In the 21st century, the medical device industry has developed rapidly. The fields involved by the medical robot alone include ophthalmology, hepatobiliary, orthopedics, neurosurgery, otology, dermatology, rehabilitation, etc. The following is an example of the development history of the surgical robot:
1985: The first surgical assistant robot “Puma 560” in history was applied in clinic
1992: The first real medical robot ROBODOC was born
1997: AESOP (Aesop), the first surgical robot to be commercialized, was successfully developed
1998: The medical robot ZEUS (Zeus) with endoscope was born
1999: Da Vinci, known as the most successful medical robot in history by Forbes website, was successfully developed
2000: Da Vinci was certified by FDA
2001: The first remote robot surgery with ZEUS (Zeus)
……
Leonardo da Vinci, who has a free-moving arm and wrist EndoWrist, 3D high-definition imaging technology, human-computer interaction design of the console, has a monopoly on the market.
Since the birth of surgical robots, more than 4 million surgical applications have been carried out worldwide.
In China, the locally developed “Lancet Robot” will go into clinical practice, and the construction of 5G medical treatment is in full swing. Guangdong authorities report that a demonstration base combining remote surgery, AI doctors and other intelligent medical treatment will be built in 2020.
So the question is, the original intention of the smart medical project to benefit the people can be understood by most people, but once the surgical robot (part of telemedicine) is involved, do patients really dare to give their lives to it? Or it will become no choice.
Smart medical accidents occur frequently
What if the software and hardware bugs are not identified?
What if the network communication fails?
What if the data is tampered with by hackers?
A series of problems come to mind, and sometimes even become the last straw to crush patients, because the medical robot accident is not an exception after all.
In 2015, the first robot heart valve repair operation in the UK entered the “runaway” mode due to poor communication and unfamiliar operation, which not only stitched the patient’s heart in the wrong position, but also punctured the patient’s great artery, and finally died of multiple organ failure.
If you think this is an example, please look at the documentary The Bleeding Edge. The story in it is true and cruel. Esure, a permanent contraceptive device like a spiral needle, can cause uterine bleeding, but it has become various metal fragments scattered in the body when trying to take it out, which requires hysterectomy; There is a kind of metal chromium hip joint, but after a few years, it has Alzheimer’s disease due to the diffusion of chromium to the whole body; The doctor removed the uterus from the patient through the Da Vinci surgical robot, and the intestines in the body fell out when walking and going to the toilet. These sounds shocking, but they are bloody reality. In fact, according to the data of the US Food and Drug Administration as early as 2015, from 2000 to 2013, 144 patients died in Da Vinci robot surgery.
How to judge if there is a medical accident?
Accident liability: What is the average share of hospitals, doctors, robots and robot manufacturers?
Take the world-famous death event of Da Vinci’s cardiac valve repair surgery for example: the accident treatment cycle is three years long (accident time: 2015, accident hearing time: 2018), and the final result is based on human, so the chief surgeon and the hospital are mainly responsible. However, the medical device industry chain exposed in The Bleeding Edge is the culprit of this series of accidents. Thus, at the 2018 World AI Conference, a series of issues were discussed, such as “When a medical accident occurs to a medical intelligent robot, should it be attributed to technical failure, improper operation, design defects, or the error of the machine manufacturer, subjective intention, or even the autonomous consciousness of the intelligent robot.
Where does smart medicine go?
In response to the frequent occurrence of medical device accidents, the Chinese government has issued a series of laws and regulations to reduce and reduce risks, and provided a certain legal basis for accident handling, as follows:
The problems exposed during the development of medical devices are normal laws, which cannot be ignored, but more importantly, they cannot be neglected and refused to develop. Constantly update medical technical solutions, make it impossible, and bring more hope to patients, such as rehabilitation robots, behavior-assisted robots, bionic prosthetics, 3D printing skin, etc. In addition to technical improvement, health care monitoring and reminding, green channel for pre-hospital emergency treatment, simplification of medical treatment process, and online medical treatment (mainly online consultation) are all good directions. However, data security is another security risk, which needs attention from all aspects.
In short, promoting a newly developed medical device product to market does not require and cannot do too many experiments and obtain corresponding practical data. However, if you want to recall or cancel them, you need a lot of data support. When you get these data, perhaps thousands of people have implanted or used them. Therefore, our government security agencies, medical equipment companies, and medical workers in hospitals: “I would rather be slow and more careful”, but also put the patient’s life in the first place.