Mobile Tech Manor #108: FDA Takes Over in the OR

9 Comments

Mobile Tech Manor (MTM) is the home office where I cover the world of mobile technology, and it’s an active scene of gadgets and apps. This column is my look back at the week and my outlet to share observations and lessons learned about the tech that crossed my path. This week was unusual as I packed up MTM and headed to the hospital for treatment. I took a small mobile kit with me that worked very well.

FDA cancels my medical treatment

I am getting a lot of questions about the hospitalization so I figured I’ll explain it briefly here. I have some observations to share about the mobile gear I took with me so it’s not totally off-topic, but if you have no interest in the medical bits just skip over them.

Tuesday of this week I headed to the hospital for treatment of a blocked carotid artery. An ultrasound performed a few weeks ago showed significant blockage in one of the arteries, and a subsequent CTA scan of the neck verified it. This scan used injected dye to highlight the blockage, and it was determined the left carotid artery was 80-90 percent blocked. The medical specialists involved at that point explained that I was the perfect candidate for putting a stent in the artery, which would eliminate the blockage. That was scheduled and this week I checked into the hospital to have the procedure performed.

The procedure is a two-step process — first a fiber-optic camera is run through the arteries to take actual images of the blockage (angiogram) in the neck. Once the surgeons visually verify the extent of the blockage and that it is situated where the stent can be inserted, the second phase kicks in. This involves inflating a tiny balloon to collapse the blockage, followed by insertion of the stent over the area. The entire procedure carries some risk, as a small percentage of recipients have life-threatening episodes triggered by the playing around in the arteries. That risk requires recovery in the ICU just in case.

Rewind to Tuesday of this week, I was in the operating room for three hours, strapped down so I couldn’t move. I am sedated against the pain the procedure triggers, but was wide awake as the doctors needed to interact with me throughout the entire process. They wanted to make sure I was lucid so they would know instantly if they had triggered a stroke with the activity in my arteries. The entire time was spent conducting the angiogram, taking images of the blockage within the carotid artery.

It became apparent to me on the table that things weren’t going as the specialists anticipated. It turns out the imaging clearly demonstrated that the blockage was only 70-75 percent, and not the 80-90 percent previous imaging had indicated. That turned out to be very significant, as the FDA only allows the stents to be used in patients like me when the blockage is 80 percent or greater. Even though the specialists felt I needed the stent to correct my problem, they were not allowed to put it in. So after three hours of intense work by a great medical team, and even though I was already on the operating table ready for the full treatment, the doctors had to pull out without doing anything other than the angiogram. They faced serious sanctions by the FDA had they continued as planned with the actual correction of my medical problem.

So my hospital stay was cut short once they were sure no bad things were triggered in the OR. I came home the next day, with a carotid blocked just like it was before I went to the clinic. My doctors’ opinions are still that I need the treatment, but now they must wait and monitor the blockage (for years) until it hits that magic 80 percent that would allow them to treat it properly. Of course if I have a stroke in the future, which the stenting is designed to prevent, then the FDA allows them to perform the treatment in response. They can’t prevent the symptom, but they can respond to it.

My mobile kit

Not knowing how the whole treatment thing would go down, I only took two gadgets with me to the hospital. I carried the Samsung Galaxy Tab, in the leather case for protection, and the HTC EVO 4G. The Tab was a great inclusion in the kit as it handled all online things I wanted to do, namely tweeting about the hospital stay, and was also my e-book reader. While I normally prefer using the Galaxy Tab “naked,” bringing the case turned out to be a wise move as the Tab was knocked off the hospital bed. It fell a good four feet to the hard tile floor, but the case protected the device nicely. Using the Tab in the case is much like holding a paperback book, and I found it comfortable.

The EVO was more useful than I expected, as the hospital was in a Sprint 4G coverage area. I was able to tap the fast network for short periods, although since I wasn’t doing anything heavy the 3G network was sufficient much of the time. I felt more comfortable using the 4G in parts of the hospital where standard phone data connections weren’t allowed.

E-book of the week

I had a lot of time to read and I raced through a thriller by James Patterson. Worst Case is a fast-moving tale of a serial killer with a political agenda, perhaps the worst kind. Patterson tells the story as only he (and his coauthors) can, with lots of twists and turns.

Wrap-up

That’s the week in Mobile Tech Manor, which was a true mobile workspace. The week demonstrated that mobile gear is indeed getting smaller, but more powerful at the same time. Until next week, be safe and happy mobile computing.

