Vacuum blood collection vessel is a blood sample collection container. It was first invented during the Second World War in 1937. It began commercial production in Europe and America in 1943. It was introduced in Japan in 1964 and applied to clinical blood collection in 1971.

In 1991, Hunan Liuyang medical instrument factory produced the first vacuum blood collection vessel in China and began to promote it in clinical practice. In 1999, the State Food and Drug Administration issued the mandatory industry standard yy0314-1999 disposable venous blood sample collection container, marking the orderly development of China's vacuum blood collection vessel manufacturing industry.

Reviewing the 24 years of China's vacuum blood collection industry from 1991 to 2015, it can be divided into three stages.

From the birth of China's first vacuum blood collection vessel in 1991 to the first eight years in 1998, it belongs to the initial stage of the industry. During this period, China's vacuum blood collection vessel industry grew from scratch and experienced the stage of pure manual production to semi-automatic assembly.

In 1999, the former State Food and Drug Administration promulgated the industry standard of yy0314. From this year to the second eight years of 2007, it belongs to the growth period of vacuum blood collection industry. Since the former Ministry of Health issued WS / t225-2002 collection and treatment of blood samples for clinical chemical test, it clearly stipulates that blood samples used for chemical test must be collected by vacuum blood collection vessels, According to the characteristics of China's vacuum blood collection industry, domestic upstream enterprises have launched a series of special equipment for blood collection manufacturing, which has promoted the automatic production of vacuum blood collection rapidly, and social capital has begun to enter this field one after another. By the end of 2007, the number of vacuum blood collection enterprises in China had reached more than 30, and the production and sales volume had reached 1.2 billion.

The eight years from 2008 to 2015 were the rapid development period of China's vacuum blood collection industry. The number of enterprises increased rapidly and the investment scale increased continuously. There were one GEM listed enterprise (Guangzhou Yangpu, 30030), three new third board listed enterprises (Ruiqi technology 831079, Xinle medical 832294 and Yaohua medical 833141), and many listed companies successively (for example, Kehua biology 002022, Kelun pharmaceutical 002422, Qianshan pharmaceutical machinery 300216, Yuyue medical 002223, Changhong technology 300151, etc.) invest to establish subsidiaries to enter this field.

Upstream and downstream enterprises in the vacuum blood collection industry began to emerge one after another and gradually become large-scale. In 2015, there were 115 vacuum blood collection enterprises completed and put into operation in China, with production and sales of nearly 5 billion tubes. In addition to a large number of exports of vacuum blood collection vessels, peripheral products such as automatic production line of vacuum blood collection vessels, butyl rubber stopper for blood collection vessels, tube embryo of blood collection vessels and venous blood collection needles also occupied some international markets.

During this period, foreign capital also began to favor the Chinese market. Japan's Shuishui, Taiermao, niplo and American BD successively invested and built factories in China and established production bases in Beijing, Hangzhou, Shanghai and Suzhou respectively.

1、 Industry start-up period

In 1991, Hunan Liuyang medical instrument factory was established to produce the first vacuum blood collection vessel in China. In 1996, Beijing Xiangfang Medical Instrument Co., Ltd. introduced the automatic production line of vacuum blood collection vessel from agr company in Britain, marking that China's blood collection vessel industry began to enter the era of automatic production. In 1996, Guangzhou Yangpu Medical Technology Co., Ltd. was established, giving birth to the first listed company in the vacuum blood collection vessel industry 。

These three companies are representative enterprises in the initial stage of China's vacuum blood collection industry, and have experienced the birth, development, failure or success of most Chinese enterprises.

1. Hunan Liuyang Sanli medical instrument factory

China's first manufacturer of vacuum blood collection vessel and the founder of blood collection vessel industry.

