Record retention/retrieval for 30+ years? (The lifespan of the medical device)

cubix rube

Involved In Discussions
#1
We are a 13485 certified contract manufacturer, and some of the devices we make components for, have a lifetime of over 30 years. All of our records for the past 4 years or so, are both scanned, and stored in hard copy format, however, not in fireproof cabinets. My understanding is that if no electronic files are stored and backed up, paper files must be maintained in fireproof cabinets. If electronic records are maintained, they must be backed up, and retrievable for at least the lifespan of the medical device, which in some of our cases, is over 30 years.

Our current backup system can retrieve documents only for a rolling 24 month period. If you have similar requirements, how does your company handle backups, etc., so that these records can be retrieved so far into the future? Do you save one tape from each year? What if I file a record today, it somehow gets deleted 6 months from now, but we don't realize it until we try to retrieve it 5 years from now?

I have a meeting scheduled with my company president, and our IT service provider next Tuesday, and would like to be able to propose some ideas, based upon what others in our industry are doing.

As always, thank you so much for your input!
 
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Wes Bucey

Quite Involved in Discussions
#2
Re: Record retention/retrieval for 30+ years??

Laying aside the question of "required" for the moment, consider that many organizations, not just regulated ones, have a need to retain "some" records indefinitely. Thus there are numerous "solutions" available from "records management companies" easily accessible via the internet. These solutions can be hard paper copies, microfilm, tape, disk, etc.

The two primary considerations in record storage after "safety" are

  1. retrieval when and if necessary
  2. periodic review to make sure the documents remain intact and that the available tools to review and retrieve them remain in working order.
If the document storage and retrieval system doesn't meet the criteria, then the organization needs to convert to a system which does, limited to exact type only by volume of records and budget for such system. This means an organization with only a few hundred documents can easily store hard copies both on and off-site in secure file cabinets. An organization with millions of records probably needs an elaborate electronic data storage system, continually monitored by staff to assure the equipment either stays intact or is periodically replaced and the data recopied to new media.
 

somashekar

Staff member
Super Moderator
#3
We are a 13485 certified contract manufacturer, and some of the devices we make components for, have a lifetime of over 30 years. All of our records for the past 4 years or so, are both scanned, and stored in hard copy format, however, not in fireproof cabinets. My understanding is that if no electronic files are stored and backed up, paper files must be maintained in fireproof cabinets. If electronic records are maintained, they must be backed up, and retrievable for at least the lifespan of the medical device, which in some of our cases, is over 30 years.

Our current backup system can retrieve documents only for a rolling 24 month period. If you have similar requirements, how does your company handle backups, etc., so that these records can be retrieved so far into the future? Do you save one tape from each year? What if I file a record today, it somehow gets deleted 6 months from now, but we don't realize it until we try to retrieve it 5 years from now?

I have a meeting scheduled with my company president, and our IT service provider next Tuesday, and would like to be able to propose some ideas, based upon what others in our industry are doing.

As always, thank you so much for your input!
30 years is a way too long, and yes, such requirements do exist, and you will need a robust system for storing these OR outsource same to professionals.
When you say you are a contract manufacturer, you must be having OEM's as your customers and what components you make are eventually the OEM's, going into his device. What is the lifetime of the final medical device of your OEM ?
After some reasonable period of holding at your end, say like 5 years., why not talk with the OEM's and transfer the records to them.
If you are not certain about how you have addressed this record retention aspect in your OEM agreement, have a re-look into it and agree with your OEM that after certain initial period of retention, the records will be transferred back to OEM for his managing.
It costs to retain records indexed and safely. Have you covered this cost for 30 years holding within your costing ?
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Have you considered ISO/IEC 27000? Perhaps your IT services provider is already familiar with it - might be worthwhile discussing with them.
 

Marcelo

Inactive Registered Visitor
#5
Our current backup system can retrieve documents only for a rolling 24 month period. If you have similar requirements, how does your company handle backups, etc., so that these records can be retrieved so far into the future? Do you save one tape from each year?
If your requirement is that you must maintain docuemntation for 30 years (because f your device lifecycle), then your storage must be designed for it (in those case of more than decades I usually suggest using special services of document maintenance).

What if I file a record today, it somehow gets deleted 6 months from now, but we don't realize it until we try to retrieve it 5 years from now?
If a risk analysis of your maintenance process reveals that this is possible, you need to develop safeguards so this does not happen. If not your requirement won?t be fulfilled.
 
J

javielo

#6
I recommend iron mountain to store your documents however you can always establish a process with your IT group and backup your data and review data anually.
 
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