Technical inspections of spirometers – safety, reliability and compliance with standards
Technical inspections of spirometers – safety, accuracy and compliance with standards The spirometer is one of the basic diagnostic tools in pulmonology, occupational medicine, primary care and hospital departments. The reliability of lung function assessment, the diagnosis of obstructive and restrictive diseases and other therapeutic decisions depend on its correct operation. Therefore, regular maintenance of spirometers is not a formality, but a genuine element of patient and staff safety. Why is spirometer testing so important? During a spirometry test, the device measures very small differences in airflow and volume. Even small technical deviations can lead to the following consequences: misinterpretation of results, misdiagnosis (e.g. COPD, asthma), incorrect assessment of work capacity, problems with inspections by the health supervisory authority, the PIP or the national health service. Regular maintenance can detect sensor wear, calibration of the measuring sections, mechanical damage or software problems. How often should a spirometer be serviced? The manufacturer's recommendations and good service practice state that: A technical inspection should be carried out at least once a year, additionally after every repair, every fall of the device or if abnormal results are suspected, and even more frequently in occupational health facilities and in cases of intensive use. Scope of the technical inspection of the spirometer A professional inspection includes not only a visual inspection, but also a complete functional evaluation of the device: Standard scope of services: Inspection of the housing and mechanical components, inspection of the flow sensors and measuring path, testing of volume and flow measurement accuracy, verification of correct calibration, inspection of the electronics and power supply (battery, rechargeable battery, power supply unit), verification of communication with the computer and software, electrical safety tests, assessment of the condition of filters, mouthpieces and patient-contact parts. At the end of the inspection, the user receives a service report confirming the technical performance of the device. Standards and formal requirements Inspections of spirometers should be carried out in accordance with the applicable standards for the safety of medical devices, in particular EN 62353 – electrical safety tests after repairs and during operation, requirements of the manufacturer of the respective model, internal procedures of the medical facility. Compliance with these requirements is crucial during audits, inspections and in the event of medical incidents. Consequences of failing to carry out regular inspections Neglecting technical inspections can lead to: loss of testing reliability, legal liability for the facility, withdrawal of the device's operating licence, unnecessary repair costs due to late detection of defects. A spirometer is a precision diagnostic device that requires regular technical inspection. Regular maintenance is an investment in diagnostic quality, patient safety and the safety of the facility. It gives medical staff the assurance that the results obtained are reliable and that the device meets all technical and formal requirements.
