As you can easily imagine, medical devices need to undergo health checks from time to time and require regular maintenance. Who is responsible for the condition of medical devices in a particular facility? Who is authorised to carry out inspections? These and other questions will be answered in today's article. Maintenance and servicing The head of the respective healthcare facility is responsible for the proper maintenance of medical devices. The Medical Devices Act of 20 May 2010 makes it clear that equipment in a healthcare facility must be maintained and used as intended, and that employees are not allowed to use equipment that has not undergone a recent service inspection. Medical devices require maintenance, and the healthcare facility must determine, based on the manufacturer's recommendations, how often and to what extent this must be carried out and which bodies are authorised to do so. The Regulation of the Minister of Economy, Labour and Social Policy on the technical requirements for the technical supervision of the operation of certain pressure equipment of 9 July 2003, in turn, states that ad hoc inspections of pressure equipment (e.g. autoclaves, sterilisers) may be carried out by the competent technical inspection unit as part of monitoring compliance with the provisions on technical inspection. Interestingly, the Atomic Energy Act of 29 November 2000 requires certain facilities (e.g. those offering radiotherapy, X-ray diagnostics, etc.) to take preventive measures against medical radiological accidents. These facilities must also have the physical parameters of the radiological equipment checked. What is worth knowing? The healthcare facility must keep records of every maintenance, adjustment, calibration, verification, inspection, etc. of the medical equipment. The records must include the name of the facility performing the maintenance or repair, the date the service was performed, a detailed description of the service, and notes on the equipment in question. The documentation must be in writing, but the legislator has not specified a universal template.
