5dogs Posted July 19, 2013 Share Posted July 19, 2013 Does anyone know long blood bank manufacturer's inserts need to be kept once the version is no longer in use? Thanks! Link to comment Share on other sites More sharing options...
David Saikin Posted July 19, 2013 Share Posted July 19, 2013 i keep mine with outdated procedures - at least 5 y rs.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. Link to comment Share on other sites More sharing options...
Justina Posted July 19, 2013 Share Posted July 19, 2013 As far as I know, we just replace them. I don't think any place I worked saved them. Link to comment Share on other sites More sharing options...
aafrin Posted July 19, 2013 Share Posted July 19, 2013 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. Link to comment Share on other sites More sharing options...
Sandy L Posted July 19, 2013 Share Posted July 19, 2013 We treat them using the same rules as policies and procedures, keep them for 5 years when superceded. Link to comment Share on other sites More sharing options...
5dogs Posted July 19, 2013 Author Share Posted July 19, 2013 Thanks for the replies! Link to comment Share on other sites More sharing options...
macarton Posted July 22, 2013 Share Posted July 22, 2013 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 When one changes I move to an out of date file. tbostock 1 Link to comment Share on other sites More sharing options...
L106 Posted July 23, 2013 Share Posted July 23, 2013 Keep for at least 5 years. Link to comment Share on other sites More sharing options...
Malcolm Needs ☆ Posted July 24, 2013 Share Posted July 24, 2013 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. Deny Morlino, AMcCord and Eman 3 Link to comment Share on other sites More sharing options...
SMILLER Posted July 24, 2013 Share Posted July 24, 2013 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 Link to comment Share on other sites More sharing options...
Sheryl Kochman Posted July 24, 2013 Share Posted July 24, 2013 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. Link to comment Share on other sites More sharing options...
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