Does anyone know long blood bank manufacturer's inserts need to be kept once the version is no longer in use?  Thanks!

i keep mine with outdated procedures - at least 5 y rs.  I don't know that there is a regulation/standard which addresses pkg inserts.

As far as I know, we just replace them. I don't think any place I worked saved them.

We actually make a separate file of package inserts every year. If there are changes mid-year we place the particular new insert in the file and mark the old insert as "out-of-use" and date it. These files are stored for 5 years.

We treat them using the same rules as policies and procedures, keep them for 5 years when superceded.

Thanks for the replies!

 

I keep all my inserts on line and as many instrument manuals as are available. They are never handy to find when you need them, and can easily be found on any computer in our lab.

 

When one changes I move to an out of date file. 

Keep for at least 5 years.

We have to keep all records for 30 years in the UK.

I sometimes wonder whether, if we transfuse a person who is 100-years-old and they then die of old age, we are supposed to keep the body for 30 years. Bad taste, I know, but it does get so frustrating.

I beleive we do 2 years (since we are inspected every two years) or at least as long as we continue to use whatever system goes with the manufacturer's inserts.

scott

You need to keep your package inserts for as long as you keep your records of tests that you conducted with the associated product. See 21 CFR 606.160 for US FDA requirements.