Who is responsible for the failure of the robot's surgery? The ethical risk of surgical robots and countermeasures

In recent years, the popularization and application of robots in medical systems has made positive progress.
medical robots can be divided into four categories: surgical robots, rehabilitation robots, auxiliary robots and service robots.
surgery robot overcomes the problems of poor precision of traditional surgery, long operation time, doctor fatigue and lack of 3D precision vision, which not only brings better clinical return to patients, but also shortens the learning curve of doctors for complex surgery.
, the rapid growth of the surgical robot market, financing mergers and acquisitions hot in recent years, the global medical robot market has grown rapidly, of which the largest scale of surgical robots, and maintain a rapid growth rate.
market for remote-controlled surgical robots will reach $6.6 billion by 2019.
addition, financing mergers and acquisitions in the global surgical robot sector continue to maintain a high degree of heat, 2019 is the year of the surgical robot industry financing outbreak, financing of large amounts of mergers and acquisitions frequent events.
February 2019, Ethicon, a subsidiary of Johnson and Johnson, bought Auris Health and its FDA-certified Monarch surgical robot for $3.4 billion, making it the largest medical robot acquisition to date.
's Monarch Platform robotics, which is currently used for bronchoscopy diagnosis and treatment, will play an important role in Johnson and Johnson's lung cancer program.
August 2019, Siemens Medical acquired Corindus Robotics, a surgical robot company, for $1.1 billion.
CorPath telestrual robot, developed by Corindus for interventional therapy, is the first FDA-approved medical device to assist in the coronary artery interventional therapy (PCI) procedure, helping doctors improve accuracy when placing stents.
September 2019, Steck acquired MobiusImaging and its subsidiary Cardan Robotics for $500 million.
Szczyk acquired Mobius's Airo CT mobile diagnostic imaging equipment, as well as Cardan Robotics' Orian surgical robot, with which it performs endoscopic spinal surgery, giving it the ability to provide one-stop solutions from imaging to navigation to surgical robots.
from the domestic point of view, the application of surgical robots is becoming more and more popular.
the introduction of the first Da Vinci robot from the PLA General Hospital in 2006, the U.S.-owned Intuitive Operations has a monopoly in the Chinese market.
in order to break the monopoly situation of foreign enterprises, in recent years, the domestic Tianzhihang, Weigao, Boshi, Park Huiweikang, Crafty, Szherui and other representative enterprises have entered the track.
figure 1 2013-2019 domestic hospital da Vinci surgical robot installed data source: Firestone creation according to public information finishing II, surgical robots face ethical risks Surgical robots for many patients to bring good news, but also face technical safety, responsibility determination, patient privacy leakage, fair benefits and other ethical risks and challenges.
technology safety risk Surgical robot as a product of emerging technology, the technology is not yet very mature, itself is difficult to avoid certain technical or design defects.
At this stage, the surgical robot is a combination of instruments, usually an endoscope (probe), knife scissors and other surgical instruments, robotic arms, micro-cameras and joysticks and other devices assembled.
current surgical robot is a surgical aid system that does not in itself have the ability to fully intelligently perform surgery from the main, but requires remote control and mechanical drive to assist the surgeon.
most worrying for patients and their families who have underwent surgery is whether they can ensure the absolute safety of the surgical robot.
although the operation robot is often debugged and calibrated for a long time before each operation, and the operation is carried out by experienced surgeons, it is still difficult to ensure that the operation of the robot is safe.
Surgical robot in surgery directly act on an organ in the patient's body, it does not have the ability to cope with special conditions of self-regulation, in the event of a safety hazard, the robot's robotic arm can not rely on clinical experience to make autonomous adjustments, and minimize injuries.
Most surgical robots are still semi-automatic co-robots in the primary stage, the stability of power systems and control systems is very high, if there is a sudden power failure restart or control system failure and other unexpected circumstances, restart reset of the surgical robot arm is likely to cause irreparable damage to the patient's body organs.
the probability of a safety accident is very low, but once it occurs, the damage to the patient's life and health is irreversible.
