The United Kingdom is far behind countries like the Republic of Ireland in checking the quality and safety of imported medical equipment. Here at PortableUltrasoundMachines, we regularly test our scanners, measuring the mechanical and thermal outputs at various power and frequency levels. We believe that supplying safe, reliable equipment is the core responsibility of an ultrasound company, and as so many of us are actively involved in ultrasound research as well, we also find this work interesting from an academic point of view. For example, did you know that every ultrasound transducer is unique and has its own ultrasonic ‘fingerprint’?
It is sad to see that the latest online scam involving ultrasound has now turned to safety. Just like the training scams whereby substandard CPD badges are used to legitimise equally substandard training courses, some individuals are now using irrelevant markings as a way to trick people into thinking ultrasound equipment has been tested for their specific application.
Myth: A CE mark proves a product is safe
CE is a self-certification, which means that no third party actually checks the equipment that is being CE marked. The manufacturer declares that they believe the equipment is worthy of a CE mark, and prints it on the product. One would hope that the vast majority of manufacturers make this declaration in good faith, but it is an unfortunate certainty that there will be many that do not.
In hydrophone testing we performed at Imperial College last year, for example, we found that some manufacturers were applying a fake ‘mechanical index’ figure on their ultrasound scanners. When we tested these scanners, the real MI bore no relation to the one printed on screen.
CE marking is not a universal requirement. For example, it is a requirement for human ultrasound equipment being used in the NHS, and it is likely that higher-end systems have been properly tested and certified for human use. If an entry-level veterinary ultrasound scanner is CE marked, however, it may actually be a warning sign that it may not be fit for purpose. On lower-end ultrasound scanners, a CE mark is a red flag that this is likely to be a human bladder scanner that is being manufactured in bulk, and repurposed for veterinary use without ever having actually been calibrated for small animal use. This may not be a big problem if you are scanning a Labrador’s liver, but its ultrasonic outputs may be too high to safely scan small animals during pregnancy, and that is a concern.
How to buy safely
If you want to be sure that the equipment you are buying has been tested for the application you intend to use it for, there is no substitute for buying from an ultrasound company. An ultrasound company is a company that specialises in ultrasound, with industry experts on their team. It is not simply a company or an individual who resells ultrasound machines – anybody with internet access can do that.
At PortableUltrasoundMachines, we are:
- An NHS supplier
- Suppliers of multinational aid organisations, all of whom require stringent tests and certifications for any equipment purchased
- Award-winners – most recently, ‘Most Innovative Ultrasound Technology Supplier 2022’ at the Healthcare & Pharmaceutical Awards
- Inventors, owning numerous IP registrations
- Industry professionals, with two accredited sonographers, an ultrasound physicist and a vet nurse on team
We work with universities and academic institutions worldwide to stay at the cutting edge of science and deliver the very best ultrasound technology to our clients.