News - April 1998

Company News

Seton buys another urology business...

In April 1998, Seton Healthcare bought EMS Medical's urology business. The range includes urine drainage bags and catheters, including the new coated intermittent catheter, "AquaCath".

The range will be marketed under the Seton Continence Care umbrella. The brand name of EMS will be available in the short term for some of the products.

This is the third major urology acquisition made by Seton, with Simpla and DePuy being the previous ones.

Regulatory News

UK labelling requirements causes unease.

At a recent ABHI/IBC conference in London, concern was expressed about the view of the UK Medical Devices Agency (MDA) on CE marked products which are manufactured by a third party, but marketed by companies under their own name. These products frequently carry the names of both "manufacturers".

The controversy centres around the practice of some manufacturers requiring prominent positioning of their name on the packaging even if they are not the manufacturer with the regulatory responsibility for the device.

Many in the Industry would prefer to continue with their current practice, but the MDA are sticking to their interpretation of the Medical Device Directive, that the person placing the product on the market under his own name is the legal manufacturer regardless of other names that may appear on the label.

Hip fiasco raises questions about the Directive.

At the same conference, the medical device industry expressed fears that the recent problem with the 3M him implant case was causing many to question the efficacy of the Medical Device Directive.

The 3M Capital Hip Replacement was the subject of an MDA hazard notice in February 1998, after several hospitals reported implant failure in up to 21% of cases by 5 years.

The hip was CE marked, and this has made many question how a CE marked product can exhibit such a flaw.

It appears that the device was classified as a IIb device, and CE marking was affixed via the quality system route. The technical file of the Capital Hip was not specifically examined as part of the inspection by the notified body, although examples of other technical files were. (This is legitimate under the Directive).

Alan Kent (chief executive of the MDA) acknowledged that there were perceived weaknesses with the system, and increasing pressure from the public and governments, who are perhaps reading too much into isolated problems. The MDA intend to increase its auditing of UK notified bodies and increase the number of companies it inspects annually. The MDA believe that this incident shows the importance of clinical data prior to CE marking.

News archive.

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URL: http://www.smtl.co.uk/News/April98.html
Last Modified: Friday, 08-May-1998 16:06:05 BST