bioethics paper 2 take three

bioethics paper 2 take three - Kyle Harbison Todays Medical...

Info iconThis preview shows pages 1–2. Sign up to view the full content.

View Full Document Right Arrow Icon
Kyle Harbison CM 1090 Today’s Medical Device Advancement: Helping or Hurting? In November of 2006 Matthew Herper and Robert Langreth published their article “Dangerous Devices” in Forbes magazine. Herper and Langreth bring about quite a few ethical issues concerning the biomedical industry’s role to provide innovative, yet clinically-proven products. It seems to me that the main issue behind all of them is that a balance needs to be found between protecting public welfare through strict regulatory standards, and yet still allowing biomedical companies to maintain efficient, innovative production. The first ethical issue I found in this paper is whether it is ok for surgical devices to be “grandfathered in” by use of the 501(k) loophole. This is an issue because regulation exists to enforce the red-tape policies involved with clinical trials when it comes to products that do not resemble pre-1976 devices. However, there is not a clear line drawn that indicates what exactly constitutes enough similarity towards a product created before 1976. This creates an opening for human judgment to take precedence over concrete regulation, making it possible for companies to take the easy way out solely because it is easier, not because it is firmly justified. Another similar ethical issue is whether it is ok for the FDA to toughen its standards for introducing new implants of all kinds. One side of the issue is that by restricting product release excessively, innovation will come to a halt in the United States. This could potentially cause public harm in the distant future by not allowing the release of necessary products. The other side of the issue is that by not restricting the increasing amount of implants being created every year, public welfare is put in harm’s way due to lack of sufficient clinical trials and evidential support. So as was stated above, balance plays a key role in the formation of this ethical issue. Regulatory entities such as the FDA must enforce sufficient clinical trials in order to protect public health, however if there are too many restrictions they could ultimately hinder any progress made in the medical field. A third ethical consideration brought about in this paper is whether it is ok for medical professionals to be involved in the development of medical devices as paid consultants. This is an issue because once medical professionals become a paid element of the engineering process, a possibility for conflicts of interest between the industry, medical community and the patient (aggregate) arise. Being “consultants” sounds innocent enough, but the ethics behind this issue actually stems from this, and are more evident in the details. How exactly are the surgeons getting
Background image of page 1

Info iconThis preview has intentionally blurred sections. Sign up to view the full version.

View Full DocumentRight Arrow Icon
Image of page 2
This is the end of the preview. Sign up to access the rest of the document.

Page1 / 3

bioethics paper 2 take three - Kyle Harbison Todays Medical...

This preview shows document pages 1 - 2. Sign up to view the full document.

View Full Document Right Arrow Icon
Ask a homework question - tutors are online