I. Classification of Adverse Events
1. Adverse Drug Event
Definition in SFDA: Adverse Drug Event (ADE) and Adverse Drug Reaction have different meanings. Generally speaking, ADR refers to a reaction whose causality has been established, while ADE refers to a reaction whose causality has not been established.
It often appears in foreign drug instructions, this reaction can not be sure that the drug is caused by the reaction, need to be further evaluated. The international definition of an adverse drug event is that it is an adverse clinical event that occurs in the course of drug therapy and is not necessarily causally related to the drug.
2, medical device adverse events
Medical devices, as products of modern science and technology, have been widely used in the prevention, diagnosis, treatment, health care and rehabilitation of diseases, and have become an important diagnostic and therapeutic means in the field of modern medicine. However, like drugs, the use of medical devices also has certain risks.
Therefore, it is very necessary to monitor and manage the reporting of adverse events of medical devices to maximize the control of potential risks of medical devices and to ensure the safe and effective use of medical devices. Adverse event of medical device is defined as any harmful event not related to the expected use effect of the medical device that occurs under normal use of the approved and qualified medical device that causes or may cause human injury.
3, nursing adverse events
Adverse events in nursing scholars have put forward their own views. American scholars define it as: an injury caused by nursing care that prolongs a patient's hospital stay, causes a disability, or both.
Domestic scholars believe that adverse events in nursing care refers to nursing-related injuries, in the process of diagnosis and care of any possible impact on the patient's diagnosis and treatment results, increase the patient's pain and burden and may cause nursing disputes or accidents.
Two, the grading of adverse events
1, the first level of adverse events
means that has occurred, resulting in the patient's death, disability, tissue and organ damage leading to functional impairment, aggravation of the condition, delayed recovery of the event, or one of the following circumstances, namely, nursing fault behavior caused by the effective complaints or disputes, outbreaks of hospital-acquired infections, the surgical identity part of the identification of the wrong body, the body of the remaining surgical instruments, patient's death due to accidental events.
2, secondary care adverse events
means that has occurred and increased the patient's pain, but the patient's condition and treatment results have no impact on the event, and the degree of harm to the patient of the event is divided into no harm, mild harm, moderate harm and heavy trial harm. In addition to the above 10 categories of situations in addition to 8 and 9 categories of situations, other situations that have occurred and involved patients but have not yet reached the first level of nursing adverse events are included in the scope of this level.
3. Level 3 Adverse Nursing Events
Refers to hidden events, which are events where the adverse event did not actually occur or the event did not involve the patient due to inadvertent or real-time interventions, or events caused by non-nursing behaviors (e.g., public **** facility events, medical equipment and device events).
Expanded Information:
. p>Adverse event monitoring methods:
1, manual monitoring
Mainly focusing on the reporting and management of adverse events that have occurred, including active reporting and non-active reporting in two forms. Generally speaking, manual monitoring methods are able to monitor all types of adverse events. Due to the arbitrariness and time-consuming and laborious nature of these monitoring methods, their clinical use is limited, but they are useful for research.
2, composite monitoring mode
With the development of information technology and the improvement of electronic monitoring methods, computerized monitoring has been gradually introduced to form a composite monitoring mode combining electronic monitoring and manual monitoring, which is accurate, efficient and low-consumption.
3, fully automated monitoring system
In the clinical, some adverse events can not rely on the judgment of health care personnel, through the completely quantitative way to make a judgment, therefore, can be used to fully automated monitoring system without human intervention.
4, adverse event reporting system
Adverse event prevention and management of another powerful measure is the formation of the adverse event reporting system, the World Health Organization's Alliance for Patient Safety in its 2005 guidelines clearly proposed that each hospital should establish a comprehensive adverse event reporting system, and make it networked.
Through such a system, not only can all kinds of adverse events be detected and dealt with in a timely manner, but also lessons can be learned from the adverse events that have already occurred, so as to avoid similar mistakes from happening again.