Expected life span of Medical devices - X-Ray based diagnostic medical devices

#1
Hi Everyone!
Greeting of the day!!
I am new in this forum and looking for solution of my query..

We are the manufacturer of X-Ray based diagnostic medical devices. We have one query regarding Life span of Medical devices. How can we calculate the life of a device?
Let suppose our device life is 10 yrs on the basis of life of critical component but minimum life of one of the critical component is 6 yrs and this part is replaceable if in case get damage. We can change this part at customer end easily and this replacement will not affect the device performance and intended use, Device will work as previously. Due to electronic component it can be damage anytime. Other component life is more than ten years only one or two component have less life but those are replaceable.
Please guide can we consider this or we have to do something else.

Is there anyone have this experience that can explain and help me?

Millions of thanks!
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
IMO the life span of an X-ray machine is determined by the time at which the user will have to decommission it, i.e. it will no longer be able to be used safely and meet its performance spec. A necessity to replace one component or another doesn't mean end of life span. Of course, if at some point the majority of components need to be replaced to keep the machine going (refurbishment) I would consider it end-of-life of the original device.

Does that make sense?
 
#3
Thanks Mr. Ronen,
if you have any template or guidance document please share with us so that we could satisfy to auditors...

Thanks a lot..
 
#4
"the extent to which a product retains, within specified limits, and throughout its period of storage and use, i.e., its shelf life, the same properties, and characteristics that it possessed at the time of manufacture.

A device's "shelf life should not be confused with a device's "useful life.'' The useful life of a device is the duration of actual use or the number and duration of repeat use before some change results in the device's inability to achieve its intended function.

I hope this old document could bring alacrity: https://www.fda.gov/media/72487/download.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Ask yourself (and your auditor):

When your car needs new tyres, does that mean that it's life-span is over? Not really.
A new engine?... you could get the engine replaced, but it could then be argued that this in fact will be a refurbished ("renewed") car.
A new chassis? definitely.

Here is my template: Common sense.
 
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Ronen E

Problem Solver
Staff member
Moderator
#7
I had difficulties with defining lifespan, with the auditor demanding that it should be stated as xx years. Fortunately I came across a guidance document, from Biomedical Engineering Advisory Group South Australia, that I have used since.

Can be found here:
http://cedglobal.org/download/Life Span of Biomedical Devices - Guidance Paper Final.pdf
Seems very useful for dealing with auditors who only look for a formal-looking paper so that they could tick the box and move on. The real essence of the matter, though, is:
The Life Span estimates provided in this document are a guide only and do not always indicate an age after which biomedical devices should not be used. In some cases the life of a biomedical device may be longer or shorter depending on a number of factors, including the:
• Frequency of use
• Nature of use
• Environment of use
• Experience and knowledge of the user
• Care and attention paid to use and operator maintenance
• Existence, capability and cost of maintenance support
• Stage in product life cycle
• Management of scheduled and unscheduled maintenance
• Availability and cost of consumables and spare parts
• Availability and cost of replacement devices
• Relative efficacy and effectiveness of the alternative methods and devices
• Business and safety risks associated with continued or discontinued use
• Strategic and political risks associated with continued or discontinued use
• Compliance with current codes and standards
• Technological or clinical redundancy
• Funding availability

BEAG recommends that a risk management approach is taken when developing a replacement program for Biomedical Devices and that risk factors, including those above, are considered together with the age/lifespan ratio.
Added in edit: Please also note that this document is considering the issue from an economical/practical perspective, for those in charge of managing / replacing aged equipment in hospitals (hospital biomedical engineers). A device might still be usable and safe (i.e. within its technical/medical life-span), but for whatever other reason recommended for replacement.
 
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