EBME Forums Forums Free discussion Free discussion Can normal equipment become a medical device?

There was a recent post in the Technical Assistance forum concerning Electrical Safety Testing of a fitness cycle machine and it raised a question in my mind that I have been fighting my mind with for some time.... Can a normal standard piece of equipment become a medical device??

Thinking of the exercise bike - at a gym it is seen as a piece of fitness equipment where people go to tone up or do whatever they want. However, if that same excercise bike was then used in a Physiotherapy capacity as part of a recommended physio regieme, is it then a medical device?

It also brings back memories of a story I was told of some medical students visiting an ICU. One of them noticed that a fan had been positioned near the bed and was being used to keep the patient cool. So then the dabate started amonst them "is the fan a medical device?". Is it, isn't it?? I don't know iof they actually came to a decision in the end or not.

People's input on the above would be appreciated. It would be good to know what people in the industry think about devices being traated as medical devices (or not as the case may be).

Looking forward to your views

The short answer to your question must be:- "yes"!

It all depends upon the environment it is being used in.

In the case you mention, don't forget that the rider in the gym is likely to be a fit, healthy person ... whilst the patient in physio may not be. In both cases, the folk in charge have a Duty of Care, but that should be a more onerous responsibility in the hospital setting.

Regarding the fan:- everything within the patients' "clinical area" (or, if you like, reach) should be carefully used and correctly maintained ... otherwise they can become (literally) an accident waiting to happen. This is especially the case in places like ICU where the patient is already compromised.

The fan may not be a medical device per se, but that won't stop it electrocuting the patient if electrically faulty (or indeed slicing off his fingers if he pokes them into the blades, or his ears if it topples onto his head)!

The seasoned biomed should always be alert to stuff like this, and act in a positive (and if need be, assertive) manner whenever s/he comes across it (as will no doubt happen from time to time).

Meanwhile, let's link!

One way of looking at it would be to think about the initial criteria for the purchase of the item in the first place. Was the device purchased for use in patient care or therapy in the first place? If it was, you then have to look at if the device passed an acceptance test carried out by the EBME department in the hospital. Did the device meet the requirements of IEC60601-1?

But doesn't IEC 60601 only apply to equipment that is manufactured for the intention of being used in the "Diagnosis, Treatment or Monitoring" of a person?

If a manufacturer didn't make their product for this purpose then surely it wouldn't be manufactured to IEC 60601 standards. But when a standard piece of kit is then used in a clinical environment, does it then become classed as a medical device and therefore what testing / electrical standard should be applied?

I am of the same mind as Geoff here, which is if the device is in close proximity to a patient then the most appropriate test should be conducted and apply common sense.

Perhaps your question was awkwardly phrased, Chris.

Maybe it would have been better to have asked:-

"Should the biomed tech take care of non-medical equipment that has found its way into the clinical environment"?

Answer:- yes, of course ... who else is going to give a damn about it?

No it is only what the manufacturers declare it to be. I have had dealings with a company selling a monitor that warned if a confused patient was getting out of bed. But the literature kept mentioning "clients" and not patients. It also said in the literature that it was CE marked but when we looked further it was the transformer that was CE marked to the Low Voltage Directive.
We thought that the US manufacturers were pulling a fast one to get it in to Europe without the expense of medical CE marking so sought advice from the MHRA.
They said (whilst sitting on the fence) that it was what ever the manufacturer declared it to be. If we took it in to the Trust and used it on patients then it was our responsibility to make sure it was safe.

How about if a manufacturer was to make a machine that blew oxygen down a tube with a mixture of other gases in it but did not CE mark it, could we decide to use it as an anaesthetic machine?

This is when any good Clinical Engineering department earns it money - by stopping unsafe practice. See this thread on centrifuges
RoJo

You can only stop unsafe practices if:-

1) You come to hear about them*
2) Your Manager has any balls!

Surely everyone knows that patients are known as "clients" in some places (and documents). It's naff I know, but you even hear that term being used sometimes in UK hospitals.

Forget the MHRA (and all the rest). As I continually indicate, the onus is on us - the Custodians of Electrical Safety in the Hospital!

Meanwhile, see my earlier post about a better way of phrasing the question.

* Yet another reason why I strongly advocate the idea of the "walk through inspection"!