材料訊息|食品藥物管理署重申「含塑化劑-PVC材質醫療器材之相關管理規定 The Food and Drug Administration reaffirmed \"the relevant regulations containing plasticizers -PVC material of medical equipment

No.415 report on consumer magazine "cure or pathogenic? Medical equipment containing plasticizers big test," the Food and Drug Administration (hereinafter referred to as the Food and Drug Agency) to enable consumers to clarify the use of medical equipment safety concerns, for 'containing Related regulations plasticizer -PVC material of medical equipment "as follows:

First, PVC (Polyvinylchloride, hereinafter referred to as PVC) Since both the softness, durability and other characteristics, when in clinical use less prone to blockage or breakage deformation pipeline rupture, reduce dosing problems or other treatment of hemorrhagic risk, which is widely used for many medical procedures; to maintain the flexibility of the material of a high PVC, the manufacturing process is added plasticizer of different components, including bis (2-ethylhexyl) phthalate (Di (2-ethylhexyl) phthalate, under said DEHP), is also currently the international medical equipment commonly used material of PVC plasticizers.

Second, countries around the world were disabled by the investigation of medical equipment containing DEHP, US, EU, Canada, Japan, Britain and other major countries in the world, the Department released were taken note messages, license information revealed, product labeling and other management measures to reduce the associated medical equipment products on the health risks of concerns sensitive groups; the other is to consider the characteristics of the product category, cost and penetration of alternative materials and other factors, the country has neither declared open banned, restricted, set the amount of DEHP content or dissolution Mandatory standards and other advanced management regulations.

Third, the Department of Health before taking into account any relevant international management trends, in 100 years May 23 announcement of high DEHP exposure risks of PVC (PVC) material medical equipment related notes and labeling requirements (such as bulletin annex), in order to reduce the and other products on the health risks of sensitive population concerns, taking into account the medical equipment in the clinical treatment of choice, let the medical staff, as the case immediate choice of appropriate products.

Fourth, the high risk of DEHP exposure polyvinyl chloride (PVC) material medical equipment, such as infusion sets and extend the pipeline, umbilical vein catheters, blood bags and infusion tubing, enteral nutrition feeding bags, nasogastric feeding tubes, peritoneal dialysis bags and tubing, tubing used in vitro artificial blood circulation or cardiopulmonary bypass surgery, the dialysis tubing and other products, should be opened in accordance with the announcement, in the smallest package should be sold to the user or consumer can clearly identify The way to highlight "This product contains plasticizer DEHP" or related marking symbols; and in Chinese instruction sheet should bear the "product may dissolution plasticizer bis (2-ethylhexyl) phthalate (Di ( 2-ethylhexyl) phthalate, DEHP), baby boy, pregnant or lactating women, adolescent males and other sensitive groups using this product, medical professionals will be incorporated into the health risk concerns DEHP treatment of clinical considerations. " Offenders, involving violation of the Pharmaceutical Affairs Law, Article 75, Article 92 in accordance with the law at NT $ 3-15 yuan fines.

Fifth, since the frequency of use of medical equipment of relatively low daily necessities, medical equipment identification register case review material security, is a reference to the international standard ISO 10993, to consider the final product with the body contact time with the contact area, simulate product use scenarios to assess its biocompatibility. The foundation will use the test method, and not in line with actual usage of medical equipment, and consumer groups will sample testing products include elastic tape, OK stretched and nursing patch and other medical equipment, not on the open announcement "a high risk of exposure to DEHP PVC material medical equipment, food items, "Criterion.

Food and Drug Agency appealed to consumers not to panic, you should follow the health care professional judgment, depending on the choice of appropriate products for patients instant case, in order to avoid delaying treatment. Food and Drug Department has established mechanisms for proactive monitoring of drug safety information, in addition to adverse drug reaction reporting system outside, also for safety-related messages at any time to understand, in order to protect the public's health and safety; Food and Drug Administration Department reminded the medical institutions, health care or disease suffering, such as medical equipment cause suspicion because open use of adverse events, please inform the pharmaceutical, food and immediately after the listing of cosmetic quality management system, adverse drug reactions bulletin Line 02-2396-0100, Website: http: //qms.fda .gov.tw / tcbw /.