Yang Xiaolin
Subject classification, culture, education and health management law
Source: China Hospital, No.4, 2007, page 3 1-34.
The identification and sharing of medical risks is a * * problem faced by clinical medicine, health administrative law, civil law and social security law. The comprehensive application of legal methods and evidence-based medicine methods can objectively distinguish disease risks, medical tort risks and medical development risks, so that the causal attribution of medical risk management, judicial identification of medical tort and social security application of medical risks are basically the same way of identification and sharing, so as to deal with risks with technology and system, avoid triggering new risks and promote the further development of comprehensive medical risk management.
Medical risks; Risk identification; Risk sharing; social security
Writing year 2007
main body
Medical risks need to be dealt with comprehensively. In governance, the identification of medical risks is an important prerequisite and sharing is the key. Only on the basis of identifying risks can we objectively and fairly divide the rights and obligations of relevant subjects and make them bear corresponding responsibilities, so as to realize multi-agent cooperation and coordination in various ways, and control, prevent and share medical risks.
1 the concept of medical risk
1. 1 Definition of medical risk from the perspective of hospital management
(1), "Damage during diagnosis and treatment" Medical risk refers to the uncertainty of events that may lead to loss and disability and all possible unsafe events, such as medical accidents, medical errors, medical accidents and complications.
(2) "Medical Accidental Injury Theory" Medical risk refers to the patient's physical damage caused by unintentional, accidental and unplanned medical accidents in diagnosis and treatment, which is different from medical accidents (medical errors) caused by doctors' mistakes in diagnosis and treatment.
(3) "Total Loss Theory" Duke University in the United States defines medical risk as "the possibility of suffering losses". This kind of loss can be not only the harm to patients, but also the cost of hospital's claim, including the loss of market share.
(4) The theory of "fault damage" refers to the risk of unsafe events such as death, disability, physical tissue, physiological function and mental health damage caused by medical mistakes or negligence in the process of medical service.
The above four medical risk concepts are of great significance to the medical safety management of hospitals. In order to comprehensively manage medical risks, it is necessary to redefine the connotation and extension of medical risks, so that the unified concept of medical risks can be applied to clinical medical risk control, medical tort civil litigation and social security.
1.2 Definition of medical risk from the perspective of comprehensive management
According to the theory of risk sociology, the basic characteristics of risk are objective potential, loss size and uncertainty of occurrence or not. Different fields have basically the same understanding of the concept of risk, and believe that the core essence of risk is uncertainty. However, the scope and emphasis of different research fields are different, and the definition of risk concept extension shows obvious differences. The key to define the concept of medical risk is to clarify its extension, that is, to clarify the scope, nature and content of medical damage, and to make necessary amendments to the connotation of risk according to the characteristics of this field.
(1), non-essential medical injuries Injury epidemiology defines injury as injury, which is called injury because of the transmission or interference of energy (mechanical energy, thermal energy, electrical energy, chemical energy or radiation energy, etc.). ) Exceeding the human body's tolerance, leading to tissue damage, suffocation leading to hypoxia, and stimulation leading to mental trauma. According to this definition, medical damage can be defined as: physical injury, mental trauma and corresponding property damage caused by medical behavior.
From the point of view of clinical medicine, the damage caused by diagnosis and treatment includes two situations: one is necessary medical damage, and the other is unnecessary medical damage. Necessary medical damage refers to limited damage caused to patients for diagnosis and treatment of diseases, such as skin and subcutaneous tissue damage during lumbar puncture and injection, and normal tissue and organ damage during radiotherapy, chemotherapy and surgical treatment of cancer patients. Unnecessary medical damage refers to damage that does not help to achieve the purpose of diagnosis and treatment, or even runs counter to the purpose of diagnosis and treatment. If the necessary medical damage exceeds a reasonable limit, it belongs to unnecessary medical damage.
Necessary medical damage is bound to happen. Doctors and patients can clearly foresee this situation and make limited choices. Sometimes they have no choice, even if they are unwilling, they can only accept it, which does not belong to the category of medical risks. Non-essential medical damage is in a potential state before it occurs, and whether or not the damage occurs and its size can be predicted, but it cannot be confirmed. & gt
Question 2: Definition and characteristics of medical risks. Medical risk refers to the uncertainty of events that may lead to damage or disability and all the safest things that may happen in the whole process of providing medical services to patients. Medical risk refers to the risk of unsafe events caused by medical mistakes or negligence in the process of medical service.
