Ultrasound Equipment and the Law

Catherine

As discussed in previous articles, ultrasound is very safe. The biggest danger in its operation is almost certainly that which is common to all electrical devices: electrical safety, trip hazards, the machine being pulled off a table and injuring an animal or person, and so on.

If your scanner were to malfunction and pass an electrical charge to a person or an animal, the legal responsibility would lie with the manufacturer, right?

Not necessarily. In the absence of a cooperative manufacturer willing to take responsibility (which, when purchasing from abroad, is almost guaranteed), the eyes of the law will fall upon the operator. Under UK law, the operator of the equipment is responsible for the safety of the patient and bystanders, and in the event that any harm came to these parties, could be required to prove in court that they have done their due diligence. Suddenly, saving a few hundred pounds by buying from China on eBay doesn’t seem like such a good idea.

 

Is your machine CE marked?

This is fundamental. It is your responsibility to check for a CE mark on any and every piece of equipment you use in a professional capacity. For example, if a nurse performs a home visit and helps a bed-bound patient out of bed with the patient’s own hoist, if the patient falls and the nurse did not check that the equipment was CE marked before helping the patient to use it, that nurse is responsible for the accident (and will almost certainly be struck off). It’s that harsh, and that serious.

So if you scan somebody’s animal with equipment that does not bear the CE mark, it’s an automatic fail. Even your insurance is highly unlikely to cover you.

 

Did you purchase your equipment legally?

This may sound like a silly statement, but it is a sad truth that the vast majority of medical equipment purchased on sites like eBay from China are imported illegally. If the seller underdeclares the value of the equipment – with or without your instruction to do so – you are complicit in tax evasion. You have committed a crime.

So whilst a 20% saving on a £1000+ piece of equipment feels great at the time, again, it may come back to haunt you. After all, if you purchased from a company willing to help you to break the law, you must have known that they would be equally unscrupulous with regard to their safety standards, right? Or so the argument may go in court.

 

In summary, when buying an ultrasound machine, always make sure:

  • That it is CE marked
  • If you are importing your machine from abroad, that all customs paperwork is accurate and truthful
  • That TI and MI are displayed on the screen

 

Additionally, it is important to find out:

  • Is there UK service available? If not, whatever warranty you may or may not have with your machine is likely to be worthless
  • Can the seller provide any training or support? The vast majority of companies calling themselves manufacturers online are no such thing. If they’re on eBay, check out their other items for sale: if they’re simultaneously selling yoga mats and sex toys, chances are, they know far less about ultrasound than you do. Another immediate tip-off is to look out for machines which advertise as being “3D.” 3D ultrasound scanning requires a transducer in the range of £20,000 – £100,000. Any eBay listing for a 3D ultrasound machine is taking advantage of the fact that most people don’t know very much about what they’re buying when they first start out – which already tells you quite a lot about how reliable such a company’s safety testing or backup support might be!

 

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