Barrios_AARA_Ethics
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University of Florida *
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HSC3032
Subject
Medicine
Date
Dec 6, 2023
Type
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.
HSC3032: FOUNDATIONS OF HEALTH EDUCATION -
Module 6 AARA
What was your perception of what
happened to Mrs. Tammy Jackson?
I was shocked to see what happened to Mrs. Tammy
Jackson. Medical devices should not be approved
through the 510(k) pathway. Seeing that the FDA did not
require human studies for the mesh that was used for
Tammy’s procedure had me floored. Additionally,
hearing that no one was trained on how to properly
remove the mesh was baffling. No matter how long it
takes, all devices/tools that are going to be medically
implanted in someone’s body should be properly
evaluated and studied.
What was the ethical issue involved with
Mrs. Jackson and how could that be
overcome in the future?
The ethical issue involved with Mrs. Jackson was the lack
of training to remove the device if there were
complications. There were various images of the mesh
imbedding in the skin after removal. To avoid this issue,
doctors should be trained to see if that kind of mesh
they used if feasible for surgically treating urinary
incontinence. I think that doctors should be a part of the
team when it comes to medical devices that will be
inserted into patients. They should also be required to
learn how to properly remove devices in a way that is
least damaging towards the patient having
complications.
What was your perception of what
happened to Mrs. Julie Dailey?
It was shocking to me to hear that Mrs. Dailey’s doctor
only preformed hysterectomies with the DaVinci robot.
It makes me wonder if she was aware of the potential
complications and how many surgeries her doctor had
performed with the DaVinci robot.
What was the ethical issue involved with
Mrs. Dailey and how could that be
overcome in the future?
The biggest ethical issues involved in Mrs. Dailey’s case
was the lack of training to use the robot. Although the
robot can assist in minimally invasive surgeries, it
requires intense training to operate effectively. To
avoid/overcome this issue in the future, surgeons must
be required to go through comprehensive training and
be able to demonstrate proficiency when using the robot
before being allowed to perform surgeries on patients.
Provide your overall reflection about the
content in this video.
How did it make
you feel?
What can be done to prevent
more people from becoming victims of
the medical technology industry?
Overall, I was shocked by the content in the video. It
annoyed me how many companies don’t care to go
through the process of properly regulating and testing
their devices before they go out on the market. Medical
devices should be helping people with their problems,
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HSC3032: FOUNDATIONS OF HEALTH EDUCATION -
Module 6 AARA
not creating more. I think that the 510(k) pathway
should never be used again so that there can be less
victims of the medical industry. Strengthening the ways
that the FDA approves and regulates medical devices is
another way we can prevent having more victims.