In the spring of 1991, Wen Yongsheng, the inspection department of Liuyang people's Hospital in Hunan Province, brought back several vacuum blood collection vessels and supporting needle holders produced by BD company in the United States. According to the product principle of BD company, Wen Yongsheng applied for a utility model patent, and then took the patented product to more than a dozen medical device manufacturers in Jiangxi, Jiangsu, Hunan and other places to jointly develop them, but eventually these Medical device manufacturers didn't accept this product. There are two main reasons: first, they haven't seen it in the market, and they are afraid that it is difficult to cultivate the market. At that time, medical institutions in China used disposable syringes to collect venous blood, and then injected it into the test tube after pumping the blood. Vacuum blood collection, which puncture the vein through the blood collection needle and then connect the negative pressure tube, has high manufacturing cost, and everyone is not confident to go On the other hand, we can't find the equipment and raw materials suitable for the production of vascular products.

In the second half of 1991, Mr. Chen Pingxuan and Mr. Ji Shiru, the current owners of Sanli medical instrument factory in Liuyang, Hunan, met Wen Yongsheng through friends. During the conversation, he introduced the relevant information about the patented products of vacuum blood collection. At that time, they were from a construction engineering company and didn't pay much attention. They just asked for a blood collection vessel out of curiosity. Later, after research, they thought that this product was relative to a syringe Blood sampling has many advantages, so I decided to buy the patent of blood collection vessel and organize production.

At that time, even the patent applicant didn't know what to do, so he had to think of his own way. At that time, Ji Shiru was responsible for the technical development. After a period of analysis, he worked out a set of production plan, bought some small equipment, modified and assembled himself, and found a mold factory to open a small mold to make a dispensing plug (natural rubber was used at that time) , the needle holder was changed to butterfly Hebei soft connection double needle blood collection needle (the latex sheath was made by itself, the template was installed, the needle core was glued, the coagulant was inserted into the latex, and then taken out for drying). Under such difficult conditions, some samples of blood collection vessels and blood collection needles were produced.

In Liuyang people's Hospital, I found the director of the nursing department to help me try it out. This trial was very successful. Later, I found the director of the nursing department of the Second Affiliated Hospital of Xiangya, Hunan Province, and it was also very successful. The director of the nursing department also made an evaluation. Although the cost of using vacuum blood collection is too high for the hospital and is not suitable for the current market, if the product quality can be guaranteed, it must be a development trend in the future. That's it Mr. Chen Pingxuan and Mr. Ji Shiru were determined to invest in factory production. At that time, they rented a private suite of 50-60 square meters, one for blood collection vessels and the other for blood collection needles. The bathroom and kitchen were changed to cleaning and drying rooms.

Next, we prepared some materials for the registration and approval of blood collection vessels (the materials were very simple at that time) and sent them to the medical device Department of Hunan Provincial Medical Administration. At that time, the staff also looked at the materials. Because they had never seen vacuum blood collection vessels and special blood collection needles, it was difficult to determine the management category, vacuum blood collection vessels and blood collection needles (only draw blood out, and do not inject drugs into blood vessels) , I called the State Food and Drug Administration and other provincial bureaus, but there was no conclusion. In this case, I issued the production license and medical device product registration certificate for blood collection vessels and blood collection needles as class II medical device products.

Next, several people were recruited to start formal production. After the blood collection needle was made, Hunan Academy of Agricultural Sciences was entrusted to assist in radiation sterilization. After the first batch of products were made, it was the Spring Festival in 1992. At that time, there was a drug fair after the Spring Festival in Liuyang City, so the vacuum blood collection vessel and blood collection needle were taken to the venue for promotion. Everyone said they had not seen it, and the price was high. It must be difficult to sell. One of them at this time My good friend Zeng Huinan (teacher of Liuyang middle school) saw this product and thought it was good. He proposed to work together and be responsible for sales. Then he recruited several salesmen and brought materials and products to promote and promote in hospitals in Hunan and surrounding provinces and cities.