The characteristics are: 1, and risks run through the medical process; 2. Both doctors and patients lack correct understanding; 3. Systematic factors lead to risks.
Question 3: What is the definition and characteristics of medical insurance? Social security and medical insurance is to reimburse medical expenses. Drugs are divided into two categories: A, B and C. The proportion of reimbursement for Class A drugs is higher than that for Class B drugs, and Class C drugs are not reimbursed at their own expense.
Safe people wish you a safe life!
Question 4: What does medical care mean? Basic medical insurance is a social insurance system established to compensate workers for economic losses caused by disease risks. The medical insurance fund is established through the contributions of employers and individuals. After the insured person has medical expenses, the medical insurance agency will give certain economic compensation to avoid or reduce the economic risks caused by illness and treatment. Basic medical insurance is one of the most important types of insurance in the social insurance system. Together with basic old-age insurance, industrial injury insurance, unemployment insurance and maternity insurance, it constitutes a modern social insurance system. At present, China has established the basic medical insurance system for urban workers, the new rural cooperative medical system and the basic medical insurance system for urban residents. Among them, the basic medical insurance for urban workers is paid by employers and individual workers in accordance with state regulations, and a medical insurance fund is established. After the insured person has medical expenses, the medical insurance agency should give certain economic compensation to avoid or reduce the economic risks caused by illness and treatment. The new rural cooperative medical system and the basic medical insurance for urban residents shall be combined with individual contributions and subsidies, and the treatment standards shall be implemented in accordance with state regulations.
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Question 5: Risk of medical devices refer to three EU directives on medical devices:
In order to eliminate trade barriers among member States, the EU has gradually established a unified big market to ensure the free circulation of people, services, funds and products (such as medical devices). In the field of medical devices, the European Commission has formulated three EU Directives to replace the original member certification system, so as to coordinate the laws and regulations for putting such products on the market.
These three instructions are:
1. Active implantable medical devices directive (AIMD, 90/335/EEC) is applicable to active implantable medical devices, such as pacemakers and implantable insulin pumps. AIMD came into effect on1October 1993 1 day. The transition deadline is 1 99465438+Feb. 3 1, and it will be enforced from199565438+1Oct.
2. In vitro diagnostic equipment instruction (IVD), which is suitable for in vitro diagnostic medical equipment such as blood cell counter and pregnancy detection equipment.
3. The Medical Device Directive (93/42/EEC) has a wide range of applications, including almost all medical devices except active implantable and in vitro diagnostic devices, such as passive medical devices (dressings, disposable articles, contact lenses, blood bags, catheters, etc.). ); And active medical devices, such as nuclear magnetic resonance vibrator, ultrasonic diagnostic instrument, infusion pump, etc. The directive came into effect on June 1 995+1October1day, the transition deadline was June 1998, and the implementation time was June 1998 to June 14.
The above directive stipulates that only medical device products with ce mark can be sold in the EU market after the directive is formally implemented.
When selling products to the EU market, China medical device manufacturers and exporters must abide by the above instructions and affix the ce mark, otherwise it will be difficult for products to enter the EU market.
Basic requirements of medical device instructions
The basic requirements described in MDD Appendix I include general requirements related to design and structure. According to the intended use, products must meet the basic requirements applicable to them. This must be proved by corresponding tests. The product meets the basic requirements, that is, meets the requirements of the manual. The simplest way to meet this requirement is to adopt the coordination standard formulated by CEN and CENELEC. CEN and CENELEC standards are mostly formulated with reference to international standards.
EU standards are not mandatory, because other methods can usually be used to prove that the basic requirements of its directives are met. However, adopting uniform standards will bring great benefits to manufacturers. As long as the manufacturer's products meet the requirements of the corresponding coordination standards, they are considered to have met the basic requirements. It must be pointed out that the so-called harmonized standards refer to those European standards published in the official magazines of the European Union.
