Week 6 & 7 

          With spring break over and a lot of time to research how devices are being regulated, I feel I need to extend the subject of my last post about the FDA and EU. I am going to discuss the main debate in the medical device industry right now; safety concerns and approval speed. You can check out where I've received this info at http://mullingsgroup.com/medical-device-debate-balances-safety-concerns-approval-speed/, but I will convey the debate in my own fashion. One interesting thing is that this article is from 2012, but very little has changed policy-wise to improve the system. Steven Baker, a 56 year old from Minnesota, received a FDA-approved artificial elbow that malfunctioned one day while he was passing through a metal detector. The device locked up leaving him in tremendous pain. He argues that the FDA needs to toughen its standards when regulating devices so that there are no faulty devices that make the situation worse than it was before he had the surgery. Thus, his concern is the FDA's incapability to safely approve medical devices. On the other hand, there are people such as my father's friend or the six million people that travel each year to Europe to have a surgery, device implant, or simple procedure. A majority of people who do travel to Europe do so because American healthcare is expensive, however, there are many individuals that require a medical device that simply has not been released or approved yet in the United States. Thus, there is also a concern over approval speed. I, probably like most people, can see both sides of this debate.

          To ensure that these medical devices be regulated to the FDA's fullest capability as well as be approved in a timely fashion for people who need surgery rather quickly, it seems there needs to be almost two medical device regulatory departments; one for extensive evaluations, one for time-sensitive situations. People such as Steven do not want to have to receive a medical device that ends up causing more of a problem than prior to the device being implanted. They would ease any pain with smaller less significant medicines or surgeries until the permanent device is completely and thoroughly examined by the FDA. However, there are many others who simply need a newer version of an implantable medical device that is not yet released in the United States. They would go through the time-sensitive department to receive a new medical device not fully regulated, but of course at the complete discretion of both the FDA and device company.  I am not attempting to mend any government problems, but rather am voicing my opinion on how I believe the regulation should be done in order for more Americans to receive an implantable medical device in both a safe and timely manner. There comes a point where people have to ask themselves whether they can live with the pain one more day, week, or month. Is the pain worth waiting for a safe and approved device that might not be available for a couple more years? However, people eventually have to weigh the pros and cons. Clearly though, many people do travel to other countries to receive implantable devices, in which most do go out of country for the expenses, however, people take that risk so who is to say people will not take that risk in the United States if a medical device is available here.

         

                          

          The regulation and even testing of implantable medical devices is incredibly difficult. In the case of testing, often companies determine that a device is sufficient and reliable to be implanted even though there may be some small aspects with the device that fail to operate properly even though that system is not a major part of the device that is life-sustaining. A majority of the time devices do work properly, but occasionally there is a recall across the medical device industry and that makes people wonder whether that small aspect that failed caused the device to be recalled and though sad to say, caused people to suffer. The same goes with the FDA and regulatory committees as they approved the recalled device and made the terrible decision to release the device into the market. Though a majority of this industry is statistical, there are many life or death situations, moral difficulties, and emotional decisions for medical device companies, regulation committees, and even the patients.