EBME Forums Forums Management Medical Equipment Management Electric Beds - PAT or Medical Safety Testing

It's easy to get portable medical grade safety testers with additional safety test standards built-in for other types of device; including PAT.

There's no getting away from the fact that electric beds are active medical devices covered by the MDD and not portable appliances used in a domestic, industrial or commercial environment.

So, if you consider the application, the equipment used around the bed and the environment it's used in, ideally we should have electricians using a medical tester to test electric beds - preferably without patients still in them.

If I remember correctly the HSE guidelines on electrical safety testing say that the environment where the devices are used must be considered and appropriate level of testing performed.

The risk of electrical safety issues on electric beds, particularly applied parts, are likely to be negligible (since I don't hear much talk of adverse incidents involving patients receiving an electric shock).

Testing to manufacturing standards is probably only an issue for manufacturers and regulatory processes at the design/development/construction stage or those involved in device evaluation & acceptance testing.

This means PAT testing of electric beds is probably sufficient in practice but this is not testing to an applicable general or particular medical device standard.

So PAT testing is not really appropriate but obviously goes most of the way to ensure the bed is safe. Is this good enough? is the question then.

If PAT testing ensures an acceptable level of risk, even if it does not assure the equivalent level of safety testing to medical or any other specific device standards, then perhaps it's use is justified? I suppose the argument for PAT testing goes somthing like this:

PAT is sufficient to ensure safety to an acceptable level of risk and it gets us away from the complexities of testing to medical manufacturing standards plus it allows the employer to meet HSE requirements.

Thereby ensuring an acceptable degree of safety of electric beds without having to repeat relatively complicated and time consuming manufacturing based tests for conditions whose probability of occurring is probably negligible in practice.

I guess this is why we need a test standard, like IEC 62353, for routine testing of medical devices used healthcare in much the same way as employers & HSE need a PAT standard for domestic, commercial and industrial appliance testing in the general workplace.

Also to save time and effort when we know that the medical safety tests of electric beds in particular, probably are in excess of what's required for routine safety checks.