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Medical devices related to pharmaceuticals, machinery, electronics, plastics and other industries, including rapid development of plastic medical devices. In the 1930 of the 20th century, the first use of synthetic polymeric materials – celluloid film as made of artificial kidney dialysis membrane used clinically since the success of polymer materials is gradually replacing the traditional inorganic materials such as metal, glass, ceramic, hydroxyapatite preparation for medical devices.
This is because: (1) polymer material has good of physical mechanical performance and chemical stability, compared for medical field using; (2) polymer material source rich, and price low, for made one-time medical supplies, avoid has traditional material products for price high and had to times using led to of disinfection and II times infection of problem; (3) plastic has or more easy modified sex get good of Organization compatible sex, and blood compatible sex products; (4) plastic making cost low, for variety forming way, Easy to process into complex shapes, and the development of new medical products.
Preparation of plastic medical devices requirements
As a medical device, the primary requirement is that the safety and efficacy of the product, in product safety and effectiveness must also be guaranteed on the basis of the effective. Medical plastic products are mainly for safety products, medical and health care personnel, patients and product reprocessing are safe. In order to meet the security requirements of plastic medical devices, from product design, selection of raw materials, plastic medical devices production technology and production processes, production, product quality specifications to meet the requirements, and many other considerations.
With General plastic compared, medical with plastic requirements high: (1) due to most monomer and gathered real toxic, so medical with plastic on above material of residues has strictly of limit; (2) plastic in aggregate process in the inevitable to contact to reaction Kettle, and metal catalyst,, often contains trace metal ion, according to medical with plastic of GB requirements, on zinc, and lead, and CD, and copper, and barium, and Tin, metal ion residues situation are has clear provides; (3) for medical with plastic of resin requirements purity high, and molecular volume distribution more narrow; (4) Plastic in processing or modified sex process in the need added various additives, as in medical with PVC products in the of plasticizer dosage often up to 30-60%, so requirements as used nontoxic additives, long-term using Shi to prevent or reduced additives of precipitation, so as not to effect products performance and treatment effect; (5) according to medical with plastic of using requirements, often needed makes products has surface hydrophilic, and anticoagulant blood, and resistance radiation sterilization, function.
Plastic medical supplies market
Guang Pu medical supplies
Includes: infusion sets, syringes, transfusion, blood collection needles, dressings, surgical towel gloves. Major domestic manufacturer: weigao group, Xinhua medical equipment, xinjin County, Chengdu city, Jiangxi Hongda.
Guang Pu type of medical supplies to a large scale, the market demand for large, widely used, characterized with low added value. For example the production of disposable infusion set enterprises in China number more than 200, industry brands have more than 300 more. Average production of 140,000 or so per plant per day, some 14 billion for the year, not only meet the domestic demand, exports accounted for about 30%. Disposable syringes in China more than 300 enterprises, which formed since syringes in the production scale of approximately more than 10, it not only meets the needs of the domestic market, but also exported. For the major manufacturers in the industry, technology is more mature. 2006 injector 121 million US dollars, an increase of 47.33%, export features, share of Shandong, Jiangsu, Zhejiang, Shanghai 73.57%. Broad spectrum of such supplies are gradually achieve scale, automation, and increasing technology, precision infusion, pre-filled syringes, safety Lancet and other new products not only to ensure product safety, increased added value.
Includes: endotracheal intubation and laryngeal mask, closed suction catheter, pressure extension tube, anesthesia breathing circuits, respiratory masks, first aid breathing ball, atomizing DOSER, tracheostomy, shaped tracheal intubation, anaesthesia puncture bags, bag, normal suction of endotracheal intubation tube, double lumen laryngeal mask.
Includes: (1) ventricular drainage device: device for intraventricular cerebrospinal fluid drainage to the outside of the body. (2) precision ventricular drainage system: ventricular drainage devices increase intracranial pressure measurements on the basis of function by gravity measurements in patients with increased intracranial pressure. (3) the lumbar cistern drainage devices: the use of intracranial and lumbar cerebrospinal fluid within the same principles, from the waist down for continuous drainage, reduce the risk of transfer in patients with cranial and pain. (4) the cranioplasty.
Since entering the 21st century, kidney disease has become one of the main hazards to human health, hemodialysis is at present and in the coming decades to treat end-stage renal disease (uremia) the principal means. Equipment for hemodialysis treatment mainly consists of dialysis machines, dialyzers, blood components, such as circuit, dialysis is hemodialysis equipment, mainly medical supplies. Japan and the United States and Europe and other developed countries consumes a lot of dialyzers, only Japan consumes about 30 million dialyzers annually and growing at a rate of five a year. Dialysis in China's current annual consumption of more than 10 million. Dialyzer market prospect in China is very wide and highly commercial value and social significance.
