A few days ago, the Department of Medical Affairs of the Ministry of Health and the Chinese Medical Doctors Association*** co-organized the 2005 International Symposium on Medical Risk Management and Patient Safety and the first working meeting of the research on "China's Medical Risk Monitoring and Early Warning Mechanism Issues" in Beijing, where Chinese and foreign experts and participants exchanged and discussed the necessity of medical risk management, the related procedures, the evaluation and treatment system as well as the legal basis. Experts pointed out that the gradual establishment of a medical risk monitoring and early warning mechanism will be conducive to eliminating preventable errors and reducing the incidence of potential medical accidents.
Medical risks seem to have long attracted attention from the industry. The most influential research paper in this regard is the report "To Err is Human: Building a Safer Healthcare System," which was made public by the Institute of Medicine (IOM) in 1999. The healthcare system is not as safe as people expect, and a set of data disclosed in the report is now widely quoted: 44,000 to 98,000 people die from medical errors every year in the United States, more than car accidents, breast cancer and AIDS, with annual economic losses amounting to $17 billion to $29 billion. Domestic data show that the clinical misdiagnosis rate in China is around 30%, and the misdiagnosis rate of difficult cases reaches more than 40%. The survey report of the Chinese Hospital Management Association Misdiagnosis and Mistreatment Research Association shows that the misdiagnosis rate of individual single diseases is as high as 90%. Studies have shown that the clinical diagnosis and pathological anatomy diagnosis rate of compliance is about 70% to 80%, and about 20% of the patients in the pre-life of the clinical treatment received and the disease suffered almost no relationship; in the medical level, diagnosis level, the process of continuous progress in medical equipment, clinical misdiagnosis rate not only exists, and is bound to maintain a certain percentage. It is an indisputable fact that medical treatment involves risks.
At present, there is no clear, unified definition of the concept of medical risk at home and abroad. Duke University in the United States is more simple definition - the possibility of suffering damage, while the domestic more refers to the medical process of adverse phenomena. Recently, some domestic experts have made such a statement: the uncertainty of harm factors in the medical process, directly or indirectly lead to the possibility of patient death or disability is medical risk. Many studies have shown that uncertainties in the medical process are not always harmful, but only because medical personnel do not know enough about them or cannot grasp the timing of their appearance. Professor Wang Beijing, legal adviser to the First Affiliated Hospital of Peking University, puts it in a more juridical way: the uncertainties brought about by, or caused by, a medical act, or occurring after its implementation, lead to the possibility of unfavorable consequences for the patient, i.e., medical risk, which is a contingent rather than an inevitable result.
Lack of correct understanding between doctors and patients
Compared with other industries, people pay far less attention to medical risks, and there is no national regulatory mechanism for medical risks in China. The safety of the civil aviation system has always been of concern to everyone and has been the focus of social attention from time to time. In fact, after years of construction and improvement, China's civil aviation safety management system has matured, and its voluntary (confidential) reporting system for aviation safety (SCASS), as a complementary information system, has a series of characteristics conducive to the collection, analysis and feedback of information, such as independence, voluntariness, confidentiality, non-punishability, regular reporting and database processing. In a certain sense, whether or not to use airplanes as a means of transportation is optional, whereas medical care is about health, so closely related to basic life that it cannot be avoided.
Many medical school teachers have warned would-be practitioners with one foot in the hospital and one in the courtroom, but this educational legacy does not empower medical professionals with sufficient awareness of risk. In contrast, the shock of an instance is far more profound than conceptual education, and the damage and distress caused by the occurrence of risk is often irreversible. a case of a child with cerebral palsy in a dragon and phoenix baby v. a hospital for irresponsible nursing care in Hubei province in 2000, the hospital was ordered to pay 2.86 million yuan in damages, but the harm suffered by the patient and the patient is not something that can be measured by money and compensated for. In recent years, almost every medical dispute case involves medical technology, personal injury, financial compensation and even moral condemnation, and the issue of medical risk has appeared more and more frequently in the social focus. Professor Wang Beijing, editor-in-chief of China's health law magazine, believes that the main factors of medical risk are constantly changing, which is an important reason for the dilution of risk awareness among medical workers, who only have a perceptual understanding of medical risk and lack of rational understanding of it, and whose awareness of risk and the law needs to be strengthened.
In the increasing number of medical disputes can be seen, the patients and their families on the medical risk of knowledge is quite limited. The patient's lack of medical expertise, high expectations of the doctor, and insufficient communication between the doctor and the patient are some of the reasons, and the bad mood caused by the disease makes the patient and his family unable to objectively view the unsatisfactory medical results and the possible adverse reactions of the drugs and equipment. Deng Liqiang, a lawyer of Huawei Law Firm, believes that at present, patients and their families have no doubt about the diagnosis of medicine, the efficacy of treatment and the benefits brought to the patients, but they do not know enough or even ignore the fact that there are risks in the process of medical treatment. More and more patients wrongly believe that just coming to the hospital is tantamount to transferring the dangers they incur as a result of their illnesses to the hospital or the doctor.
