Environmental plasticizers have now been widely used, annual consumption rate of 3.5 million tons a year, the usual plastic products are added additives, environmental plasticizer characteristics: tasteless, harmless, environmentally friendly, non-toxic field. Many people do not know that it is also available in medical devices, and the FDA assesses that DEHP safety is a way to accept the ratio of DEHP intake to the body's tolerance intake (TI) to DEHP in patients treated with various PVC medical device products. By derivation, the FDA noted that the tolerable intake of parenteral contact pathway was 0.6 mg/kg/d and that the tolerated intake of enteral contact pathway was 0.04 mg/kg/d. July 12, 2002 issued a safety notice, proposed that may contain DEHP plastic PVC medical devices include: vein (IV) infusion bags and piping, umbilical artery catheters, blood bags and infusion lines, enteral nutrition feeding bags, nasal and gastric tubes, peritoneal dialysis bags and piping, extracorporeal circulation (CPB) piping, membrane pulmonary oxygenation pipeline ( ECMO) and dialysis piping, etc.
1. In 2002, the
United States FDA issued a public health circular on the possible hazards of
PVC medical devices containing DEHP, recommending the use of PVC products or non-PVC
products that do not contain DEHP.
2. EU: In addition to meeting the REACH regulations, it is also necessary to meet the European Union standard DIN EN ISO 3826-1 (plastic containers for human blood or blood components), that is, plastic blood bags can not affect medical effects or may release substances that can cause toxic and harmful reactions.
3. The Medical Device Technical Review Centre (CMDE of SFDA) of the state Food and Drug Administration provides that, starting in the second half of 2009, all components of the product, including the main material and all its auxiliary materials, are submitted in accordance with the Guiding Principles for the Declaration of registration of products for the disposable use of infusion instruments. Environmental plasticizers are now available on medical devices, showing a higher level of safety.