After one year's promotion, although some hospitals accepted and used the vacuum blood collection device, they lost all the invested funds and paid off the debts at the end of the year. After discussion, they planned to give up. Finally, they believed that the director of the nursing department of the Second Affiliated Hospital of Xiangya, Hunan Province said that "only ensuring the product quality is the development trend in the future" Therefore, we decided to continue to do so. So we summarized our experience, collected and analyzed market information, found out the reasons and ways out, and finally decided to find ways to vigorously improve product quality and expand publicity and marketing

At that time, there were two problems in product quality. One was that the vacuum was unstable, and the production of the same batch was high and low; the other was that the vacuum degree could only be maintained for 3 to 4 months, which decreased significantly. Because the original vacuum blood collection production equipment was guided by a vacuum pump tube to each station to pump negative pressure (the initial design is to make the rubber plug longer, first insert the rubber plug into the test tube mouth, leave two-thirds of it outside, stab it in from the side with a needle, draw out the air, and use a negative pressure gauge to control the vacuum) , the pressure instability of this method is also affected by the proficiency and skills of the operators, so the vacuum degree of the product is unstable. Later, a large capacity air storage tank is added in the middle to stabilize the air pressure, and then the pressure problem is solved by shunting, but the rubber plug is natural rubber (poor air tightness, and butyl rubber plug was not widely used in domestic blood collection enterprises until 1999) It can be maintained for 8-12 months after adjusting the vacuum degree of the formula.

After the success of the initial test, Liuyang Sanli medical instrument factory expanded its publicity and marketing efforts by collecting the information of national hospitals and medical and health units (since there was no computer and network at that time, it bought two national hospital and medical and health unit information summaries) , three letters and postcards were sent by hand to hospitals and medical and health units across the country to expand publicity and marketing and improve influence. Due to the lack of finalized equipment and strict product standards in the early stage of plant construction, the control and improvement of product quality has been stagnant. Even so, during this period (less than two years from the second half of 1992 to 1993) There were eight vacuum blood collection manufacturers in Changsha and Liuyang. Due to the lack of core technology and sales channels, the other seven closed down in the first half of 1994, and all the remaining raw materials were sold to Liuyang Sanli medical instrument factory.

In 1994, in Jinxian County, Jiangxi Province, which is close to Liuyang, several medical device manufacturers successively took the opportunity of talking with Liuyang Sanli about sales agents to buy some products and began to study vacuum blood collection. From 1995 to 1997, there were Jiangxi Yikang and Xingbai (now Fuerkang) , Zhiyuan in Hubei and Yangpu in Guangzhou have joined this industry. Liuyang Sanli medical instrument factory has also developed from a small workshop to a modern medical instrument manufacturing enterprise with an annual output of more than 300 million vacuum blood vessels.

2. Beijing Xiangfang Medical Instrument Co., Ltd

Han Yue, a Chinese (the grandson of Han Fuqu, a famous military general in the period of the Republic of China, and Han Fuqu's word Xiangfang), was a joint venture with Beijing No. 6 pharmaceutical factory at that time and built in Beiyuan, Beijing. At that time, it had more than 800 square meters of 100000 class clean workshop. An automatic assembly line was introduced from agr company in the UK, with a daily production capacity of 54000 blood collection vessels, and according to foreign standards (Sherwood company, the second largest manufacturer of blood collection vessels in the United States at that time) developed cleaning silicon coating machine and cartoning machine.

At that time, the raw materials of radiation-resistant sterilized glass tubes used in the production of vacuum blood collection vessels needed to be imported from New Mexico, and most of the raw materials such as butyl rubber plugs, additives and separation glue also needed to be purchased from abroad, resulting in high production costs, high market prices and great difficulty in promotion. In addition, the supporting venous blood collection needles were not provided by formal manufacturers in China, so we asked our company for help It developed and OEM blood collection needles with Zhejiang kantlai company. At that time, the main market of the products was Xi'an (Xijing Hospital Affiliated to the Fourth Military Medical University) and OEM for Tyco.

Beijing Xiangfang medical device Co., Ltd. gradually withdrew from the market in 2002, mainly due to high production cost, broken capital chain, withdrawal of Beijing No. 6 pharmaceutical factory, etc.

