MEDICAL DEVICE RECORD RETENTION

Cont'd

Medical Device Sterilization and Record Retention

Medical device sterilization is often overlooked as being an important component to the device’s manufacturing process. Yet Ethylene Oxide sterilization and Gamma sterilization service providers often are overlooked with respects to record retention. It is your responsibility as the manufacturer to ensure your service providers are maintaining records associated with the sterilization (manufacturing) of your device. If your sterilization provider has a specific record retention period, then it is your responsibility to obtain the records from them if your device has a longer retention period.

Records that you should ask for:

Sterilization process batch records
Maintenance Activities including equipment calibration

Basically, you will need a copy of anything that would have had an influence on the sterilization of your product. Sterilization batch records alone will not tell you if there was a non-calibrated thermocouple measuring chamber temperature (Ethylene Oxide sterilization) or if the inbleed filters were adequately changed, etc.

End of Article

Go To Start of Article