正畸销售:电商平台固定器具

IF 0.5 4区 医学 Q4 DENTISTRY, ORAL SURGERY & MEDICINE Australasian Orthodontic Journal Pub Date : 2022-01-01 DOI:10.21307/aoj-2022.003
Y. Kamarudin, N. N. Zakaria, Violette Ong Xinhui
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引用次数: 0

摘要

正畸材料作为医疗器械,其销售受到监管,以保护患者。然而,电子商务平台上的正畸产品可能不受监管,危及患者安全。目的研究固定正畸器在本地和全球电子商务平台上的销售情况。材料与方法对Shopee和Amazon上销售的正畸材料进行横断面分析,关键词为托槽、弓丝和绑扎。在删除重复和不相关的搜索结果后,对每个关键词搜索的前50个产品进行分析。记录了产品名称、产品类型、卖家、成本、星级、评论数量、销售数量、发货地点和品牌标识。在医疗器械监管机构进行了品牌注册检查。将收集到的数据制成谷歌(spreadsheet)表格,得出描述性统计数据和频率表。结果共筛选了800条搜索结果。确定了348个相关结果,其中约三分之二来自Shopee。在Shopee(39%)和Amazon(80%)上,Ligatures产生了最高的搜索结果。与亚马逊提供的固定正畸材料相比,Shopee上销售的固定正畸材料有更多的评论,更高的星级和更低的每件商品成本。相比Shopee(5%),亚马逊(97%)上的产品更有可能拥有品牌标识。Shopee上可识别的品牌都没有在监管机构注册,而亚马逊上列出的8种产品都注册了。这两个电子商务平台的大部分发货地点都来自中国。结论在Shopee上购买正畸托槽、弓丝和结扎线比在Amazon上更容易获得。这些产品的质量和安全无法得到保证,因为大多数产品要么没有清晰的标签,要么没有根据医疗器械法规进行注册。
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Orthodontics on sale: fixed appliances on E-commerce platforms
Abstract Introduction The sale of orthodontic materials, considered as medical devices, is regulated in order to protect patients. The availability of orthodontic products on e-commerce platforms, however, may go unregulated and compromise patient safety. Objective The present study aimed to investigate the sale of fixed orthodontic appliances on a local and global e-commerce platform. Materials and Methods A cross-sectional analysis of orthodontic materials sold on Shopee and Amazon was conducted using a specific keyword search for brackets, arch wires and ligatures. After deleting duplicates and irrelevant search results, the top 50 products for each keyword search were analysed. Product name, the type of product, seller, cost, star rating, the number of reviews, the number of sales, shipping location and brand identification were recorded. Brand registration with a medical device regulatory authority was checked. Collected data were tabulated in Google (spread)sheet to derive descriptive statistics and frequency tables. Results A total of 800 search results were screened. Three hundred and forty-eight relevant results were identified, approximately two-thirds of which originated from Shopee. Ligatures generated the highest search outcome in both Shopee (39%) and Amazon (80%). Fixed orthodontic materials sold on Shopee resulted in a larger number of reviews, higher star ratings and a lower cost per item compared to those supplied by Amazon. Products on Amazon were more likely to have brand identification (97%) compared to Shopee (5%). None of the identifiable brands on Shopee were registered with regulatory bodies, whereas eight products listed on Amazon were registered. A large portion of shipping locations originated from China for both e-commerce platforms. Conclusions Orthodontic brackets, arch wires and ligatures are more readily available on Shopee compared to Amazon. The quality and safety of these products cannot be assured as the majority of the products were either not clearly labelled or their registration was not identified under the regulation of medical devices.
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来源期刊
Australasian Orthodontic Journal
Australasian Orthodontic Journal Dentistry-Orthodontics
CiteScore
0.80
自引率
25.00%
发文量
24
期刊介绍: The Australasian Orthodontic Journal (AOJ) is the official scientific publication of the Australian Society of Orthodontists. Previously titled the Australian Orthodontic Journal, the name of the publication was changed in 2017 to provide the region with additional representation because of a substantial increase in the number of submitted overseas'' manuscripts. The volume and issue numbers continue in sequence and only the ISSN numbers have been updated. The AOJ publishes original research papers, clinical reports, book reviews, abstracts from other journals, and other material which is of interest to orthodontists and is in the interest of their continuing education. It is published twice a year in November and May. The AOJ is indexed and abstracted by Science Citation Index Expanded (SciSearch) and Journal Citation Reports/Science Edition.
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