Shopping for medical devices online can yield real bargains, but it's crucial to verify their quality, writes PRISCILLA LYNCH
IRISH CONSUMERS have become very familiar with buying clothes, gifts, books and other items online. You can make significant savings and it’s convenient and quick.
While the past couple of years has seen a well-documented increase in the purchase of illegal and counterfeit medicine online – 822,484 dosage units of counterfeit and illegal medicines were detained by the Irish Medicines Board (IMB) last year, a 66 per cent rise on 2009 the year – and subsequent warnings about the dangers of such purchases, most people don’t realise the same risks apply when buying medical devices online.
The term medical device covers items such as contact lenses, blood glucose monitoring kits, condoms, healthcare testing kits, syringes and a wide range of medical aids such as wheelchairs, etc.
Such items can cost Irish households a considerable amount of money and as cash gets tight, the IMB has voiced concern that consumers and even healthcare professionals may now be exploring new, ostensibly cheaper, ways of buying medical devices.
This means the buyer could end up inadvertently using counterfeit medical devices or items that are not cleared for use in the Irish market.
A new safety notice from the IMB about these counterfeit devices warns: “Access to global markets, global suppliers at trade fairs and the internet has increased the accessibility and range of products available to the consumer.
“However, vigilance is required to ensure that the medical device that is being offered/purchased is a genuine CE-marked product from the authentic manufacturer, which complies with the EU medical devices legislative requirements.”
While the IMB acknowledges that many genuine medical devices are available for purchase online, a large number of internet sites are unauthorised, unregulated and may offer non-compliant products.
“Buying medical devices online may appear to be an attractive alternative due to the perceived convenience, lower price and the privacy afforded to individuals. However, the potential risk to users who purchase medical devices over the internet may be relatively high.”
And it’s not just the internet that can pose a risk – counterfeit products may also be supplied to a distributor, wholesaler or directly to a hospital or a retail outlet, so purchasers have to remain vigilant at all times.
As the IMB points out, the safety and quality of counterfeit medical devices cannot be guaranteed as they may not be manufactured to the required standards or conform to the requirements of the medical devices legislation.
Therefore, counterfeit medical devices pose a risk to public health and safety.
The consequences of using counterfeit medical device products vary but can potentially be deadly.
In some instances the user may suffer direct physical harm, or in the case of a medical testing kit the use of a counterfeit product may result in the patient not being diagnosed or treated appropriately.
The IMB says the counterfeit products that have been identified to date in Ireland do not suggest that there is a particular focus on any specific categories of medical devices.
However, low-cost, over-the-counter products such as condoms and injection needles and more complex products used by specialist healthcare professionals such as surgical meshes and contact lenses have been the subject of counterfeiting.
The IMB has put together advice for healthcare providers, the public and suppliers to try to protect against purchasing counterfeit medical devices.
The IMB’s advice for members of the public is:
Talk to a healthcare professional, such as your GP, before buying a medical device.
Make sure the device that you are planning to buy has a CE mark.
Devices that are CE marked and sold on the European market must have a European-registered business premises. Look for a European address on the packaging and labelling of the device.
Ensure that the labelling and instructions for use (if applicable) have been provided in English. It is a requirement of the medical devices legislation that the labelling and instructions for medical devices placed on the Irish market are provided in the English language.
Consider buying directly from the manufacturer or authorised distributor.
Complete the warranty form (if provided) so that the manufacturer can contact you if they need to (eg if they need to recall the product).
Do not buy medical devices from websites that you have not verified.
If you suspect that you may have bought or that counterfeit medical devices are available for sale in Ireland, please contact the IMB at enforcement@imb.ie.
