FDA & #039;s Root Causes and Use Error

Since 2016, the FDA Recalls Database has had a pull-down menu of the FDA-determined root cause of each recall. There are 43 items on the list, including "other," "pending," "under investigation by firm," and "undetermined/unknown." This list appears to have hierarchical issues in that some items (e.g., device design) seem to encompass other items (e.g., component design/selection and software design change). I have not been able to find any explanation of these 43 terms or the methodology by which FDA selects them, and my inquiries to FDA in this regard went unanswered despite an autoreply from DICE that I would get a response in one to two days. Recalls have been tagged with these terms on the individual recall pages long before they appeared in the pull-down search menu. It might also be noted that entering these same terms in the "reason for recall" box gives a different set of results. Using the "simple search" option also yields recalls that are different from those found using the menu. One of the terms in the menu is “use error,” defined elsewhere by FDA as referring to “to a situation in which the outcome of device use was different than intended, but not due to malfunction of the device.” An alternative FDA definition is “user action or lack of action that was different from that expected by the manufacturer and caused a result that (1) was different from the result expected by the user and (2) was not caused solely by device failure and (3) did ...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news