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

Explore posts in the same categories: Insulin Pumps, research

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3 Comments on “FDA crack-down on insulin pumps?”

  1. Saffy Says:

    500 deaths?! Did I read that correctly?????!

    I have two friends who recently got upgraded to a whiz bang pump that does everything in a super clever way. Unfortunately super clever doesn’t always equate to super reliable. They’ve both had to get replacements.

    I’m currently running on a pump from the ark. Seriously, it’s old. Doesn’t have the fancy gizmos but it hasn’t missed a beat. I’m a little apprehensive about what my plan will be when it comes to its end of life in about 8 months time.

    Yay to the FDA for getting some traction on this.

    • nici Says:

      Yes, you read it correctly.

      The number of deaths is for all types of infusion pumps, though, not just insulin pumps.

      Still, 500 deaths over five years seems like a rather large number, doesn’t it?

  2. Jacquie Says:

    I’ve never had a problem with my pump, but that entire-thing-emptying-in-the-night situation haunts my dreams.

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