Can normal equipment become a medical device?
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