Systemic factors leading to risks
In fact, experts are exploring the causes of medical risks as the importance and necessity of such risks become more widely recognized. Yin Dakui, president of the Chinese Physicians Association, believes that the plague, avian influenza, as well as the recent emergence of SARS, swine streptococcal infections are caused by changes in the ecological environment of the disease, human beings in the use of nature at the same time, but also in the change and destruction of nature, the ecological imbalance, atmospheric pollution, the greenhouse effect has seriously impacted the living environment of human beings, and promote the emergence of new diseases; scientific and technological development in the medical diagnosis and treatment of the level of at the same time, but also for the medical behavior of increased risk The development of science and technology has increased the level of medical treatment and diagnosis while increasing the risk of medical behavior; and the pressure of social responsibility and operation of medical institutions are also important reasons for the risk. Li Dachuan, Director of the Ministry of Health, pointed out that the industry generally believes that the limitations of medical science and the characteristics of the disease itself are the causes of risk; hospital management factors, the doctor's level of practice can not be avoided; and the factors of medicines and medical devices need to be emphasized. Wang Beijing, on the other hand, included the limitations of medical science, the status quo of recognizing diseases but not necessarily treating them, the spectrum of diseases that are constantly changing, and the individual differences of patients in the factors of nature, as opposed to human behavioral defects, including the management level of healthcare institutions, the medical staff's medical behavior irregularities, as well as the patient's expectations exceeding the current level of medical care, and the problematic behaviors of those who participate in the treatment, and so on.
Many studies have shown that systemic factors are the main cause of medical risks.The IOM report concluded that more than half of all adverse medical events are caused by preventable medical errors; most medical errors occur not because of the recklessness of the individual physician but rather because of biases in the healthcare system (e.g., lack of necessary training of the physician, long hours of work, ampoule profiles similar to those of the patient, laxity in management supervision, etc. ). Researchers believe that improving the healthcare system can prevent adverse events and ensure patient safety.
It has been reported that around 2002, four preterm infants sued a Tianjin maternity hospital for retinopathy of the retina (ROP) after oxygen therapy, and similar cases of blind children suing hospitals have been reported in Shanghai, Jiangsu, Zhejiang, and Heilongjiang. Chen Zhihua of the Beijing Bar Association's Medical Disputes Committee, who has studied many cases of ROP after oxygen therapy for premature infants, believes that although the causes of retinopathy of prematurity are multiple (including prematurity, low body weight, and inappropriate oxygen therapy, etc.), we should not overlook the systemic causes of such cases: lack of knowledge and training of medical staff and lack of relevant oxygen therapy standards; The occurrence of ROP is not always the fault of the physician, although we do not want to completely deny the individual factors of the medical staff. in April 2004, the Ministry of Health issued the Guidelines for the Therapeutic Use of Oxygen in Preterm Infants and the Prevention and Treatment of Retinopathy for medical staff to follow in their practice.
Government to play a leading role in risk management
Industry insiders believe that the improvement and refinement of management systems can have a multiplier effect on eliminating preventable errors and reducing the incidence of medical risks, and government departments exercising managerial functions are in a key position to do so. At present, some of the official or private form of exchange of experience are consciously focusing on the behavior and experience of foreign governments in the process of medical risk regulation, and then think about the corresponding role and function of our government.
It is understood that the Ministry of Health, "China's medical risk monitoring and early warning mechanism," the study has been launched in April this year, the subject of the Ministry of Health Department of Medical Affairs, led by the Chinese Medical Association, the Ministry of Health, Evidence-Based Medicine Center, Nanjing Medical University, Peking University First Hospital, Capital Medical University, and other units **** with the participation of the subject of the organization, design, research and analysis work. The launch of this project will undoubtedly make the related research scattered in various disciplines and fields more systematic and organized, and will also attract more social forces to participate in it. According to Dr. Liu Qilin, a member of the research team and a member of the Chinese Physicians Association, the research will establish a medical risk monitoring and early warning mechanism in line with China's national conditions, which will provide a scientific basis for scientific decision-making by the national health authorities and administration in accordance with the law, and the long-term goal is to set up a nationwide medical risk monitoring network on the basis of the research, so as to reduce the medical risks and improve the quality of medical care.
Wang Beijing believes that the government exercise of management functions to reduce medical risk should start from two aspects, one is the implementation of mandatory norms in the form of legislation; the second is the use of departmental regulations to regulate specific medical behaviors (such as diagnosis, nursing care work). It is understood that July 1 this year, the official implementation of the "Interim Provisions on the Management of Physicians Outside Consultation," that is, belong to the departmental regulations, "the management of the clinical application of special medical technology" is also being drafted, and the previous implementation of the "Rules for the Implementation of the Regulations on the Management of Medical Institutions," the modification of the work is underway, and more special technical access to the contents of the hospital will be included in the treatment of the subject to be managed.
In the process of reform of the medical system and the direction of the issue has once again become a social hotspot, to reduce medical risks and ensure patient safety is more operable: medical risk has been the industry *** knowledge; foreign experience and lessons learned is not lacking in reference value; medical institutions over the years of self-examination and industry associations (academic) will play the function of the government management to implement the seminar work has a relatively mature platform. The platform is relatively mature for the governmental management to implement the seminar. More importantly, more protection for patient safety and fewer or more reasonable solutions to medical disputes will help establish a harmonious doctor-patient relationship and promote the process of healthcare reform. By Ruan Cong; Xiong Guangming