With the publication of Whitehall training’s new course on Device Safety & Vigilance, it is a good time to look at the sector and the strong parallels with pharmacovigilance.
The global medical device sector was worth around $300 billion in 2012, with the US accounting for a massive 38%. In the same year, US device exports were worth over $44.2 billion.
The sector is phenomenally broad – ranging from massive ticket items such as imaging equipment, like MRI machines, to disposables such as hypodermic needles and syringes. It is hard to imagine any aspect of modern medicine that does not benefit from developments in devices.
Like drugs, devices can have unwanted effects – sometimes due to malfunction and sometimes because of inherent design and functionality issues. As you’d expect from its market share alone, the US leads the world on vigilance systems for devices – in many ways mirroring the pharmacovigilance systems in place for reporting adverse reactions to drugs.
The new course starts with a brief history of device vigilance. Since 1984, all manufacturers and importers of medical devices have been required to report to FDA any device-related deaths, serious injuries, and certain malfunctions. European rules came into force from 1993 to 1998, in the shape of the European medical device directives.
Much of the course examines the nature of adverse events and how they should be reported in areas such as the US, Canada, Europe and Japan. Like drugs, the identified risks and methods of reporting fall distinctly into the pre-clinical and post-marketing camps.
Pre-clinical adverse events have usually been well documented, produced in controlled conditions and are medically confirmed. Post-marketing ones are only sometimes medically confirmed, may suffer from duplicate reporting and inaccuracies – but they do score in terms of volume.
All adverse device events are classified on two axes – “seriousness” and “intensity/severity.” These two are often confused but are actually very different.
A patient with mild dizziness is clearly suffering from a non-serious event of mild-severity, but if the dizziness becomes so marked that they are unable to work and may need hospitalisation, they are still suffering from a non-serious event but of severe intensity.
It is “seriousness”, ie medical significance that dictates when a device event needs reporting. Even a very mild heart attack is a serious medical event.
As any researcher knows, causality can be hard to prove – which is why the course goes into some length explaining the different levels of certainty that an adverse event has been directly produced by the device. Positive re-challenge gives the highest level of confidence – bordering on absolute certainty.
It is assessment of risk that forms the backbone of all vigilance processes. Device Vigilance and Safety summarises different approaches to trend analysis and risk assessment. It also explains the device class system – usually three or four classes where Class I poses the least risk and demand the least rigorous reporting and the highest rated class is essential in supporting life but where there may be insufficient information to ensure safety through the procedures used for the other classes.
Device Vigilance and Safety was written by Steve Jolley - a Cambridge University graduate with 25 years’ experience in drug & device safety & vigilance, who specializes in global safety compliance, business process improvement and signal detection. He is the Chairperson of the DIA Clinical Safety and Pharmacovigilance steering committee for North America and has worked with over 80 clients in the US, Europe and Japan. He is a featured speaker with the FDA and MHRA at DIA conferences and webinars on drug safety topics including auditing and signalling).
