MONITORING AND VALIDATION SYSTEMS


Validating for peace of mind in healthcare facilities


Marcus Stacey-Bradbury, UK Commercial director of the Ellab Group, explains how hospitals and other healthcare facilities juggling with their finances and staffing issues can ‘maintain a safe environment, and, simultaneously, save money’, by embracing third- party mapping, calibration, and validation services for pharma fridges and freezers, and other equipment found in Central Sterile Services Departments.


The ongoing consequences of the COVID-19 pandemic have naturally focused healthcare minds on extra measures to maintain a sterile environment in areas such as storage, operating theatres, hospital wards, and morgues. To protect against bacteria like Legionella, fridges, freezers, and water systems, also need to meet environmental and healthcare standards. The less human intervention, then, the better. Maintaining effective hygiene controls in critical areas or equipment housing medical supplies on a 24/7 basis can be a headache for healthcare professionals, but failure to take appropriate action could be extremely costly. There is no hiding place from a visit by an inspector looking for a chink in procedures that could put the public at risk. Healthcare estates may be creaking under the increasing usage of their services, but in some cases hard-pressed staff are still being taken off their key duties to ensure that vital equipment is performing optimally in dry or refrigerated storage units. Many man-hours can be saved using the latest validation solutions that simplify the process of maintaining optimum conditions.


Manual intervention not an effective use of time Environmental conditions need to comply with standards and regulations associated with the storage of drugs, tissues, biopsies, blood, and so on. Manual intervention is not an effective use of time and resources when highly accurate technology is available that can automatically provide real-time reports and alerts electronically. This also frees up valuable storage space from paperwork or floppy disks. However, effective validation, calibration, and mapping, on healthcare estates goes much deeper than identifying hot spots or cold spots in storage areas or a walk-in freezer.


After donation blood must


always be stored at a temperature between 2 and 6 °C.


Ambient spaces housing everything from a catering operation to patient wards should also be monitored for safe and appropriate conditions – not to mention laboratories and operating theatres, where other factors such as airflow and humidity also come into play. Healthcare staff do not have the


time to map and validate areas and equipment to ensure the highest level of accuracy and data integrity. This is where validation technology from the likes of the Ellab Group comes into its own – qualifying protocols and executing them. Documenting the entire process provides accurate data to ensure the safety of processes, and highlights any weak links. Having the right equipment performing to its highest possible efficiency level in the right place can reduce liability – whether it’s in a warehouse, an operating theatre, or even a mortuary, which generally has to be mapped every year. Mapping identifies where the hot or cold spots are to enable effective ongoing monitoring of products and their surroundings. Before operations can be carried out, for example, all equipment has to be cleaned to prevent dirt sticking to the surface when being sterilised. The latest electronic validation


equipment ensures that steam steriliser functions are performing in accordance with current norms, and that the equipment is sterilising to the expected standards.


Wireless sensors A wireless conductivity and temperature sensor will validate the washing and disinfection processes in hospitals and other medical facilities, offering stable and highly accurate measurements within different thermal parameters such as conductivity and steam penetration. It processes the data and provides a test result electronically, saving on paper. All test results can be presented in reports, including audit trails. Organisations such as MHRA, CQC,


HTA (Human Tissue Authority), and even the FSA (Food Standards Agency), will turn up at NHS Trust premises, often unannounced, to retrieve evidence of good GDP control, and to ultimately ensure that sites remain compliant. Inspections will take place of the storage conditions for a range of items – from supplies of blood, vaccines, or human tissue, to food in hospital kitchens. All could well have been cycled through a range of temperatures. Validation can notify if monitoring


March 2023 Health Estate Journal 45


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