Regulatory Open Forum

 View Only

  • 1.  Reprocess vs. Rework

    Posted 08-Oct-2015 12:01

    Hello,

     

    I have a quick question/clarification request for reprocessing vs. reworking sterile single use devices. 

    If packages are opened within manufacturing facility and devices are within specification would we clean/repackage/sterilize and qualify as a reprocess?  Consequently, if they are out of spec and brought back up to spec including cleaning/repackaging and sterilization, would we qualify as a rework? 

     Thank you


    ------------------------------
    Gretchen Upton RAC
    Texas
    United States
    ------------------------------



  • 2.  RE: Reprocess vs. Rework

    Posted 08-Oct-2015 16:34

    It is a simple question without a simple answer. Part of the problem is where, in the product life cycle, these activities occur.

    I can think of different cases and the answer would have distinctions in each case. In one instance the devices are in the production process before release for distribution 820.80(d). In the second, the devices have been released for distribution, but not shipped to a customer. In the third, they have been shipped to a customer, but not used. In the fourth they have been shipped to a customer and used.

    I infer you mean the first case because you say the packages are opened in the manufacturing facility. If not, let us know.

    If you are opening sealed packages, you probably suspect they are nonconforming product. You must handle them as nonconforming product evaluate them following 820.90(a) and disposition them following 820.90(b)(1).

    Presumably the evaluation shows some conforming product so you disposition them as clean/repackage/sterilize. Many people use the term processing for the initial sterilization and reprocessing for subsequent sterilization. Neither processing nor reprocessing are defined terms in QSR. Sterilization requires process validation under 820.75. Often, FDA Investigators will ask for a process validation that demonstrates a second or subsequent sterilization does not damage the device.

    On the other hand some of the product is nonconforming and the disposition is rework as defined in 820.3(x). You must follow 820.90(b)(2) including documentation in the DHR. The reworked product must then follow another clean/repackage/sterilize cycle. Using the argument above this is reprocessing.

    So I would say that in one case the disposition is reprocess (the product was conforming) and in the other case (the product was nonconforming) the disposition is rework followed by reprocessing.

    You need to be careful in writing your dispositions because of other terms. Notice that you are not a remanufacturer as defined in 820.3(w), so you would not have to register as a “Reprocessor of Single Use Device”. In some of other scenarios you would have to register this way.



    ------------------------------
    Dan O'Leary
    Swanzey NH
    United States
    ------------------------------


    Original Message


  • 3.  RE: Reprocess vs. Rework

    Posted 09-Oct-2015 11:32

    Thank you so much for your thorough reply. Yes, we were scenario one, but I appreciate your insight regarding the other two. 


    ------------------------------
    Gretchen Upton RAC
    San Antonio TX
    United States
    ------------------------------


    Original Message


  • 4.  RE: Reprocess vs. Rework

    Posted 09-Oct-2015 13:09

    Hallo Gretchen:  My question is why are you planning to repeat manufacturing steps?  Did you detect any non-conformity?  Anyway, if your device is still in manufacturing it would  be easer rework or reprocessing.  The interpretation of reprocessing is typically applied for devices that are already in use and send returned to a re-processer for repair, modification, etc.  These re-processor will sell those devices as used.  A typically application are the Scope industry.  Rework is typically applied  after you have found a manufacturing defect after your device is released for commercial distribution.  Typically failure modes could be out of Spec or label updates.

    I am more than happy to further if needed.

    Thanks

    Armin

    ------------------------------
    Armin Beck
    CEO SunTrix Consulting
    Beck
    El Dorado Hills CA
    United States

    925-212-7683
    ------------------------------


    Original Message


  • 5.  RE: Reprocess vs. Rework

    Posted 09-Oct-2015 14:49
    Gretchen,

    You may refer to the definition of "rework" under 21 CFR 820.3(x) in view of the term "reprocessing" defined in FDA guidance on reprocessing.   

    Simply put, the "rework" refers to your action taken on your non-conforming product to meet the product specifications defined in your DMR before its release. 

    Thank you.  

    s/ David
    ____________________________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    President and CEO | REGULATORY DOCTOR and GCS
    Phone (Toll-Free): 1-(800) 321-8567


    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.



    Original Message


  • 6.  RE: Reprocess vs. Rework

    Posted 09-Oct-2015 16:22

    820.3(x) "Rework means action taken on a nonconforming product so that it will fulfill the specified DMR requirements before it is released for distribution."

    In other words, and in my  understanding, "Reworking" is taking an out-of-spec product and running it through a non-standard work flow to bring it back into spec. Concurrent validation is required. Generally there is no SPECIFIC SOP or validation for each re-work, since it is customized to the problem, but at a minimum, verification (retesting) should be performed. The product should be tested for all release criteria, including any re-testing.
     
    Reprocessing is taking a material (in-spec or out-of-spec) and reintroducing it to an existing (validated) process. Retesting would not be expected as long as the process is validated, but the testing identified in the validation would, or course, be performed.
     
    That's my understanding, and if I'm wrong, I am sure someone will be kind enough to let me know.  ;)


    ------------------------------
    Andrea Chamblee Esq., RAC, FRAPS

    This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and do not necessarily represent the official views of the agency or the United States. Consult the Agency for an official position.

    Silver Spring MD
    United States
    ------------------------------


    Original Message


  • 7.  RE: Reprocess vs. Rework

    Posted 09-Oct-2015 16:35
    Andrea,

    "if I'm wrong, I am sure someone will be kind enough to let me know.  ;)"

    I wouldn't say you are wrong. To be more relevant and applicable to the original description, reprocessing, when it comes down to SUD, generally refers to making "contaminated or sterility-compromised SUDs" to get READY for patients including, but not limited to, "cleaning, testing (functional), disinfection, repackaging, OR sterilization," whatever applicable at the time for the SUD device. 

    In a way, an out of spe issue is remotely relevant in this case per se. 

    Thank you.  

    s/ David
    ____________________________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    President and CEO | REGULATORY DOCTOR and GCS
    Phone (Toll-Free): 1-(800) 321-8567


    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.



    Original Message


  • 8.  RE: Reprocess vs. Rework

    Posted 12-Oct-2015 09:37
    Dan originally referred to a recent Warning Letter on the LinkedIn's UDI and Device Labeling Group concerning "inadequate process validation on the laser etching" used to etch lot numbers on implantable devices, which has practical implications to the UDI labelers (e.g., DPMs) per 21 CFR § 820.75(a)

    I just noticed that it also has an item cited for "rework" in violation of 21 CFR § 820.90(b)(2). 


    Thank you.  

    s/ David
    ____________________________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    President and CEO | REGULATORY DOCTOR and GCS
    Phone (Toll-Free): 1-(800) 321-8567


    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.



    Original Message