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How far can the validity of 'piggy-backed' products be stretched?

London, 28 September 2006 -- In the upcoming November 2006 issue, the Journal of Medical Device Regulation (JMDR) will publish an article written by David R Pickard from the UK consultancy Quality First International entitled Ethylene oxide sterilisation validation - How far can the validity of 'piggy-backed' products be stretched? The article examines many crucial issues of so-called piggy-back medical devices, an increasingly-used term in the medical device industry when referring to the addition of similar products, totally different products, or the same products but in different primary packaging, to the scope of an existing ethylene oxide (EtO) sterilisation validation study.

According to Mr Pickard, this practice is often used as a shortcut to demonstrating compliance to Essential Requirement 8.4 of Directive 93/42/EEC, which states that 'devices delivered in a sterile state must have been manufactured and sterilised by an appropriate validated method'. David Pickard outlines the practices and microbiological background of piggy-backing and raises some crucial questions about liability in case of adverse incidents and product recalls.

A short summary of the article will be available as from 1 November 2006 on the website www.globalregulatorypress.com. The full article is accessible only to subscribers of the Journal.

About the author

David is a microbiologist with extensive experience in the sterilisation of medical devices, sterilisation validation, cleanroom monitoring and product testing. He spearheads Quality First International Limitedís Microbiology Advisory Programme acting as contract microbiologist to over 25 medical device companies in the UK, and also specialises in medical device biological safety evaluation. Quality First International is a leading medical device regulatory consultancy based in London, UK.

About the Journal of Medical Device Regulation

The JMDR is intended to educate, provide professional guidance, develop core competence of regulatory professionals, and promote debate on fundamental and topical matters within the medical device industry. In addition to publishing review and discussion articles by opinion leaders from the device community, the Journal summarises the news headlines from around the world and provides useful reference information in the form of charts and briefing documents. The Journal is a quarterly, subscription-only publication which is currently only available in electronic format.

For more information

Please contact Marija Capek at Global Regulatory Press, phone number +49 (0) 621 16 623 26 or visit the Global Regulatory Press website at www.globalregulatorypress.com.

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