facility’s existing WiFi network. As Argus Labs is an Internet of Things (IoT) company, all data resides in the cloud with no local software installation required. The only hardware installed in the facility are the sensors. The system features a mobile application that is compatible with Apple and Android devices, and the sensors have WiFi, cellular, and Bluetooth capabilities. The use of WiFi and cellular allows the sensors to communicate to the available network, while Bluetooth ensures the sensors can be easily programmed at the facility. The sensors can simultaneously monitor multiple parameters which include dual temperature, humidity, motion, CO2, dry contact, and more. Snap-calibration probes are available for annual NIST traceable verification of calibration. The system is CFR 21 Part 11 compliant and includes an IQ/OQ validation protocol.
EDL-LoRaWAN from Marathon Products, Inc
Marathon’s EDL-LoRaWAN wireless data loggers use gateways to monitor temperature and relative humidity around the clock in a compact package for stationary applications. All data is captured at pre-defined intervals and then stored on the user’s local server or cloud for data retrieval and review.
The system is scalable and easily upgradable to meet the facility’s needs. Three models are available, all of which monitor ambient temperatures from -29°C to 380°C, plus additional features: the Temperature & Humidity model, the Dual Sensor, and the Dual Sensor High Temperature.
Wireless Temperature Monitoring from SensoScientific, Inc
The SensoScientific Wireless Temperature Monitoring System meets CDC, VFC, The Joint Commission, USP, and cGMP compliance standards, among others. Data loggers utilize existing WiFi to upload data to the SensoScientific Validated Cloud, and real-time alert notifications are sent 24/7 via email, text, SMS, voice, fax, or pager when temperatures fall outside the desired range. Through the cloud, users can access unlimited data, generate reports, view A2LA accredited and NIST traceable calibration certificates, document corrective actions, and utilize the benefits of government-grade security in partnership with the Microsoft Azure cloud platform. The SensoScientific Cloud is FDA 21 CFR Part 11 validated, ensuring all data is timestamped and recorded for ease of auditability and traceability. Upon request, the technical support team can complete onsite visits to install devices and validate IQ, OQ, and PQ standards. The platform is scalable to the size and growth of the facility’s operational needs, regardless of department, and comes with a warranty.
OneVue Sense from Primex, Inc
Primex OneVue Sense temperature monitoring solutions help ensure the safety of valuable assets, including COVID-19 vaccines, using two NIST-traceable temperature probes. The standard probe monitors the temperature from -40°F to 221°F (-40°C to 105°C), while the cryogenic probe monitors temperatures as low as -328°F (-200°C). If a fluctuation in a storage unit temperature occurs, users will receive audible and visual notifications, as well as real-time email, phone, or text alerts, helping to ensure prompt action.
In addition to the peace of mind in knowing that assets are stored at correct temperatures, OneVue helps complete compliance tasks as well. With automatic logging, the system documents the first date of use, logs routine temperature checks, and stores data for easy audit reporting. In addition to temperature monitors, the OneVue Sense portfolio offers an array of monitoring solutions, including temperature and humidity sensors that feature the same alerting and data logging capabilities to monitor indoor air quality. The sensors are designed to be easy to install and relocate and use AC or PoE for power and feature standard battery backup.
DL2B Data Logger from Accucold Division, Felix Storch, Inc
Accucold’s DL2B is a USB temperature logger designed for use with a variety of refrigerators and freezers. As an NIST calibrated temperature probe, it is encased in a glycol-filled bottle to better simulate the temperature of refrigerated items. Users may set their own recording intervals, and the device can store up to 32,000 groups of data through its internal memory, or up to 4 GB using the included USB flash drive. Offering accurate logging, the device offers a measurement uncertainty of ±0.09°C. The LCD display screen provides a continuous display of the minimum, maximum, and current temperatures, and for durability, the logger is encased inside a steel housing. Additional features include password protection, audible/visual high/low temperature alarm, 120V DC power adapter, backup battery, and start delay recording function.
Wireless Sensors from Temptime, a Zebra Technologies Company
Zebra’s family of wireless Bluetooth-enabled sensors monitor and record temperature data 24/7. The M-300 and S-400 programmable dataloggers are designed for monitoring temperatures during transport or storage, letting users view and share temperature data with a free mobile app that allows customized alarm limits, datalogging intervals, and startup options. Users may also store unlimited data on the cloud and generate reports with the complimentary Web app.
Providing visual warnings when temperature limits have been exceeded during shipping and storage, Zebra TransTracker temperature indicators, manufactured by Temptime, are single-use devices that monitor heat, freeze, or dual heat-freeze exposures of temperature-sensitive products.
Temperature Monitoring from Cardinal Health
Cardinal Health offers a portfolio of temperature monitoring devices, including data loggers and wireless monitoring solutions, that come with a variety of features and configurations. With their abilities to monitor and record temperatures, these devices help to ensure an accurate temperature history and support regulatory requirements.
Smart Vue Pro System from Thermo Fisher Scientific
Smart-Vue Pro from Thermo Fisher Scientific is a next-generation remote monitoring solution for sample storage and processing. The ability to select the configuration of probe, module, and network type allows users to build the system to their specific needs. The modular, customizable architecture allows for easy expansion without costly upgrades, and the system is compatible with multiple brands and types of equipment. New equipment can be added to existing Smart-Vue Pro systems easily, and with the longer range LoRaWAN receiver, scalability is possible across multiple labs, floors, or buildings.
Temperature Monitoring Systems from SmartScan Technologies, a Division of CIMTechniques, Inc
SmartScan Technologies, a division of CIMTechniques, offers a variety of temperature monitoring systems for critical applications. The company is ISO-9001 certified and is also an ISO-17025 certified calibration lab. Offering easy configuration to meet the unique needs of the facility, available hardware components include wired elements, 900-mHz long-range wireless elements, WiFi, and Bluetooth capable options. Each group of sensors can be part of a total monitoring solution, allowing for remote collection of temperature data, alarms, notifications, and the necessary reporting to satisfy regulatory requirements. Bluetooth-enabled DQ sensors ensure local connectivity for real-time viewing of temperature readings on a smartphone or tablet. All available system configurations offer sensors for ambient temperature, probes for refrigerators and freezers, and a range of other monitoring options including humidity, differential pressure, CO2 levels, and I/O capabilities, such as door-open status.