Some requirements for medical equipment of physicians in Ukraine
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Requirements on physicians' medical equipment in Ukraine
According to the requirements of licensing conditions that regulate the medical practice carried out by individuals and healthcare facilities (hospitals, polyclinics, infirmaries, etc.) and other healthcare regulations, each doctor’s office shall be equipped with a certain list of medical devices and instruments. Such equipment may be common throughout the medical sector or may depend on the specific medical specialty.
Thus, standard lists of equipment for various doctor’s offices are determined by the Order No. 739 of the Ministry of Health of Ukraine of 31.10.2011, which approves the lists of medical equipment and devices to be used for the structural units of the consulting and diagnostic centers. The full list of equipment for doctor’s offices of various areas of expertise is available for download here.
It should be noted that these lists are not exclusive and, in certain cases, they allow for some deviations, for example, the list of equipment may be expanded.
The current law of Ukraine also provides for the first-aid kits, tonometers and other first aid equipment, which shall be available in all private doctor’s offices and medical institutions.
Information on the material and technical resources requires the specification of the equipment details such as its condition, date of manufacture and legal basis for its use. The last paragraph shall include the number and date of the equipment lease agreement or reference to ownership, if the equipment has been purchased.
The offices, which are used for medical practice, but are not directly specified in the Order No. 739 of the Ministry of Health of Ukraine of 31.10.2011, can be equipped at the discretion of the licensee taking into account the functional purpose of the office.
If the doctor’s office is equipped with the medical equipment subject to metrological calibration testing, the fact of the calibration shall be confirmed by a relevant certificate, label or other document issued by the authorized enterprise in the field of metrology, certification and standardization. Such equipment includes sterilizers, autoclaves, ultrasonic diagnostics devices and equipment for functional diagnostics, etc. Compliance of measuring equipment with metrological requirements can also be confirmed by the manufacturer’s mark.
Each of these devices is subject to its own calibration interval, which determines the calibration frequency. The lack of such calibration tests and details of the calibration certificate in the statements on the material and technical resources (Statement No. 1) may afford refusal to issue a medical license.
In any case, regardless of the calibration tests, each medical equipment has its own maximum service life. As an example of an act that stipulates such a term can be used the Order No. 158 of the Ministry of Health of Ukraine of 11.04.2005, which approves the list of equipment of the workplace of a dentist and dental lab technician. This regulatory legal act defines the service life of such equipment as an X-ray device, dry-heat sterilizer, autoclave, orthopantomograph, etc.
This article reveals only a few aspects of the legal requirements for equipment of doctor’s offices. If you want to get more extensive consultations regarding the requirements for the material and technical resources of your healthcare facility or doctor's office, don’t hesitate to contact us. Our medical lawyers will advise you on all issues, and, if necessary, assist in obtaining a medical license in Kyiv.
You may also find interesting our publications about the requirements for the structure of premises used for medical practice, as well as about the education and other requirements for doctors and other medical personnel.
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