What Is an Adverse Event?

Adverse events are defined as injuries caused by medical treatment, as opposed to the natural outcome of the disease, which extends the length of a patient's hospital stay and all events that lead to disability, including preventable and unpreventable adverse events. Unpreventable adverse events refer to unpredictable damage caused by correct medical behavior; preventable adverse events refer to damage caused by unprotected errors or equipment failure in medical treatment.

Chinese name: Adverse event
Foreign name: adverse event


Brief introduction: There are many types of adverse events, basically divided into
Adverse event: SFDA (March 28, 2008)

1. Adverse events 1. Classification

There are many types of adverse events, which can be divided into: adverse drug events and medical device adverse events and nursing adverse events.

1.1 Adverse events 1.1 adverse drug events

As defined in the SFDA (March 28, 2008):

Adverse Drug Event (ADE for short) is different from Adverse Drug Reaction. In general, adverse drug reactions are reactions with a causal relationship established, and adverse drug reactions are reactions with a causal relationship that have not yet been determined. It often appears in the instructions of foreign medicines, and this reaction is not necessarily caused by the drug, and further evaluation is needed. The international definition of an adverse drug event is: an adverse drug event is an adverse clinical event that occurs during the treatment of a drug, and it may not have a causal relationship with the drug.

1.2 Adverse events 1.2 Medical device adverse events

As a product of modern science and technology, medical equipment has been widely used in the prevention, diagnosis, treatment, health care and rehabilitation of diseases, and has become an important means of diagnosis and treatment in the field of modern medicine. However, as with medicines, the use of medical devices has certain risks. Therefore, it is necessary to monitor and manage the reporting of adverse events after the medical device is marketed to maximize the potential risks of medical devices and to ensure the safe and effective use of medical devices.

Medical device adverse event refers to any harmful event that has been approved to be marketed and qualified medical devices under normal use conditions that causes or may cause human injury that is not related to the expected use of medical devices.

1.3 Adverse events 1.3 Nursing adverse events

All scholars have put forward their views on adverse nursing events. American scholars define it as: injuries caused by nursing extend the length of a patient's hospital stay, cause disability, or both. Domestic scholars believe that nursing adverse events refer to nursing-related injuries. In the process of diagnosis and treatment, any event that may affect the patient's diagnosis and treatment, increase patient suffering and burden, and may cause nursing disputes or accidents.

2. Adverse events 2. Methods for monitoring adverse events

2.1 Manual monitoring mainly focuses on the reporting and management of adverse events that have occurred, including active reporting and non-active reporting. Generally speaking, manual monitoring methods can monitor all types of adverse events. Because these monitoring methods are relatively random, time-consuming, labor-intensive, and limited in clinical use, they are very useful for research.

2.2 Composite monitoring mode With the development of information technology and the improvement of electronic monitoring methods, computer monitoring is gradually introduced, forming a composite monitoring mode that combines electronic monitoring and manual monitoring. This monitoring method is accurate, efficient and low-cost. It is mainly used In the following areas.

2.3 Fully automatic monitoring system In the clinic, some adverse events can be judged by a fully quantified method without relying on the judgment of medical staff. Therefore, a completely automatic monitoring system can be used without manual intervention. Including the following two categories.

2.4 Adverse event reporting system Another powerful measure for the prevention and management of adverse events is the formation of an adverse event reporting system. The World Health Organization's "Patient Safety Alliance" clearly stated in its 2005 guidelines that every hospital should establish Establish a comprehensive adverse event reporting system and network it. Through such a system, not only can various adverse events be found and processed in a timely manner, but also lessons can be learned from the adverse events that have occurred to avoid similar errors from happening again. At present, hospitals in the United States, Japan, and Australia have similar adverse event reporting systems.

3. Adverse events 3. Process and content of active adverse event reporting

The reporting process greatly affects the timeliness and quality of reports. The design of the reporting procedure should be simple and convenient to prevent adverse events from being reported due to complex processes.

