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随着医疗器械在临床上发挥的作用日益增大,更多的医疗机构开始使用翻新的医疗器械。据调查,5年前我国的翻新CT机(医用X射线断层检查仪)就有1821台,占当时全国CT机总数的1/2。所谓翻新再用的医疗器械是指由原生产企业或委托的企业收回、翻新后再次销售和使用的医疗器械,也称之为二手医疗器械,目前能够成为翻新再用的医疗器械的一般为CT、MRI(磁共振)、X光机、超声诊断设备、血管造影机等产品,而且在国内能够成为翻新医疗设备多数是被三甲医院淘汰的进口产品。我国在20世纪90年代初期对二手设备实行开放政策造成国内不少医疗机构进口大批境外二手医疗器械。1996年7月23日,原国家计委(现国家发改委)、卫生部联合发布了《关于加强大型医用旧设备管理有关问题的通知》,明令禁止任何形式的二手医疗设备进口和使用。1998年前后,海关总署、国家质检总局、原外经贸部等5部委也发文禁止包括医疗设备在内的二手机电产品进口。2005年初,国家食品药品监督管理局给医疗器械企业下发了一份关于《翻新再用医疗器械监督管理规定》(简称《规定》)征求意见稿,允许已使用过的医疗器械,由原生产企业或委托企业收回、翻新后再次销售、使用。2005年6月27日,国内众厂商在京联名上书商务部,反对该《规定》出台,随后有消息称国家对这一规定的讨论已经暂停。到目前为止,该《规定》还没有正式出台。医疗机构到底该不该采购翻新的医疗器械,本期辩论会,记者邀请了医疗领域持不同观点的专家和业内资深人士就此辩题展开了激烈的辩论。
With the increasing role of medical devices in clinical practice, more medical institutions are beginning to use refurbished medical devices. According to the survey, there were 1821 refurbished CT machines (medical X-ray tomographs) in China five years ago, accounting for 1/2 of the total number of CT machines in the country. The so-called refurbished and reused medical devices refer to medical devices that are re-sold and re-used by former manufacturers or entrusted enterprises, and are also known as second-hand medical devices. The current medical devices that can be used for refurbishment and reuse are generally CT. MRI (Magnetic Resonance), X-ray machines, ultrasound diagnostic equipment, angiography machines and other products, and in the country can become refurbished medical equipment is mostly imported products eliminated by the top three hospitals. China’s open policy on second-hand equipment in the early 1990s caused many domestic medical institutions to import a large number of overseas used medical devices. On July 23, 1996, the former State Development Planning Commission (now the National Development and Reform Commission) and the Ministry of Health jointly issued the “Circular on Strengthening the Management of Large Medical Old Equipment”, which explicitly prohibits the import and use of any form of used medical equipment. Around 1998, five ministries, including the General Administration of Customs, the General Administration of Quality Supervision, Inspection and Quarantine, and the Ministry of Foreign Trade and Economic Cooperation, also banned the import of used mechanical and electrical products, including medical equipment. In early 2005, the State Food and Drug Administration issued a draft for the medical device companies on the “Regulations for the Supervision and Administration of Refurbishment and Reuse of Medical Devices” (referred to as “the Regulations”), permitting the use of used medical devices from the original production. The company or the entrusted company repossesses, refurbishes, sells, and uses again. On June 27, 2005, all domestic manufacturers submitted a letter to the Ministry of Commerce in Beijing and opposed the publication of the “Regulations.” Then there was news that the state’s discussion of this provision had been suspended. So far, the “Regulations” have not yet been formally introduced. In the end, the medical institutions should not purchase refurbished medical devices. In this debate, the reporter invited experts and industry veterans with different opinions in the medical field to hold fierce debates on the subject.