Classified for decades as a “least risk medical device,” surgical staplers have been recently associated with at least 41,000 injuries and 360 deaths in the last ten years (FDA Letter to Healthcare Providers, 2019). This shocking development has generated calls for a broad investigation into the errors involved in surgical stapler use and reform of the regulatory protocol for medical devices. Current regulatory infrastructure and framework operate with understandings that combine risk inherent to the device and that which is born by the operator (FDA Classification Call, 2019). This thesis explores the aforementioned classification error and its adverse outcomes from an epistemological standpoint. Social epistemic analysis is applied to FDA regulation and to the comparison of two scenarios in reference to the current status-quo classification and to the proposed risk reclassification of surgical staples. Expert versus novice error avoidance surgical performance capabilities are discussed under these two different classificatory scenarios and epistemic social roles.
Garbayo, Luciana G
Self, William T.
Bachelor of Science (B.S.)
College of Medicine
Burnett School of Biomedical Sciences
Howard, Jacob E., "Understanding Medical Error in Surgical Stapler Use: A Philosophical Scientific Analysis" (2020). Honors Undergraduate Theses. 797.