FDA has published a press release from proceedings of the US Dept of Justice case in which RAM Medical has admitted to importing and selling counterfeit and contaminated surgical hernia mesh. The full release can be found here. We examine what this means for markets outside the United States where distribution channels are less well regulated.
RAM Medical, a US importer of overstocked and discounted products from wholesalers and suppliers all over the world, resells these products to distributors and end-users in the United States. The company has admitted that the mesh, which was ostensibly manufactured by Davol Inc., a subsidiary of C.R. Bard, was periodically sold and distributed to seven RAM Medical customers. The company also admitted that numerous boxes sold between December 2008 and June 2009 included adulterated mesh which contained numerous microorganisms. It also acknowledged that boxes the company distributed between October 2008 and January 2010 contained misbranded, counterfeit mesh.
In October 2008, RAM Medical purchased approximately 420 boxes of surgical hernia mesh from Alpa Vision F.Z.E. in the United Arab Emirates, which in turn had purchased the mesh from M/S Medserve in Delhi, India. RAM Medical also purchased approximately 100 additional boxes directly from Medserve in September 2009.
FDA first issued a warning in March 2010 which included lists of the affected products and lots, recommending that users should closely inspect their inventory, not use the affected lot numbers and contact Bard should they have any concerns.
So what about outside US?
What’s without question is that importing any device, counterfeit or otherwise into the United States is more difficult than most places in the world, certainly in Europe. On this basis alone in the “Outside United States” (OUS) markets we have to be vigilant about the potential for importation of counterfeit medical goods of all types, everything from condoms to pharmaceuticals having been counterfeited in the past.
Eucomed, the European Medical Device Industry body contributed to the discussion in 2008 with some interesting statistics and observations. It suggested that pharmaceuticals and medical devices and diagnostics were the third most counterfeited products in the world and cited a report in which it was claimed that 5% of all such goods being used in USA were fake. That sounds like an overestimate to us, but even if it’s 1% it’s still a concern.
With over 500,000 medical devices being circulated through complex networks of intermediaries around the world the potential for counterfeiting is high. Add to this the financial incentive with high priced products which are often high volume and relatively simple to manufacture, coupled with a lack of regulatory control over supply chains and it’s a certainty that counterfeiting is a common practice.
Presumably the organisation responsible for the fake hernia mesh, likely based in India, did not restrict its ambitions to the USA only, although it’s (again) worrying that there’s significantly less reference to the problem outside the USA. But we’re not only talking about this one case, we’re talking about the potential and likelihood that whether in finished goods or component level widespread counterfeiting remains a possibility, indeed probability.
The bigger question is how to address this global issue and the answer is that it probably doesn’t work “top down” only. In other words, it’s unlikely that bureaucrats are going to solve this problem, at least in the short term. Technology does of course help us here. Barcoding, QR codes, RFID tags etc will all help provide a form of passport for a medical device, but usage of these technologies is not yet widespread enough to put the fakers off. In conclusion, medical device users in particular would be well advised to buy from reputable sources with contractual agreements with known manufacturers. And don’t think “it couldn’t happen to this hospital”… the hernia mesh incident reported here proves that it could and that however convincing the packaging is, in these days of sophisticated equipment it’s really not that difficult to fake.
And if you want another headache to ponder, consider the potential that your medical device may be correct in every way except the labelling/expiry date information.
Source: FDA, medlatest staff