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Manufacturer Test Reports vs. FDA 510(k) Validation for Sterilization Pouches

Key Takeaways: Pouches are medical devices and must use validated FDA 510(k) Cleared Claims for specific sterilization cycles in any sterilization process. A Vendor report from pouch manufactures are not the same as a cleared Indications of Use statement from the FDA.

Does this test report cover my sterilization pouch usage?

Here comes that vendor with another test report stating their peel pouches can now be used in a new sterilization cycle. Before you accept that new sterilization cycle claim, you must do your homework. Sterilization pouches are classified as medical devices that need to be tested, validated and cleared for use with devices and in specific sterilization modalities and cycles.

Understand the Complexity of Testing

Pouches must undergo rigorous testing to prove their safety and efficacy. Critical tests include:

  • Material compatibility
  • Sterilant residual following sterilization studies
  • Biocompatibility
  • Half cycle sterilization validation
  • Drying time
  • Aeration time
  • Package integrity testing
  • Sterility shelf life using real-time aging studies

Testing is conducted in the worst-case sterilization conditions using the worst-case pouch contents and load configurations; for example, material compatibility testing is only performed in the longest cycle programmed on the sterilizer.

The most difficult test of those performed is half-cycle sterilization validation testing. This test requires highly resistant bacterial spores to be placed at difficult to sterilize areas of the medical device, for example inside lumens. The device is then pouched and sterilized in a cycle programmed with half of the cycle’s exposure time. All the spores must be dead at the end of the half cycle for the test to be considered successful.

510(k) Clearance Supports Vendor’s claims

In the United States sterilization pouches are Class II medical devices and all testing data is shared with the FDA (Food and Drug Administration) when submitting a pouch for clearance in a specific cycle or sterilizer.  Then the FDA compares the validation data with that of a legally marketed sterilization pouch (a predicate) to determine if the proposed pouch is substantially equivalent (at least as safe and effective) as the predicate and if so clears the proposed pouch for sale in the US. The clearance letter is specific to the testing and test cycles/sterilizers submitted for review and the cleared indications for use will list all approved cycles and sterilizers. The instructions for use provided by the pouch manufacturer will also list the validated sterilization cycles for specific pouches.

What to do when the intended use is general

Though today’s 510(k) clearance letters list all the validated cycles, older clearance letters may only list the sterilization process. In these cases, some assumptions can be made about the validated cycles based upon the sterilization processes that were available at the time of clearance. For example, a pouch cleared before 2006 for hydrogen peroxide sterilization could not be cleared for a V-PRO Sterilizer since this type of sterilizer was not sold until 2007. To ensure you are prepared for an audit with proper documentation, ask the pouch manufacturer for a list of validated sterilization cycles.

Your responsibility

Healthcare facilities have a responsibility to follow the instructions for use provided with a medical device. If a medical device is used in a way not consistent with the instructions for use, it is off-label use. New sterilization cycles discussed in vendor letters or test reports that do not include an updated instruction for use are still considered to be off-label use of the product.

The next time you receive a letter or test report claiming a new sterilization cycle for your sterilization pouches, do your homework before implementing a policy change. Contact the pouch manufacturer and ask for the FDA 510(k) clearance letter, or updated instructions for use.