FDA crack-down on insulin pumps?

This story at Diabetes Health caught my attention today. Apparently the FDA has launched a program to further evaluate the safety of external infusion pumps, including insulin pumps.

You might have heard of the tragic death of Steven Krueger due to a massive dose of insulin. Apparently his insulin pump malfunctioned, reverted to prime mode, and then proceeded to empty his entire reservoir of insulin into him one night while he slept. While there has been no admission of fault on the part of the pump manufacturer, this story has had me a little nervous ever since I read about it. For details, see the story here.

Then there was the recent recall of Lot 8 infusion sets. I had wondered why my sugar was running high after I changed my site. I figured it had to do with the new insertion and that my body was just adjusting to the new “hole.” I had doubled the amount of my fixed prime to try to account for the change.  Months later, I received the nondescript letter in the mail. The manufacturer was recalling all of their Lot 8 infusion sets because the pressure in the set was not quite right, resulting in either too much or too little insulin. I guess I’m just lucky that I was on the “too little” end of the spectrum, not the “too much” end.

Shannon does a nice job of summarizing both of these situations in this post over on her blog.

And then there was my personal experience with one insulin pump manufacturer over five years ago when I upgraded from my first-ever insulin pump, to the latest and greatest. Despite repeated calls to the support line, to my CDE, and to local company reps, and having returned my brand new pump and three different refurbished replacement pumps, I could not get a good resolution from the company.

The pumps were all faulty, with issues ranging from blouses stopped after delivering .2 units, low battery and battery failed warnings immediately after inserting a brand new battery, and, worst of all, failure to deliver basal insulin after infusion site changes, sometimes for hours. All four returned pumps required a response to the FDA, and all three responses were a canned form letter stating that the manufacturer could find no fault with the product.

Nearly a year later, having moved to a new state and having found a new Endo, l requested a prescription for a new pump from a different manufacturer. This new Endo finally put me in contact with a local company rep who admitted that the company had been seeing these problems frequently. After that, I received a new pump with a new software version that worked as designed.

Each time something like this happens, I wonder why there is not more regulation on such a critical piece of equipment. How can these malfunctioning products make it to market and how can the manufacturers get away with brushing aside the health consequences they cause?

So it probably goes without saying that I am happy to see that the FDA is taking a closer look at infusion pumps and their safety. According to the FDA’s press release, they have received 56,000 reports of adverse events associated with the use of infusion pumps in the past five years, including 500 deaths. The press release goes on to say that “many of the reported problems appear to be related to device design and engineering.”

The FDA has also sent a letter to pump manufacturers informing them that they may be required to conduct additional risk assessments before new or modified pumps can be cleared.

They are holding a public workshop May 25-26, 2010 in which participants will discuss observed safety problems and ways to improve designs in order to reduce pump malfunctions and errors. According to the FDA’s Infusion Pumps Website, the workshop is open to the public, but space is limited to 300 participants. You can register online at (http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm203299.htm)

You can also report an infusion pump problem at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/InfusionPumps/ucm202503.htm

For more information about the FDA’s infusion pump safety initiative, visit the Web page at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/InfusionPumps/default.htm

A Tight Fit

Monday I went shopping for maternity clothes with my mom. I am down to just one pair of regular pants that fit. They are two sizes bigger than my normal size. And I am relying heavily on four extra-large long sleeve t-shirts to cover my top half. Even though my weight is only up a pound or two from pre-pregnancy, all of my clothes are tighter, especially in the waist.

The bad news is that most of the better department stores either don’t carry maternity clothes at all, or don’t carry them in the mall. Thankfully, there was one store in the mall devoted to maternity clothes: Destination Maternity. Unfortunately, they had next to nothing for a short girl like me (I’m 5’1″).

I did manage to find three pair of pants there, but they all need to be hemmed because they are at least three inches too long. Also, I learned that the stretchy belly panel that covers the whole belly is particularly bad for pumpers. I ended up with a lot of cord snaked around underneath and then on top of the panel before I found a pocket to put my pump in. I am hanging my hopes on a seamstress that my mom knows. Hopefully while she is shortening the length she can sew in an access hole or something. Also, one pair that I found doesn’t even have a pocket, so I will need to find some other way to wear my pump with those. Hopefully the seamstress has some ideas.

None of the shirts fit me there, either.  Everything seems to made for a super skinny girl who wants to show off her belly … and her hips and thighs and butt.  How many pregnant girls are super skinny? I’m certainly not one of them!

I did find two long sleeve maternity t-shirts at Gap Maternity. They are huge on me now, but I think they will come in handy in the next couple of months because my extra-large t-shirts are already a little on the short side.

Next it was on to the lingerie shop for the best news of the day: my bra size is a full two cup sizes bigger. Amazing.

I am still on the lookout for a couple more shirts, especially something that I can also wear now during this in-between stage, and a pair of slip-on shoes. It is getting harder and harder to tie my shoes, and I don’t want to be stuck one morning before work without any shoes to wear. I’d also like to find some sort of cardigan or other sort of layer. It is freezing in my office, but my internal thermometer seems to be on the fritz lately … I’m either hot or cold, but never comfortable.

Do you have any tips for where to find well-fitting maternity clothes for short women? It turns out that most of the maternity lines do not even offer petite options. Any other ideas?

Getting this blog started

So. I am one of those lurkers that all of the DOC bloggers talk about. I have been avidly reading the blogs of all of you famous diabetes bloggers, and living vicariously through your stories.

But I think it is finally time to share my story. I am a 31-year-old type one diabetic. I was diagnosed at the age of four, back in the days when blood sugar tests involved test tubes, eye droppers, and urine. Today I use a Medtronic Minimed Paradigm pump and a One Touch meter. It’s amazing how far we’ve come.

My husband and I have been married for three years. We “dated” for about eight years before that. Now we are ready for the next big step: Parenthood.

I expect to use this blog to document our journey through TTC, pregnancy, and parenthood, all against a backdrop of my type 1 diabetes.

Hopefully this blog will not end up being a duplication of the other of blogs with this theme, but, instead, will serve as a supplement to those blogs, telling my story, and my experiences.

So. That’s the idea. Now I need to get ready for work. More to come soon.