Can I trust my medical device?

You’ve bought a piece of medical equipment.  How do you know you can trust it?

In developed countries with strong regulatory frameworks for consumer goods, it’s not often most would question the trustworthiness of what they’re buying.

Sure, some of us may have finely-tuned detectors for selling tactics.  Many will be conscious of the ingredients or other components of the goods they buy.  Increasing numbers of consumers choose what they buy based on values such as ethical supply chains and environmental impact.

Does this scrutiny extend to determining if a product can be trusted?  And if so, how can you tell?

Knowing where your food comes from is one thing.  Being able to trust if an AED (automated external defibrillator) is going to help save a life and not cause further harm to a patient, is another.

Regulatory approval

You may be fortunate enough to live in a part of the world where you can trust what it says on the label of the product you’ve purchased.  This trustworthiness is the product of highly sophisticated regulatory systems for truth in advertising and quality control.

These systems were set up to protect consumers and users from sellers of unsafe or just plain fictitious medicines and equipment that proport to save, but actually harm.

Thanks to the world’s regulatory bodies governing the provision and sale of medical equipment and medicines, we can worry less about the quality and efficacy of products that claim to improve our health and wellbeing.

These bodies haven’t eradicated the snake oil salespeople – but they have done a lot to help us avoid them.

Regulation of medical devices

In countries and territories like the United States, the UK, the EU, Japan, China and Australia, it is illegal to sell medical devices that have not been approved by relevant governing regulatory bodies.

These bodies have stringent processes to assess and approve medical devices for sale in their jurisdictions.  Securing their approval is a long, highly involved process.

This process covers every aspect of a device’s design, manufacture, supply and use.  Overall, regulators are looking to confirm four things – that the device is fit-for-purpose, safe to use,  secure and of high quality.

Fit-for-purpose – what problem is the device designed to solve, and does it deliver this solution?  For an AED, this means more than just detecting aberrant heart rhythms and delivering shocks.  It’s about being reliable, portable, affordable and robust enough to allow it to be made available where and when it needs to be.

Safe to use – does the device minimise any risk of harm to patient or user?  This is a particularly important question for AEDs, which need to be sophisticated enough to automatically detect and deliver the correct level of shock appropriate to the patient.

Secure – is the device safe from cybersecurity intrusion?  Is the owner and / or patient’s data protected?  As medical devices become IoMT-enabled (Internet of Medical Things), the protect of data and the device itself is a key focus for regulators.

Quality – are the overall design, manufacturing methods, components and other physical aspects of the device up to standards expected of this sort of equipment?  How do these aspects translate into device durability and other considerations, such as battery life and need for replacement parts?

So, how do I know I can trust my device?

An approved device should carry your jurisdiction’s regulatory mark on its label and packaging.

If you’re still not sure, regulatory bodies typically publish online registers of approved devices.  Many also offer resources and services explaining what their regulations cover, and advise on how to report any concerns.