Regulatory Open Forum

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  • 1.  Surgery start time?

    Posted 19-Sep-2016 10:20

    Dear RAPS Friends,

    Is there a national standard for what is considered "during surgery" or what determines the start of surgery?  I have always been of the understanding the "incision" is the official start of the surgery, but that is being questioned by some of my peers.  Some argue that induction to anesthesia, positioning, draping are also part of the surgery, thus "Patient in the operating room" should be the official start time.  Is there any clear standard for this?

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    Gerald Mickam
    Jacksonville FL
    United States
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  • 2.  RE: Surgery start time?

    Posted 19-Sep-2016 21:32

    I don't know if there is a national standard.  I've dealt with the question in the context of analyzing complaints/assessing risk for a surgical product, but unless that's why you are trying to define a starting point, my experience probably wouldn't be relevant.

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    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 3.  RE: Surgery start time?

    Posted 20-Sep-2016 08:12

    I am also not aware of any standard definition for "during surgery." In my experience, a number of times are routinely captured during a surgical procedure, including Patient in room, anesthesia start and incision.  It would make sense to use the one that best fits for a particular purpose and to be very clear about which one is being used.

    Hope this helps.

    Kathy

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    Kathryn Wekselman
    Senior Director, Regulatory and Scientific Affairs
    CTI Clinical Trial and Consulting Services
    Cincinnati OH
    United States



  • 4.  RE: Surgery start time?

    Posted 20-Sep-2016 17:47

    My experience is similar. In my current company, we track a number of time variables.

    - total OR time

    - skin to skin time

    - treatment time (we make a surgical treatment system)

    - total procedure time (in our case includes OR time plus prep plus imaging time etc)

    I don't think there is a "standard" so it is typically better to try and be very clear on what you mean in any given usage.

    g-

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    Ginger Glaser RAC
    Vice-President, Quality and Regulatory Affairs
    Maplewood MN
    United States



  • 5.  RE: Surgery start time?

    Posted 21-Sep-2016 13:44

    I used to be a CRC. For all the studies in which I was involved, the sponsors wanted the start time as the time of the first incision. I don't know about a standard time.

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    Kathryn Howland RAC
    Regulatory Affairs Specialist
    Penngrove CA
    United States