There’s danger in buying medical devices online

ONLINE shopping platforms offer a wide variety of products, including medical devices.

The term “medical device” refers to any product intended for medical use, and can range from contact lenses to pacemakers and surgical knives to medicines.

In fact, even dental braces are being sold online, and at affordable prices too! For example, a removable jelly-like brace called “teeth trainers” claims to correct the alignment of children’s teeth with a one-size-fits-all approach.

Then there are platforms that advertise conventional metal braces with colourful ties. Marketed as do-it-yourself home kits, all the necessary material and equipment are provided to customers who will have to stick the braces onto their own teeth.

If you are interested in buying braces online, or any medical device for that matter, there are several concerns that you must consider carefully.

The sheer number of products sold online makes it challenging for regulatory bodies to closely monitor them, especially those that are imported.

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 consumer.

Typically, the level of control the MDA places on specific medical devices depends on the associated risks to the user.

The intended use, duration of use, and 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.

A recent study by a team at Universiti Malaya reported that most braces sold on a local ecommerce platform were not registered with the MDA.

Without going through the appropriate risk assessment process, these products may be of poor quality, counterfeit, expired or contain dangerous and prohibited ingredients.

There have also been reports of illicit medications, such as period regulation and breast enhancement tablets, being marketed online as supplements rather than drugs to confuse consumers.

The MDA has seized unregistered medical devices worth more than RM500,000 up to October this year alone.

Another concern in the healthcare sector is the direct delivery of medical devices to the consumer, bypassing the involvement of qualified healthcare providers.

In Malaysia, unscrupulous individuals have taken the opportunity to purchase cheap braces online in bulk to set up “braces fitting” services.

Without appropriate assessment and monitoring by a qualified clinician, fake braces can lead to worsening of the teeth alignment, development of cavities, onset of gum disease and the risk of tooth fractures.

There is also the potential danger of harmful ions and metals from the counterfeit materials leaching into the body.

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 the United Kingdom, United States 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. Without appropriate diagnosis and planning as well as monitoring by a trained dental specialist, this can also lead to health risks.

Consumers can check an establishment’s registered licence and medical devices on www.mda.gov.my or mdar.mda.gov.my.

DR YASMIN KAMARUDIN and DR NOR NADIA ZAKARIA

Department of Paediatric Dentistry and Orthodontics,

Faculty of Dentistry,

Universiti Malaya