EBME Forums Forums Management Medical Equipment Management How long should we keep records?

How long do you keep records?

We keep them for 7 years, but a colleague was telling me it should be 21 years. What do you do?

Is there any law stipulating how long?

All medical records, radiology files ? We based our PACS storage on being able to store a minimum of 5 years, but that is out here, not the UK. the information was supplied by the director of medical records.

I think that we can easily get confused between keeping technical records and medical records.
I think the regs in Saudi will be different to here.
I tried searching the DoH sites and gave up.

Are you asking about equipment histories, maintenance records and stuff like that, John?

How long do your present equipment records stretch back for? Five years, ten?

Why not keep them indefinitely? Especially, of course, if they are held in computer files!

The only special consideration I would give is to kit that has been scrapped, disposed of, de-commissioned (whatever). Records for those get put in the "archives" box!

If we need "rules", then I would suggest it should be this:- maintenance records should be retained (and kept in reasonably good order) as long as the equipment to which they refer remain in service. A matter of common sense, I would have thought!

On the other hand, I wouldn't be too zealous about it all. After all, would it be the end of the world if a few PM records dating back five years or more got, shall we say, mislaid?

Meanwhile ... back to Saudi - we even had to hold on to (and account for) "used" spare parts, to be handed over to the next (incoming) contractor! Even to the extent of storing boxes of old blood-filled tubing, ex-Coulter counters. It was getting ridiculous in the extreme! I think I may have already mentioned the efforts I went to get the MoH types out there to abandon this idea, and simply, er ... trust people a little more (in truth, my real aim was to be able to cannibalize those parts, many of which - it seemed to me - had very little wrong with them). All without result, of course. I wonder if it still goes on (probably, I should imagine).

The sort of thing we are discussing (maintenance records) leads me to mention once again the ugly (to some) spectre of contracts. A biomed services contractor would know exactly what his obligations were in this regard, and would keep records according to his contract. If required, he would hand them over when his tenure expires. If not, no doubt he would bin them!

One last thing, just as "full service history" usually helps when selling motor vehicles, it's always nice to have service records accompanying used equipment when it comes up for sale. Why? Because it provides proof that the thing has actually been well looked after! I mention this rather obvious fact as I suspect that some users of the forum many not have been involved much (if at all) with this aspect of the biomed scene!

My understanding is that in the current climate, Medical Device Maintenance records should be kept indefinitely. These then could be used in case of Malpractice issues.

Do you also have to maintain hard copies or is it ok to store on a server... what happens if the server crashes?

Please clarify. Is there any thing written any where?

That's OK, all will be well ... "climate change" is just around the corner!

To my mind, the fact that nothing is written down, or made clear, about stuff like this is simply indicative of the overall problem! As you know (outside of the armed forces, and - perhaps - contracts in Saudi Arabia), biomed has always been like this, and probably always will be. In a word, confused!

"Best Practice" advice (whose? er, mine) must surely be to hang on to service records indefinitely. Or, at least until you retire, or are otherwise deemed to be of diminished responsiblity!

Yes Geoff, service, training, and management records. In these days of cheap electronic storage i suppose it make sense to keep them indefinately. :>) I will change my QMS to reflect.

This is one of those "how long is a piece of string" questions me thinks.

No particular "rules" down under but we tend to allign to those of medical records/HR with is 7 years. The 21 years thing comes from the storage of birthing records only.

However, if we are looking at things from the point of view of "full life asset management/planning" then it would be more appropriate to keep, at least in summary form, the records until after the asset is decommisioned and disposed of.

But then again, if you are running paperless and you have enough storage space, don't worry about it, let IT deal with the problem.

The "Complete Equipment" should comprise the item itself, any or all accessories, any special parts needed to support it, service documentation (that is, users' and service manual) and full set of maintenance records (PM procedure, service history and all the rest).

That is, service records should be considered as part of the equipment, and looked after in the same way. By definition, then, they should accompany the equipment throughout its life.

In My Book, all this stuff should be cared for, and properly accounted for, from purchase all the way through to ultimate disposal (and, hopefully, beyond ... when it is sold on, donated to those less fortunate, or whatever).

Obviously, any period such as seven, or 21 years, is quite nebulous.

Except in electronic form, it is not, I think, practical to keep all documenation across the life of a piece of equipment. What the exact figure for earth leakage (or whatever) was 15 years ago is not nessesary, only that the overall test was done (and passed we hope). Reality is that, to store complete records for all systems is not practical (or "green"), unless, as said before, in electronic form.

That being said, we run paperless, are you? (and that is a general question not aimed at John). Paperless changes the picture.