The priority for each medical facility, in particular a hospital, should be broadly understood patient safety. Therefore, performing all medical procedures in a medical facility should always take place using technically appropriate equipment, ready for its immediate use in situations when the patient’s health or life is threatened in a manner adequate to the diagnosed condition of the patient or the injury he suffered.
When analyzing the functionality of medical and diagnostic devices as well as surgical instruments, there is a certain amount of risk, in which the indicated medical equipment may contain manufacturing or constructional defects. Often the abovementioned device faults are the result of human neglect and lack of compliance by the personnel using such equipment with the principles of its maintenance. The occurrence of defects in medical equipment is much more likely to be caused not by defects of a constructional nature but by the fact that medical personnel exceed the permitted periods of use of the indicated equipment or use it improperly or contrary to its actual purpose. The aforementioned problem was reflected in the content of the judgment of the District Court in Lublin from 4th April 2002., case no.: I C 656/99, which concerned a situation in which the patient suffered severe foot burns as a result of damage to the hot water bottle or an unexpected increase in its temperature.
There are indications that the liability of a medical facility should be considered in the context of the risk principle. The adoption of the principle of risk for the right kind of liability results from the assumption that a professional medical facility is responsible for the use of adequate quality equipment, properly certified and, as a consequence, safe. A patient who has been injured as a result of malfunctioning or inadequate medical equipment should be entitled to seek redress directly from the medical entity in which the patient suffered damage. In such a situation, even if there is no fault on the part of the medical facility, it is precisely on a risk basis that it should repair the damage suffered by the patient because further the medical facility is entitled to a recourse claim against the manufacturer of medical equipment. It does not seem appropriate for the patient to claim his claims directly from the seller, producer or, finally, the importer of such medical equipment.
In relation to the above considerations, it is worth paying attention to the content of the judgment of the Supreme Court from 11th May 1983 under the number: IV Cr 118/83, which concerns the issue of allowing the use of inoperative medical equipment. As evidenced by the Supreme Court judgment cited, the use of medical devices that threaten the life or health of patients by the medical facility staff should be understood directly as culpable negligence of the medical facility officers, which, as a result, based on art. 417 of the Polish civil code directly creates the responsibility of the State Treasury or a specific medical facility. It is worth noting that the problem of resolving the nature of civil liability for damages suffered by the patient is extremely important due to the wide range of possible consequences that may be caused by faulty use of medical equipment.
In the case in question, the plaintiff underwent lung surgery, during which his legs and hands were burned with a surgical instrument and – an electric knife, as a result of which he had to undergo a 5-month treatment. Despite the treatment, the scars after these burns classified as burns from I to III degree remained visible. What is important, the court determined permanent disability of a former hospital patient at 15%.
The patient filed a lawsuit against the State Treasury – owner the hospital, demanding compensation for the harm suffered and determining the liability of the defendant hospital for the future in relation to the burns suffered. The hospital presented the case to the Supreme Court indicating that it was not liable due to the fact that medical devices are subject to inspection every 4 years. The Supreme Court did not agree to this argument indicating that pursuant to art. 355 § 1 of the Polish civil code the defendant hospital bears full responsibility for proper protection of medical and operating equipment in such a way that it does not threaten both patients and medical personnel working with it. The Supreme Court assessed that the hospital did not fulfill the abovementioned obligations and, as a consequence, negligently caused liability of the State Treasury within the meaning of art. 417 of the Polish civil code.
The above argumentation of the Supreme Court seems perfectly accurate. It should also be stressed that the judgment clearly implies that the Supreme Court accepts far-reaching responsibility of medical personnel for using medical equipment that is faulty or threatens the life or health of patients. The Supreme Court acknowledges that for any defect or malfunction of medical equipment the responsibility is born directly by the staff of the medical facility in which the surgery or medical procedure was carried out. The Supreme Court separates completely the issue of the control of medical devices, the issue of the possibility of defects in the production of devices from the obligation of people working in a medical facility to exercise due diligence within the meaning of the aforementioned art. 355 of the Polish civil code. Therefore, the Supreme Court accepts an extremely broad concept of responsibility, which is characterized by a considerable dose of “rigour”.
The position adopted by the Supreme Court regarding the liability of a medical facility for the effects of using defective medical devices is extremely beneficial from the point of view of the patient’s interest. The Supreme Court’s opinion cited above deserves full approval in respect of defective or unusable equipment resulting from the lack of proper, timely inspections or maintenance.
Doubts arise only when it is necessary to decide whether the concept of such a far-reaching liability of a medical facility should be adopted also when in a given state of fact the source of defect of the medical device results only from the medical device’s production process. In such a situation, it seems reasonable to assume that liability for damage caused by the use of a faulty or unreliable medical device will rest directly on the manufacturer of such a device and not on a medical facility.
The above-mentioned issues have not yet received the well-established position of the Supreme Court, however, it should be stated that under Polish law – as in other legal systems – the liability of medical staff is usually based on the principle of guilt, which is reflected in particular under US law.
In the US law system, the courts impose on medical personnel the obligation to conduct thorough research and to carry out the selection of medical devices used in such medical facilities. The physicians are directly responsible for not fulfilling the abovementioned obligations, although hospitals bear much higher responsibility. The difference is that physicians are responsible only for easily visible and detectable defects, while the hospital’s responsibility in this area is extended also to the hidden faults of devices, eg related to structural defects and, as a consequence, the medical facilities bear a fault-based liability. It is worth noting that many times the courts recognize the occurrence of defects in medical devices as failure of the obligation to provide patients with the appropriate level of safety for medical purposes.
The fact of exempting a medical facility from liability on fault basis results in directing claims to the manufacturer of the device, responsible for faults in the production process, design defects of the device and failure to provide proper information about the product. In case of the product’s faults cause it to be treated as a dangerous product, the liability of the producer take place on risk basis.