144 people died in nearly 600,000 operations between 2000 and 2013, according to data released by the FDA.
In addition to the fatal patients, the Da Vinci surgical robot caused burns to 193 patients by arcing or lighting during the operation; its shedding parts fell into the patient's body more than 100 times; and the number of adverse events caused by video failures or system errors was more than 800.
2. Responsibility determination risk Unlike surgeons, surgical robots do not have self-awareness and emotional input during surgery, and if a system failure occurs during surgery, which damages the life and health of the patient, it will be very difficult to determine liability after such a medical accident.
Surgical robot is a technical auxiliary system, from its operating principle, although the operating robot directly contact patients and perform surgery, but the main body of control operation is still the surgeon, the success of the operation requires the effective cooperation of doctors and machines.
accidents caused by surgical robots may be caused by surgeons' operational errors, or by product design defects or machine quality problems.
generally believe that the damage caused by the quality problems of the surgical robot itself should be the responsibility of the manufacturer, and the improper operation during the operation should be the primary responsibility of the doctor.
there are relevant legal documents in China to divide the responsibility for medical infringement, but for medical accidents caused by surgical robots, the responsibility should be borne by which party, the current law has no relevant express provisions.
similar liability determination challenges exist in other countries.
South Korea has reportedly had a case in which a South Korean entertainer used a surgical robot for a kidney removal operation that resulted in a ruptured zoophageal intestine leading to a sequelae and ultimately death.
the hospital and the surgical team were taken to court, but South Korean prosecutors said the incident had no direct contact with the hospital or the surgical team and ruled the appeal invalid.
for the new thing such as surgical robots, internationally recognized standards for medical robots have not yet been established, there are international organizations are currently carrying out relevant research, and China's relevant standard-setting is also in its infancy.
privacy disclosure risk The development of intelligent medical treatment has brought new problems to the protection of patient privacy.
need to collect, store and transmit sensitive and private information such as basic personal information, pathological information, surgical process information and biological genes for a large number of patients.
manufacturers of surgical robots, medical workers, medical institutions and related information technology departments may be exposed to this information.
management of patient information is an important link that can not be ignored in the process of surgical robot use.
In May 2018, the European Union introduced the General Data Protection Regulation (GDPR), which sets out the legality of the use of data, the right of the user to be forgotten (i.e. the user may individually request the responsible party to delete his or her own data records), the illegal handling of data breaches, etc.
China's "National Health And Medical Big Data Standards, Security and Service Management Measures (Trial)" formulated in September 2018 also put forward principled requirements for the management of medical data and patient privacy, in which Article 17 stipulates that "responsible units shall establish and improve the system of management and use of health care big data involving state secrets, and strictly manage the production, audit, registration, copying, transmission and destruction."
" 4. Fair benefit problem The research and development cycle of surgical robots is very long, high risk, high investment, lack of core talent and other issues make China's surgical robot industry has not yet formed a corresponding scale, technology and market dominated by foreign manufacturers monopoly, huge profit margins.
most hospitals in China use da Vinci surgical robots imported from abroad, which cost about $1 million and are about three times more expensive at home.
the cost of acquiring the machine itself, maintenance costs remain high.
given the existing medical conditions and level of economic development, most hospitals with conditions for the use of surgical robots are concentrated in economically developed and densely populated developed cities.
The fair and effective allocation of medical resources is essential to enable most patients to enjoy technologically advanced, high-quality medical care, ethically involving social justice and justice, if the majority of patients do not enjoy the benefits of medical technology progress, then the public will have resistance to surgical robots, thereby affecting their development.
the development of surgical robots may exacerbate the contradiction of medical resource allocation, how to carry out the principle of medical justice is a difficult problem that needs to be solved at present.
