A new FDA section addressing sterile medical devices will require additional measures for the control of contamination by microorganisms or particulate matter focusing particularly on the cleanliness required during assembly and packaging operations.

To ensure sterility is preserved, documentation of the following is needed:

  • Records of sterilization process parameters must be maintained for every batch.
  • Sterilization records also must be traceable to each production batch.
  • Documented procedures must be in place for validation of sterilization and sterile barriers prior to implementation.
  • Validation of sterility control method is now required.
  • Conclusion results must be documented for all validations.
  • Sterile barrier systems (of sterile medical devices) are considered a constituent part of the medical device.