The technical passport is a document in which current entries are made about the installation, maintenance, calibration, repair and other activities carried out on a specific medical device. Every medical device used for medical diagnosis and treatment should have such a passport. What else is worth knowing about this document? Technical passport: Which devices are affected? A technical passport must be available for every medical device, whether under warranty or after the warranty period has expired. Healthcare facilities are legally required to keep technical passports for at least 5 years after the device in question is no longer in use. Which medical devices specifically must have their own passport? These include, among others, treatment, surgical and germicidal lamps, medical scales, foetal heart rate monitors, inhalers, audiometers, spirometers, ECG, ultrasound and EEG devices, dental units, ultrasonic cleaners, inhalers, ophthalmic and dental instruments, X-ray machines, autoclaves, endomotors, etc. The technical passport for the device in question should be kept at the place of use, and all documentation should be archived at the relevant healthcare facility (for at least the above-mentioned 5 years after the device is no longer in use). Data in the technical passport Entries in the technical passports of medical devices may only be made by an authorised medical device service centre. For each maintenance, repair, software update, inspection, etc., the service provider enters the date and name of their company. However, that is not all. The entry must contain a detailed description of the activities performed as well as important comments from the service technician regarding the device in question. The technical passport can be checked by the competent authority and can also serve as evidence in a case of medical malpractice. When purchasing a new medical device, the technical passport is usually supplied with the device. For older devices that are already in use, the passport must be kept by the healthcare facility that owns it.
