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  • 1.  Abnormal Use v Use Error - FDA

    Posted 06-Mar-2014 12:49

    I'm looking for some clarification of USFDA manufacturer reporting requirements.

    The GHTF SG2 makes a distinction between "use errors" and "abnormal use".  FDA seems to adopt this terminology in human factors considerations.  In discussion of MDR, they devolve to more general "user error" terminology and state it is reportable.  The GHTF states "abnormal use" need not be reported by the manufacturer.  Does FDA make distinction between "abnormal use", "use error" and "user error" in regards to MDR requirements?

    In general, if a device is deliberately misused, does FDA believe this to be a malfunction which would be reportable if it could lead to death or serious injury if it were to recur?

    I appreciate any clarification.  I'm currently reviewing internal reporting procedures.
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    Joseph Hooper
    Amendia
    Marietta GA
    United States
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  • 2.  RE:Abnormal Use v Use Error - FDA

    Posted 07-Mar-2014 10:31
    I don't know what FDA thinks, but to me it is clear that deliberate misuse is not an error.  Errors are not deliberate; that is why they are called "errors."

    "Knowing" misuse is slightly different; the user didn't set out to (deliberately) misuse the device, but they did misuse it and they knew they were misusing it when they did it, usually out of sheer laziness or apathy or haste to make waste.

    I don't think the long-standing tradition of not reading the manual until the device fails can be considered deliberate misuse.  To deliberately misuse a device, first you have to know how it is supposed to be used. :(

    I am inclined to think of abnormal use as something closer to off-label use, than any type of error, but I can see "normal" being defined as the way it is described in the instructions, and "abnormal" as anything else.

    From a reporting standpoint, FDA probably wants to know about user errors because good design can sometimes prevent some types of honest user errors.  So can good instructions, but only if the user honestly reads them. Good design can also prevent some types of not-so-honest deliberate misuse.

    If the regulations and guidances are ambiguous, you can always make your best call and then write a memo to file explaining your rationale for doing it the way you did it.  Or, so you don't have to keep writing memos to file, you can adopt the definitions in your reporting SOP.  Or...you could just zap off an email to  and ask FDA what they think.  However, if you are wise, this last approach will considerably reduce your options for what you actually do.  To like, one.





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    Julie Omohundro RAC
    Durham NC
    United States
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    Original Message


  • 3.  RE:Abnormal Use v Use Error - FDA

    Posted 12-Mar-2014 13:05
    Regardless of the definitions or scenarios, an expectation once the error became known would be to review /update the device risk analysis wiht the new (if new) hazard, then folllow thru with any mitigation actions that may be determined (ex: update IFU wiht a "Don't Do This" caution, addiitonal info on device label, etc.).

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    Carroll Hoyle
    Sr. Global Regulatory Affairs
    BSN Medical
    Rutherford College NC
    United States
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    Original Message


  • 4.  RE:Abnormal Use v Use Error - FDA

    Posted 31-Mar-2014 16:00


    Joseph,

    I teach a seminar on complaints, MDRs, etc. and this is a common issue. I recommend you look at two FDA-CDRH draft guidance documents. The advice from GHTF while useful, is not definitive in the FDA-CDRH setting. Draft guidance documents are "stronger", and tend to reflect current expectations.

     

    The two I recommend for this case are:

    Applying Human Factors and Usability Engineering to Optimize Medical Device Design, June 22, 2011

     

    Medical Device Reporting for Manufacturers, July 9, 2013

     

    The human factors guidance is written from the point of view risk management and considers "use error" as a type of use-related hazard. It includes:

    Device use is inconsistent with user's expectations or intuition about device operation

    Devices are used in ways that were not anticipated

    Devices are used in ways that were anticipated but inappropriate and for which adequate controls were not applied

     

    Figure 2 of the draft guidance shows that some hazards are use-related, some are device failure, and some are both.

     

    On the other hand, the MDR draft guidance uses the term "user error" meaning a device-related error or mistake made by the person using the device. The FDA expects reporting of user errors when they cause or contribute to death or serious injury.

     

    Your question relates to reporting deliberate misuse of a device that leads to death or serious injury (or could if it were to recur). I infer from these two draft guidance that deliberate misuse is reportable.

     

    Regards,

    Dan

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    Dan O'Leary
    Swanzey NH
    United States
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    Original Message


