EFHSS Questions and Answers - Question Q00774

Folks,

I have been asked to find out how long we need to retain autoclave records? We were told 7 years, but I was hoping someone could provide me a reference from the FDA or whomever. We are a medium sized inpatient/outpatient facility (450+ beds) Thank you.

Dear Daniel

The retaining time of sterilization records has to correspond with the legal requiremnts i.e. it is mainly a legal issue. Therefore you find record storage times for 1,2,5,7,10 or as in Germany 30 years.With appropriate software tools documents can be stored over 100 years without space problems and fading indicator colours.
Legally relevant basic facts for the records storage time are:

• The regulation of the National Medical Device Act
• The hospital laws of the individual states
• The relevant national and Continent (USA, Europe) standards
• The Natioanl jurisdiction

If there are no specific national statutes, the infection control commitee and / or the responsible body of the individual hospital has to define the storage time for sterilization documents.
Please see also Q00178.

Best wishes
Josy Holdener