Regulatory Open Forum

 View Only

  • 1.  cleaning and disinfection -reusable devices

    Posted 27-Jan-2019 23:09
    Hi,
     
    For high level disinfection , if we are using a high level disinfectant which is not FDA cleared but is recommended by CDC and is the preferred choice of the user facility, can we use such a disinfectant ?
     
    If our validation is done for the higher concentration than the CDC recommendation , do we need to repeat our validation with the CDC concentration ?
     
    Is sterile water necessary for the final rinse disinfection ( all levels).
     
    Many a times the user facilities do not have the agent recommended by the manufacturer , can they use their own method for disinfection and can the manufacturer then include a disclaimer in the IFU.
     
    Can low level disinfection be carried out at the discretion of the user facilities or does the manufacturer need to explicitly recommend the process ?
     
    Thanks & Regards,
     
    Rashmi Pillay
    Regulatory Affairs Associate

    Ellex 
    3-4 Second Avenue
    Mawson Lakes SA, 5095
     
    T + 61 8 7074 8105
    E  rpillay@ellex.com
    W ellex.com
    .............................................................................
     
    One Powerful Vision.
    Confidentiality: This e-mail is from Ellex Medical Pty Ltd, ABN 35 008 276 060. The contents are confidential and intended only for the named recipient of this e-mail. If the reader of this e-mail is not the intended recipient you are hereby notified that any use, reproduction, disclosure or distribution of the information contained in the e-mail is prohibited. Viruses: Any loss/damage incurred by using this material is not the sender's responsibility. No warranty is made that this material is free from computer virus or other defect. Ellex Medical Pty Ltd entire liability will be limited to resupplying the material. If you have received this e-mail in error, please reply to us immediately and delete the document. 
     

     
     
     


  • 2.  RE: cleaning and disinfection -reusable devices

    Posted 28-Jan-2019 09:05
    Hi Rashmi.

    My gut says that the answers, as is all to often the case, is "it depends".  In this case, I think it depends on what you are "validating" whether or not you need to go through additional steps.  If you are validating the kill of pathogenic or opportunistically pathogenic organisms and you use a lower than the recommended concentration then I think you need to validate that your concentration is sufficient to ensure the safety of the device from user to user.  If, on the other hand, you are validating the safety of the rinse of the sterilant used then​ I think you could go without further validation testing since the higher concentration is being safely eliminated provided you are using the same elimination steps that the CDC has previously recommended.

    I would always recommend a water rinse that is shown to be acceptable for the use of the product.  So if this is potentially going to be used say in a surgical suite or somewhere where there is the potential for exposure of sterile areas of the body, then a sterile water rinse in my mind would be required scientifically.  If however, this is something where a low level commensal bacteria limit is normal then the need for sterile water might be over-the-top.  No matter what you use, you need to be able to show that the product is safe when you are ready to use the product again.  So if the decision is to go with anything less than sterile water, the water needs to be tested and you need solid scientific rationale why you have chosen to use something less than sterile.

    Whenever you are using a process or an agent that is not readily available to the user community or in the facilities of the users, you run a risk in my mind of someone using a less-than-sufficient methodology or rinsing or whatever which ultimately could impact your device and result in MDR requirements and potentially more significant regulatory issues.  I don't know whether or not a simple disclaimer in the IFU will be sufficient to mitigate this risk as I am not able to determine what your company's tolerance for risk might be nor am I a legal professional.  I strongly suggest that you consider having a long discussion with management and your legal advisors on this issue because this could be an area where I could see some significant hurdles in the future for you and your company if this is not done properly.

    I am a strong proponent of generally providing explicit instructions for something like disinfection.  If you don't and someone is injured (even if it is something as limited as a self-limiting infection of cutaneous tissue) you are going to need to explain it to lots more people than just that individual.  That is to say that if you have provided explicit recommendations on how to disinfect, if the user facility chose to "do it their way" then the response is we explicitly inform the users that this is the method we performed all of our testing using.  If you choose to change the method then it is your responsibility to ensure that the method is validated to mitigate patient risk to infection.  While this is not a guaranty that you won't have further problems or issues, it is still something that you can at least point to as a "but for" causal link in the chain of events that you had no direct influence over and that caused the problem.

    These are just my thoughts.  Looking forward to everyone else's comments on this one!

    ------------------------------
    Victor Mencarelli
    Director Regulatory Affairs
    United States
    ------------------------------

    Original Message


  • 3.  RE: cleaning and disinfection -reusable devices

    Posted 29-Jan-2019 14:00
    Rashmi,

    Lots of questions here, in a very complex space. I'll take a stab at them.

    For high level disinfection , if we are using a high level disinfectant which is not FDA cleared but is recommended by CDC and is the preferred choice of the user facility, can we use such a disinfectant ?
    In general, yes. However, recognize that this will raise the FDA expectations for you, as the burden of showing that 1) residuals on the device are not toxic, 2) the disinfectant is effective at the doses you describe, with a maximum level of soil in place, including in all challenging geometries of the device, 3) the impacts of "misuse" - using too much disinfectant, or too little, for too long and too short of a time, 4) potentially toxicity testing on the steriliant/disinfectant

    I highly suggest reading FDA's guidance on this topic - it is complex.
     
    If our validation is done for the higher concentration than the CDC recommendation , do we need to repeat our validation with the CDC concentration ?

    Possibly not, but you might need to assess the likelihood that the lower concentration will be used and whether it will be effective. Generally, think in terms of "highest" dose being needed to assess safey (toxicity and residuals) and "lowest" concentration being needed to effect effectiveness.
     
    Is sterile water necessary for the final rinse disinfection ( all levels).

    It depends. For some devices water rinse isn't necessary or could be detrimental - maybe alcohol or some other substance would be better. In general though, if you need to use water, cleaner water, even sterile water, is better. Water tends to carry bioburden/endotoxin and grow organisms quite well.
     
    Many a times the user facilities do not have the agent recommended by the manufacturer , can they use their own method for disinfection and can the manufacturer then include a disclaimer in the IFU.

    In my experience this has changed a lot over the years. In the past, you could use your single set of instructions (for disinfection and/or for sterilization cycles) and expect it to be followed or push responsibility to the user. That has changed a lot in the last few years. Now many sites will expect you to qualify THEIR disinfectants, their disinfecting machines and their sterilization cycles. They tend to have sterilization processes that they expect staff to follow and don't want the complexity of having numerous different ones. Thus you should really survey your potential customers about what they use and qualify as many as reasonable. If there really is ONLY one way to disinfect and sterilize without causing device problems I'd think twice - about the only way you can guarantee it is to provide the sterilization system with the device and engineer the device to ONLY fit in this system. And even then....
     
    Can low level disinfection be carried out at the discretion of the user facilities or does the manufacturer need to explicitly recommend the process ?

    Generally you need to recommend the process, or at least the characteristics of the processes if you have used a wide range. e FDA web page

    Reprocessing of Reusable Medical Devices
     
    and guidance on this topic....

    https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM253010.pdf

    g-




    ------------------------------
    Ginger Glaser RAC
    Chief Technology Officer
    MN
    ------------------------------

    Original Message


Related Content