最后一句话:营销塑身疗法

通过Dr Selena Langdon14军2018

Selena Langdon博士讨论了她对英国人体轮廓治疗的监管和市场营销以及她认为需要改变以确保患者安全的问题。

市场研究公司IMARC Group估计,2016年全球塑身治疗市场价值53亿美元,预计在2017-2022年期间将以大约7%的复合年增长率(CAGR)增长,达到80亿美元。许多从业者会注意到,为满足这一需求,可用设备的数量和类型在不断增加。

I believe that like many other 德赢官网登入aesthetic treatments and devices in the UK,there is a lack of appropriate regulation in regards to product safety and pre-market testing.这导致越来越多的设备向公众销售,其中许多都没有或几乎没有证据表明其有效性或安全性。As well as this,many users are implementing misleading marketing messages and using devices,是否进行了适当的监管和测试,in settings with no medical oversight.

An unregulated device market – the root of the issue

The Medicines and Healthcare Products Regulatory Agency (MHRA) is charged with regulating medical devices in the UK to ensure they work and are acceptably safe.2If 德赢官网登入aesthetic devices make no medical claim,they are currently outside the current scope of regulation.3The Care Quality Commission (CQC) as the healthcare regulator for England,只有许可和监管涉及外科手术的美容治疗,而不监管非外科部门德赢APP。这使得人体轮廓仪及其操作目前不在任何直接调节范围之内。

在我自己的实践中,我依赖食品药品监督管理局(FDA)的批准,因为它需要安全性和有效性的证据才能在美国销售。5,6相反,目前欧洲对医疗器械的等效标准是CE标志,不会对设备进行类似程度的审查。因为身体轮廓仪不是,at present,在欧洲被归类为医疗设备,而被归类为电气设备,8 the CE Mark applied to these devices only relates to the Low Voltage Directive (LVD) 2014/35/ EU9 and the Electromagnetic Compatibility (EMC) Directive 2014/30/EU.这两种方法都不需要对患者安全性进行认证或测试,治疗效果或上市后监督,监测或报告并发症。9,十即使身体轮廓仪被归为医学类,第二类医疗器械的要求仅不同于要求通知机构进行合格评定以批准制造商的声明。11尽管要求医疗器械分销商向主管当局(MHRA)报告不良事件,没有义务将临床调查数据作为身体轮廓设备的批准提交文件的一部分提供。11

非医疗运营商复合风险

I believe there is an issue with non-medical professionals performing body contouring treatments without the oversight of a medically trained and regulated practitioner.While side effects,complications and other problems can potentially arise from most treatments,能够正确评估禁忌症,如男性妇科疾病,疝气,肿瘤,右心房舒张,淋巴结肿大或脂肪瘤是非常重要的。在没有医疗监督的情况下,使用未经充分检查的器械进行身体塑形治疗只会增加风险,当患者有禁忌症时使用此类器械可能导致严重的治疗后并发症。

作为一个例子,2017伤口护理杂志(JWC) reported a complication case that involved a 53-year-old woman.她在一家美容院接受了一位美容治疗师的60分钟未透露姓名的冷冻脂肪分解治疗,导致严重的冻伤。A few hours after the treatment,据报道,两个疼痛的皮肤水泡发展与进行性红斑。The salon owner did not recommend the patient seek immediate medical attention and the injury progressed to full-thickness frostbite injuries after one week.12Unlike non-medics,谁没有

任何需要遵循的专业指南,medical operators of body contouring devices have a responsibility to follow professional guidelines and are subject to professional standards such as those laid down by the General Medical Council in its ‘Guidance for doctors who offer 德赢APPcosmetic interventions'.十三

From my personal experience,I am aware that several major body contouring manufacturers and their distributors carry out a process of due diligence on those seeking to purchase and operate their devices.制造商告诉我,这是为了确保医生充分参与咨询和治疗过程,因为他们认为治疗的结果和安全性是,部分地,operator dependent.

