Defining the lifetime of medical devices - long lasting parts such as bone screws.

T

Tiffany

#1
Hi folks,

I am in the mist in defining the lifetime of the medical devices. It is understand that medical devices have its own lifetime. But how to define the lifetime of the medical devices that can last long in the market although it has consume throughout the lifetime of the patient (ie. bone screws, plates, nuts, hospital locker, hospital cabinet, hospital beds and etc.). It is due to the retention period of the records which required by the ISO 13485, it is important to define the lifetime of the medical devices and it will impact on the retenrion period of the records. Furthermore, it is mandatory requirement to define in the Quality Manual and Standard Operating Procedure.

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

Millions of thanks!

Tiffany
 
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chris1price

Trusted Information Resource
#2
Re: defining lifetime of medical devices

Hi

This can be a difficult issue. For permanent implants, you could be looking at an indefinite life-time, ie forever in other cases it could be 25 years or more. For hospital capital equipment (eg beds) the time will probably be less, but check what marketing clam for the product and also what your warranties say.

This does mean that documents may have to be retained for very long periods. Your backup procedures have to be effective and if you archive documents or store them off-site, this should also be within your procedures.

One final thought, if you claim a long lifetime, you should validate it.
 

Scott Catron

True Artisan
Super Moderator
#3
Re: defining lifetime of medical devices

One final thought, if you claim a long lifetime, you should validate it.
I'm not a device expert, but don't you have to do this BEFORE you assign a lifetime? For drug manufacturing, you can't just guess at an expiration date - either real-time shelf stability or accelerated stability tests must first be completed.
 
F

freelovefest

#4
Re: Defining the lifetime of medical devices - long lasting parts such as bone screws

I would really be careful in defining the EXPECTED life. You want to choose something realistic but not overly burdensome. While the device may last 25 years in reality you can choose an expected life of 15 years for it. The life you choose is how long you think it will last and should relate to the component with the shortest life span. You can often use literature for similar products to determine the life. You could do HALT testing, but generally this will only be required to substantiate claims which are different than others already in the market.

Remember, if you say it will last 25 years, that is what you are bound too for regulatory purposes. You will have to keep records for 25 years plus 5 to meet most requirements, and if your devices begin failing in 23 years, you may have to resubmit to regulatory bodies with updated information. That is records of pretty much everything, and depending on your volume, could be a big cost just for storage.

The wise thing to do from a regulatory perspective is to act conservatively. Look at what people are doing in the market and follow that. You generally will not gain a competetive advantage with a longer life, but you will certainly gain a regulatory headache.... the MDD is calling for 15 years of records for implantables. Seems like a good lifetime to me. Most users of the device understand why a certain life is chosen; to speed the product to the market.
 
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