Recently I went trolling through the FDA website and stumbled upon an article entitled "Wanted: Consumers to Report Problems (http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm354560.htm#report). It's a great article that at its core, is a plea to the consumers of medical devices to aide in the reporting of discovered adverse events related to the use of medical device products. At first this plea seemed odd to me in that with the technology that we possess nowadays why is it so difficult to get this information. In a environment that has essentially made the masses into amateur journalists via Twitter, Facebook, Pinterest, blogs, etc. why does the FDA need to ask for this assistance. Most of the time people, on their own accord, blow the whistle. Yet the fact that this article exists should highlight an opportunity for improvement in the medical device field.
The more I have pondered this article, not the information within the article, but the existence of the article itself, I have come to a singular conclusion. The FDA, or any other medical device governing body, should not be asking for assistance, instead these governing bodies should be ensuring that consumers know what to do in the event an adverse event occurs. By empowering consumers with the knowledge of what to do in the event an adverse event occurs the system should provide for a voice of the customer/user, a la Twitter, Facebook, Pinterest, blogging, etc.
By performing a simple web search on http://www.fda.gov one can find the medical device labeling regulations (21 CFR Part 801) in which there is no requirement of informing the customer of how to report adverse events. The simplest update that could funnel consumers to reporting events would be the creation of a requirement. I'm not saying it's be best solution, I'm not even implying that medical device manufacturer's would be on board with it, I'm just saying that if the FDA is serious about getting the voice of the customer then regulations will have to enable and educate customers of what to do, when to do and how to do.
- MJB