How to define Expected life service life of medical device

Kuldeep Singh

Involved In Discussions
#1
As we manufacturing the Medical device class IIb having Expected service life of 10 years.

We are trying to justify the class on the basis of critical components include a justification for repairable parts as some of these components have life of 7 years.Its a long discussion with Notify body during audit.So what can we do for defining the expected service life of medical device.

Do you have any template or guideline for defining the service life of medical device.

Thanks in advance
 
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Jean_B

Trusted Information Resource
#2
Expected service life comes from IEC 60601-1.

In the 2005 (third) edition it is stated to be:
"maximum period of useful life as defined by the MANUFACTURER"
In its integral update (3.1 edition; currently valid in nearly all situations) it is stated to be:
"time period specified by the MANUFACTURER during which the ME EQUIPMENT or ME SYSTEM is expected to remain safe for use (i.e. maintain BASIC SAFETY and ESSENTIAL PERFORMANCE)"
With the note: "Maintenance can be necessary during the EXPECTED SERVICE LIFE."
Beware you note 'define' instead of specify. Are you following the appropriate edition?

Two key things then are:
  1. Specified by the manufacturer, meaning you state it.​
  2. During which it is expected to remain BASIC SAFETY and ESSENTIAL PERFORMANCE.​
These last two are risk management core principles.
In short: first do no harm, second do the (clinical) good you must do to avert (an increase of) risk.

Thus reliability of combination of components leading to either aspect remains important.
If you always fail-safe, you don't have basic safety concerns that affect expected life. [This is the main concern to prove for 'shorter than expected service life' replaceable parts; and you could make a case for preventive/predictive maintenance through replacement (think tires of your car) to also serve this].
If you have no risky absence of clinical performance you have no essential performance concern.
The twist comes when you do have some failure modes (both unintended/unexpected as well as intended/expected) that increase risk, and often a case can be made that such risks do exist (but might be accepted!).

Hence on it becomes a bit of a discussion and interpretation, where usually the reliably predictable absence & accepted presence of (unsafe) failure modes determines what is useful life. Needed is a mastery of the risk management report and where you decide what is and is not acceptable risk, and how you justify accepting unacceptable risk becomes key inputs in the cut-offs for this, taking note that given the 'right' state-of-the-art indicated by standards and competitors these need not be zero risk.
Widely understandable example: as long as your post-market surveillance observes the occurrence and severity of irreducible (if you want to maintain your main effect) side-effects for medication to not exceed the levels you set as acceptable (based also on your competitors/society requirements) for within-shelf life product, the occurrence of the side-effect does not mean you broke basic safety or essential performance.
 

Kuldeep Singh

Involved In Discussions
#3
thanks for your clear vision.

From your comments i able to understand that we have to involve the risk factor.

But i am bit confusing that, how we document the service life of our device.We agree that we placed the device in market along with residual risk with risk benefit ratio and also we done preventive maintenance of each and every device. but yet there are some cases where we get breakdowns which is a normal for a machinery (Like puncher in your car).

How can we specify the service life of device
 
#4
We had some difficulties with our NB over service life.
We said 'its a box of electronics - it does not wear out so it does not have a service life'.
They said - you have to define it and show that information in the Operators Manual.
Fortunately, we came across a guidance document (internet search) that gave a list of different devices and an expected service life for each type. We use that now as our justification.

Link to the guidance document (it covers many types of device):
http://www.flinders.edu.au/medicine...LifeSpanofBiomedicalDevices-GuidancePaper.pdf
 

Jean_B

Trusted Information Resource
#5
We had some difficulties with our NB over service life.
We said 'its a box of electronics - it does not wear out so it does not have a service life'.
They said - you have to define it and show that information in the Operators Manual.
Fortunately, we came across a guidance document (internet search) that gave a list of different devices and an expected service life for each type. We use that now as our justification.

Link to the guidance document (it covers many types of device):
http://www.flinders.edu.au/medicine...LifeSpanofBiomedicalDevices-GuidancePaper.pdf
But electronics do wear out, in non-intuitive ways. There are cycle, environment and stress limitations on their components and by extension the total device.
Referencing a 15 year old paper partly based on a for the medical industry outdated risk management standard is a quickfix that shouldn't be condoned.
Even the 1960's type military component reliability compendia indicate that these are based on assumptions you need to check against your case.
 
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