For the FDA jurisdiction, remember that FDA considers medical device user error to be a nonconformity. That's right, a nonconformity, even if the labeling is adequate. FDA considers user error to be a nonconformity because, it says, human factors and other similar tools should have been considered during the design phase of the device. This is asserted in the preamble to the Quality System Regulation. Therein, FDA acknowledges that a manufacturer can't foresee every possible misuse during design, but FDA still maintains that when the manufacturer does become aware of misuse, the corrective and preventive action requirements are to be implemented.
Although a manufacturer might feel that the labeling is adequate, it is nonetheless the user and the user's needs that are the ultimate barometer. Because FDA views user error to be a nonconformity, it means the labeling changes that the manufacturer thinks are just "strengthening" or "reinforcing" labeling may be viewed by the agency as a correction. Consequently, any conclusion that the labeling is adequate needs to be supported by sufficient user feedback from label design validation testing. For the U.S., this remains true for untrained lay-users in the home, as well as for professional users. This might seem strange regarding professional-use devices, especially in light of FDA's 21 CFR 801.109 stating that such devices are exempt from adequate directions for use. But remember FDA's confounding caveat stating that such exemption only remains valid if labeling (whether or not on or within the dispensing package) that gives information for use contains adequate information for such use, including methods (among other things).
Ultimately, if the labeling actually is adequate, but user error continues nonetheless, then the device manufacturer becomes accountable for whatever actions are, commensurate with risk, necessary to assure public health in association with its devices. Proper user training or other interventions would be included in this accountability, up to, and including recalls.
Categorization of nonconformities and consequent remedial actions can be region-specific. For example, the statutory/regulatory language is different for triggering recalls for the U.S. FDA, European Union, and Canada. I advise firms to be diligent in learning the differences, because what may be a recall in one jurisdiction may not be a recall in another, and vice versa. No one wants to ever have to explain to the CEO why we did a 3 million dollar recall when we didn't really need to.
Whether or not labeling adjustments are a recall is an assessment that, for the U.S., needs to be made in careful consideration of FDA's guidance document entitled "Distinguishing Medical Device Recalls from Medical Device Enhancements". FDA also elaborates on that topic in its CDRH Learn presentation and transcript posted at https://www.fda.gov/Training/CDRHLearn/ .
But overall, remember that if any correction or removal (these concepts have official definitions in the U.S.) is taken to reduce a risk to health, then it essentially becomes, based on corresponding U.S. statute and regulations, very difficult to avoid categorizing that action as a recall. And no one wants to face an agency citation where we have to explain to the CEO why we didn't categorize an action as a recall and report it to the authorities when we should have.
Hope this helps,
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Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
Principal Consultant
ComplianceAcuity, Inc.
Golden CO
United States
www.complianceacuity.comCopyright 2018 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 07-Jan-2018 17:32
From: Anonymous Member
Subject: Adverse event , user error and recall
This message was posted by a user wishing to remain anonymous
Hi,
If there's been an adverse event , a trend is identified with user error but the labelling is considered adequate - only the existing labelling is strengthened or warnings reinforced , would that amount to a recall ?
What is the manufacturer's liability for training if the equipment is for professional use?
How does the QMS need to address this change- A CAPA has been raised as preventative action . How does this need to be tracked for effectiveness ?