Week 4 

          Well, the fourth week is over and my eyes are sore from reading both code and articles. First, I will start with my internship. One of my main functions during my internship is to function as an operator. Essentially, I load a test onto the computer, plug a chip into a large tester, and then sometimes attach a massive hairdryer piece of equipment, which can range from -20 degrees C to 135 degrees C, before starting the test. I let the test run for any given time period and  once the test is complete, I inspect the data to ensure any failures are either expected or are barely out of specification, in which now and then, chips need to be retested. If a chip still fails a test and should not after retesting, then the oscilloscope must be brought out to test the chip manually as I discussed in my prior post.

          Now, onto my research. Most people simply trust that the medical devices that are implanted into them are working properly, but people may not know that there have been many malfunctions and even deaths due to medical devices. I am not trying to scare anyone, but just give the facts. We trust that the medicine we take will truly help our sickness or we trust that our car's airbags will not shoot shrapnel out if we ever crash or we trust that our friends will catch us as seen below. However, there are times when our trust can not live up to our expectations. 

          One of the primary factors that leads to us trusting so much in our lives is the regulatory practices completed by administrations such as the Food and Drug Administration. We too often assume everything we use or take is safe for us without ever looking into the regulation ourselves. I am not saying that we must halt our lives to investigate every aspect of well, everything, otherwise we would not really be living our lives to the fullest. However, I do believe that if either you yourself, a family member, or close friend is about to receive an implantable device, about to take a new medicine, or even about to buy a new car, some research needs to be done to ensure what is being used is safe and reliable.

          In 2009, Medtronic voluntarily recalled 40,000 pacemakers that were implanted due to a .17%-.30% lifetime failure rate, in which 100 device failures were ultimately found. Thus, out of that batch of pacemakers, .0025% caused a shorter life span. However, with all medical procedures, people must ask themselves the difficult question of whether or not a medical procedure had truly prolonged someone's life. In 2011, the number one most implanted medical device was artificial eye lenses, of which there was a 1%-2% chance of retinal detachment that when left untreated could have led to complete vision loss in the eye treated. Johnson and Johnson in 2010 had to recall hip replacements of 93,000 patients, in which another surgery was required for one out of eight patients after five years. This data can all be found at http://247wallst.com/healthcare-economy/2011/07/18/the-eleven-most-implanted-medical-devices-in-america/2/. With all this information, I hope more people consider fully and extensively researching an implantable medical device before having a surgery because there are sometimes malfunctions and there are issues that arise over time despite the years of testing and pre-market regulation.
        
           Now, back to the FDA regulation. All implantable medical devices are considered Class III devices and receive more intense scrutiny as well as require a Pre-Market Approval (PMA). A PMA requires a company to submit summaries of non-clinical data and clinical data, extensive literature regarding the device, and a thorough inspection of the manufacturing facility. Class I and Class II medical devices usually only require companies to submit a 510(k) notification demonstrating that a device is substantially equivalent to a device already on the market. This process is much less time consuming and only needs FDA clearance rather than an intense inspection. I will continue to talk about FDA regulation in future posts since there is just so much information.

 

           Since so many people do receive medical device implants, I am very glad to see through my internship and my research how much testing and paperwork goes into the overall process of implanting medical devices. The next couple weeks I plan to dig into the global interaction of regulation administrations and how medical companies make use of multiple administrations.