Domestic hospital dialysis 95% dependent on Europe, Japan and other imported products such as Germany Fresenius (Fresenius), Sweden Campbell (Gambro) and Japan Asahi (Asahi), Japan NI Pu Luo (Nipro), Germany Braun (B.Brau), and so on. Domestic production only accounted for about 5% on their own, such as Hua Ding of Shanxi province, Changzhou Akio and Shandong weigao, and product quality, production equipment, process technology and imported products have a big gap. Dialysis supplies products including: dialyzers, dialysis tube and needle.
Is the use of peritoneum during peritoneal dialysis as a semi-permeable membrane, peritoneal dialysis solution is injected, with peritoneal side of the capillary plasma and peritoneal dialysis fluid and solute concentration gradient in osmotic gradient, principle to remove solutes by diffusion through osmosis ultrafiltration principles of clear water. Peritoneal dialysis consumables products including titanium metal joints, inner tube, outer tube, liquid bags.
2011 188,000 cases of cardiac surgery in China, 150,000 cases of extracorporeal circulation and rising growth continues to grow each year. At present, the country has more than 600 hospitals in cardiovascular surgery. Heart cardiopulmonary bypass products: Oxygenator (artificial lung) and through the semipermeable membrane in different osmotic pressure, blood gas exchange at the membrane surface, so venous blood (low blood oxygen) into the arterial blood (oxygen-bearing blood). Microsphere arterial filter is about to enter the body's arterial blood, mostly gas or solid emboli, cardiopulmonary bypass blood vessels road, intubation, catheterization of inferior vena cava, aorta blood concentration (UF) for the treatment of discharged patients with excess body fluid and concentration of cardiopulmonary bypass caused by excessive blood thinning treatment. Can also be used for blood filtration and hemodialysis. Blood acts as a patient's blood during heart surgery for temporary storage space. In addition, infusion, infusion needles, barrier device, in front of the pump filter, suction, torch, holder of the heart, heart valves and other accessories.
International products are mainly manufacturers of heart surgery:
(1) Italy Sorin company
Founded in 1978, is Italy's largest and most vibrant biomedical companies. Sorin Group Italy company's core competence is reflected in two major market area: they are the heart and lungs (cardiac surgery) and blood (autologous blood and machine) market, the world's largest producer of supplies during cardiopulmonary bypass and lung 2011 in film market share first in the world.
(2) the terumo Corporation
Founded in 1921, headquartered in Japan, Shibuya, Tokyo, is a medical device and pharmaceutical products for large enterprises. Products include disposable medical equipment, blood transfusion equipment series, pharmaceuticals and nutritional medicine series, catheter angiography and treatment, medical electronic products, artificial heart and lungs products, infusion pumps, syringe pumps, pump blood transfusion, anesthesia pump, target-controlled pumps, test products, home health care products, is the world's leading medical device group.
(3) United States Medtronic
Founded in 1949, is headquartered in United States Minneapolis, Minnesota, is a leading global medical technology company, is committed to provide life-long treatment programmes for patients with chronic diseases. In the area of chronic diseases in medical technology, Medtronic China by providing safe, reliable and efficient solutions and become a trusted leader, so as to ensure common development and continued health of their employees. Its main products cover arrhythmia, heart failure, blood vessel disease, heart valve replacement, heart support, minimally invasive heart surgery, malignant and non-malignant pain, movement disorders, diabetes, gastrointestinal diseases, diseases of the urinary system, spine diseases, nervous system diseases, and surgical treatment of facial features, and other fields.
Domestic manufacturers of heart surgery:
(1) in Tianjin plastics Research Institute
Tianjin plastics Research Institute was established in 1965, medical plastic products in 40 years has been committed to the development, research and production, was approved by the State food and drug administration "three types of" Enterprise specializing in the production of medical devices. At present, built the world's 5000 square meters with the industry's largest class 100,000 clean room, passed the ISO 13,485:2003 quality management system certification, medical devices, a variety of products have obtained CE and FDA certification.
Plastics Research Institute since the beginning of the 70 's of the last century of medical plastics research and development, production, with strong technique and product storages. Product cover with cardiopulmonary bypass cardiac surgery, anesthesia breathing classes, such as neurosurgery, dialysis and other five series categories, sold more than more than 400 hospitals in cities across the country. In 2007 into the international market, the current products are exported to more than 30 countries. Among them, vascular road, filters and other occupied Russia 40% the market.
