IFU inside or outside Ortho Implant Sterile Device

J

Jwreeves

Can anyone provide specific standard on requires for where IFU must be placed in packaging. Currently IFU is inside sterile pacakge pre-sterilization. But discussion about putting IFU post sterilzation against package under shrink wrap.

I think this is issue with sterile feild in OR if IFU needs to be reviewed in OR.
 

Stijloor

Leader
Super Moderator
Can anyone provide specific standard on requires for where IFU must be placed in packaging. Currently IFU is inside sterile package pre-sterilization. But discussion about putting IFU post sterilization against package under shrink wrap.

I think this is issue with sterile feild in OR if IFU needs to be reviewed in OR.

Any medical device experts who can help?

Thank you!!

Stijloor.
 

pkost

Trusted Information Resource
there is no specific requirement regarding where it is placed as long as it is with the device. There is no issue with it being sterile as it won't be unless you place it inside the double pouch which i have never seen. I would suggest that you wouldn't want it in the sterile field as it is more likely to get covered in blood etc.

From a clinical perspective I have never known one to be required in the sterile field (to be honest I rarely see them being used anyway). If they were needed by anyone that was sterile then they could have it read to them

we just place the ifu in the box which is shrinkwrapped. It goes through the sterilisation process but can't be considered sterile.
 
Top Bottom