Navigating the narrow straits of device regulation
Published date : 07 February 2012
Article date : 07 February 2012
Several medical devices have hit the headlines in recent months. Most recently the story of PIP breast implants has played out publicly in Europe and the USA,1 and prior to this, the debate about the ASR hip2 and other metal on metal implants.3
Device regulation has become a hot political topic: Obama picked up on it in the State of The Union Address and UK Secretary of State for Health Andrew Lansley has announced a review of the safety of cosmetic clinics.4
More often than not, the reflex response to crises like these is a rush to tighten regulation, but this could stifle innovation, deny patients access to new devices and hit business. Industry advocates make a strong case for speeding up regulatory processes,5 and the European body Eucomed has acknowledged weaknesses in the present system.6
Innovators, industry and health care professionals therefore find themselves in a quandary – how to stimulate the development of new devices without putting patients at risk, and how to recognise the different needs of device manufacturers from pharmaceutical and toy companies.7
How do you think device regulation can be improved?
Proposed solutions include demands for new devices to be enrolled in clinical trials and an insurance-based system for new devices which would survive business failure or bankruptcy. At Which Medical Device, we are interested in sharing the best information about devices, but what else should the regulators be doing? Please take our short survey and tell us what you think - it's just seven questions:
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References
2. Which Medical Device. ASR Hip Resurfacing. 2010.
3. Which Medical Device. Surgeons cautioned about large diameter metal on metal hips. 2011.
4. Department of Health. Reviews to ensure safety of people seeking cosmetic treatments. UK. 2012.
5. Advamed. AdvaMed's Competitiveness Agenda Infographic. USA. 2011.
6. Brennan J. Eucomed. How should the EU regulatory framework change because of the PIP incidents? 2012.
7. Boseley S. Medical devices and Chinese toys share same level of safety checks. Guardian. 2012 January 6.
