Healthcare purchasers in the UK are being warned to check for proof of authenticity when buying medical devices after an alert was issued over counterfeit ligating clip cartridges.
The Medical and Healthcare products Regulatory Agency (MHRA) has issued a warning after manufacturer, Ethicon Endo-Surgery (EES) released a Field Safety Notice following the discovery that fake versions of its Ligaclip Extra Ligating Clip Cartridges - product code LT300 - are being made available over the internet.
Counterfeiters are fully aware of the requirements of the EU laws and any initial visual inspection by the purchaser or end user may not always identify that the device is counterfeit
While there is no evidence they have been purchased by UK hospitals, the MHRA alert says the manufacturer cannot guarantee the safety of any devices not purchased through authorised distributors.
The counterfeit products are identifiable by both an unusual font used on the sales box units that distorts the company name; and the misspelling of the word ‘sterile’ as ‘stemike’ on the individual clip packages. The boxes the fake equipment is dispatched in are also shrink-wrapped while the genuine product is not.
The Field Safety Notice states that EES has found the counterfeit devices on the market and cannot guarantee mechanical properties, biocompatibility or sterility.
The discovery compounds fears that since the popularity of online sales has grown, so has the potential for fake goods to be sold increased.
Only a month ago the MHRA carried out a series of raids across England as part of a blitz on unapproved clinical equipment being sold over the internet. This led to the seizure of 400 fake digital thermometers, which were being sold cheaply online, but did not have appropriate CE safety markings, warnings or instructions. When a mother used one of the devices on her young child who was suffering from leukaemia, he was said to have a normal temperature, despite in fact having a high fever.
After this week’s alert, BBH spoke to the MHRA, where a spokesman said: "The MHRA is aware of counterfeit Ligaclip cartridges within the supply chain outside the UK. We have no current evidence that these have reached UK patient level, and the agency is working with the manufacturer to ensure that UK patients are protected. The agency is monitoring the UK supply chain and will react to evidence as and when it is received. However, we would urge end users to be vigilant and report any suspected counterfeit medical products to the agency's dedicated counterfeit hotline.”
It is important that when purchasing any medical products from third parties all relevant checks are carried out to satisfy compliance and authenticity at all levels of the supply chain
Warning healthcare procurement specialists to check for authenticity when purchasing equipment, he added: “Manufacturers of medical devices are required by law to make sure that any medical devices that they make are safe. The UK and the rest of Europe have the same legal requirements for medical device safety and performance and a medical device that meets those requirements will display a CE mark. Counterfeiters are fully aware of the requirements of the EU laws and any initial visual inspection by the purchaser or end user may not always identify that the device is counterfeit. It is important, therefore, that when purchasing any medical products from third parties all relevant checks are carried out to satisfy compliance and authenticity at all levels of the supply chain. Contact with original manufacturer, certificate confirmation, in-depth research of the third parties are some examples of measures that can be adopted, particularly where the price seems unusually low to protect the supply chain from counterfeit devices.”