3.1 Incident Report Objectively report adverse events that have occurred. This method mainly draws on the treatment of adverse events in the industrial field, such as the aviation industry and the nuclear power industry. It is characterized by the fact that it is not the right thing, it is a reporting method without penalty and liability, and does not hold specific responsibilities. It is currently the most important method for monitoring adverse events in hospitals. However, it is not the most effective management method because it will interrupt the work process and subject the parties to legal punishment. However, it is still widely used because it can provide a large number of Detailed information, including how the incident happened, what catastrophic consequences it caused, how it changed, what lessons can be learned, and so on.

3.2 Immediate reporting is achieved by urging medical personnel to report the adverse events in a timely manner, that is, immediately report the adverse events to the management department. In a study in the United States, residents received emails every day reminding them to report adverse events, and they were also required to report the occurrence of adverse events during daily shifts and weekly meetings. In this way, the medical staff in each class will pay close attention to the occurrence of adverse events or even potential adverse events, so as to effectively prevent and manage adverse events.

4. Adverse events 4. Management of adverse events

4.1 Timely response to reduce losses

After receiving the report form, the Quality Control Department should investigate and communicate with relevant departments in a timely manner. Loss reduction refers not only to reducing the harm that adverse events do to patients and their families, but also to the impact on health care providers and the reputation of the hospital. When an adverse event occurs, the hospital should actively take measures to reduce the damage to the patient. At the same time, take necessary measures to appease patients and their families to prevent unnecessary conflicts. Don't just blame the medical staff concerned. Support and help should be provided, including an open attitude at the hospital level, support from colleagues, and necessary psychological counseling. The hospital should also establish a clear error discussion system, train doctor-patient communication skills, and popularize basic legal knowledge. Timely processing of adverse event reports can reduce memory ambiguity or dislocation caused by time and reduce errors.

4.2 Fair treatment, focusing on the system

The treatment of adverse events should be based on the attitude to the wrong and the wrong, and focus on the problems in the entire system rather than individuals, so as to help to find the root cause of adverse events and effectively prevent similar errors. A study of surgical adverse events in UK general hospitals revealed that most adverse events were related to improper communication. Mistakes by medical staff are rarely intentional, and system defects in hospitals are often the root cause of patient safety incidents. Therefore, treating each adverse event fairly and focusing on the system rather than individuals. Finding and solving problems from the process and system levels not only has higher benefits, can effectively prevent similar incidents from recurring, but also helps to establish a wrong discussion mechanism. Form a culture of active reporting of adverse events.

4.3 Analysis feedback, information sharing

After receiving the report, the Quality Control Department shall conduct an on-site investigation in a timely manner, and shall not adopt a telephone investigation to prevent distortion of information transmission. The method of investigating adverse events mainly adopts Root Cause Analysis (RCA). The United States JCAHO cited RCA in a hospital adverse event investigation in 1997. In recent years, the international medical community generally agrees that RCA is one of the important methods to improve patient safety, but it has not been effectively promoted in China. The root cause analysis method emphasizes finding out the proximate cause of the event in the diagnosis and treatment process, and then investigating the system cause of the organizational system and the diagnosis and treatment process. After root cause analysis, you can understand the process and cause of adverse events, and then review and improve the process.

4.4 Follow up and strengthen management

The purpose of adverse event management is to reveal the shortcomings and defects of the system. Therefore, we emphasize the need to analyze and track all events, attach importance to each small event, and prevent large problems through small events.

4.5 Continuous improvement to prevent recurrence

Risk management is a systematic, systematic and systematic process that identifies, analyzes, and handles risks in a planned, continuous manner, including two different phases: the possibility of accident prediction and impact strategies, and the measures to be taken after an accident. Risk management is divided into two main processes: risk assessment and risk control. The introduction of risk management into the management of adverse event reports is beneficial to reduce the possibility of unexpected injuries, identify risks in a timely manner, and effectively prevent adverse events. ^[1]

Summary of adverse events

With the continuous improvement of the medical adverse event reporting system. Take the initiative to report adverse events and discuss the positive, relaxed work environment in which problems exist. Actively reporting medical adverse events is also a continuous improvement and continuous improvement work. It is necessary to give full play to its preventive effect, increase incentives, strengthen protection measures, eliminate adverse factors that affect active reporting of adverse events, and maximize mobilization. The enthusiasm of employees to report adverse events, promptly identify and resolve problems, and achieve the purpose of finding hidden dangers and ensuring hospital quality and safety.