Inspection and Testing of Mechanical Ventilators and Anaesthesia Machines

Mechanical ventilators are used in intensive care units and in operating rooms. It consists of filtering, air compression, and humidifying control board units. A mechanical ventilator is a device that combines the patient’s respiratory tract to assist the respiratory system in conditions where the patient has difficulty in breathing or after operations. The device supplies controlled air to the patient by the inner compressor. The breakdown of the oxygen sensor and the heating of the circuit boards (if the filter is not cleaned) are the most common problems in mechanical ventilators. They may not stabilize with required values over time and the tester is used to maintain stability. The device must be calibrated regularly or if the gauge of the test device does not match the standard values of gas flow, volume, pressure and oxygen parameters. The anaesthesia machine delivers pressurised medical gases like air, oxygen, nitrous oxide, heliox etc. and controls the gas flow individually. It composes a known and controlled gas mixture at a known flow rate and then delivers it to the gas outlet of the machine. Therefore, the fresh gas flow is serviced to the anaesthesia circle breathing system in order to make artificial respiration in the patient and monitor vital functions closely. For patient safety, the most important thing is to check out the system regularly and in pre-use and to ensure that there exists a ready and functioning alternative solution for ventilating the patient’s lungs. Standards and regulations for the production and post-market surveillance of medical devices, including anaesthesia devices, have been examined. Given the lack of proposed methodology for post-market surveillance of both devices, a new validated method is introduced.