Foreign companies monopolize the sale of medical devices

Luo Hansheng was the deputy chief technician of the Medical Equipment Division of Hubei Provincial People's Hospital. Now he is a hospital-level researcher and has been engaged in medical equipment maintenance and management for more than 30 years. He also served as the fourth medical device of the Wuhan Medical Association. Professional committee chairman.

On November 16, 2014, Luo Hansheng just returned to Wuhan from the China National Medical Equipment Industry Development Conference in Beijing. One of the topics of the conference was “Breaking the monopoly on the after-sales service of medical equipment in China”. This topic is a hot topic of the conference discussion. .

Now, foreign medical equipment manufacturers monopolize the after-sales service of medical equipment has become an indisputable fact. "I and many of my colleagues have been working on this issue for many years, but there has been no major progress. Now I hope that everyone will unite and use the existing laws and regulations to break the monopoly of foreign medical equipment manufacturers in the equipment after-sales service." Luo Hansheng accepted the reporter During the interview, he said that in fact, the entire medical institution is the victim in this matter, and the common people are the biggest victims.

Manufacturer set up password?

In the opinion of Luo Hansheng, foreign medical device manufacturers did not monopolize equipment after-sales service. In the 90s of last century, he participated in two overseas training invitations for manufacturers, and important documents such as equipment circuit diagrams and maintenance manuals were also included. "I used to be in the equipment department. The size of the hospital is maintained by our department."

In 2000, the first failure of a hospital in the hospital during the warranty period of the spiral CT machine. Fortunately, Luo Hansheng and colleagues had previously used the 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 replaced the damaged circuit board to the edge for emergency treatment. After two hours, the equipment was put into emergency use. Subsequently, after the manufacturer sent a new circuit board to replace it, it completely solved the problem of ring artifacts.

However, Luo Hansheng slowly discovered that when the equipment fails, they can solve fewer and fewer problems and have to rely on the manufacturers to solve the problem. Because the manufacturer starts to set a password on the device, only the designated engineer can enter the background system after entering the password. After some of the machine passwords were cracked, the manufacturers changed their dynamic passwords. Moreover, suppliers no longer provide key data such as technical specifications when they deliver the equipment, so that the equipment section cannot study the internal structure of the machine.

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

Lin Gong, a medical equipment repair company in Guangzhou, said that even professional maintenance organizations can hardly crack dynamic passwords, and they can only rely on non-public methods to obtain passwords from manufacturers. "The manufacturers' sales network will be divided into regions. We sometimes think of ways to cross the area where the machine is located and find friends in other areas to get the password."

Lin Gong bluntly stated that this is an unconventional route that requires some expenses and that it does not pass every time. For medical institutions, it is the most important thing to be able to solve the faulty machine in the first place. Therefore, they do not dare to easily access the maintenance work of some advanced equipment. “There are many patients in the top three hospitals, and there are many foreign patients. If a machine fails, the hospital thinks of how to quickly repair the machine. Based on this, we usually recommend that the hospital directly to the factory.”

Applying Regulations to Break Monopoly Ice

"Actually, it is not difficult to break the monopoly of foreign companies. China has laws to follow, but they have drilled loopholes in supervision." Luo Hansheng reluctantly stated that although medical equipment suppliers provide medical equipment to users is a kind of Business conduct, but must strictly abide by the national standards for the safety of medical equipment.

The “Administrative Regulations on Medical Device Specifications 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 requirements in accordance with the "Regulations." label. Medical device manual refers to the basic information produced by the medical device registrant or filer, provided with the product to the user, covers the product's safe and effective, and is used to guide the correct installation, commissioning, operation, use, maintenance, and maintenance of technical documents.

Article X of the "Regulations" stipulates that medical device manuals shall comply with relevant requirements of national standards or industry standards, including product performance, major structural composition or composition, scope of application, instructions for installation and use, or diagrams, maintenance and maintenance of products. And so on. At the same time, in order to ensure the correct installation and use of operators and users, it should also include product installation instructions and technical drawings, circuit diagrams, environmental conditions necessary for the correct installation of the product, and technical information for correct installation.

