FDA Takes a Closer Look at Insulin Pumps

Ann Bartlett Health Guide
  • This past week, the Wall Street Journal reported that the FDA is investigating the stability of pumps for diabetes management. The concern arises from the possibility of misuse by the patient and less likely a pump defect. Within a five year period, there have been 18 recalls and 17,000 reports of health problems. The FDA is not focused on one company in particular, but pump manufacturers as a whole. The FDA is questioning whether things be done differently to correct the reported issues. It is estimated that 375,000 people wear a pump and with that number growing, I think the FDA is right to look at where the problem is stemming. Is it the push to sell, coupled with a lack of education? Are doctors looking at their patients' capacity to handle living with a pump?

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    Last fall, I went to a lecture on technology and research advancements for diabetes given by JDRF researchers and investors. One of the speakers was a VP for Johnson & Johnson who spoke about the global consumption of pump technology. For most Europeans, health care is state run and items like pumps do not fall on the list of "must haves" for diabetes management. Ninety percent of the diabetic population in Europe is using syringes and, in some cases, like Germany, rDNA insulin is even rejected by the state health care system. The reasons for limiting access to things like pumps by state run health care is a result of the question of whether they offer better management for the cost. Perhaps this is a worthwhile question for us now that the FDA is shedding light on the issues here in the United States. Is enough being done to make pumps a safe product? With the decreasing availability of doctors and shorter pump training sessions given by manufacturers, do we have sufficient knowledge and support?

    A great example of part of the problem is my recent visit to my endocrinologist's office. Both Dr. Huang and I are in agreement that I generally do better on injections then I do living on a pump. But her CDE/PA felt that my cgm graphs showed insulin stacking resulting in lows that caused spikes. Therefore, her advice was to be on a pump. After explaining that it did not prove an easy solution for me, she suggested that it was my inexperience with the pump that caused the problem . I had spent four years on the pump and the overall management of my diabetes did not improve and I struggled emotionally. In addition to working with my personal CDE for over a year, I experienced three pump failures, tubing leaks and a canula recall. In the end, I simply felt I needed to have one variable for my insulin delivery and that would be me! My endo's office is great, but they're often overloaded with patient needs and it can take up to 24 hours for a return call from the CDE. If this was my only consult to a pump problem, that could be far too long and result in more serious issues!

    Globally, the United States is the largest consumer of pump technology and so I think it's a good idea that the FDA is keeping an eye on the product. Many newly diagnosed patients are given the advice that the sooner they get on a pump the better. Perhaps the rush is not helpful when a diabetes newbie, or a child, is too quickly assessed and placed on a technology that could have dire consequences. I worry when parents and patients are so eager to be on a pump without understanding the management piece - it's too easy to make a mistake and not know what to look for in terms of a pump issue or metabolic flux from diabetes.


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    For many, the pump has been a lifesaver, and for the continued health of those people, I would like to see standards placed on the technology to keep it as a lifesaving advancement! We all know that safety can fall between the cracks, and, in our case, we can't afford the lack of attention to detail.

Published On: March 09, 2010