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Defining Product Lifetime - Medical Devices

T

Tiffany

#1
Dear matEs,

I have a query on the definition of product lifetime for medical devices as request in ISO 13485 and MDD. How to define those medical devices which is category as hospital bed, hospital cupaboard, and other hospital furniture???
As these medical device can be use for lifetime!!!

It is same as the implantable orthopaedic medical devices (ie bone plates, screws, wires and etc.). These devices can be implant in the patient body for lifetime and it also depends on the conditions of the patients!!!

How shall we define product lifetime for these above medical devices???:mg:

Tiff
 
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DannyK

Trusted Information Resource
#2
Re: Defining Product Lifetime

Determining the product lifetime is not so straight forward.
If you refer to ISO TR 14969:2004, section 7.1.3 it says that you should document the basis for determining the lifetime of the device and may consider the following:
a. shelf life of the medical device
b. expiry dates
c. number of cycles or periods of use
d. anticipated material degradation
etc...

For hospital beds, how often do most hospitals keep their beds? Is it more than 10 years?
You are allowed to make assumptions, just make sure they are documented.
 
Last edited:
T

Tiffany

#4
dear mateS,

As I know the hospital bed is only given 3-4 years of warranty period. And this is how the manufacturer define the lifetime of hospital bed. BUT, the TUV auditor is query in this definition!!!

I have a query is that one of the incident happen is: -

The hospital bed is misused and cause the mulfunction, furthermore the auhority in the hospital did not take any action to repair and correct it immediately but still put in use in the hospital. What if there is any accident happen after a couple of years (after 11 years) due to the mulfunction where the previous mulfuction was not addressed?

Should the hospital bed manufacturer still bear the liability if we define the product lifetime is like 12 years?
OR what if the hospital bed manufacturer define the lifetime of product is base on the warranty period?

Need the experts and mates advice .... As we are facing problem in defining the product lifetime.

What is actually the industry practicing? Any notification/ certification body can advice here?

Same as for implantable orthopaedic medical devices....

:mg:

Tiff
 

DannyK

Trusted Information Resource
#5
Product liability and lifetime are 2 different issues. You can limit your warranty to whatever makes sense and as long as you honour the warranty you should not have any issues.

If the bed was mis-used and you can prove it, you do not have to be rsponsible for the malfunction or repairs.
 
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