Abstract

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.

Thesis Completion

2020

Semester

Summer

Thesis Chair

Garbayo, Luciana G

Co-Chair

Self, William T.

Degree

Bachelor of Science (B.S.)

College

College of Medicine

Department

Burnett School of Biomedical Sciences

Degree Program

Biomedical Sciences

Language

English

Access Status

Open Access

Release Date

8-1-2020

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