Luo Hansheng is facing a violation of the rules and regulations of medical equipment manufacturers. He believes that when it comes to the sale of imported medical devices, suppliers generally do not comply with the provisions of 6.8 (mandatory standards) in the “National Standards Law of the People's Republic of China” (GB9706.1-2007/IEC 60601-1:1988). The issue of providing "technical specifications" to the end-users in random documents has been suspected of violating Article 42 of the Regulations for the Supervision and Administration of Medical Devices.

"We must use the current laws and regulations to open up the monopoly of imported medical equipment after-sales service." Luo Hansheng said that in recent years he has repeatedly reported to the Hubei Province, Wuhan Food and Drug Administration and other regulatory authorities, and has also obtained Positive response.

For this issue, a provincial food and Drug Administration Director said that the supervision of the food and drug supervision department for medical devices should refer to the "Medical Device Supervision and Management Regulations" to ensure the safe and effective use of medical equipment. "We have a record of medical devices, registration management, and management of product specifications and labels."

The reporter found that the new version of "Regulations on the Supervision and Administration of Medical Devices," Chapter 27 of the second chapter found that medical devices should have instructions, labels, which should indicate the installation, instructions, maintenance and maintenance methods. The aforementioned director emphasized that manufacturers must present these documents when submitting their equipment, and they cannot use intellectual property protection as an excuse to refuse delivery.

"Medical institutions and people are victims"

"Foreign brand's monopoly on medical equipment after-sales service, the entire medical institution is a victim." Luo Hansheng believes that the high charges for hospitals by manufacturers are ultimately passed on to patients. The hospital obviously cannot afford such a high maintenance cost. The entire medical institution And the Chinese people are victims.

Secretary of the Chinese Medical Equipment Association Bai Zhipeng said in an interview with the media that in China's first-tier cities, such as Beijing, a CT machine will serve 70 to 80 people a day, while in county hospitals in Shaanxi, Henan, and Shandong provinces, A hospital will have only 7 to 15 patients in the day to CT. Luo Hansheng bluntly stated that if we can break the warranty monopoly and save money for the hospital, this is to relieve everyone's burden.

Xiaochen Chen, a member of the Medical Technology Department of Ubisoft, also pointed out that because Chinese companies do not have the right to speak, hospitals have to pay high fees to multinational corporations, which, to a certain extent, lead to increasingly expensive medical treatment for the people. At present, the prices of most domestically-made equipment are about 30% cheaper than foreign products of the same type, the same grade, the same level of technology, and the same quality standards, and the post-maintenance service is only half that of foreign companies.

For hospitals, choosing domestic equipment is a double-edged sword. While enjoying high cost-effectiveness, it may also need to consider product technology capabilities and after-sales services. At present, most domestic companies still stay in market promotion and expand their production capacity, and they do not pay enough attention to after-sales service.

Lin Gong, who has over 20 years of maintenance experience, stated that some medical device manufacturers did not provide reasonable preventive maintenance plans for hospitals, did not conduct inspections, telephone calls and maintenance on time, and rarely carried out quality assessments for hospital technicians. Control training. "Imported brands have a better quality of after-sales service than local companies. It is a guarantee for hospitals." Luo Hansheng said that he sometimes goes to grass-roots hospitals to help repair machines. Because of the after-sales service of manufacturers, some primary medical institutions have encountered After the obstacles, they can only rest and idle.

In stark contrast to most local companies, many foreign medical device companies will focus on sales as a marketing strategy. In 2013, GE's China Innovation Center launched the "Smart Response Center", completed online connections with thousands of diagnostic equipment at different levels of medical institutions across the country, and conducted pilot projects for boot protection solutions with five hospitals in Shanghai. Li Kechang, Equipment Division of People's Hospital of Shiyan City, Hubei Province, confirmed to reporters that foreign-funded enterprises can clearly grasp the operation of the equipment through the technical background and upgrade the service from passive to active management equipment.

Faced with the "accusations" of Chinese technicians, foreign companies are also somewhat depressed. “We have always been acting in accordance with Chinese laws and regulations.” A related person in charge of a well-known foreign medical device company told reporters earlier that foreign medical device companies do not have a “monopoly” in China.