首页
外语
计算机
考研
公务员
职业资格
财经
工程
司法
医学
专升本
自考
实用职业技能
登录
外语
The European Commission said on Thursday it would toughen the regulation of medical devices as a result of concerns raised by br
The European Commission said on Thursday it would toughen the regulation of medical devices as a result of concerns raised by br
admin
2011-02-03
40
问题
The European Commission said on Thursday it would toughen the regulation of medical devices as a result of concerns raised by breast implants produced by the defunct French company PIP, even as a scientific expert review it ordered concluded there was currently "insufficient evidence" that women using its products faced greater health risks than others.
John Dalli, health and consumer policy commissioner, pledged to examine surveillance and operation of the "notified bodies" that scrutinise medical devices across the EU in a current review of legislation, stressing: "The capacity to detect and minimise the risk of fraud must be increased."
His comments followed an official report released on Wednesday in France that called for national and EU-wide co-operation including random inspections and sampling of medical devices to prevent a repeat of the fraudulent use of substandard non-medical-grade silicone by PIP in implants sold to up to 400,000 women around the world.
Xavier Bertrand, France’s minister of health, called for enhanced action in France and across Europe in the wake of the study, which highlighted that Afssaps, the French medical regulator, did not inspect PIP from 2001 until a tip-off led officials to inspect and close down the company in 2010. Jean-Claude Mas, its founder, is under police investigation for manslaughter.
Mr. Bertrand has pledged to hire more health inspectors and undertake random checks on medical device companies following growing concerns over its regulatory system highlighted by the widespread use of PIP’s substandard breast implants.
A French decision at the end of last year to offer all women free removal of PIP implants triggered similar proposals in the UK, Germany and the Czech Republic and has helped spark a fresh debate over tougher EU regulation of medical devices, which are subject to far less scrutiny than pharmaceuticals.
However, a review released on Thursday by the EU’s own Scientific Committee on Emerging and Newly Identified Health Risks concluded: "Breast implants can fail, regardless of manufacturer, and the probability of failure increases with time since implantation. In most cases, breast implant failure appears to be without identifiable health consequences for the patient with the exception of possible local complications."
It stressed that limited data meant that while there was no link between breast implants and cancer, there was a need for further work to understand the specific risks from the PIP products.
Mr. Bertrand has endorsed calls for a parliamentary inquiry in France as well as a report from the country’s social affairs inspectorate, mirroring similar moves that led to tough new requirements for the pharmaceutical industry introduced last year in the wake of concerns about Servier’s drug Mediator.
Medical device manufacturers have called for reforms to ensure that the national "notified bodies" which audit the quality of their products across Europe are of a consistently high standard, while cautioning that tough new regulatory requirements could harm the EU’s competitive advantage.
The French study showed that Afssaps had received multiple warnings over the relatively high failure rate of PIP implants compared with those made by other companies, even though the overall proportion remained modest.
From Financial Times, February 2, 2012
Which of the following statements is true according to the passage?
选项
A、There is a consensus on the EU regulation of medical devices in the European Union.
B、All breast implant failure appears to be without identifiable health consequences.
C、Tough new regulatory requirements could harm the EU’s competitive advantage.
D、The overall proportion of the implant failure is relatively high compared with others.
答案
C
解析
本题为概括题。根据第六段“spark a fresh debate over tougher EU regulation of medical devices”可知A错误;根据第七段“breast implant failure appears to be without identifiable health consequences for the patient with the exception of possible local complications”可知B错误;根据倒数第二段“while cautioning that tough new regulatory requirements could harm the EU’s competitive advantage”可知C正确;根据最后一段“even though the overall proportion remained modest”可知D错误。
转载请注明原文地址:https://kaotiyun.com/show/cM1K777K
0
专业英语四级
相关试题推荐
Thethoughtofgoingbackhomewas______kepthimhappywhilehewasworkingabroad.
Whydoadultsbelievethatalcoholicawarenessprogramsteachyoungpeoplenottoover-drink?Recently,readinganarticleabout
Thegreatestrecentsocialchangeshavebeen【C1】______thelivesofwomen.Duringthe20thcenturytherehasbeenaremarkable
WhatdidmostEuropeanscholarsbelievebefore17thcenturyaboutthesizeoftheuniverse?
ThemandidthefollowingthroughtheInternetthatdayEXCEPT_______.
NowyoucanuseanykindoftreetofeedyourwildfriendsduringtheChristmasholidays.Sharethebountiesoffoodwiththewi
TheEuropeanCommunitysaysitwillconsiderusingforce______isneededforpeacekeepingintheregion.
Simplythinkingabouttheideathatherhusbandmightdieanyminuteonthebattlegroundwouldmakeher______throughandthro
TheAustriaBigDry______.
Caraccountfor______thegreenhousegasesintheUS.
随机试题
2017年年初,甲公司与乙银行签订一份协议,约定甲公司一旦发生特定事件引起财务危机时,有权从乙银行取得500万贷款来应对风险。在协议中,双方明确了甲公司归还贷款的期限以及获得贷款应当支付的利息和费用。针对甲公司采取的措施,下列各项中表述正确的有(
高温掺合阀TV05106的作用是调节制硫燃烧炉出口工艺气的温度确保一级转化器入口温度正常。
A.化生B.机化C.分化D.再生组织细胞从胚胎期不成熟细胞到正常成熟细胞的生长发育过程
大量输入生理盐水治疗等渗性脱水可导致
低分子右旋糖酐抵克力得
表证和里证的鉴别要点为()
原告蒋发与被告高金于2007年3月8日经法院判决离婚后,属双方共有的位于河池市某局的一套房改房和位于河池市江北路的一栋五层楼房在判决中没有分割处,双方离婚一直也没有对共有房屋自行协商分割处理。原、被告于2007年3月8日离婚后至2007年11月间,原告蒋发
商业银行操作风险即是金融欺诈和金融犯罪。()
下列关于北京故宫保和殿的叙述中,正确的是()。
软件测试的目的是尽可能发现软件中错误,通常【】是在代码编写阶段可进行的测试,它是整个测试工作的基础。
最新回复
(
0
)