将专业人员保持在较高的标准并不能保护公众不受专业机构的监督。虽然专业监督有助于提高专业环境中的标准,它不会捕获设备的所有操作员。Without sufficient regulations being in place to control the sale and use of the devices,或者强制医疗监督,那么对公众的风险依然存在。

Marketing

I believe the marketing of body contouring devices is also an issue.塑身治疗的营销遵循某些标准,例如化妆品干预广告指导,德赢APPand monitoring of compliance with this guidance is the responsibility of the Advertising Standards Authority (ASA).14,15,十六

美国广告标准局的化妆德赢APP品干预广告指导声明,除其他要求外:

  • 广告不得因夸大产品或服务的能力或性能而误导他人。
  • objective claims must be backed by evidence,if relevant,包括对人进行的试验

为要亚撒追查广告主的假称,it is likely that a patient would need to raise an issue with the ASA and will probably only do so once they become aware that the claims made in the advertising are false.这很可能发生在治疗失败或受伤后。

Advertisers who fail to remove misleading or inaccurate advertisements can be referred by the ASA to the National Trading Standards (NTS).NTS是美国广告标准局的法律后盾,可以起诉广告商无限期罚款或最高两年监禁。17,十八

然而,这种处罚是最后的手段,而且,在大多数情况下,广告被修改或撤销,更严厉的惩罚只适用于重犯。因此,对广告商做出虚假或误导性声明的动机是很高的,消费者只能得到适度的保护,免受关于治疗效果和安全性的虚假或误导性声明的影响。19

A change to regulation

2017年5月25日,监管发生了重大变化,with the introduction of EU Regulation 2017/745,which becomes applicable from 25 May 2020.21 This specifically includes equipment intended to be used to reduce,remove or destroy adipose tissue.The devices will need to undergo clinical evaluations which shall be based on relevant data concerning safety,including data from post-market surveillance,上市后临床随访,and,如果适用,具体临床调查。制造商还必须报告严重事件和其他可报告事件,以及支持主管当局协调对此类事件和事件的评估。21报告不良事件很重要,因为不良事件可能因故障而发生,unclear instructions,糟糕的用户实践或服务和维护问题。This change in regulation will bring the EU more in line with the standards and practices of the FDA in terms of regulation,monitoring and consumer protection.尽管很难确定英国法规在多大程度上反映出欧盟脱欧后的法规;I believe this is an extremely positive step forward for 德赢官网登入aesthetics in the UK.

从这里到哪里??

The demand for body contouring treatments is growing and the new EU Regulation will increase oversight of body contouring devices.The question is the extent to which the UK will incorporate the new regulation into its own,post-Brexit。我希望英国选择在医疗器械监管方面与欧盟协调,这将通过提供更多的监督来提高患者的安全性,更好的市场前测试和更多的控制身体轮廓设备在市场上提供。Assuming an improved regulatory framework for these devices,clinical evaluation prior to certification and mandatory reporting of adverse incidents to a competent authority (the MHRA in the UK),,二十一我预计在2020年后身体轮廓治疗市场将以积极的方式发展。与此同时,I believe it is necessary for medical practitioners to help patients understand the treatment choices and risks associated with the various methods for body contouring available,提供有效的治疗监督,并根据专业标准和ASA指导宣传治疗。

工具书类

IMAC,塑身市场:全球行业趋势,Share,Size,Growth,2018-2023年机遇与预测

2。MHRA服务和信息。

三。英国,决定你的产品是药品还是医疗器械,MHRA2013

4。CQC,监管活动。

5.美国食品药品监督管理局第三步:审批途径。

6。美国食品药品监督管理局Information Sheet Guidance For IRBs,Clinical Investigators,赞助商经常问一些关于医疗器械的问题,2006.

7。英国,Guidance CE marking,2012.

8。1993年6月14日关于医疗器械的理事会指令93/42/EEC,1993。

9.欧洲委员会,低压指令(LVD)2016.

10.欧盟官方刊物,DIRECTIVE 2014/30/ EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL,2014。

11。英国,Guidance Medical devices: conformity assessment and the CE mark,2015。

12。ChoongW.L.WohlgemutH.S.哈勒姆,M.J.美容院冷冻脂肪溶解治疗后冻伤:一个案例研究,伤口护理杂志,第26卷,NO 4,2017年4月,pg.188 to 190

13.GMC指导提供整容手术的医生,德赢APP2016.

14。美国皮肤外科学会,ASDS SURVEY: SEVEN OUT OF TEN CONSUMERS CONSIDERING 德赢APPCOSMETIC PROCEDURES,2017。

15。CAP,德赢APP化妆品干预广告指南(非广播和广播)

16。ASA,我们的资金,2018。

17.ASA,Sanctions,2018。

18。国家贸易标准,Protecting Consumers & Safeguarding Businesses,2018。

19。ASA,谁抱怨广告?A regional breakdown,2016,,

20。欧洲议会和理事会2017年4月5日关于医疗器械的条例(欧盟)2017/745,欧盟出版物

21。2017年4月5日欧洲议会和理事会条例(欧盟)2017/745,Official Journal of the European Union.

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