Every year, thousands people get heart valve replacements. There are multiple options for replacement valves that can be generalized as either mechanical or biological. One of the mechanical options from the 1970s and 1980s was the Bjork-Shiley valve, which became infamous because of the controversy surrounding its stress fracture failures. These failures resulted the death of about 400 people, causing the valve to be taken off the market. The decisions made leading to this issue must be examined using various ethical frameworks so that an incident like this will not occur in the future. Ultimately, the FDA should require either third party or FDA in-house testing in order to ensure the safety of a medical device before it is approved for market,
…show more content…
The first thing to consider is what should have been done to prevent the original incident. At the time, the most straightforward solution would have been for Shiley Laboratories and Pfizer to tell the FDA the issues with the stress fractures and redesign so that the problem could be minimized or, at least, disclosed. However, it might not have mattered, since at least one study since then has shown that the porcine valve option at the time has had about the same survival rate as the unaffected Bjork-Shiley heart valve (Bloomfield, 1991). At this point, the system for regulations from the FDA should be considered as the main defense against reoccurring incidents. The FDA’s policy of ensuring a device is safe for market should change so that FDA in-house or third-party testing is required. This could be done using equipment owned and operated by the FDA so that there are no conflicts of interest with the company itself. If done by an outside company, it should also be selected by the FDA to protect impartiality to the result. This ensures the safety of a medical device before it is approved for market by a company with no, or limited, bias toward the outcome of the …show more content…
Using utilitarianism, actions of Shiley Laboratories, Pfizer, and the FDA resulted in unethical consequences that affected a large number of people. Using Kantian deontology as a framework, this incident shows that Shiley Laboratories, Pfizer, and the FDA failed to properly consider their responsibilities to the general public, including facilitating a fully informed decision when choosing a heart valve. Based on this incident, the regulations imposed by the FDA on approving medical devices and reporting issues with medical devices have been changed. The circumstances under which an issue should be reported has been better defined and a timeline for reporting has been put in place. The FDA has also been given more authority to penalize companies that do not follow these rules. Many things remain to be done in order to further ensure similar failures are prevented. Medical device companies must take responsibility when it comes reporting issues. This could come in the form of more internal regulations and compulsory testing, and by considering more ethical philosophies directly when making decisions. Ultimately, the Bjork-Shiley heart valve serves as an example of failing ethical actions and sets a precedent for a future framework to manage the handling medical device flaws to the benefit of the
The first thing to consider is what should have been done to prevent the original incident. At the time, the most straightforward solution would have been for Shiley Laboratories and Pfizer to tell the FDA the issues with the stress fractures and redesign so that the problem could be minimized or, at least, disclosed. However, it might not have mattered, since at least one study since then has shown that the porcine valve option at the time has had about the same survival rate as the unaffected Bjork-Shiley heart valve (Bloomfield, 1991). At this point, the system for regulations from the FDA should be considered as the main defense against reoccurring incidents. The FDA’s policy of ensuring a device is safe for market should change so that FDA in-house or third-party testing is required. This could be done using equipment owned and operated by the FDA so that there are no conflicts of interest with the company itself. If done by an outside company, it should also be selected by the FDA to protect impartiality to the result. This ensures the safety of a medical device before it is approved for market by a company with no, or limited, bias toward the outcome of the …show more content…
Using utilitarianism, actions of Shiley Laboratories, Pfizer, and the FDA resulted in unethical consequences that affected a large number of people. Using Kantian deontology as a framework, this incident shows that Shiley Laboratories, Pfizer, and the FDA failed to properly consider their responsibilities to the general public, including facilitating a fully informed decision when choosing a heart valve. Based on this incident, the regulations imposed by the FDA on approving medical devices and reporting issues with medical devices have been changed. The circumstances under which an issue should be reported has been better defined and a timeline for reporting has been put in place. The FDA has also been given more authority to penalize companies that do not follow these rules. Many things remain to be done in order to further ensure similar failures are prevented. Medical device companies must take responsibility when it comes reporting issues. This could come in the form of more internal regulations and compulsory testing, and by considering more ethical philosophies directly when making decisions. Ultimately, the Bjork-Shiley heart valve serves as an example of failing ethical actions and sets a precedent for a future framework to manage the handling medical device flaws to the benefit of the