Medical electrical equipment, defined by the CEI EN 60601-1 standard as “instrument equipped with an applied part capable of transferring energy towards the patient”, must be periodically subjected to electrical safety checks, be it an automatic external defibrillator or an electrosurgical knife, not only to ensure the safety of the patient but also that of healthcare workers and non-healthcare operators.
The reference standards of the CEI EN 62353 series define guidelines for verification and periodicity which differ depending on the classification of the medical electrical equipment, or the “medical electrical system”.
MET-LIFE, in addition to performing the electrical safety test service according to the applicable standards, offers the management of the fleet of devices supplied by monitoring the status of the devices and the periodicity of the checks.
Tests are preferably carried out at the customer/user site.
Some medical devices, such as defibrillators, multi-parametric monitors, electrocardiographs, neonatal incubators and others, in addition to being subjected to electrical safety tests, must also be subjected to verification of quality performance verification defined by the standards “Essential Performance”.
In fact, the devices are subjected to a series of tests with reference calibrators that simulate the patient in various critical conditions and then you evaluate the correctness of the measurements detected or, in the case of the defibrillator, the currents actually delivered.
Medical devices suitable for storing drugs, blood, plasma, tissues, stem cells and much more must be subjected to rigorous compliance checks from the moment they are installed. The international GMP (Good Manufacturing Practice) standards and the guidelines issued by the WHO (World Health Organization) indicate the parameters to be verified:
– at the end of the installation to validate and therefore approve the correct installation (IQ – Installation Qualification);
– at the first activation of the device to validate its “operability” and the actual achievement of the technical specifications (OQ – Operational Qualification);
– periodically to verify and validate the maintenance of the technical and functional characteristics of the device under real conditions of use (PQ – Performance Qualification)
According to the UNI 13306 standard, preventive maintenance is the “Maintenance performed, designed to assess and/or mitigate degradation and reduce the probability of failure of an entity”. Applied to the AED (Automated External Defibrillator), preventive maintenance results in systematic inspection, carried out by technical operators and including tests, measurements, adjustments and replacement of consumable parts, in order to keep the defibrillator in absolute operating conditions and prevent failures.