Polyvinyl chloride (PVC) materials are widely used in the medical device industry, mainly because of the good physical properties of polyvinyl chloride materials. PVC is also the material with the largest amount of disposable sterile medical devices, affected by the new coronavirus epidemic, the shortage of medical supplies, the upstream PVC market has also been affected to a certain extent.

Polyvinyl chloride is influencing the medical device industry

The physical properties of polyvinyl chloride (PVC) materials include the convenience of PVC materials and the good compatibility between these materials and intravenous (IV) injections and blood. PVC products commonly used in healthcare contain dihexyl phthalate (DEHP) plasticizers. The effect of dihexyl phthalate is to increase the elasticity of PVC products. DEHP, one of the most cost-effective and widely used plasticizers, works to make PVC soft and flexible.

Medical products made from plasticized polyvinyl chloride (plasticizedPVC) were originally used as an alternative to natural rubber and glass in medical devices. The reason for the substitution is that plasticized PVC materials are more sterilizable, more transparent, and have better chemical stability and economic effectiveness. Plasticized PVC products are easy to use and, due to their inherent softness and elasticity, avoid damage to the patient's sensitive tissues and avoid discomfort for the patient.

Plasticizers are added to PVC to improve the softness, cold resistance, and light stability of PVC. The amount of plasticizer added to PVC products for different purposes is different. For example, the weight ratio of phthalates in PVC for food packaging is about 28%, and the flexible plastics used in toys reach 35%~40%. Studies have shown that PVC containing phthalates is easily released when exposed to grease or at high temperatures above 100°C. Due to the different perceptions of the hazards of PVC containing phthalate esters, the scope and degree of impact of its recognition are different, so the restrictions on the use of PVC containing phthalate esters vary from country to country.

There are two standards related to DEHP in the national standards for medical devices. GB14232.1-2004 "Human Blood and Blood Component Bag Plastic Containers Part 1: Traditional Blood Bags" is applicable to blood bags based on PVC using DEHP plasticizers, and stipulates that the alcohol output (DEHP) is not more than 10mg/100ml when the nominal capacity of blood bags is 300ml~500ml, not more than 13mg/100ml when it is 150ml~300ml, and not more than 14mg/100ml when it is less than 150ml. The standard also stipulates that the residual amount of vinyl chloride monomer is not more than 1ppm, and the residual amount of ethylene oxide is not more than 10mg.

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