Medical device adverse event discovery, collection, reporting and control procedures
Chapter I medical device adverse event discovery and collection
1 medical device use unit related personnel should have received the unit and/or other relevant units organized by the monitoring of adverse events in the medical device regulations Relevant training, with medical device adverse event monitoring awareness, understanding of the use of medical equipment products, found or aware of medical device adverse events can be completely recorded, analyzed, controlled.
2 know the occurrence of adverse events of medical devices should be in accordance with the relevant requirements to the unit monitoring department report, the unit monitoring department monitor is responsible for the unit of all the adverse events of medical devices occurring in the collection and summary, and in accordance with the provisions of the record of the situation, fill out the relevant forms, such as: "Suspected Adverse Events of Medical Devices Reporting Form", and report to the Municipal Food and Drug Administration.
Chapter II of the investigation and analysis of medical device adverse events
1 should be found on the suspected medical device adverse events for investigation and evaluation. For deaths, emergencies, cluster of medical device adverse events, the reporting unit should immediately organize an evaluation team to evaluate, including: the correlation between the occurrence of the event and the medical device, the degree of harm of the event, the cause of the analysis and the control measures that have been taken; and in the completion of the evaluation of the evaluation work will be completed within 24 hours after the detailed evaluation of the opinion of a written report to the Municipal Food and Drug Administration.
2 unit monitoring department monitors should be organized in accordance with the relevant work procedures to verify the process of the "event" to understand the use of the device, the patient information, such as: the patient's condition (whether the original time suffered from a direct or indirect disease leading to the occurrence of the event, the patient's relevant signs and symptoms and a variety of inspection data, treatment, The consequences of adverse events, the time of adverse events, rescue measures, return, etc.), the use of the situation (purpose, use of the basis, whether the combined use of drugs (devices), the operation process of the use of personnel, the same or the same batch of products of other users of the situation, consumption and storage environment, maintenance and repair, the use of the period of time) and so on. If necessary, it should also be reported to the national monitoring and management department, applying for the regulatory authorities of the experts to collaborate in the analysis and discussion.
3 can be basically recognized as a medical incident should be reported to the relevant departments of the unit in accordance with the relevant provisions; can be basically recognized as a product quality issues should be reported to the local food and drug regulatory authorities in accordance with the relevant provisions of the quality of the incident; is an adverse event of medical devices should be handled in accordance with the "Adverse Events Monitoring and Re-evaluation of Medical Devices Management Approach (for trial implementation)" relevant provisions.
Chapter III Reporting of Adverse Events of Medical Devices
1 Discovery of suspected adverse events of medical devices due to the registration of the record, the report of after-sales department for follow-up and observation, and through the Medical Device Adverse Event Reporting System online report. If you do not have access to the Internet, you can report to the Municipal Drug Monitoring Center by fax, e-mail and letter.
2 For events that cannot be determined to be serious injuries, but lead to or may lead to injuries to patients, users or other personnel, should be reported.
3 Discovered and determined to be an adverse event of medical devices, should fill out the "Medical Device Adverse Event Report Form".
4 Events that lead to serious injury, may lead to serious injury or death, shall be immediately reported to the adverse event emergency response team, and to the location of the provincial (regional, municipal) medical device adverse event monitoring technical organizations.
5 "Medical Device Adverse Event Reporting Form" should be filled in the content should be true, complete and accurate, and should be consistent with the medical device instructions, registration certificates and other documents.
6 The use of units in the completion of the above report at the same time, should notify the relevant medical device manufacturers.
7 The use of units deemed necessary, can be reported to the next level, but should be promptly informed of the location of the transgression of the province (district, city) medical device adverse event monitoring technical institutions.
7 The use of units should take the initiative to cooperate with medical device manufacturers to collect information on medical device emergencies, cluster adverse events, and provide relevant information.
8 to establish and maintain the medical device adverse event monitoring records. Records should be saved to the medical device labeled after 2 years of use, but the record retention period should be not less than 5 years. Medical device adverse event monitoring records include: "Medical Device Adverse Event Reporting Form", "Medical Device Adverse Event Supplemental Reporting Form", and the discovery of adverse events, reporting, evaluation and control of the process of documentation.
9 in the discovery of suspected medical device adverse events, found and determined to be medical device adverse events, should be reported in accordance with these rules, and take the necessary control measures. According to the degree of harm of medical device adverse events, if necessary, the problematic device to take control measures such as deactivation, sealing, and report to the Municipal Drug Monitoring Center, and at the same time notify the relevant production and management enterprises.
Chapter IV Control of Adverse Events of Medical Devices
1 Discovery or knowledge of adverse events of medical devices should be timely analysis of the possible causes of the event, a detailed record of the relevant monitoring situation, timely feedback to the relevant medical device manufacturers. For the reported events, should also actively cooperate with the medical device manufacturer and the monitoring department in charge of the investigation of the reported events, provide relevant information and according to the severity of the event and the possibility of recurrence, to take the necessary control measures (such as: suspension of the use of sealing "samples" and record-keeping, etc.).
2 Knowing the administrative supervision department, medical device manufacturers for serious adverse events to take control measures, the user should be timely and actively cooperate.
3 of medical devices, sudden, group adverse events should be highly valued, in taking appropriate control measures at the same time should actively cooperate with the regulatory authorities at all levels of investigation, treatment, and in accordance with the relevant emergency plan issued by the food and drug administration departments at all levels, with the regulatory authorities, medical device manufacturers, business enterprises to respond in a timely manner.