Can I share a proposal text that you can use in the IFU, relating to this subject?
? WARNING
Contents supplied STERILE using _____________ [an ethylene oxide (EO) / a Radiation] process. Do not use if sterile barrier is damaged. If damage is found, call your company representative.
For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.
After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.