MONITORING AND VALIDATION SYSTEMS
traditional thermocouple systems ensures full data integrity, giving staff more control, and reducing the amount of time spent downloading and checking the information, enabling them to get back to their actual job.
Reducing the risk of recalls Poor environmental conditions can also be responsible for potentially ineffective vaccines and other medicines entering the system, and the associated costly and hugely damaging risk of recall. Hospital staff are under huge pressures, so it makes sense to ease some of them by removing manual reporting from day-to- day duties, and instigating a much more effective and accountable automated system wherever possible. If, for instance, a hospital has an aseptic laboratory where it is manufacturing its own drugs, accurate validation kit is available to prove that the monitoring equipment is meeting all of the key requirements, continuously recording and storing a critical log of historical temperature data. Reacting quickly to temperature
fluctuations, rather than relying on an ‘after the horse has bolted’ type system, can also help avoid significant financial loss incurred from ruined products. A validation process has had proven success in assisting organisations execute their Installation and Operational Qualifications. With many Trusts and healthcare
facilities having to count every penny, calibrating wireless monitoring technology to ensure maximum performance can not only give early warning of pending environmental problems due to heat, humidity, and pressure deviations, but will also assist in reducing operating costs. Comprehensive calibration of high-grade instruments and measuring systems such as data loggers ensures that they are conforming to standards, and that documentation is complete.
Proof is in the pudding Highly accurate measuring devices should receive calibration regularly. It is recommended that sensors are calibrated annually, but this is dependent on the type and amount of usage of the measuring device. Regular calibration can make a significant contribution to overall product quality. It will also eliminate the need for non-essential re-work and help minimise waste.
In an ideal world, all conditions that
require monitoring will be streamlined under a single system that not only provides alerts in the event of a potential issue, but also real-time and historical information locally or remotely, or both. Effective reporting not only helps to avoid disasters, but also provides easy proof that products were kept under the correct conditions wherever they started and ended up.
The Ellab TrackSense Pro data logger combines with ValSuite validation and calibration software.
When you enter a healthcare facility, you
enter a regulated world. If there is a coffee shop it technically should be monitored. Even latex gloves and pads need to be stored within a temperature band. Tubes used for intravenous blood or drugs, or cannulas – all have a storage operating temperature. Realistically you could have a temperature monitoring system in every room, in every corridor, and every fridge across a healthcare estate, making life really easy.
Well-documented records Now, there is no excuse for every healthcare facility not to have market- leading mapping, calibration, and validation systems that provide well- documented records and data on how equipment is performing over a continuous period of time. This not only brings significant advantages in that it can save time, reduce costs, and maintain reputation – but also significantly reduces risk for patients and healthcare staff across the entire estate. With a validated system, data is logged
in spreadsheets and converted to PDF format, so is almost impossible to forge. Two signatures are required for any changes, so the authorities will know that there has been no sneaky back-room adjustment of figures in an effort to pass scrutiny.
Conclusions It’s not just the physical cost of replacing drugs or medicines that are spoiled; the human cost is almost incalculable. Think about cancer patients attending Oncology for chemotherapy treatment, for example. If the drug is not available, not only does the hospital have to re-book the appointments, but it could have an extremely detrimental effect on the health of those patients.
Marcus Stacey-Bradbury
Marcus Stacey-Bradbury is the UK Commercial director of Ellab Group. The company says that its industry- specific validation, calibration, and monitoring and control systems ‘lead the way in accuracy, radio telemetry, and software’. Marcus has particular expertise in validation and monitoring solutions for the pharmaceutical and healthcare sectors, and works with blue chip clients in those markets across the world.
March 2023 Health Estate Journal 47 As drugs and medicinal products
become ever more sophisticated, so the demand for more precise monitoring increases. There are new products continually in development, and new technologies will always emerge to help meet that demand. A single supplier of monitoring and validation equipment with the flexibility to work with multiple departments will provide benefits not just to those at the frontline of medical care, but also financially.
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