By: Dr. Yasmin Kamarudin, Dr. Nor Nadia Zakaria
In this digital age, the shopping experience for both customer and businesses have evolved over the years. With the increasing accessibility of e-commerce platforms and social media, customers can buy almost anything, anywhere and anytime, through various mobile devices with the simple click of a button. Online platforms offer convenient ways for customers to purchase products by linking them directly to businesses or private sellers. Shopee is by far the most popular e-commerce platform in Malaysia, raking in approximately 55 million monthly visitors during the first quarter of 2022.
These online platforms offer a wide variety of products ranging from children’s toys, stationery, clothes, various accessories and even healthcare products. But is it safe to buy healthcare products or more precisely, medical devices online? The term “medical device” refers to any product intended for medical use. It applies to a range of products from contact lenses to pacemakers. Even some smartphones and smartwatches, although not considered medical devices by themselves, offer medical apps that can track your heart rate, blood oxygen level, or body fat percentage. Covid-19 test kits, examination gloves, oximeters and blood lancets have been sold openly online during the height of the pandemic. In fact, you can even find braces being sold online!
A quick search will show that braces are widely available at extremely cheap prices online. A removable jelly-like brace called ‘Teeth trainers’ are claimed to offer simple alignment of teeth for children with a one-size-fits all approach. Too good to be true? The popular conventional metal braces with the colourful ties are marketed as Do-It-Yourself home kits. Having the braces delivered directly to the doorstep, customers are provided with all the necessary material and equipment to stick the braces directly onto their own teeth. Would you be keen to buy braces online to straighten your teeth?
There are several concerns with buying braces, or any medical device online. The concern is less to do with the availability of the products but the lack of regulation. The sheer number of products sold online make it challenging for regulatory bodies to closely monitor products, especially those being imported from overseas. It is a legal requirement, however, for medical devices to be registered with the Medical Device Authority (MDA) to safeguard the health and safety of patients and consumers. Typically, the level of control the MDA places on specific medical devices depends on associated risks to the user. The intended use, duration of use, and the part of the human body involved, are all factors influencing the risk assessment. For instance, metal braces have been categorised by the MDA as having a low to moderate risk (Class B) as it is considered relatively invasive (present within the body orifice) and intended for long term use. Depending on the risk category, medical devices need to be assessed and tested to ensure they reach quality and safety standards.
A recent local study by a team at Universiti Malaya reported that most braces material sold on a local e-commerce platform were not registered with the MDA. Without going through appropriate risk assessment, these products pose a significant risk to the consumer. The products me be of poor quality, counterfeit, expired, or contain dangerous and prohibited ingredients. There have also been recent reports on illicit medications such as period regulation and breast enhancement tablets being marketed as supplements, rather than drugs, to confuse consumers. Up until October, the MDA has seized unregistered medical devices totalling to more than RM500,000 this year alone.
A growing concern in the healthcare sector is the direct delivery of medical devices to the consumer, by bypassing the involvement of qualified healthcare providers. In Malaysia, unscrupulous business-minded individuals have taken the opportunity to purchase cheap braces online in bulk, to set up ‘braces fitting’ services. Such services are commonly referred to as ‘fake braces’ in the media. Without appropriate assessment and monitoring by a qualified clinician, fake braces can lead to worsening of the teeth alignment, the development of cavities, the onset of gum disease, and the risk of tooth fractures. Additionally, there is the potential danger of harmful ions and metals leaching from the counterfeit materials.
In recent years, there is also the trend of purchasing clear aligners online directly from suppliers. Although not so common in Malaysia, DIY aligners are causing serious concerns in countries such as UK, USA and Australia. Customers are sometimes sent moulding kits through the post so that they can take moulds of their teeth and post them back to the supplier to get their customised aligners made. But this too, can lead to health risks without appropriate diagnosis and planning as well as monitoring by a trained dental specialist.
The convenience of purchasing products online cannot be denied, as we can purchase almost anything, anytime, and anywhere. But just because we can, doesn’t mean we should. As a consumer, we need to know our rights and purchase responsibly. Consumers can check an establishment’s registered license and their medical devices via MDA’s website at www.mda.gov.my, or its medical devices database at mdar.mda.gov.my.
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The authors are from the Department of Paediatric Dentistry and Orthodontics, Faculty of Dentistry, Universiti Malaya.
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