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Foam mattresses used in hospitals - compliance with MDR requirements?

RA_QA_Expert

Starting to get Involved
#1
Hi all,

must foam mattresses (without any clinical benefit, no prevention of bedsores (dekubitus) declared) used in hospitals meet MDR requirements?

Is it accessory for a hosptal beds? This type of mattresses
- is not being itself a medical device,
- is intended by its manufacturer to be used together with hospital beds
- supports the medical functionality of the hospital beds in terms of their intended purpose - to support patient body

Could manufacturers say, that that type of mattresses is neither ‘medical devices‘, nor ‘accessory of medical device‘?
The standard hospital requirements are hygiene and comfort "only".

Thank you in advance for your opinion.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#2
IMO it is a Medical Device because an intention to mitigate/prevent many conditions is implied from the use.
As an example, a "hygiene requirement" implies prevention.
 
#5
How can a hospital bed not have a medical purpose?
Location of a product does not define use, otherwise everything in a hospital would be a device. (An easier definition to implement though!!)

If it is a device, is the bed the device or is the mattress?
I would have thought that the mattress is the device and the bed the accessory (it just supports the mattress)

Under MDR, accessories have to be mentioned in the IFU and described in the technical documentation of the device.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#6
Not location per se, but in this case the location goes hand in hand with a certain use which includes a medical purpose (in contrast with an ordinary bed at home). If we examine a proper hospital bed/mattress (not just any bed in a hospital) against the medical device definition, I think its intended use falls in at least one of the qualifying categories.

Whether the bed and the mattress (or maybe they are one product in some cases?) are medical devices or accessories thereto is an interesting question - it might be possible to argue both ways and the final result probably depends on the specifics (IFU contents, product specifications etc.). I didn't think it would matter too much though (not nil too, I agree), because accessories are essentially subject to the same requirements under the MDR as devices.
 
#7
Sorry, went off question! - "must foam mattresses (without any clinical benefit, no prevention of bedsores (dekubitus) declared) used in hospitals meet MDR requirements? "
Under UK law - "Provision and Use of Work Equipment Regulations 1998 (PUWER)" requires that employers USE suitable equipment:

Safe use of work equipment. Provision and Use of Work Equipment Regulations 1998. Approved Code of Practice and guidance - L22

"53 Equipment must be suitable, by design, construction or adaptation, for the actual work it is provided to do. This means that when you provide work equipment you have to make sure it is suitable for the work being done and is used in accordance with the manufacturer’s specifications and instructions. If work equipment is adapted it must still be suitable for its intended purpose. "​
"138 Employers providing work equipment for use in the workplace should ensure that it has been made to the requirements of the legislation implementing any product Directive that is relevant to the equipment. This means that in addition to specifying that work equipment should comply with current health and safety legislation, you should also specify that it should comply with the legislation implementing any relevant EC Directive. You can check to see that the equipment bears a CE marking and is accompanied by the relevant certificates or declarations (ask for a copy of the EC Declaration of Conformity), as required by relevant product Directives"​

So, if it is intended for a medical use - yes the employer has to use CE marked mattresses.
If no medical use (guest accommodation?) then no. But the employer has to perform a risk assessment before choosing what to use.

PUWER implements Directive 2009/104/EC – use of work equipment
 
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