The main contents of MDD basic requirements are summarized as follows:
general requirements
-Must be safe;
-It must be designed and manufactured in accordance with currently recognized technologies;
-Expected performance must be achieved;
―― The safety and performance of products must be guaranteed within the specified service life.
-Appropriate transportation and storage requirements must be specified;
Considering the degree of danger that the design and manufacture of medical devices may bring to human body, medical devices can be divided into the following four categories:
First-class low risk
Level IIa is low to medium risk.
Level IIb medium risk
Three-level high risk
The classification description is as follows:
Level 1 low risk is defined as follows:
A non-invasive device for transporting, storing or injecting blood or body fluids.
B. Non-invasive devices that come into contact with injured skin to stop exudates.
C temporary use of invasive devices shall not exceed 60 minutes.
D use invasive devices from the mouth to the throat and from the ear canal to the eardrum in a short time of not more than 30 minutes.
E. reusable surgical instruments
F. Invasive devices implanted in teeth for a long time
G. active devices not belonging to class II
Non-sterile medical devices, such as examination gloves, latex gloves for examination, bandages, operating tables, operating lights, artificial limbs, wheelchairs, electric scooters, cold and hot compress bags, medical devices, etc.
Medical instruments that need sterilization, such as surgical sterilization gloves, knives, OK tension, etc.
Level IIa low to medium risk, defined as follows:
A. Non-invasive devices for transporting, storing or injecting blood and body fluids ............................................................................................................................................................ >
Question 6: The meaning of risk There are roughly two definitions of risk: one focuses on the uncertainty of risk; Another definition emphasizes that risk is expressed as the uncertainty of loss. If the risk shows uncertainty, it means that the risk can only show loss, and there is no possibility of profiting from the risk, which belongs to the narrow sense of risk. The uncertainty of risk shows that the result of risk may bring loss, profit or no loss and no profit, which belongs to generalized risk, and financial risk belongs to this category. Risk and income are directly proportional, so generally speaking, aggressive preference for high risk is to obtain higher income, while prudent investors focus on security considerations.
Question 7: What is the definition of β coefficient? What kind of risk is beta coefficient used to measure? Beta coefficient is a measure of the impact of a single asset's risk on market portfolio risk, and correlation coefficient is the correlation degree of asset risk in the portfolio.
Question 8: What medical income does the hospital's medical income and expenditure include, that is, the income obtained by the hospital in medical service activities, including outpatient income and hospitalization income? 1. Outpatient income refers to the income obtained from providing medical services for outpatients, including registration income, examination income, laboratory income, treatment income, operation income, sanitary materials income, drug income, pharmaceutical service fee income and other outpatient income. 2. Hospitalization income refers to the income obtained by providing medical services for inpatients, including bed income, examination income, inspection income, laboratory income, treatment income, operation income, nursing income, sanitary materials income, drug income, pharmaceutical service fee income and other hospitalization income.
Medical expenses, that is, the expenses incurred in the process of carrying out medical services and auxiliary activities in hospitals, include personnel expenses, expenses of medicines and sanitary materials consumed, depreciation of fixed assets accrued, amortization of intangible assets, withdrawal of medical risk funds and other expenses, excluding depreciation of fixed assets and amortization of intangible assets formed by financial subsidies and income from science and education projects. Among them, personnel funds include basic salary, performance salary (allowances and bonuses), social security contributions, housing accumulation fund, etc. Other expenses include office expenses, printing fees, water charges, electricity charges, post and telecommunications fees, heating fees, basic management fees, travel expenses, conference fees, training fees, etc.
Question 9: What do the numbers on the instrument mean? Is the patient dangerous in this situation? Please ask a friend who knows professional medical knowledge to help, thank you! It is difficult to judge the parameters of the monitor, but I can tell you that the first line of green shows ECG and heart rate, the second line of blue shows pulse oxygen saturation, the third line of yellow shows respiratory rate, and the fourth line of red shows noninvasive blood pressure.
At present, according to the data displayed on the monitor, there are tachycardia, hypoxia (both low oxygen saturation and high respiratory rate indicate hypoxia) and hypertension. The specific reason depends on the patient's own situation and examination. But look at the current oxygen saturation and respiratory rate, if it is not a device error, it must be intervened.