Although Xiangfang company existed for a short time and withdrew from the market due to objective reasons, the automatic production line purchased at that time set a benchmark for Chinese enterprises in the automatic production of vacuum blood collection vessels. The joint development of venous blood collection needle products with Zhejiang kantlai company and the joint development of special butyl rubber stopper for vacuum blood collection vessels with Shijiazhuang No. 1 rubber factory provided great convenience and help for later enterprises It is conducive to the smooth development of the industry.

3. Guangzhou Yangpu Medical Technology Co., Ltd

Founded in 1996, Yangpu medical has always adhered to the medium and long-term development goals of "specimen expert", "inspection expert" and "nursing expert", and provided the best solution for standardized operation for clinical laboratory and clinical nursing through continuous technical and management innovation. In 2009, Yangpu medical became the first medical device enterprise listed on the gem of Shenzhen Stock Exchange in Guangdong.

As a national high-tech enterprise based on independent R & D and innovation, Yangpu medical has established Guangdong Key Laboratory for "Research on blood compatibility of medical materials", undertaking a number of major projects such as 863 plan, R & D of clinical immune diagnosis system, special fund for industry university research cooperation in Guangdong Province, and industrialization platform construction project.

After 18 years of unremitting efforts, Yangpu medical has owned 8 core proprietary technologies and 65 scientific research patents for the production of blood collection vessels, and upgraded its main product, the third generation vacuum blood collection system, to a high-end product with the most complete product specifications, the most types of special detection tubes and the best serum preparation quality and speed among its peers at home and abroad. Yangpu medical is the definer of the third generation vacuum blood collection system and the first variant before sample analysis It is the only enterprise in the domestic vacuum blood collection system registered by FDA.

At present, Yangpu medical has formed a product sales and service network covering more than 90 countries and regions around the world, providing extensive product, technical and service support to nearly 10000 medical colleges, research institutions, hospitals and diagnostic laboratories all over the world.

2、 Industry growth period

1) Policy promotion:

In 1999, the State Food and Drug Administration issued yy0314-1999 disposable human venous blood sample collection container.

2) Economic and social development needs:

In 2002, the Ministry of Health issued WS / t224-2002 vacuum blood collection and its additives and WS / t225-2002 collection and treatment of blood samples for clinical chemical examination.

3) The manufacturer and clinical application reached a consensus:

In March 2014, the people's Health Publishing House published the consensus on standards before analysis of blood samples in Chinese clinical laboratories edited by Fu Weiling and Wang Baolong.

One of the representative enterprises in this period is gradually becoming large-scale from small to large, such as Zhejiang Gongdong Medical Technology Co., Ltd., Jiangsu Kangjian Medical Products Co., Ltd., Chengdu Ruiqi Technology Industry Co., Ltd., Hebei Xinle Technology Co., Ltd; Another is to become the benchmark of the industry with the help of high starting point and high investment in the capital market, and compete with foreign-funded enterprises in key technology R & D and core technology application. Such as Guangzhou Yangpu Medical Technology Co., Ltd., Liyin precision medical products (Shanghai) Co., Ltd. (formerly Shanghai Kehua laboratory medical products Co., Ltd.), etc.

1. Liyin precision medical products (Shanghai) Co., Ltd

Formerly known as Shanghai Kehua laboratory medical products Co., Ltd., it was founded in 2007 by Shanghai Kehua Bioengineering Co., Ltd. in conjunction with Zhu Dexin and Shen Yuneng.

In 2015, Kehua biology changed its name after transferring its shares to Shenzhen Changhong Technology Co., Ltd. This company is an epitome of the development of China's vacuum blood collection industry - from small to large and gradually into scale from technological breakthrough and accumulation.

Especially after undertaking the project of "research and development and industrialization of key technologies of vacuum blood collection" of Shanghai Science and Technology Commission, the enterprise has continuously broken through a number of key technologies in the field of blood collection, such as room temperature preservation technology of thrombin, the main component of vacuum blood collection coagulant, synthesis technology of high-end separation gel, stabilizer for nucleic acid (DNA / RNA) extraction, room temperature preservation and transportation Isolation and purification technology of mononuclear cells, special stabilizer for the determination of tumor marker parathyroid hormone related protein (PTH RP), renin angiotensin aldosterone