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Medical Device Sterilization and Cleaning Validation to ISO 17664 and FDA guidance

ANSWERED ON THIS PAGE:

  • What are the regulatory obligations for medical device sterilization and cleaning validation?
  • What are the applicable cleaning and sterilization standards for reusable devices?
  • How do we demonstrate to regulators that proper cleaning and sterilization processes were used for our device?

Medical devices contaminated with pathogens may be a source of infection for humans. To ensure that medical devices can safely be reused, reprocessing must be both effective and traceable. According to EN ISO 17664, medical device manufacturers are obliged to provide validated and documented methods of reprocessing (cleaning, disinfection, and sterilization) for reusable medical devices.

In collaboration with our colleagues at UL, Emergo can help you ensure that your reusable device meets applicable standards for device sterilization and cleaning validation, including ISO 17664 and US FDA guidance on reprocessing medical devices.

Cleaning and sterilization standards for reusable medical devices

Requirements for cleaning, reprocessing, and sterilization procedures for medical devices fall under two major categories:

  • Cleaning and sterilization of medical devices that have been sterilized
  • Cleaning, disinfection and sterilization of reusable medical devices (reprocessing) according to ISO 17664

In both categories, it is important to note that manufacturers may only apply validated sterilization processes to devices that have undergone cleaning and disinfecting methods.

ISO 17664:2004 requirements for re-sterilized medical devices

For reusable medical devices, ISO 17664:2004 lays out reprocessing information that manufacturers must maintain and provide to regulators. Manufacturers should record and maintain reprocessing information, including:

  • preparation, cleaning, and disinfection methods;
  • drying methods;
  • data pertaining to inspections, maintenance, and testing;
  • and methods for packaging, sterilization, and storage.

Meeting ISO 17664 requirements should be mapped out as you begin designing a reusable device to fully understand use and reuse issues, and to develop more robust instructions for use. Our experts in Human Factors Engineering and device usability can also assist with this.

We can help you meet ISO 17664 requirements for sterilization and cleaning of your reusable medical device

When it comes to cleaning, reprocessing, and sterilizing your medical device, our team has deep technical expertise as well as state-of-the-art labs and facilities to help you comply with ISO 17664 requirements. Our services include:

  • Cleaning and sterilization of devices delivered in a sterilized state
  • Cleaning, reprocessing, and sterilization of reusable devices
  • Validation of sterilization processes for sterile as well as reusable devices
  • Documentation assessments to ISO 17664

Our team of regulatory consultants and engineers can assist with every phase of the cleaning and sterilization validation process, from reprocessing to documentation. Ask us for detailed information on medical device sterilization and cleaning validation for medical devices.