FDA Sets Panel Meeting Investigating Insulin Pumps
According to a report published in the Federal Register the FDA will convene a panel meeting to investigate insulin pumps. According to the report; “On March 5, 2010, the committee will discuss and make recommendations regarding clinical risks and benefits of post-market actions in response to insulin pump failures. Insulin pumps are intended for continuous delivery of insulin at set and variable rates and as an aid in the management of diabetes mellitus in persons requiring insulin.”
While the report did not address any specific insulin pump company for some time Diabetic Investor has been reporting on the dismal state of pump patient education and a possible design flaw in the Medtronic (NYSE:MDT) paradigm line of insulin pumps. Some may also recall that back in June of last year the FDA issued a warning letter to Medtronic regarding their insulin pumps and that company also had to initiate a recall of their infusion sets.
Frankly it’s about time the FDA looked into this issue as the evidence of a problem has been mounting for some time. Just in case anyone doubts there is a problem here Diabetic Investor suggests you visit the FDA’s web site and review the many adverse event reports related to insulin pumps. As we have reported in the past these reports indicate a disturbing trend where many of these reports can be directly linked to poor patient training.
While it’s true that insulin pumps have become more reliable and easier to use over the years this does not mean a patient can simply open the box and use the product. The reality is even with newer, “smarter” pumps proper training is not just critical for better control but an essential life saving tool. Seeing reports where patients are priming their pumps while it’s attached is only example of poor training.
Seeing as how some of the pump companies deal with these types of issues, it will be interesting to see if at the panel meeting they blame those “pesky” patients. There’s no doubt statements will be made from the respective companies about how seriously they take this issue and how they will fully cooperate with the panel.
Although Diabetic Investor isn’t a big fan of government intervention, this is one time intervention is warranted. Had companies like Medtronic remembered that those “pesky” patients are real people whose lives could be at risk when the product they make fails or is used improperly, this whole thing could have been avoided. Prior to being acquired by Medtronic, MiniMed set the standard for outstanding customer service. This panel meeting is further evidence that this once great company, who actually cared about their customers, has become another example of big company ruining a smaller company they acquired.
Let’s hope that Medtronic takes this message to heart and doesn’t pursue their usual path of blaming those “pesky” patients. `
