If you haven’t already, you’ll need to attend two insulin pump classes prior to its use.  Well, this is at least true in the United States and probably true for many other parts of the world.  The first pump class is typically faciliated by an endocrinology group and in our case it was taught by Seattle Children’s Hospital.  Our class was led by an RN and included 8 other families.  Based upon our experience, the first class is to ostensibly expose patients to all of the insulin pump options – and in an ideal world – should be done agnostically without showing any obiously favoritism towards any singular pump.  Unfortunately, our pump class was full of bias.  I’ll give the RN the benefit of the doubt and assume it came from a good place, which is likely the case.

I’m not investing anytime investigating how this process evolved to include two insulin pump classes or why patients are kept at arms’ length from the manufacturers themselves, but I’m guessing some good intentioned folks at the FDA thought we patients needed the assistance of clinicians when making decisions around medical devices.  While well intentioned I’m sure, it’s created other issues for patients.  The medical device space is a self-regulatory mess.  I suggest watching this Netflix documentary on the medical device industry called, “The Bleeding Edge.”

The immediate problem with this arms’ length approach to your insulin pump manufacturer is that it leads to illegal kickbacks, which has allegedly touched our space – cough, cough Omnipod (Insulet).  The pharma/medical space is rife with kickbacks and I think we should revisit how clinicians educate promote insulin pumps to their patients.  There are some inherent opportunities for malfeasance.

Anyways, the RN presented information about the Omnipod, Medtronic, and Tandem insulin pumps in our virtual class.  She walked through marketing decks for each, which I imagine are provided to her by each of the respective pump manufacturers.  I totally understand that she’s educated as a registered nurse but I’d like to think she takes a class or two, provided by the hospital and encouraged by the legal department, surrounding how clinicians should present information like this.  They should clearly avoid anything that could be construed as promoting one medical device over another for very obvious reasons.  The RN who taught our class wasn’t shy about highlighting which pump she perferred.  She’s not a diabetic herself so I assume her perference is either based upon that of her patients’ experience or she has a strong preference for the local Omnipod sales rep, with whom I imagine she interacts.

At the conclusion of the ‘training’, she asked each of the families to share which insulin pump they’d like to learn more about – in most cases, which one they’ll likely select for their child.  The process needs work.  First, it’s not done in private and while this may appear laughable there is plenty of evidence to show that ‘group think’ impacts people of all backgrounds around all types of subjects.  Think of a lay person, not really understanding the differences in the pumps showcased, and being the last person to decide for their child which pump to go with they just go with the pump that had the most ‘votes’.  More importantly, we heard two families tell the RN they were going to choose Tandem but based upon her presentation ‘pitch’ they changed their minds to go with Omnipod.  If the RN was reflective this should have bothered her or at a minimum, should have asked each, “What did you hear from me today that changed your mind?”

Again, I believe the RN is coming from a good place, at least I hope so.  While trying to help, she’s not considering biases that might be impacting her opinion.  Recency and confirmation biases are two that I can think of which could negatively impact the conclusions she may be drawing from the experience of her patients.  She really needs to present the information as flat as possible and answer questions.  You know what she doesn’t offer to the families? Safety information about each.  At a minimum she should let the parents know that she’s offering a limited amount of information and they should google each and then come back to her with a decision about the pump they’d like to move forward with.

I’m always shocked when I ask RNs at Seattle Children’s if they’ve ever searched the FDA MAUDE website for some safety data on the pumps for which they’re showcasing.  None of the nurses have even heard of MAUDE.  The data contained in the MAUDE database shouldn’t be used a a single source for medical decisions, but I think it should be at least one source of information used when making a decision involving a medical device.

Moving forward I hope clinicians will be more agnostic when hosting an insulin pump class and begin to share safety information as part of the process.

You can find MAUDE here.