For full functionality of this page it is necessary to enable JavaScript. Here are the instructions how to enable JavaScript in your web browser Manufacturers of Medical Devices Must Be Aware of Hacking Risk

Manufacturers of Medical Devices Must Be Aware of Hacking Risk

By Mark Buckingham, Recall Consultant

We live in an increasingly connected world. All around us, we have devices that speak to us and to each other – from small items like the mobile phones in our pockets to much bigger objects like the cars in our driveways. We can communicate with our fridges and our thermostats, among a myriad of other household objects.

And the trend is only going in one direction – over the next ten years, we can expect to see a dramatic increase in the number of smart devices. Many sectors will be affected by that trend with one key area that of healthcare. Whether it is portable blood pressure monitors, AI-powered insulin pumps or connected inhalers, there is huge potential to benefit the lives of people suffering from chronic conditions. And the advantages extend even further. With devices helping people live healthier lives, there will be a significant easing of pressure on already-stretched healthcare providers.

But while the increasing use of smart devices is predicted to be a major trend in healthcare going forward, it is crucial that manufacturers are also mindful of the potential downsides and are prepared to deal with any negative consequences.

One major risk – as with anything that is connected to the internet – is that smart medical devices are susceptible to hackers.

The reality of this is genuinely frightening. In August of 2017, the Food and Drug Administration in the United States was forced to recall 500,000 pacemakers. Why? Because they were deemed to be vulnerable to hackers, who could in theory run the batteries down or even change the heartbeat of a patient.

With potentially devastating repercussions, it is imperative that manufacturers are cognisant of the need to quickly recall devices, should vulnerabilities be discovered. Recalls are never simple, but the degree of difficulty of course rises exponentially when the product in question is not sitting on a shelf somewhere but is actually inside a living person.

In the above example, the solution was not to remove the pacemaker devices but instead to issue a firmware update. That shows that these problems can be dealt with, but only if manufacturers move quickly and effectively. The first step should be ensuring a clear recall strategy is in place – because the reality of not having one and being on the back foot in this sector hardly bears thinking about.

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