Barrios_AARA_Ethics

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University of Florida *

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HSC3032

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Medicine

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Dec 6, 2023

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docx

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Uploaded by ElderGerbilMaster74

HSC3032: FOUNDATIONS OF HEALTH EDUCATION - Module 6 AARA Instructions: Please watch “The Bleeding Edge” (2018) on Netflix or using this link ( https://vimeo.com/286151015 ). The documentary is 1h and 40 min. Feel free to get together with a group of your classmates to watch it and discuss. This assignment should be completed individually . I encourage you to look at the questions before you watch the documentary . Make sure you answer all the bolded questions. What is the Medical Device Amendment? The Medical Device Amendment established three regulatory classes for medical devices. What year was the Medical Device Amendment? 1976 What does the FDA acronym stand for? Food and Drug Administration What is the role of the FDA? The FDA is a consumer protection agency that regulates everything that comes in contact with our body. What is the 510(k) process? It is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective because it is substantially equivalent to a legally marketed device. What is MAUDE and what is the purpose of this website? MAUDE stands for Manufacturer and User Facility Device Experience. Its purpose is to monitor the safety and performance of medical devices that are on the market. It houses medical device reports submitted to the FDS by mandatory reporters such as manufacturers and voluntary reporters like patients and healthcare workers. It is a reporting system that relies of self-reporting.

HSC3032: FOUNDATIONS OF HEALTH EDUCATION - Module 6 AARA What was your perception of what happened to Mrs. Angie Firmalino? What happened to Angie Firmalino was devastating. To go from being able to do so many things with your children to constantly being in pain is saddening. There should have 100% been more testing done for Essure as it is a permanent birth control. It was shocking to see how it was approved by the FDA with so many of the panel’s questions unanswered. What was the ethical issue involved with Mrs. Firmalino and how could that be overcome in the future? With Mrs. Firmalino, there was inadequate testing done to ensure that safety of Essure and it was still approved by the FDA. The medical device manufacturers should do thorough testing on implants like Essure to ensure the safety of patients. Testing should go on for at least a year to ensure that there are no problems with the device and that it is not negatively impacting the patient’s problems. What was your perception of what happened to Dr. Stephen Tower? I think what happened to Dr. Stephen Tower was unfortunate. I think that there should have been more testing to ensure that the metal-on-metal hip replacement would be safe to use. What was the ethical issue involved with Dr. Tower and how could that be overcome in the future? The ethical issue involved with Dr. Tower was the regulatory oversight by the FDA. The device manufacturer should have also made sure to report all potential risks. To overcome these ethical issues the FDA can enhance their regulation process to ensure the safety of all patients. Either getting rid of the 501(k) process or strengthening it to no longer allow devices that are substantially equivalent without further testing. Device manufacturers should also conduct rigorous testing and research and be sure to report all the results to the FDA.

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