Independent examination of medical equipment is one of the types of engineering technical research. In a narrow sense, it is a procedure that involves analyzing a device for compliance with the characteristics and operating standards.
Objects of analysis
In medical institutions, various types of technological equipment are used, designed to identify diseases in the early stage, medical examination, sterilization of consumable medical items, surgical interventions, etc.
The most common medical equipment includes:
- magnetic resonance and computed tomographs;
- equipment for ultrasound examinations of the body;
- X-ray devices;
- dental equipment;
- disinfection equipment;
- devices for cosmetic medical procedures;
- physiotherapeutic units;
- electrocardiographs;
- electroencephalographs;
- glucometers;
- c in some cases - various types of medical furniture (cabinets for storing medical equipment and consumables, beds for patients, chairs, etc.).
What issues are resolved by the expert?
Depending on the reason that necessitated a comprehensive analysis by a specialist from an accredited organization, the following issues can be resolved as part of an independent examination:
- Does the actual operation of the medical equipment comply with technical regulations and the product passport , if not, then what signs directly or indirectly indicate this;
- is there a dysfunction, signs of abnormal operation, if so, what is the nature of their occurrence, do they appear one-time or constantly;
- is continued operation of a medical device with defects safe for medical staff and patients;
- is it possible to carry out restorative repairs of medical equipment and, if so, at what cost, and is it advisable;
- whether there were facts of improper operation by persons authorized to work with the device, or the malfunction arose as a result of natural wear and tear;
- other questions.
Procedure examination of medical equipment
The procedure can be carried out:
- at the request of interested parties (both individuals and legal entities);
- at the request of authorized regulatory authorities ( Rostekhnadzor, Gossanepidnadzor, etc.);
- at the request of the judicial authority, which is considering a criminal, arbitration or civil case.
In this case, the customer is obliged:
- provide the expert company with unhindered access to the research object;
- hand over technical documentation (passport, operating manual, certificate of conformity, registration certificate, test report, etc.) for review;
- indicate the alleged reasons for the inoperability of medical equipment or the appearance of signs indicating freelance work.
The procedure may vary based on the reasons, the range of applicants, the type of medical equipment, but in general it represents consists of the following sequence:
- receipt by an accredited company of a request from a client orally or in writing, conducting an initial consultation;
- reaching agreements regarding the conditions, terms, place and time of the examination, its cost, in the absence of disagreements - conclusion of an agreement;
- travel to a medical organization to inspect the equipment and resolve previously raised questions, to record defects and damage using audiovisual means;
- preparation of a conclusion in in writing, containing legal justification for the judicial authority regarding the reasons for the breakdown /the circle of persons guilty of improper operation /the possibility of further use of medical equipment for its intended purpose, etc.
Reasons for applying for conducting an examination of medical equipment
Court hearings in cases directly or indirectly related to professional devices for diagnosis, examination or treatment, and independent examinations carried out within their framework, occur in connection with the occurrence of a number of events, such as:
- causing damage to the health or life of a citizen who applied for medical care due to abnormal operation of medical equipment;
- incurring losses by a medical organization of both state and private forms of ownership, in connection with the acquisition from an authorized person of a device that does not meet the stated safety requirements;
- identification by an employee of a medical institution or other person of signs of counterfeit or production of equipment by an unauthorized person;
- proof of the fact that the medical device application to
