Healthcare facilities are required to maintain complete documentation on medical devices. The documentation must contain information on the installation of these devices, their repairs, maintenance, servicing, inspections, calibrations, safety checks, etc. This obligation is imposed by the Act of 20 May 2010 on medical devices, the Act of 29 November 2000 on nuclear law and a number of regulations. Technical device passport The technical documentation for a specific medical device is referred to as a technical passport. Companies that carry out technical inspections of medical devices are required to make up-to-date entries. The passport contains, among other things, the basic data and operating parameters of the device, as well as instructions for operation. For each inspection, maintenance, repair, calibration, etc., the company performing the work must enter the date of performance, its name, a description of the work performed and comments on the devices in question (always until the end of their service life) in the passport. The technical passport of the medical device must be kept for at least 5 years from the date on which the device is no longer used. Among other things, ultrasound devices, ECG devices, X-ray devices, inhalation devices, devices for measuring foetal heart rate, endoscopes, ophthalmic, dental and many other devices must have such a passport. It is recommended that the technical passport be kept at the place of use of the device in question and that all documentation be archived at the relevant healthcare facility. Checking the technical passport Possession of a medical passport is mandatory for every medical device in a given healthcare facility, regardless of whether it is within the warranty period or not. The technical passports of medical devices may be checked by the health supervisory authority, among others. The reliable maintenance of medical passports is in the interest of all medical facilities. This is because the passports can be used as evidence in proceedings against certain facilities.
