Week 9 

          As my project is slowly coming to an end, so is the flow of new interesting topics. With my internship, I have simply continued to work as an operator, but as my father's team nears the end of their own project, I have helped make many more graphs and presentations. Basically, I am formatting all the data that has been collected as well as assisting in organizing the final report that will be sent off to the production groups. At the production level, the data will be used to adjust any programming and such in the silicon chips that will be in the actual pacemakers people will be implanted with.

          It has been an absolute blast taking this stepping stone before college this fall and has been awesome to truly see how much I have learned from others these past months. Overall, this project has been quite worthwhile as I have not only seen both what I want to do and don't want to do in my own future, but have been given the opportunity to hopefully impact the world in a positive way by sharing my research. 

Week 8 

          This last week I learned that many implantable medical device companies make programmers for doctors and nurses to use that check up on the status of the implantable device. Before I begin discussing the programmers specifically, one interesting thing is that the FDA often relies on the medical companies to make their own regulatory devices. Medical device companies make programmers to collect data on how the devices are operating and then use that data to make improvements for the next up-incoming device. Now, more in detail on the programmer. The programmer is designed to check a variety of parameters such as the battery level, the pacing rate, impedance (detection of loose screws or lead fractures), threshold (minimum amount of energy required to depolarize chamber being paced), and the amount of time the patient is pacing on his/her own. When a patient visits a doctor, the doctor places the programming head of the programmer onto the patient's chest where the medical device was implanted, which then receives the information and sends the visual data onto the programmer screen. With the information collected regarding the device and how a patient's heart functions, in the case of a pacemaker programmer, the doctor can adjust the therapy. All changes are sent by the doctor to the pacemaker making the process of altering a medical device much easier as no surgery is involved.

       

          In 2009, Carol Kasyjanski of New York received the first Internet-based pacemaker by St. Jude Medical. When Kasyjanski visits home, at least once a day, the pacemaker downloads all information collected, such as that by a programmer, and automatically checks the performance of the pacemaker as well as the condition of her heart. All information is then uploaded to a central server where her doctor may browse the data collection at his/her leisure. In addition, any abnormalities or dangers found by the pacemaker notifies the doctor at once. Internet connected medical devices will most likely by entering the market in the next decades as this massive technology movement continues. Few devices currently are connected to the Internet as there are many more systems that need revising and perfecting. For one, collecting data requires memory space, which in turn requires greater energy consumption. With so many updates as well as the desire to make medical devices smaller and smaller, there needs to be changes to the internal system while still ensuring the device functions properly and safely. However, with connection to the Internet, devices need to be better secured. In a 2012 episode of the TV show Homeland, a Vice President is assassinated by a terrorist who hacks his pacemaker and accelerates the pacing until he dies of a heart attack. I am not trying to scare anyone, but there needs to be serious caution as the Internet becomes more prominent in medical devices. If a specific medical device that happens to have Internet access is needed by a patient, the good thing is that the wireless function can be disconnected.

       

          Overall, the integration of the Internet into medical devices both offers a more efficient and convenient addition as well as some realistic concerns as hackers become more and more prevalent. For now though, almost all people with pacemakers will continue to make the trip to the doctor for a routine check-up by the programmer.  

 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.