Unexpected failures in refrigeration equipment can lead to expensive stock losses of medicinal products. Next Systems, producer of a new monitoring service, claims it can eradicate such events and maintain necessary temperature records
A fail-safe system designed to protect refrigerated medication from the manufacturing process right through to the patient has been introduced into the UK against the background of reports that the health service has had to dump more than 800 tons of unfit medication worth around £202m.
Produced by Next Systems, a UK refrigeration monitoring company, Tutela automatically monitors refrigerated ingredients and stock to ensure that conditions are ideal. Checks are made every 15 minutes, or more frequently if specified.
It is guaranteed to cut out the negatives of unexpected temperature changes in fridge and freezer monitoring, including loss of efficiency, stock/revenue losses and other incidents that could lead to legal liabilities.
The system, which meets all current and anticipated legal requirements for record keeping, can support a wide range of sensing options like temperature probes (including ultra low temperature), digital status and alarm contacts, humidity sensors, pressure transducers, energy metering, liquid levels and gas sensing.
Tutela was developed with the pharmaceutical industry in mind and is designed to both protect and monitor temperature-sensitive medicines, from the raw material stage through processing and packing to the point of delivery to end users.
Although it is a British development, the system was initially test-marketed in the US where it has been installed successfully in a number of hospital pharmacies and where the company has a growing order book. American customers include Lifeblood Biological Service, the American Red Cross and Precision Therapeutics.
In the UK, Tutela is already the preferred choice for Wrexham University Hospital, the Peterborough NHS Trust and the innovative and modern "Blizzard" building at The Queen Mary University of London Hospital.
To maximise security, one hospital has chosen to keep it completely separate from existing building and energy management systems (even though they are also from Next Systems), to ensure the system's recording and reporting ability is fully protected.
Tutela's Alarm Call Centre is fully manned round the clock. It runs on either GPRS or ethernet connections that don't interfere with other on-site applications.
Off-site sensor data recording is fully automatic and therefore minimises staff involvement, as there is effectively no on-site system to manage. The round-the-clock, fully automatic alarm generation and management service means electronic records are available at any time (from anywhere) and multiple site records can be viewed from a common location.
Full system validation uses the ISO9001 quality framework to deliver a 30-year electronic record backup to MHRA standards, including user activity logs and alarm incident management records. These electronic and legally com-pliant historical records are published in real time on secure web pages that customers can access at any time using a single web browser. Factory or production managers can therefore check on the status of their refrigeration at any time from remote sites.
To reduce the possibility of human error, Tutela has safeguards built into its alarm systems. Exemption alarms are notified immediately by Tutela staff to site operatives who have to follow a set, web-based procedure; this requires them to work on-line and identify themselves with a pin-code and electronic signature, acknowledge receipt of the alarm and then report on action being taken to protect the product, also recording temperature changes and the time the cabinet returns to optimum.
Further benefits are that the system is geared to identify and report any repeat failures of equipment and all calls are recorded for additional audit trail and back-up security. The system can be expanded at any time and it can be accessed by approved users from anywhere in the world.
A significant feature is speed of response. A service operator will quickly call any number of contacts once an alarm has sounded, day or night, to provide customers with enhanced control over physical and perishable assets.
On-site installation is simple. Any number of distributed remote-sensing modules are connected to a smart control box that utilises a private worldwide global positioning radio frequency to link with a dedicated website at the Tutela alarm monitoring centre. An option with the control box is to have a simple local viewing panel that shows the status of the system.
The system can be fully maintained or self-installed and full system training and support can be provided for the duration of the contract.
Benefiting from its American experience, Next Systems has established a Tutela Division specifically to serve the medical profession. It plans to roll out the service through manufacturers, distributors, hospitals, pharmacies and individual general and private practices.