9 Comments

Dane Stout

Robert in SF is absolutely correct. I work for a regulatory consulting firm focused on FDA matters, and the law is clear about the FDA not having jurisdiction over the practice of medicine (that is regulated by state laws). FDA regulates products used to diagnosis or treat a disease, which includes drugs, biological products, and medical devices.

While FDA regulatory policy is not without controversy and confusion for manufacturers of regulated products, a physician can prescribe any product or use any device in the treatment of a patient without fear of any FDA action against them. Legal liability and other issues such as reimbursement by insurers may carry elements of risk if they choose to use these products “off label”, but not FDA action.

I would encourage you to find out the real reason why the procedure was apparently cancelled, but I can assure you it has nothing to do with FDA regulating your physician.

bluespapa

I’m glad you got out with your head still attached, and that there’s no writing blockage. Golly, though, it’s hard to understand the reasoning sometimes if you were strapped in they were already in your artery for hours.

I was afraid that the Evo/Tab combo would be excellent. I’m trying to resist the Tab because the size of the Evo screen is so good.

I’m glad you’re okay, but obviously this is frustrating.

Andrew Bradley

Hi James,

Thanks for the updates – I’m sorry for the frustration you’ve had to endure. I’m a doctor in the UK, and over here a blockage in the carotids of 70-75% are recommended for surgery called a carotid endarterectomy. Like ash mentioned, often if the bloackage is not critical then the risk the surgery confers would be greater than the benefit, however there is clearly a discrepancy between europe and the US on where the cut-off lies.

I thought you might find some of the material on the following page interesting – the surgeon is a consultant I worked with in the past – one of a team that climbed Everest a few years ago to conduct experiments regarding hypoxia on the summit http://www.christopherimray.co.uk/arterialsurgery/carotidarterydisease.htm

Back to the tech – I’m becomming more and more convinced by the Tab – seems like it would be the perfect size to slot in a bag and browse on the go :) May have a play with one today and see what I think first hand!

Cheers,
Andrew.

asiriusgeek

James: I’m sorry that your treatment didn’t proceed as you anticipated, but hopefully the doctors will help you manage your health effectively to mitigate the problem.

I always enjoy reading your MTM posts, so agree completely that you were a worthy winner of that Ink Blot award.

Wishing you the best!

Lee

James. Best of luck on your medical challenges. We have to keep the 2010 Ink Blot award winner in good shape for many more years of excellent tech blogging Happy Holidays.

karenclassic

Sorry to hear about the procedure — sounds frustrating :-(

Thanks for sharing your experience using mobile tech in the hospital. Both the Tab & EVO seem perfectly suited to use during bed rest, glad they worked out well!

David

James, it is good to hear that you are okay. Thanks for the updates. I thoroughly enjoy your online postings as you have made a difference in my Gadget Purchase decision making.

BTW, except for Zinio, I rarely pick up the iPad anymore. It is now an expensive Kids device for games. The Samsung Galaxy Tab has totally replaced the iPad, and more.

Robert in SF

Hi,

I work in the pharmaceutical field, in the Quality area, and have also worked in the medical device manufacturing field as well, again in Quality.

I was under the impression that the FDA regulated what the manufacturer promotes a device or drug for (i.e., which treatment is approved by the FDA as the indication the drug/device may be promoted), but *not* that the FDA regulated the actual use by the doctors. I thought it was fairly common knowledge that once a drug/device was approved by the FDA for sale that the *doctors* were the ones who had final say on the use, in any case they deemed appropriate. This is called “off label” use and is completely legal.

Did the doctors tell you the FDA restricted the stent’s use in this case and that they, the surgeons, would somehow be punished for using it outside those approvals? If so, I am going to have to do some research with others I know in the industry, as this does not sound right.

I know that *health insurance companies* will have limits on uses for drugs/devices, especially those that are expensive, so they can control costs. Perhaps their red-tape was blamed on the FDA?

ash

I’m sorry to hear about your carotid artery blockage. I’m sure that was a scary and frustrating time period for you. As a medical student I think i might have some insight as to why they did not continue with the procedure as planned and just wanted to speak to that if i could.

Likely what the case is (it’s been a while since I’ve done vascular surgery) that the blockage percentage that you have currently does not increase your risk of a stroke to a greater percent than the chance that the procedure itself could cause a stroke. For that reason it wouldn’t make sense to proceed with the procedure at this point in time. I’m sure they put you on some medications to hopefully stop the blockage from growing, and if that’s the case your chance of getting a stroke per year is less risky than you getting the stenting done.

I hope that makes sense and hope that nothing happens to you further. Stay healthy!

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