New FDA Expectations for Reusable Device Reprocessing Validations

In March of 2015, the FDA published a new guidance document titled, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.  A draft guidance on the same subject had previously been issued and has been used by device manufacturers since 2011 as the leading document concerning FDA’s expectations for validating reprocessing procedures for reusable medical devices.   In terms of cleaning, disinfection and sterilization validations, the most notable modifications to the 2015 document are:

  1. A more inclusive recommendation to incorporate multiple full simulated soiling, cleaning, disinfection or sterilization cycles to assess the accumulation of soil over time. 

  2. Guidance for using the worst case “master device” to validate other devices in a product family.

  3. Emphasis on visual inspection.  Visual inspection of both external and internal surfaces should be performed. 

  4. A statement recommending that devices that become hot, such as powered hand pieces or electrosurgical instruments, be validated while hot to replicate clinical use.

  5. A recommendation that two quantitative test methods be used to test for the amount of residual soil.  The recommendation of two different methods was not present in the draft version of the document.

  6. A recommendation that the type of soil chosen be justified and if the soil deviates from FDA-recognized standards then the deviation should be justified.

  7. A more detailed recommendation of what is expected from the positive and negative controls.  The Negative Sample Control is the blank - the extraction fluid only.  The Negative Device Controls should be unsoiled and undergo the same cleaning and extraction as the test devices.  The Positive Sample Control is the extraction fluid with a known amount of soil at or slightly above the limit of quantitation.  The Positive Device Control is a device that is soiled with a known amount of soil.  The Positive Device Control is not cleaned and the soil is then extracted.  The amount of soil extracted should be equivalent to or slightly lower than the amount of soil placed on the device.  

  8. An emphasis on disassembly during the soil extraction steps in order to remove soil from difficult to access areas.

  9. A recommendation to demonstrate that cleaning solutions are not penetrating internal compartments that are not intended to come into contact with soil or fluids.

Many of the changes above had been prescribed by AAMI documents and had become standard practice within the industry, while other modifications are welcome clarifications that had not been addressed previously.  What is not included in the new guidance document is also noteworthy.  Previous communications with the FDA indicated that six reprocessing cycles would be recommended before testing for residual soil. Surprisingly, this recommendation was not included in the most recent guidance document.  The only advice given by the FDA guidance document is that the number of reprocessing cycles must be scientifically justified.

Six Full Soiling, Cleaning, and Disinfection Cycles May be Needed

Yet there is still some question as to what the FDA specifically requires. Recently, a Pacific BioLabs client contacted us for reprocessing services because the FDA had rejected the client’s disinfection validation. This validation had been performed at another contract lab, and did not incorporate repeated soiling, cleaning and disinfection cycles.  The FDA, upon review, asked this client to conduct six repetitive soiling, cleaning, and disinfection cycles.  Thus, even though the FDA did not stipulate in the most recent guidance document that six full soiling, cleaning, and disinfection repetitive cycles be conducted, it appears that the FDA is internally subscribing to the policy that reusable devices should undergo at least six full cycles.  

Pacific BioLabs performs validations of device cleaning and disinfection protocols and other medical device reuse studies.