5. Challenges to the subjectivity of doctors Human beings have certain limitations in terms of brain capacity and learning ability relative to artificial intelligence.
artificial intelligence has far more learning and computing ability than human beings, its efficiency, precision and tireless advantages will be to a large extent to reduce costs, improve efficiency, is expected to gradually replace more and more people's labor.
as early as 2016, the United States famous oncologist and founder of virtual surgery Dr. Shafi Ahmed performed the world's first rectal cancer removal using virtual surgery.
millions of people watched the operation, and after the operation, Professor Ahmed declared that "it is only a matter of time before surgical robots gradually replace surgeons, and there will be no more doctors in the future surgery room where there will be endless operations from morning to night."
" AI-enabled medical robots have been playing an increasingly important role in the core medical aspects of medical imaging, auxiliary diagnosis and treatment, and the dominant position of physicians is increasingly being challenged.
surgery robot has a stronger recognition rate of patient information, higher precision and lower error rate in surgical operation, compared with surgeons have certain advantages.
application of medical AI will certainly promote the change of the existing medical model, and will also put higher demands on medical personnel.
3. Countermeasures to deal with the ethical risk of surgical robots 1.Clear responsibility for medical damage accidents of surgical robots In order to prevent and reduce the occurrence of medical damage risks of surgical robots, technical supervision and ethical supervision of surgical robots should be strengthened.
technical supervision, each surgical robot can be set up a separate code to record the robot designer, producer information;
manufacturers of surgical robots should regularly help hospitals maintain and upgrade robot auxiliary systems to reduce the risk of technical failure of surgical robots.
the operating process of the surgical robot, which can be recorded through electronic monitoring technology and can be combined with data analysis and video analysis to determine the subject of responsibility.
the ethical system, the medical and health industry should set up a special ethics committee to conduct ethical supervision of surgical robots and comprehensively assess the safety risks and ethical risks of surgical robots.
2. To strengthen the management and use of data security management data information should carry out some technical anti-leakage operations, data "anonymization" processing, encrypted storage and other measures.
For example, the patient's name, ID number, address, telephone and other information can be necessary to hide processing, electronic documents of data encryption settings, data management of the computer and network systems installed close professional encryption programs.
is essential to strengthen data security management in order to balance medical data sharing with patient privacy.
relevant responsible units should establish and improve the relevant data security management system, operating procedures and technical norms, strengthen overall management and coordination of supervision, so that relevant personnel have rules to follow, according to the rules.
in accordance with the requirements of the national network security level protection system, to build a credible network security environment, improve the critical information infrastructure and important information system security protection capabilities, effectively prevent "hackers" and other information thieves.
The use of medical big data related information in accordance with the law, strictly regulate the data access and use rights of different levels of users, establish strict electronic real-name authentication and data access control mechanism, ensure that data access behavior can be controlled and service management throughout the trace, any data breach accidents and risks can be queried, traceable to the relevant responsible units and responsible persons.
, we should step up efforts to crack down on illegal activities such as unauthorized use of medical data or illegal access to patient privacy, so as to maximize patient privacy and data security.
3. Adhere to people-oriented, clear doctor's main position Although the surgical robot has certain functions, but its own human creation and manipulation of the use, and lack of human-like emotional expression.
current surgical robots are not yet able to perform the entire operation or consultation process independently, but as an aid to doctors, doctors should play an uncontthyable leading role in the medical industry.
When choosing and using surgical robots, doctors should carefully and reasonably choose the scope and frequency of surgical robots to avoid unforeseen risks, taking into account factors such as the complexity of surgery, patient acceptance, and medical and health hardware conditions.
development of surgical robots should also go hand in hand with humanistic care, and the functions, techniques and designs of surgical robots should pay attention to details to avoid the possible negative effects of extensive human-computer interaction.
, surgical robots have revolutionized the form of surgery, changed the traditional mode of medical assistance, and improved it