Ultrasound Machines: Do you know what you’re buying?
Ultrasound currently enjoys an impeccable safety record, but it’s worth remembering that this is due to the responsible practices of professionals over the many years of the technology’s development. The current situation whereby untrained individuals can now purchase relatively low cost ultrasound equipment is historically unprecedented, and whilst it offers the potential of fantastic benefits for animal care in the right hands – as many of our own members regularly demonstrate – it’s important not to be complacent about its potential for harm.
Ultrasound equipment, by law within the UK, EU and North America, should adhere to stringent international safety standards with regard to acoustic output and electrical safety (via the AIUM/NEMA Output Display Standard and FDA). Unfortunately, a large number of ultrasound scanners currently imported into these territories do not meet these standards. Many do not even carry a CE mark. Customs forces are simply spread too thinly at present to prevent their entry.
So what happens if something goes wrong? If an animal is harmed by the mechanical, thermal or electrical outputs of that ultrasound equipment, with whom does the legal responsibility lay? You may think that the onus is on the manufacturer or the seller, but in fact, the law states that it is the responsibility of the operator of that equipment to ensure that it is CE marked and fit for purpose.
If you’re an experienced canine or goat pregnancy scanner, cast your mind back to when you first began looking to buy an ultrasound machine. You may have been trying to get your head around which type of transducer technology you wanted (mechanical or electronic?), design (convex or microconvex?), frequency range, and maybe you even thought about performing measurements and whether you could save images or videos on it. But did it ever cross your mind to ask if the equipment was FDA/AIUM/NEMA compliant? Did you ask if the machine comes with the MI (Mechanical Index) and TI (Thermal Index) displayed on the screen – now a legal requirement within the European Union, United States and Canada?
Most of us did not. And in truth, up until relatively recently, most of us didn’t really have to. The marketplace wasn’t anything like it is today. Pricing of ultrasound machines was a lot higher, meaning that people were unlikely to take the risk and buy from an unknown entity in the Far East. For this same reason, fewer companies in China bothered to stock and resell them.
This is quite unlike today’s environment where even companies with no ultrasound knowledge will try their hand at reselling scanners (often masquerading as the original manufacturer), taking advantage of the fact that their customers are equally unfamiliar with the technology. Many will employ all sorts of off-the-wall claims to make a sale, the current fashion being to advertise 3D/4D technology for a few hundred pounds, knowing that the majority of people browsing the listings won’t be familiar enough with transducer design to realise that 3D imaging requires a probe with a price tag of at least £20,000. If it ever will be available on a £900 machine, expect that to be around the year 2045 at the earliest. These same sellers willingly make false customs declarations to import equipment illegally (as anyone who watched the recent Panorama documentary on VAT fraud will know), leaving buyers not only with potentially unsafe equipment, but no legal paper trail with which to document the transaction should anything ever go wrong.
Newcomers to the industry, therefore, now have to grapple with all of the above decisions – transducer type, machine functionality, price – whilst having their efforts confounded by unscrupulous sellers who will say and do anything to make a sale. There is no longer any guarantee that a portable ultrasound machine bought online is even fit for purpose, let alone compliant with EU or North American law.
That is why knowing what you’re buying, who you’re buying from, and understanding some basic ultrasound physics and safety including the mechanical and thermal indices, is imperative. It’s also why the Animal Ultrasound Association is so important to the long-term future of our industry, as a way to verify the training, competence and equipment of its members.
Below is a short clip featuring sonographer Yvette Lovis on a VIS training course in the UK, as she discusses the importance of training and buying from a reputable source when considering becoming involved in canine ultrasound scanning.
March 13, 2020
September 23, 2018