MONITORING AND VALIDATION SYSTEMS


in an area is extremely useful data. Healthcare facilities are required to


meet very strict legislation relating to temperature, humidity, CO2


, air flow, and


differential pressure, across almost every stage. Exactly how do these regulations apply in different environments such as fridges, freezers, cryogenic chambers, laboratory incubators, and cleanrooms, to name just a few? Where are systems most likely to fall down?


As drugs and medicinal products become ever more sophisticated, so the demand for more precise monitoring increases.


equipment is not running efficiently because it needs servicing. The earlier that a problem is identified, the quicker it can be rectified, and issues avoided. To prevent the conditions that can


help Legionella bacteria to thrive, putting patients, particularly, at risk, regular monitoring of the temperature of water systems in a building can minimise the risk to people. Harnessing the services and expertise of a third-party expert with the latest mapping and calibrating sensor technology is much more cost-effective, accurate, and safe, than Estates & Facilities staff putting a temperature recorder into a water tank once a day. Monitoring hot water storage, and the equipment associated with the system – such as pumps, heat exchangers, showers, and the other constituent parts – is essential. The water temperature in the key parts of the system should be between 20 and 45 °C.


Prevention of overheating in patient areas Climate change is having an impact on healthcare estates across the UK. For example, drugs that need to be stored at between 15 and 25 °C are now exceeding this on a regular basis. Ten years ago, 25 °C might have been breached two or three times a year, but this is now happening two or three times a week. This is where validation and mapping, followed by environmental monitoring, can drastically reduce the risks associated with storage areas.


Rising temperatures in wards can lead to


patients becoming too warm and getting dehydrated. Regular mapping, validation, and ongoing monitoring, can contribute to good patient care, especially if wards have drugs stored in fridges or freezers on site. An effective ward temperature monitoring system can ease stress on frontline staff, and play an integral role in improving patient safety. Ward temperatures should be


comfortable. If cold air from air- conditioning interacts with extremely warm air, this could result in a breeding ground for bacteria. Managers must think about the risk to patients, even down to the catering. Hot food should be delivered at a temperature above 63 °C, but there is also a need to monitor cold food – you don’t want out-of-date coleslaw or a limp lettuce harbouring bacteria, and potentially putting patients already in a weakened state at even greater risk.


Matters of life and death At Ellab we have also seen a surge in enquiries for environmental monitoring equipment for mortuaries. During the height of the COVID pandemic some hospitals were reaching their capacity due to the surge in deaths, and had to set up temporary morgues to relieve the pressure. It goes without saying that dead bodies must be kept cool. Whether in hospitals or other end-of-life facilities, mortuary rooms should be mapped, and equipment validated and calibrated regularly to meet the guidance of between 2 and 6 °C. Knowing where the hot and cold spots are


Forewarned is forearmed One of the main benefits of mapping or validation solutions in a fridge, freezer, or warehouse, is that they can help catch potential errors early to initiate emergency protocols. Validation is required at least annually, or when there have been major changes. While having the right equipment to do the job can be a science in itself, it doesn’t have to be complicated, with reliable products such as data loggers and interchangeable sensors. Correct on-site calibration ensures no downtime, and that the process is kept under perfect control. Take blood bank refrigerators. After


donation blood must always be stored at a temperature between 2 and 6 °C. If the product goes beyond the upper limit for 30 minutes it is unusable, while below 2 °C the red cells become haemolysed and could freeze. At around £125 a unit for ‘O’ negative, a door left ajar on a fridge or freezer could prove very costly.


Reducing paperwork When it comes to mapping, there is a requirement in the NHS to map fridges and freezers, whether they are under the counter, benchtop, or walk-in. This should typically be undertaken annually during summer and winter. Highly innovative technology is now available where any compromised conditions trigger both immediate alarms, and comprehensive data generation, analysis, and reporting, that will keep the authorities happy and significantly reduce paperwork. A Trust could have multiple clinical departments – cardiology, pathology, oncology, gynaecology, haematology, microbiology, nephrology, neurology, ophthalmology, rheumatology, and urology, to name just a few. Then there are A&E, Critical Care, maternity departments, HDUs, and laboratories, as well as GPs’ surgeries and dentists, to name just a few others likely to be reliant upon temperature-sensitive technology. Let’s not forget catering facilities for the public, food in kitchens, or Central Processing Units where patients’ meals are prepared, pharmacies, and, of course, the morgue.


The Ellab data logger ‘family’ of products. 46 Health Estate Journal March 2023


Validation and calibration software There is reputable validation and calibration software that combines all equipment systems into a single platform. A combination of data loggers and


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