The ultimate aim of this scheme is to ‘improve the consistency of medical device reviews’; this has got to be good news for device manufacturers involved in the 510(k) process. Inconsistency has often been the industry’s experience thus far and any initiatives to tackle this issue will be welcomed by organisations all over the world and the healthcare sector in the States which oozes a cutting edge and innovative ethos.

In order to be belt and braces about a consistent approach to the 510(k) process, perhaps the scheme should be made compulsory for existing staff as well as new. You can read more about it by clicking here.

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“The nomenclature of a medical device facilitates its progression through the entire product life cycle. The use of a single system would enable consistency in classification and identification, the consistent capture of product information across manufacturers, sponsors, distributors and in the clinical setting, for example, in hospitals. It would streamline medical device recalls, adverse event reporting and postmarket surveillance and monitoring.

The GMDN is a system of internationally recognised coded descriptors used to generically identify medical devices, which is now being utilised by many of the world’s medical device regulators and industry. The GHTF therefore endorses the GMDN coding system as the preferred nomenclature system for regulatory purposes for medical devices and will continue to work to ensure its effective governance and availability.”

If this is the way to go in the future it raises the question as to what happens for those manufacturers and regulators using alternative nomenclature systems such as the UMDN. Read more on this issue at http://www.ghtf.org/about/statement-gmdn.html.

The question is should the MHRA have more powers than they currenlty have to force shops like Pound World to withdraw non compliant items straight away or have the power to remove the items themeselves. If the MHRA had such powers and could also fine the likes of Pound World perhaps the trade of non compliant goods would be significantly reduced. Judging by the number of fines and costs Pound World pays out (£9,000 costs in this example) the £1 market must be very boyant indeed. Is Pound World a one off or just the tip of the iceberg?