Polyvinyl chloride (PVC) kind of material has been widely used in medical equipment, main reason is PVC material itself has good physical properties. At the same time, polyvinyl chloride (PVC) is one of the biggest material of dosage of disposable sterile medical devices. In recent 10 years, one-time use of sterile medical devices to the growth rate of more than 20% a year, in the present world economic storm still maintained a steady growth momentum.

Polyvinyl chloride (PVC) affecting the medical device industry

Polyvinyl chloride (PVC) kind of material physical properties include: convenience made of PVC materials, and this kind of material and vein (intravenous, IV) good compatibility between injection and blood. Are normally used in the medical care of PVC products have ester contain phthalate (DEHP) plasticizer. Phthalate role lies in the process of increasing the elasticity of PVC products. DEHP, as one of the most economic and effective and widely used plasticizer, its role is to make the PVC with the softness and flexibility.

Use the plasticized polyvinyl chloride (plasticizedPVC) made the medical product was originally used to replace natural rubber and glass in the use of medical equipment. Replace the reason: plasticized polyvinyl chloride materials has the characteristics of more sterilization, more transparent, and has better chemical stability and economic effectiveness. Plasticized polyvinyl chloride (PVC) products easy to use, and because it has softness and elasticity, thus it can be avoid is sensitive to the patient's tissue damage and avoid make the patient produces discomfort.

In PVC plasticizer was added to improve PVC soft, cold resistance, increase the light stability. Different USES of PVC products, plasticizer content is different. Food packaging, for example, phthalic acid esters in the PVC ratio is around 28%, the weight of the toy with flexible plastic reached 35% ~ 40%. Studies have shown that PVC containing phthalic acid esters in grease or above 100 ℃ high temperature environment, it is easy to release. Due to contain phthalate esters, PVC different understanding to the hazard, the influence scope and degree of its recognition is different, so countries to contain phthalates limit the use of PVC is different also.

Standards for medical equipment national standards involved in the DEHP has 2 items. GB14232.1-2004 "human blood and blood components bag plastic containers, part 1: the traditional patient" applies to predominantly used DEHP plasticizer of PVC bags, the provisions of bags nominal capacity at 300 ml to 500 ml of alcohol substance (DEHP) is not more than 10 mg / 100 ml, 150 ml to 300 ml is not more than 13 mg / 100 ml, when less than 150 ml is not more than 14 mg / 100 ml. The standard also specifies vinyl chloride monomer residue is not more than 1 PPM; epoxy ethane residues is not more than 10 mg.

It is reported, most of the clinical use of cases, the dose within the scope prescribed by the state adopts two diisooctyl phthalate (DEHP) plasticized polyvinyl chloride (PVC) the amount of release of DEHP in the production of medical devices won't produce adverse reactions. Looking for PVC alternatives need to be careful of the disposable aseptic medical apparatus and instruments in the 1960 s the United States first developed, it is aimed at the American hospital blood transfusion, infusion, injection equipment, repeated use and cause many infusion, blood transfusion adverse reactions. Made of PVC material relative to other material with high quality, cost-effective medical devices and many other advantages.

PVC in recent years, however, is the medical equipment in basic research, clinical application and product recovery after burning on such problems as environmental pollution and found some new risk factors. Its scope of application as well as the risk to benefit ratio of doubt. The main risk factors are,

1, adhesive, PVC material parts use adhesive bonding, some adhesive solvent containing ethylene dichloride, it has a strong role in liver damage. Therefore, you should pay attention to the bonding methods, varieties and control of residual solvents;

2, plasticizer: currently, can be completely or partly replace DEHP varieties are: three trimellitic acid octyl ester, epoxy soybean oil, DINCH, polymeric plasticizer. It is understood that due to the plasticizer DEHP is a widely used varieties, used for infusion has forty years history, tens of billions of people. The international organization for standardization believes that use it to infusion physiological saline, glucose, water-soluble drugs are safe. There is no need to also can not replaced by other varieties plasticizer completely at once.

3, recycling: according to the regulations of the ministry of health, PVC device should be used by the specialized agencies or recycled. Currently used for PVC equipment using incineration method, according to reports in the literature after burning of waste gas containing harmful substances such as dioxins, serious damage to the environment safety. According to reports in the literature that disposable sterile medical equipment waste, the disposal for the most part can be reused.

The U.S. general accounting office (GAO), congress in July 2000 to a title for the disposable medical devices: have not found then there is a danger, but need to supervision and examination and approval of reports. Specifications according to the report, and the equipment can be recycled. At present, many enterprises to carry out the PVC material substitute for the development of research work. But should pay special attention to two points, one is PVC medical equipment which is need replace; Secondly, should choose what kind of material instead of PVC. At the same time, the PVC material substitution on the choice of some problems still need to consider:

1, suitable for extrusion molding of thermoplastic resins;

2, it should be and the same PVC material close to;

3, the room temperature changes within the scope of the material flexibility is small;

4, has been widely used in medical history.

Disposable medical instrument enterprises should be classified into the scope of GMP management, while the smaller the risk, the greater the enterprise to ensure the products safe, effective, and reliable supply market, strengthen the process control is the key. Therefore, the enterprise must strengthen the three aspects: establishing enterprise standard system, strengthening product registration work and organize production according to the requirements of GMP.

At the same time, the enterprise shall establish public technical cooperation research system. Rely on the power industry, and national support, solve key core technologies involved in the industry. Rely on their own strength is difficult to finish a lot of work. Building enterprise alliance, the implementation of intellectual property rights there are Shared, tap into the collective power to carry out the enterprise rights and self-discipline, improve technical level and management level of disposable medical supplies.