Luo Hansheng, deputy director technician, was the director of the Medical Equipment Division of Hubei Provincial People's Hospital. He is now a hospital-level researcher. He has been engaged in medical device maintenance and management for more than 30 years and served as the fourth medical device of Wuhan Medical Association. Chairman of the professional committee.

On November 16, 2014, Luo Hansheng just returned to Wuhan from Beijing to participate in the China Medical Equipment National Industrial Development Conference. This conference has a topic of “breaking the monopoly of China's medical equipment after-sales service”. This issue is a hot topic in the conference. .

Nowadays, the after-sales service of foreign medical equipment manufacturers monopolizing imported medical equipment has become an indisputable fact. "I and many of my colleagues have been rushing for this thing for many years, but there has been no major progress. Now I hope that everyone can unite and use current regulations to break the monopoly of foreign medical equipment manufacturers in equipment after-sales service." Luo Hansheng accepts The Daily Economic News reporter said in an interview that in fact, the entire medical institution is the victim of this matter, and the people are the biggest victims.

Does the manufacturer set the background password?

In Luo Hansheng's impression, foreign medical device manufacturers did not have the after-sales service of monopoly equipment. In the 1990s, he participated in two overseas trainings invited by manufacturers, and important documents such as equipment circuit diagrams and maintenance guides were also included. “I have been in the equipment department before, and the machines in the hospital are maintained by our department.”

In 2000, the first spiral CT machine in the hospital failed during the warranty period. Fortunately, Luo Hansheng and colleagues have previously used equipment maintenance software to detect the failure of the preamplifier board. They quickly identified the source of the fault in more than 40 boards and switched the damaged board to the extreme edge for emergency treatment. After that, the equipment was put into emergency use after two hours. Subsequently, after the manufacturer sent a new circuit board, it completely solved the problem of the ring artifact of the machine.

However, Luo Hansheng slowly discovered that when the equipment fails, they can solve fewer and fewer problems, and they have to rely on the manufacturers to solve them. Because the manufacturer starts to set the password on the device, only the assigned engineer can enter the background system after entering the password. After some of the machine passwords were cracked, the manufacturer changed to a dynamic password. Moreover, the supplier does not provide key information such as technical specifications when delivering the equipment, so that the equipment department has no way to study the internal structure of the machine.

“Without this information, our equipment department colleagues and third-party maintenance personnel are very difficult to do.” Luo Hansheng said that repairing a medical device must meet four conditions, maintenance materials, tools, original accessories and professional skilled workers. But now manufacturers do not provide information or train hospital engineers, and it is difficult to find circulating repair parts on the market.

Lin Gong, a medical equipment maintenance company in Guangzhou, said that even a professional maintenance organization can hardly crack dynamic passwords. It can only obtain passwords from the inside of the factory in some non-public ways. "The manufacturer's sales network will be divided into regions. We sometimes find ways to cross the area where the machine is located, and find friends from other areas to get the password."

Lin Gong bluntly said that this is an unconventional route, which requires some fees, and it is not always possible to pass. For medical institutions, it is the most important thing to solve the faulty machine in the first time, so they don't dare to pick up the repair work of some advanced equipment. "The top three hospitals have many patients, and there are many foreign patients. If a machine fails, the hospital thinks about how to fix the machine quickly. Based on this, we usually recommend that the hospital directly look for the manufacturer."

Application regulations break the monopoly of ice

"In fact, it is not difficult to break the after-sales monopoly of foreign companies. China has laws to follow, but they have exploited the loopholes in supervision." Luo Hansheng said helplessly, although medical equipment suppliers provide medical equipment to users is a kind of Commercial conduct, but must strictly comply with national standards for the safety of medical devices.

The Regulations on the Administration of Medical Device Manuals and Labels (hereinafter referred to as the “Regulations”) promulgated by the State Food and Drug Administration in 2014 states that all medical devices sold and used within the territory of the People's Republic of China shall be accompanied by instructions and in accordance with the requirements of the Regulations. label. The medical device manual refers to the technical documents produced by the medical device registrant or the filer and provided to the user with the product, covering the basic and safe information of the product, and guiding the correct installation, debugging, operation, use, maintenance and maintenance.

Article 10 of the Regulations stipulates that medical device instructions shall comply with the relevant requirements of national standards or industry standards, including product performance, main structural composition or composition, scope of application, installation and use instructions or illustrations, product maintenance and maintenance methods. And other specific content. At the same time, in order to ensure the correct installation and use of the operator, the user should also include the product installation instructions and technical drawings, circuit diagrams, the environmental conditions necessary for the correct installation of the product and the technical information to identify whether it is correctly installed.

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