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ashleyfitzsimmons replied to the topic Inadequate Testing in the forum Introduction to Project Management 7 years, 2 months ago
From reviews online, it says Lenzer has written about several devices that have been proven problematic. Investigative journalism can sometimes bring notice to problems that may be overlooked.
For example, Lenzer makes a point, “So the FDA has a database where doctors and hospitals can report deaths and serious adverse events, but they don’t know how many people are implanted with a particular device. So if you have 100 deaths in a database from a particular device – I mean, if there are only 200 of those devices implanted in people, that’s really scary.If there are 2 million people implanted, that’s another story. And that’s exactly what we don’t know because the FDA doesn’t require manufacturers to report how many people are implanted.” I think that this is something that can be adjusted and would make sense. While it may be a nuisance to have to record every single one implanted, it is not costing the hospital or company a significant amount of extra time or money and this small change can help us analyze the device risks better.
While the other problems discussed in her book probably stem larger than this, I think it is important to not defend the medical device industry until one has fully read the book to make a well-informed argument. In the past, our medical devices were not even regulated by the FDA. Thus, there is always room for improvement and investigative journalism like this should be taken seriously, while also realistically thinking about budgeting and time.
Source: https://www.npr.org/2018/01/17/578562873/are-implanted-medical-devices-creating-a-danger-within-us