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  • 1.  Biological evaluation of reusable medical devices: What role does shelf-life play?

    Posted 22-Mar-2023 07:39
    Edited by Saschka Busch 22-Mar-2023 07:41

    ISO 10993-1 „Biological evaluation of medical devices" states that according to Chapter 4.7 "The biological safety of a medical device shall be evaluated by the manufacturer over the whole life-cycle of a medical device."

    The product life cycle of a medical device consists of shelf life and in-use stability (see Figure 1)

    The shelf life of a medical device ends with the opening of the package or the initial commissioning. Subsequently, the in-use stability begins, which usually consists of several use and processing cycles for reusable products.

    According to the above consideration and the definition in chapter 4.7 of ISO 10993-1, shelf life is an important point of biological evaluation for any medical device.

    In the further course of chapter 4.8 of ISO 10993-1, the following is defined for reusable medical devices: "For re-usable medical devices, biological safety shall be evaluated for the maximum number of validated processing cycles by the manufacturer."

    According to this definition, shelf life for reusable medical devices would not play a role in biological evaluation for the time being, but only in-use stability in the form of validated processing cycles.

    Is this interpretation correctly interpreted and state of the art also internationally?



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    Saschka Busch
    Emmendingen
    Germany
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  • 2.  RE: Biological evaluation of reusable medical devices: What role does shelf-life play?

    Posted 22-Mar-2023 13:25
    Edited by Kevin Randall 22-Mar-2023 13:29

    Biological evaluation for reusable devices may reasonably not be focused on "shelf life". The heart of this question hinges first on general medical device principles regarding shelf life (or lack thereof) vs. stability over the device's lifetime.  Much has been said about that in this Forum already, so I won't retrace those discussions here unless otherwise requested.  But in summary, it has been established that not all medical devices have, or need, a shelf life. Yet all devices have a life-cycle within which there is an "expected life" (U.S. FDA), "lifetime" (ISO 13485, ISO/TN 24971), "expected lifetime" (EU MDR), etc.

    Accordingly, I don't believe that ISO 10993-1:2018 clause 4.7 ("The biological safety of a medical device shall be evaluated by the manufacturer over the whole life-cycle of a medical device.") means that shelf life is an important point of biological evaluation for "any" medical device.  Instead, the device's shelf life is germane only if the device has a shelf life.

    For example, reusable devices oftentimes don't have or need a shelf life, but instead will always have an expected useful life.  Accordingly, clause 4.7 certain requires understanding of the biological safety throughout a labeled shelf life if any such shelf life there may be.  But ultimately, for a reusable device, the main focus is generally on biological evaluation representative of the reusable device's expected useful life, which factors in stability considerations such as material aging, response to reprocessing, etc.  For example, ISO 10993-1:2018 states that if a medical device is intended to change during its lifetime, then the evaluation shall consider all the different device states.  I would expand that to whenever the medical device does/can change during its lifetime.



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    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
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  • 3.  RE: Biological evaluation of reusable medical devices: What role does shelf-life play?

    Posted 22-Mar-2023 13:30

    Minor clerical edits / typos corrected just now.



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    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
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  • 4.  RE: Biological evaluation of reusable medical devices: What role does shelf-life play?

    This message was posted by a user wishing to remain anonymous
    Posted 23-Mar-2023 08:18
    This message was posted by a user wishing to remain anonymous

    Generally, internationally, safety is expected throughout the product's lifetime - while it sits on the shelf, when it is used, when it is reprocessed and used again, until its defined end of life.




  • 5.  RE: Biological evaluation of reusable medical devices: What role does shelf-life play?

    Posted 23-Mar-2023 08:40

    Good day Saschka,

    To add some additional thoughts to what has already been provided, the easiest part of the answer is yes, this is generally recognised internationally.  As ISO 10993 series are international standards, these are generally recognised by most regulatory agencies around the world and would be considered state of the art.

    In the context of biological evaluation for a medical device, there are different aspects which need to be viewed: the device itself, the shelf-life, and use of the device over repeated times by the user.  As the biological evaluation is linked now to risk based approached, in some instances these "stages" of the life cycle of the device may or may not be applicable.  Or more importantly, may not have any impact on the overall biological characterisation of the device.  As an example, the device itself must ensure any indirect or direct contacting components are safe.  When the device is in the packaging, reviewing risk with any residues or leaching either from the device itself (exposed to increased temperature) or the packaging in which the product is stored.  (If remember the hub-bub about plastic bottles and leaching of chemicals into the contents.)  Then when the device is re-used is there any degradation of materials such as being exposed to the chemicals or cleaning agents.  Also is there any chemicals or cleaning agents which may stay on the device, thus exposing the user/patient to a hazard.

    The advice is ensure the biological characteristics are defined and explained over the entire life-cycle of the device to ensure any biological risk is identified and managed.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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  • 6.  RE: Biological evaluation of reusable medical devices: What role does shelf-life play?

    Posted 27-Mar-2023 00:18

    Saschka, 

    There has definitely been some great discussion especially regarding reprocessing/useful life. 

    Here are a few resources I like to keep handy: 

    • https://compliancenavigator.bsigroup.com/en/medicaldeviceblog/sterilization-of-medical-devices2/  - this also gets into some of the affiliated standards and considerations to demonstrate safety of the device over its useful lifetime 
    • https://www.fda.gov/medical-devices/products-and-medical-procedures/reprocessing-reusable-medical-devices - from a US perspective 



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    Stephanie Christianson, PhD
    Senior Regulatory Affairs Product Manager
    Kimberly-Clark
    United States
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  • 7.  RE: Biological evaluation of reusable medical devices: What role does shelf-life play?

    Posted 27-Mar-2023 11:11

    Hi everyone, 

    thank you very much for all the detailed comments and helpful links. 

    Saschka



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    Saschka Busch
    Emmendingen
    Germany
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