Product quality and technologies of the domestic leading level, which developed a tube resonator, variable diameter, composite extrusion technology to process various types of special catheters, intubation.
(2) Dongguan Kewei medical instrument limited company
Founded in 1993, is a research, production and sales of cardiothoracic surgical medical instruments, interventional devices, vascular catheterization specialist. Main products are oxygenators (artificial lung), catheterization, arterial Microsphere filters and pipes are major cardiopulmonary bypass with cardiopulmonary bypass and cardiac Interventional medical devices.
(3) West capital medical supplies limited
Founded in 1995, has an independent legal personality. Company specializing in the production of artificial heart-lung machine Oxygenator and auxiliary products, expansion to the active medical devices in recent years.
(4) Ningbo Feral
Is specialized in the development, production and sales of disposable surgical products business. Main products: single use filter blood blood Microsphere, disposable filters, disposable cardiopulmonary blood road (supporting tube intubation and a variety of cardiopulmonary bypass), the use of disposable products such as cold cardioplegia perfusion of the heart. Purification workshop of more than 700 square meters.
(5) Beijing, Graham meadows medical equipment
Founded in April 2012, is specializing in cardiac surgery and Anesthesiology products development, production and sales of the Sino-US joint venture. Purification plant 400 square meters. Main products include fixation and membrane oxygenator of the heart, cardiac catheterization, cardiopulmonary bypass piping, Microsphere arterial filters, blood cardioplegia perfusion device.
(6) Shanghai xiangsheng medical instrument factory
The factory was established in May 1993, is a professional production of disposable polymer materials manufacturers. Currently has a one-time cardio class and care duct two series with a total of 12 products, main products are: single use superior vena cava catheterization, left atrial pressure relief tube, cannulation of the aorta, the heart-lung machine pipe, drainage pipe, extension tube, stomach tube, suction tube, nasal oxygen cannula, etc.
(7), Changzhou Kangxin medical instrument limited company
Main products: arterial and venous catheterization, heart Fixer infusion needle, create a protective device.
(8) the weigao group
Founded in 1988, the Shandong weigao group medical polymer products subsidiary holdings in February 2004 and listed on the Hong Kong gem in July 2010 and listed on the main Board. Group has more than 400 more species, and 30,000 multiple specifications medical devices and drug, main has lost Note supplies, and surgery suture line, and medical with catheter, and heart bracket and the heart internal friction material, and indwelling needle and the various shaped needle, and blood purification equipment and the supplies, and orthopedic material, and medical equipment, and treatment type injection and the other drug, and biological diagnosis reagents, and artificial plasma, and biological planting body, and PVC and the non-PVC raw materials, series, became China maximum of one-time using medical devices manufacturer.
Along with economic development and improvement of the level of population growth and aging, as well as the strengthening of people's health awareness, global medical equipment market continues to rapidly expand. At the time of economic growth, the medical device industry is growing faster than the growth of the national economy; in times of global recession, medical devices market remains promising, the medical device industry has the typical characteristics of the positive cycle. This characteristic determines the international medical devices industry has great potential for development. Plastics with its excellent properties, reliable performance, easy molding techniques have been widely used in the medical field, and replaced a variety of materials to continue to expand the field of application in medical devices. Medicines, pharmaceutical packaging, disposable and non-disposable medical devices medical devices application, with the participation of plastic, it is predicted that the next 10 years field of medical plastics is a plastics industry is one of the most promising areas.
Plastic properties are excellent, reliable performance, convenient, inexpensive, and ought to have replaced traditional products has a wide range of applications in the medical field. According to statistics, the global medical devices market has reached $ 100 billion, medical materials market of us $ 12 billion, and growing at an average growth rate of 7%-12%, but domestic medical plastics was a new industry. 7% of medical plastics output is only developed in China. China medical device production value of nearly 50 billion yuan, about medical plastic about 6 billion yuan, experts speculated that the next 10-15 year, China medical device industry will enter a stage of rapid development.
2011 new health care reform put forward development of County Hospital policies, benefit from county hospitals to medical equipment, instruments, materials, demand growth, the medical device industry product to the next level. Countries continue to increase its support to grass-roots medical institutions, primary health care institutions for medical devices will continue to release, so medical equipment market will grow 40%.
National certified medical device company currently has more than 7,000 companies, and production of medical plastics business was only about 1000 homes. Due to the fineness of the product and other factors, most of the products are only used in small cities and rural areas, cities such as Beijing, Tianjin and Shanghai the market applications or imported products, plastic products are consumables, so the market is very large, this production of medical plastics companies will bring infinite business opportunities.