Fluke Biomedical highlights the importance of inspection and maintenance of infant incubators.
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Preterm baby incubator with infants, neonatal intensive therapy, neonatologist equipment
With each passing day, we see an increase in technological equipment and machinery being incorporated into healthcare systems around the globe that aim to make medical processes more seamless and efficient for healthcare providers and their patients. One such piece of high technology equipment commonly found in hospitals is infant incubators. Infant incubators are highly essential devices placed in Neonatal Intensive Care Units (NICU) to provide treatment to premature or ill newborns.
Why incubators are important
According to the World Health Organisation (WHO), the yearly estimate of preterm births is around 15 million, and the number continues to increase. Neonates are extremely vulnerable during their first few days; premature birth can result in underdeveloped organs, unstable vital signs, infections, respiratory issues, and other conditions that need treatment. To maximise chances of survival, premature infants and babies suffering from any illness are placed inside incubators. Incubators are devices that appear as rigid glass boxes or bassinets containing systems that can maintain and regulate environmental conditions (temperature, rate of airflow, humidity, oxygen concentration) inside it, creating an environment similar to that of a mother's womb.
These devices also have hand-access ports with doors that allow the healthcare professionals to give medicines and IVs to the infant when required. Incubators play a critical role in helping practitioners provide an ideal and controlled environment necessary for the infant's development and healing. The sophistication of this device makes it highly beneficial in the medical world. However, patients placed in incubators are the most fragile, which means that the parameters set for their treatment must be highly accurate, and the safety and performance of this device should be guaranteed.
Risks of an untested incubator
Suppose an incubator does not perform as it should or has a malfunction. In that case, a patient can suffer from hypo- or hyperthermia, respiratory issues, ear, vision, and even brain damage. The severity of these consequences makes it necessary to check the safety and effectiveness of each incubator according to the standards outlined by the International Electrotechnical Commission (IEC), the local national standards set by each country, or by using the manufacturer's recommendations.
Best practices for testing
Most local standards have been harmonised with the IEC standards as they are globally recognised to contain the best practices and testing procedures to use when conducting functional checks on various biomedical equipment. Furthermore, many, if not most, manufacturers base their specifications and testing procedures around the IEC standards, thus making the manufacturer's service manual an excellent resource for test protocols and recommendations as well.
In recent years, the general standards and requirements of safety and performance are used along with an addition of approximately 10 collateral standards and 60 particular standards. The IEC 60601-2-19 standard recommends basic safety and essential performance requirements for infant incubator testing. Performance testing and repeat functional checks on incubators based on these standards are necessary in every clinical setup and hospital. They can be done by following some routine practices, such as setting up a fixed number of inspections to take place annually (minimum requirement being one inspection in a year). The key to successfully preventing infant incubators from becoming faulty is to be consistent with the inspections.
Selecting and then adopting a formal standardised testing procedure based on the manufacturer's or the IEC's standard also makes the testing criteria more straightforward for the clinical engineers to follow when conducting, recording, and archiving the inspection data. Test automation hence improves the efficiency and accuracy of the entire process.
It is also vital to ensure that all basic tests are conducted, which include testing the temperature, humidity, airflow, oxygen concentration, and sound level inside the incubator.
Lastly, it is beneficial to archive each inspection result using a database system such as the Computerised Maintenance Management System (CMMS) as it helps provide long-term statistically relevant information for predictive maintenance of the incubator. This process enables the clinical engineers to save time and money as it allows them to predict when the next repair will be needed and pre-order the right parts in time for the check.