  • 5.  RE:Abnormal Use v Use Error - FDA

    Posted 07-Mar-2014 13:18
    Joseph,
    This is a good question because it get the heart of some FDA misunderstanding.  The FDA in different guidance documents use different terms For example they mention Use Error, which is a little bit different than User Error. User error means, just that, the user made a mistake. A Use error does not necessarily mean the user made a mistake i.e. a left handed person using a right handed device, although it did lead to a problem. Use errors include the user the uses and the environment the device is being used. Alarm deafness is considered a Use error because the user does not hear the device alarm anymore over all the other alarms in say an ICU. Use errors are commonly created because usability-thought (part of human factors) was not fully .... utilized or tested. This is commonly a design issue, a design allowance that did not take into effect all the potential risk situations. You can see now why a Use Error is reportable; the user used the device as it was designed but still ended up with a problem.
    A User error in the FDA MDR guidance (July 2013) is similar but finely different. A User error is commonly not a design error (unless the design allows for hazardous situations) but a labeling, training error or sometimes a design flaw like a confusing GUI. The user thinks they are using it correctly but instead uses it wrong. Say you have an alarm volume control but to raise the volume you turn it counter clockwise and the nurse turns off the alarms. The product works, design validated, but maybe not well labeled (say with an arrow) its counterintuitive, volume is raised going clockwise. Again you can see how this could be an MDR. If one person thinks they are following the right path, using the product correctly but it leads to a death or serious injury there is a good chance that someone else will do the same, thus an MDR.
    From a reportability view point, it does not matter (they both need to be reported). Although from a correction, product re-submission and potential recall view the two are different (though again could lead to similar outcomes) and required different root cause investigations.
    The FDA does not discuss Abnormal use in their MDR guidance but it (and reasonable unforeseen misuse) is mentioned in the human factors, risk management and usability guidance documents. These are commonly intentional errors but could also include unintentional mistakes. For example when a person deliberately does something which creates a hazardous situation like disconnecting an alarm or not performing maintenance of a product. In the risk management guidance the FDA suggests that engineers think about these types of errors and mitigate them as best as possible. They also know humans are a funny bunch and we'll do lots of dumb things (hairdryer in the shower or metal fork in the toaster) and no one can remove all risks; especially with many medical devices (making a blunt scalpel is useless). But for example if a doctor takes the protective cover off a scalpel or the anti-stick protector off a needle and someone gets injured...well that is not an MDR because ...well the user did it themselves. Unintentional misuses are also a problem but commonly they get mixed into user or use errors. This is a common problem with reusing single use devices or connecting devices from different companies (like mixing IVD reagents from one company and IVD devices and test methods from another company).
    As mentioned, there is potential overlap in some cases, so potentially reportable events need to be looked at on a case by case basis. A good example is a combination abnormal use and a user error; say a hospital two different companies infusion pumps and on one a red button starts the pump and on the other it stop the pump. Unintentionally the nurse presses the red button and accidentally stops a pump instead of starting it and the patient is injured. She has been trained and knows the difference but this time is distracted or just forgets. Its abnormal because she did not mean to make the mistake but she obviously did, the device is designed correctly BUT it does not conform to traditional (red means stop) thought (I think this is called heuristic guidelines. This could (probably should) be a MDR. A good example of unintentional errors that are also use errors is the common wire or hose issue; when a company uses similar luers to attach different types of hoses and the nurse attached the hoses incorrectly. There is a story of an anesthesiologist incorrectly attaching the suction line to the O2 line because they had similar connectors.
    Sorry for the length but I hope this helped. I can talk more about this off line if you'd like; we've helped several companies review their complaints to determine if its reportable and if a HHE is required.  

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    F. David Rothkopf
    President
    MEDIcept Inc.
    Ashland MA
    United States
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    Original Message


  • 6.  RE:Abnormal Use v Use Error - FDA

    Posted 07-Mar-2014 14:40
    FDA does not make any distinction between abnormal use and user error (use error).  User errors do not exempt the manufacturer from reporting death or serious injury events.  This is shown in the definition of "caused or contributed".  

    User errors are not a factor in making the decision on reportable malfunctions.

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    Christine Posin RAC
    Consultant
    Walnut CA
    United States
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    Original Message


  • 7.  RE:Abnormal Use v Use Error - FDA

    Posted 08-Mar-2014 16:26

    "Does FDA make distinction between "abnormal use", "use error" and "user error" in regards to MDR requirements?" 

    The answer is NO.  

    Although FDA makes somewhat distinction between the said terms above for HF requirements purposes (as part of quality and design control requirements), FDA doesn't distinguish these terms for MDR purposes.  As for these terms above, FDA recognizes IEC 62366 and ANSI/AAMI HE 75 as described in the design considerations or medical device reporting. 

    To simply put, whichever use errors (whether it is intentional, unintentional or even negligent) are involved, it falls under the definition of "has or may have caused or contributed."  

    "In general, if a device is deliberately misused, does FDA believe this to be a malfunction which would be reportable if it could lead to death or serious injury if it were to recur?"

    YES, reportable not as a malfunction but death or serious injury if injury occurred.

    As for device malfunction, YES, to the extent that a device safety feature (as an example) fails to function as intended if it were to recur and unless it is "REMOTE." Otherwise, NO malfunction if the device's safety feature functioned as intended even if the device became useless after the event.  

    Regarding "intent" or "intentional misuse," it should be an integral part of quality and design control (e.g., human factor requirements including environmental considerations, e.g., implementing tamper-resistant features, whether it is intentional or not).

    As for the differences between GHTF/EU and US regarding adverse event reporting for medical devices (all guidance documents are here), the scope is different (somewhat limited in EU but broader scope in the US).

    In EU, as part of post-market vigilance systems, it is intended to reduce or prevent the "recurrence of adverse events..."
    In the US, MDR is intended to ensure that devices are not adulterated or misbranded and are safe and effective for their intended use.  Also the reporting requirements in the US are quite broad regardless of "intent."

    If a device is abusively, grossly misused, one got injured (death or serious injury), is it reportable and if so, under what category?

    It is reportable under death or serious injury since "death" or "serious injury" was or may have been attributed to the device.

    Is it reportable under "device malfunction"?  No if the device was intentionally misused outside the scope of the intended use.

    As a practical matter, you should have a Risk Management System closely interfaced/inter-related with a complaint handling system, CAPA and MDR.

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    President and Principal
    http://www.regulatorydoctor.com
    Riner VA
    United States
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