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

Now heres one for you all. We have medical records here of people who are long past left this earth. So if there is a need to keep these should there not be a need to keep the records of all the peices of equipment they have been in contact with!!

Need for total electronic record keeping I would say as we all know the 2 year thermal paper. This also opens up the debate into patients medical records ECG prints in particular. We are working on total electronic record keeping at present. PPM sheets, infusion pump data from a calibrated infusion pump tester. The data is uploaded to a partition on the main server which we all have access to. Its early days but should be populated in about a year!!!.

Common sense and logic should prevail, no need to go overboard and over complicate the matter, sorry to repeat myself. "If there is a database then there is no need to delete, but the purchase, acceptance, work orders and PPM task sheets in hard copy should be kept on file until the equipment is disposed of, if the equipment is being 'moved-on' the hard copy should accompany the equipment. Simple logic."

Interesting, Billy (and sounds reasonable enough to me, at least).

Next time I'm passing, I'll call in and you can have me admire your efforts!

(as I keep saying) "Paperless" is the way forward, I reckon. But don't forget we also have to consider the past (but your first point is taking things a bit too far, I would have thought)!

FYI concerning Medical Devices - BS EN ISO 13485:2003 states:
"The organisation shall retain records for a period of time at least equivalent to the lifetime of the medical device as defined by the organisation, but not less than two years from the date of product release by the organisation or as specified by relevant regulatory requirements".

And DB 2006(05) mentions:-


It then goes on to list the type of information that needs to be retained. In fact, it actually includes the wording:-

"Ensure that your records provide evidence of ..."!

It also mentions the "end-of-life date" (of the equipment), but I don't see any guidance in there about how long records need to be held following that (not at all, then, presumably).

Welcome to the forum, Mate.

I recall going on a course donkeys years ago when this was discussed with a barrister. Now don't quote me on this due to my loss of grey cells over the years but it went something like this.
Records should be kept for 18 years after the life of the device.
However, records where a child is the subject of an adverse incident should be kept for 21 years. This was based on a child being a baby. The parents could sue on his/her behalf until the baby reached 18 years and after that, the now adult, could sue in the own name for a further 3 years.

Interesting. But wouldn't "incident" records be locked away somewhere, anyway? A special case, perhaps.

As I mentioned earlier, best keep (all) service records indefinitely!


After all, simply destroying service records takes time, and effort, does it not? Why not leave all that to the "fertile young minds" who are destined to be your (our) successors?

Ah but I can see a problem in this thought, we have had an incident here involving a piece of equipment that was delivering an incorrect dose. It was picked up on one patient but the question was asked of how long it was like this and how many patients had been affected.
Therefore if it was noted which equipment was attached to which patient a trail exists.
Just means that the staff are going to have to look at what they are attaching to the patient and anyway it is just one more step from what they do with drug charts.(how about another column!, simples!)


Billy

Would it be expecting too much for the equipment asset number to be noted in patients' records?

After all, is it not common (good) practice for mere engineering technicians to make a note of test equipment used when calibrating medical "devices", and all the rest?

(notice that I'm resisting any temptation to make another comment about nurses with degrees)

Sounds as if you're having fun Bill!