Remember that waste disposal is a consideration in your risk management process. Any risk associated with the waste needs to be fully considered just as any other risks and documented in your risk analysis.
Then anything documented in your IFU also then requires it be validated as part of Design and Usability Validation. The validation demonstrated the user can use the IFU to meet the intended use and properly dispose of the waste. It sounds as if this may not have been performed if you have this question.
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Edwin Bills MEd, BSc, ASQ Fellow, CQE, RAC
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com------------------------------
Original Message:
Sent: 28-Dec-2022 17:10
From: Anonymous Member
Subject: Waste Disposal in IVD IFU
This message was posted by a user wishing to remain anonymous
Where should I nestle my waste disposal information in our IVD IFUs (device meant for professionals only)? We have a Storage and Handling section and a Warnings and Precautions section. Right now our waste disposal is one line in our Warnings section (it says to look at our provided SDSs and that's it) and we are looking to bulk it up.
- Should I make it its own section or tuck in one of these other sections?
- Is there a specific guidance doc on this?
- What is most common, if anything, so that it is most intuitive for the user (ie lab tech).
Thank you for your opinions!