Paranoia of the Week

As we all know, numerous Republicans (and even various Democrats) do not fully support President Obama's health care plan and, in turn, have issues with multiple aspects of the legislation. With this particular posting, I wanted to address a specific section in the House of Representatives version, a section towards which those opponents are truly taking an alarmist's view. When addressing the establishment of a national medical device registry by the Secretary of Health and Human Services, the H.R. 3200 bill states this registry will "facilitate the analysis of postmarket safety and outcomes data on each device that (A) is or has been used in or on a patient and (B) is a Class III device or a Class II device that is implantable, life supporting or life sustaining".

The concerns being incorrectly raised by certain individuals are not so much about the registry but the actual devices themselves. With that being said, let's address the section cited above. First and foremost, the national medical device registry would include "claims data, patient survey data, standardized analytic files that allow for the pooling and analysis of data from disparate data environments, electronic health records and any other data deemed appropriate".

The proposed registry certainly seems to be an extremely valuable tool, especially considering the fact that data would contain information from Class III devices. Class III devices are defined by the United States Food and Drug Administration (FDA) as either "(1) life supporting or life sustaining, (2) for a use which is of substantial importance in preventing impairment of human health or (3) presenting a potential unreasonable risk of illness or injury". Those types of devices include brain stimulators, heart pacemakers, intrabone implants, replacement heart valves and silicone filled breast implants.

Now where the alarmists start to come out of the woodwork is the portion concerning Class II devices. Designated as such due to their need for special labeling requirements, mandatory performance standards and postmarket surveillance, Class II devices are typically non-invasive and include acupuncture needles, gas analyzers, infusion pumps, medical imaging machines, physiologic monitors, powered wheelchairs, surgical drapes and surgical needles and suture materials. However, since the FDA approved and classified an "implantable radiofrequency transponder system for patient identification and health information" as a Class II device in January 2005, critics of the current administration's health care bill are claiming that these transponder systems will be utilized by President Obama to provide U.S. citizens with the "mark of the beast" (as described by at least one white supremacist web site).

Am I saying that these transponder systems will not be a possibility in the future? Of course not. I am also not saying that I would be the first in line to volunteer for one to be implanted under my skin. At the same time, I would not oppose the implant either, especially if the new information technology involved with the process would both improve the secured access of medical records and reduce health care costs. With that in mind, many Americans continue to condemn President Obama without taking just a couple of minutes to look into the annals of the previous eight years. Under the Bush administration, all new U.S. passports issued in October 2006 and beyond were (and still are) equipped with radio frequency ID (RFID) chips which can transmit personal information, such as the name, date and place of birth, gender, nationality and a digitized photograph of the passport holder. Also during the Bush presidency, the United States Department of Agriculture implemented a program intended the extend animal health surveillance by identifying and tracking specific animals (including most livestock species, various wild game and certain species of fish) through the use of RFID tags. Last but not least, when the aforementioned "implantable radiofrequency transponder system" was approved by the FDA, the Department of Health and Human Services (which oversees the FDA) was headed by Secretary Tommy Thompson. The technology, manufactured by VeriChip Corp. (a subsidiary of Applied Digital Solutions), was officially approved in January 2005 and Thompson left his Cabinet post two weeks later. Less than six months later, Thompson was appointed as a compensated member of the Board of Directors of VeriChip and Applied Digital Solutions. And just when you thought you had heard it all, Thompson almost immediately announced that he was planning on having one of the transponder systems from VeriChip injected into his arm. (In true Tommy Thompson fashion, he never went through with the actual procedure.) However, just four days after it was announced he was joining the Board of Directors of both companies, Thompson had some very interesting things to say about the technology (things that apparently everyone has since forgotten) during an interview with CBS MarketWatch:

• "All you have to do is run a wand over [the chip] and will then bring up your medical records. So it's very beneficial and it's going to be extremely helpful and it's a giant step forward to getting what we call an electronic medical record for all Americans."
• "There will be no encroachment on privacy, there won't be any adverse impact on the arm or tissue. And so it's really, very -- it's a failsafe kind of system."
• "You can also do it to replace dog tags with the United States Armed Forces."
• "The whole health care industry is way behind in technology and this is going to give that, really that impetus, to get the changing, the transformation which I call, that's badly needed in our health care system. Ninety-eight thousand people died last year because of mistakes in hospitals, in clinics, by doctors and other providers. And the chip philosophy, the chip procedure and technology, can help to prevent a lot of those untimely deaths and a lot of those mistakes and that's why I'm so excited about it."