Makehba Nelson, BS in TWC
What did I do?
I analyzed 3 Summary of Safety and Effectiveness Data (SSED) documents that were released along the timeline of the FDA recall of Medtronic's Sprint Fidelis leads to determine common themes and changes in risk communication in order to answer the following questions: How and what rhetorical strategies are used to communicate risk within this regulatory documents? and; Did the rhetorical elements that express risk within these SSEDs change along the timeline of the FDA recall of the Sprint Fidelis leads?
What did you learn?
There were some subtle changes in how risk was expressed in the SSEDs. However, these changes did not alter how risk was communicated. Many of the changes came in the form of discursive differences that reflected the stylistic preference of the author, but did not change the overall messaging. In contrast, the numerical and linguistic aspects remained constant throughout all of the documents.
What do you hope audiences take away?
Since regulatory affairs is a niche career field, I hope audiences learn something new about medical device regulations that they did not know before! I also hope that this project expands the overall understanding of where and how technical writing can be utilized to advance public health.
What do you hope audiences ask you?
What policy should be changed in response to recalls similar to this one? In what other ways do regulatory affairs harness technical writing skills to communicate information?
View supporting artifact(s)
Provide feedback
Back to showcase gallery