Although i have not seen The Bleeding Edge on Netflix, it does seem highly interesting to watch simply because this year there have been a few products recalled by the FDA before they could potentially harm various people.
The first product was the J&J vaccine around June that had not been made properly at a plant in Baltimore, and they had to throw out about 60 million doses of the vaccine before they were distributed. This could have potentially been catastrophic because not only could it have killed people during a pandemic, but also lose the trust of various of people to get vaccinated to stop the pandemic. The recall was done in an efficiently way because it could have resulted in the public losing trust as well as deaths.
Another few products recalled this year to prevent other deaths and injury were the neutrogena sunscreens, which contained low levels of benzene. They linked this to cause cancer, and yet the product did hit the shelves, the FDA made sure to alert all those who had purchased to stop using it. I think in this case the FDA once again made sure to not have a mass amount of people who could have potentially had cancer from an aerosol.
I know the two above mentioned scenarios did not cause lethal death, but they do relate to how these devices and tools were first approved by the FDA until testing was done and found that they were faulty/dangerous. The FDA showed strictness when calling out the recall, but i think they could have been more thorough with testing. The vaccines was a huge error because they stated the lack of knowledge the employees had when creating the vaccine to be sterile. This should have been something the FDA saw immediately and needed to be stricter on, as such an EUA device needs careful watch and it is supposed to be something to protect those from a virus. Additionally, with the sunscreens, they should have tested the sunscreens for every single known chemical that could cause cancer, and they could have done such by putting the sunscreens to similar in vitro simulations with skins and a UV light simulation to see if the sprays caused and sort of chemical reaction. I believe the FDA needs to be more wary of rules and regulations, as some have not been updated, and especially during a pandemic, where everything happened so fast because it had never happened before in current times, they need to keep updating and regulating rules as time is progressing.
Recently, Armstrong Medical Limited recalled their product named AMSORB PLUS which absorbs carbon dioxide from cellular respiration during anesthesia. This substance is provided in a prefilled cylindrical container that is attached to the ventilator/anesthesia machine.
The reason for recalling this product is the difficulty in gas flow that may cause a reduced flow of air to the patient. It may also prevent ventilators from providing enough breathing assistance. As a consequence, carbon dioxide may increase in the patient's body and may have a negative health effect.
I believe that when the FDA issues a recall for goods or medicines, it is not because the product is defective per se but rather because of a recent batch that was distributed that may have a flaw that could endanger consumers. Despite the many classes being in place, there are simply too many items for the FDA to carefully monitor. Additionally, organizations that make pharmaceuticals and medical devices work hard to sway those who make decisions about the process. People always try to get the wrong product on the market and make quicky money. More transparency in the approval process and testing by the FDA would maybe eliminate the issue.
The FDA is in charge of different parts that were stated in the video. One most commonly known would be some food products. Just by looking up ‘FDA recalls’ there is an extensive list of all the items recalled and the reason why. Many food items get recalled due to a ‘potential risk of an allergen’ or a mislabeling. Many medical devices reasons vary but end up being summarized by a potential risk in the mechanism of the device. It poses the question as to why/how the FDA did not figure out this problem earlier or during clinical trials. But it does make sense in some circumstances that when a new device goes out, there is no definite way of finding out every single thing that could go wrong and being prepared for it. So when a device goes out there are still some factors that could cause some harm but it goes for the user themselves to use them with directed care as well. It becomes both parties' job to ensure safety.
