Appropriate Retention Periods - Digital linacs (linear accelerators)

M

madannc

#1
Hi I am a new user here and was hoping to get some advice

I work for a medical device manufacturer (Oncology Solutions) and the site I work at manufactures digital linacs (linear accelerators).

However the the package that is sold to the end user (new customer) is a solution. This includes software, PC's, monitors etc... when determining retention period the linacs expected life is 10 years+, but monitors etc 2 years, what is the norm for this type of situation as the monitor is part of the "solution" should the records for the lower life expectancy be stored seperately with different retention periods to the the linac.

I hope I have made this clear... thx Nigel
 
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Wes Bucey

Quite Involved in Discussions
#2
Re: Retention Periods

Hi I am a new user here and was hoping to get some advice

I work for a medical device manufacturer (Oncology Solutions) and the site I work at manufactures digital linacs (linear accelerators).

However the the package that is sold to the end user (new customer) is a solution. This includes software, PC's, monitors etc... when determining retention period the linacs expected life is 10 years+, but monitors etc 2 years, what is the norm for this type of situation as the monitor is part of the "solution" should the records for the lower life expectancy be stored seperately with different retention periods to the the linac.

I hope I have made this clear... thx Nigel
A simple analogy would be the purchase of a new car. Different components have different life expectancy. Tires, windshield wipers, motor oil, etc. have short lives while powertrains and engines have longer lives, but they are all part of the auto (transport system?)
 
M

madannc

#3
Re: Retention Periods

thx Wes,

so in the automotive industry if the expected life of the car is say 10 years would they also keep the record for the oil that was originally used prior to despatch for this period too?

thx
 

Wes Bucey

Quite Involved in Discussions
#4
Re: Retention Periods

thx Wes,

so in the automotive industry if the expected life of the car is say 10 years would they also keep the record for the oil that was originally used prior to despatch for this period too?

thx
My experience is the two industries have different regulations from government authorities on the retention of records. My point was that it seems reasonable to state in the "labeling" required of a medical device "system" that different components have different life expectancies and may require repair or replacement before other components. The manufacturer keeps a record of the total package he shipped to the customer for whatever retention period is selected. He might keep records of replacement parts shipped subsequent to the original package for only the expected life of the component.

BTW:
Welcome to the Cove!:bigwave::bigwave:

Added in edit: the auto manufacturer may keep a record of the auto for a number of years, but the auto could be destroyed driving off the dealer's lot - the record has nothing to do with what actually happens to the product after it leaves the manufacturer. It's just a snapshot of a moment in history.
 
Last edited:

Colin

Quite Involved in Discussions
#5
Re: Retention Periods

When it comes to keeping records I generally have a rule of thumb to decide how long they will be retained for:

  1. Are there any statutory or regulatory requirements relating to the time period?
  2. Does the customer stipulate how long they will be kept for?
  3. Then the organisation gets to decide.

This may not always be the case but it is a reasonable start point.
 
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