Release date: 2008-08-15
——Yin Jinghua, Changchun Institute of Applied Chemistry, Chinese Academy of Sciences Polyvinyl chloride (PVC) is one of the main varieties of general-purpose plastics. PVC plasticized with phthalic acid (diethyl) hexyl ester (DEHP) is widely used for one-off production. Medical infusion devices, such as disposable infusion sets, blood bags, hemodialysis lines, etc. However, with the extensive and deep clinical application and the development of related medical science and technology, people have found that PVC materials have hidden dangers in safety. The author summarizes the following five aspects:
1. PVC material is a polar material. It has been found that the material has strong adsorption to some alcohol-soluble, fat-soluble drugs, especially anti-tumor drugs, which makes prescription drugs inaccurate, reduces curative effect, and increases treatment costs;
2. A very small amount of vinyl chloride monomer remaining in the PVC resin or due to decomposition of the resin during processing has been tested as a carcinogen;
3. PVC infusion set contains about 30% plasticizer (usually phthalic acid (diethylhexyl) ester, referred to as DOP or DEHP), which will migrate out of the contaminated liquid during the infusion process, and may be related to the liquid medicine. Entering the human body together, causing potential harm to the health of the patient or adding new pathogenic hazards to the patient during the treatment;
4. When PVC is processed into various infusion devices, in order to prevent resin degradation, stabilizers containing elements such as calcium, zinc and strontium are usually added. These metal ions may migrate out during infusion, with liquid medicine or blood. Products enter the human body and have an impact on human health;
5. Disposal of disposable infusion devices made of PVC is difficult, and burial can cause serious pollution to the soil. Incineration will produce toxic gases such as hydrogen chloride, which will pollute the environment.
As we all know, the standard issued by the State Environmental Protection Administration in 2005 (HJ/T 209-2005) clearly stipulates that polyvinyl chloride (PVC) film is not allowed in the food packaging industry. In the Announcement No. 155 of 2005 issued by the General Administration of Quality Supervision, Inspection and Quarantine on October 25, 2005, “PVC is widely used in food and vegetable packaging, and its potential harm to the human body comes from two aspects. First, the product The residual amount of vinyl chloride monomer, such as people's exposure to excessive vinyl chloride, will have an impact on human health; the second is the type and content of processing aids used in the processing." Further, the relevant national departments have made clear in 2006. It is forbidden to sell PVC food packaging film in supermarkets, and it is forbidden to introduce equipment and production line for producing PVC food packaging film from abroad. Consumers and public opinion have recognized that PVC materials cannot be used in the food industry.
Now, in the disposable medical infusion device industry, DEHP plasticized PVC is still widely used in the production of infusion sets, blood bags, various interventional catheters. The various liquids or blood products that come into contact with these instruments are re-entered into the human body and participate in the circulation of the body. People naturally have such problems. Since the contact of foods with foods poses a potential hazard to human health, isn't exposure to drugs and blood products potentially harmful to human health? Should the latter situation be more serious?
Disposable medical infusion devices made of PVC plasticized with DEHP In addition to the above-mentioned plasticizers that release harmful effects to the human body, Professor Zhang Enjuan of the Pharmacy Department of Xinqiao Hospital of the Third Military Medical University also reported infusions made of such materials. Plastic products have obvious adsorption effects on drugs, making prescription drugs inaccurate, affecting the therapeutic effect and rehabilitation of patients (see Chinese Pharmacy, 14 (11), 694 (2003)). The article points out that PVC soft bags and disposable infusion sets for drugs acting on the circulatory system (nitroglycerin, ligustrazine, amiodarone, etc.), anticancer drugs (carmustine, paclitaxel), sedatives and analgesics (diazepam, chlorpromazine, promethazine, fentanyl), tinidazole and zedoary turmeric oil, immunomodulator (cyclosporine A, macrocyclic megidine (FK506)), biochemical preparation (urokinase, insulin) And vitamin A and so on have a certain adsorption, so that the efficacy is reduced, affecting the treatment effect and the recovery time of the patient.
At present, the United States, Europe, Japan and other developed countries have developed a variety of disposable medical infusion devices without DEHP or PVC, to provide consumers with choice. There are disposable infusion sets made of polyolefin materials in the market in China, such as the polyolefin (TPE) infusion set of Shandong Weigao Group Medical Polymer Products Co., Ltd., which does not contain DEHP plasticizers and other additives. The human body is completely non-toxic. It is suggested that relevant departments in China should support the research and development, promotion and application of non-PVC substitute products in this field, and provide safe and reliable disposable medical infusion devices to ensure the safety and health of our people. ——Shanghai Medical Device Industry Association website
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