As in the case of medicinal products, the EU legislature has placed great emphasis on minimising the risks associated with the use of a medical device. However, notwithstanding the fulfilment by the relevant operators of all requirements and compliance with strict rules taking into account, inter alia, the carrying out of a device-specific conformity assessment procedure, the maintenance and use of the device in accordance with the manufacturer's intended use and the assurance of the manufacturer or authorised representative that the device does not cause health and safety risks to users, a medical incident may occur in connection with the use of a medical device.
Referring to the provisions of European Union law, the Act of 20 May 2010 on Medical Devices (Journal of Laws of 20 May 2010) provides for the adoption of a directive on medical devices( U. of 17 June 2010, as amended. zm.) regulated the definition of a medical incident as follows, considering each:
- a malfunction, defect, deterioration in the characteristics or performance of the device, as well as an abnormality in its marking or instructions for use which may or may have led to the death or serious deterioration of the health of the patient or user of the device or, in the case of an in vitro diagnostic medical device or in vitro diagnostic medical device, indirectly another person, or
- a technical or medical cause related to the characteristics or performance of the device which may or may have led to the death or serious deterioration of the health of the patient or user and, in the case of an in vitro diagnostic medical device or in vitro diagnostic medical device, indirectly to another person, and leading, therefore, to external safety corrective action taken by the manufacturer.
In view of the serious effects on human health caused by a medical incident, precise regulations have been introduced to prevent and report these incidents. Under the Medical Devices Act, a long list of entities that have been required to report such incidents occurring on the territory of Polish to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products may be presented. They are therefore required to do so, in particular:
- the manufacturer;
- an authorised representative of the device;
- the person responsible for placing the medical device on the market;
- healthcare facilities;
- research laboratories;
- R&amp;D units;
- medical staff;
- inspection bodies cooperating with the President of the Office;
- entities conducting an external evaluation of the quality of work of diagnostic laboratories;
- repair, service, maintenance and calibration service providers;
- any entity that has been informed of its occurrence.
Any notification of a medical incident shall be made on the medical incident report form, which shall in particular contain the following information:
(1) the date and place and description of the medical incident and its consequences;
(2) the name and address of the manufacturer and authorised representative;
(3) the name and address of the supplier of the device;
(4) the trade name of the product;
(5) the generic name of the device;
(6) serial or factory number or batch or batch number of the device;
(7) the number of the notified body next to the CE mark;
(8) the name of the person reporting the incident or the name of the person reporting the incident and the name of the reporting person on behalf of that entity;
(9) address data enabling contact with the entities and persons referred to in point 8, including telephone number and, where possible, fax number and e-mail address.
In addition to the manufacturer (or his authorised representative) with general responsibility for the device, the Act indicates that the importer and distributor are required to cooperate with the President of the Office as well as other relevant entities in matters relating to the safety of devices in order to avoid or eliminate the risks posed by devices which place on the market, put into service, supply or make available. They shall also be required to participate in the safety activities of such devices, in particular to receive information from users and patients on the risks posed by devices and to communicate them without delay to the manufacturer or authorised representative and to the President of the Office, to carry out the safety measures envisaged by the manufacturer and to ensure that, while they are responsible for the device, the conditions for its safeness and transport do not adversely affect its compliance with the requirements laid down by law.
An entity which, contrary to the above obligation, does not report a medical incident or does not cooperate with the President of the Office (or any other legal entity) or does not notify the President of the Office of dangerous devices shall be subject to a fine, a penalty of imprisonment or imprisonment of up to a year. On the other hand, the law imposes a fine on anyone who obstructs the investigation of a medical incident by not providing information or making the device available for testing and evaluation contrary to the rules.
The President of the Office shall notify the manufacturer or authorised representative of the notification of the medical incident by entities other than those responsible for placing on the market and using it, and if the incident meets the reporting criteria, the President of the Office shall notify the manufacturer or authorised representative by sending a copy of the document of the medical incident report if it appears from the content of the notification that the notifier is not responsible for the device.
In the event of a medical incident being reported in the territory of Polish, the manufacturer shall always undertake an investigation. It shall then assess whether the incident reported is an event meeting the reporting criteria to the President of the Office. Currently, issues related to, among others, the issue of reporting are specifically regulated by the Regulation of the Minister of Health of 2 February 2011 on criteria for reporting incidents with devices, how to report medical incidents and activities in the field of device safety (Journal of Laws and Regulations). 16 February 2011). It should be noted that not all adverse medical device events are reported. The reporting obligation relates only to events in a medical device which together satisfy the following conditions:
(1) an incident has occurred or a situation has been identified which may pose a risk to the patient or user, in particular where the results of the device tests, the analysis of the information supplied with the device or the scientific information indicate the factor which may lead to such a risk;
(2) there is a reasonable suspicion that the event or situation may or may have caused the device;
(3) has led, may or may lead to the death or serious deterioration of the health of the patient, the user or, in the case of an in vitro diagnostic medical device, indirectly another person.
At the same time, the above-wing legal act also indicates which events are not reported and this includes, but is not limited to, an unsuitability of a device that is always identifiable and which could not be undetected by the user prior to use of the device or an event that did not lead to death or serious deterioration of health and for which it has been assessed that the risk of death or serious deterioration is very low and where such risks in the risk assessment have been identified and documented as clinically acceptable. However, in the event of any doubt as to whether an event meets the reporting criteria, it shall be deemed to meet such criteria.
Upon receipt of information on a medical incident, the manufacturer shall assess the risks associated with the devices concerned and, on the basis of the results of such an assessment, decide on the need for corrective action and on their scope. Those decisions shall then be assessed by the President of the Office, who shall review the adequacy of the measures envisaged and taken by the manufacturer in the territory of Polish and shall evaluate the manufacturer's reports and may give him guidance in this regard. Furthermore, he may, if possible, consult the manufacturer or an authorised representative to take action to clarify the causes and effects of the medical incident and to assess the design and characteristics of the device.
The Medicines and Healthcare products Regulatory Agency (MHRA) statistics from 2002 to 2004 show that medical incidents related to active and inactive implants, wheel-moving devices, monitors/incubators and other life support devices are relatively most frequently reported. On the other hand, the relatively small scale of the phenomenon in question in Poland is evidenced by data from the Registration Office, which show that, for example, in the first quarter of 2005, the Office was sent:
- 32 reports of medical incidents that occurred on the territory of the Republic of Poland;
- 1 notification did not relate to a medical incident within the meaning of the Medical Devices Act. This was a notice of defects in the products which do not have serious consequences (quality complaint);
- 144 notifications of incidents that have occurred on the territory of other EU Member States and medical devices related to these incidents are also traded or used in the territory of the Republic of Poland.