This morning Insulet joined Medtronic issuing a correction for their OmniPod DASH system. Per a company issued press release;
“As part of our ongoing quality monitoring processes, we have identified that on rare occasions, the Omnipod DASH PDM may suggest an inaccurate bolus amount based on a blood glucose value that is more than 10 minutes old when the user does not exit the bolus calculator as designed or when a system alarm interrupts a bolus calculation. If the user delivers the bolus, this may result in over or under delivery of insulin which may lead to hypoglycemia or hyperglycemia. No injuries have been reported as a result of this potential issue and the Omnipod DASH System is safe for continued use and distribution.”
While this issue does not appear to be as serious as the Medtronic recall it does point to something we have been stating with greater frequency as we move towards a true closed loop insulin delivery systems or smartphone control of insulin pumps, namely medical devices no matter how well designed, no matter how well manufactured can and do malfunction. Nothing no medical device works flawlessly 100% of the time and it’s foolish to believe anything different.
Hence the reason we have been telling all the we want it yesterday folk to slow their roll. Insulin delivery is serious business as this life saving drug is also a lethal drug when dosed incorrectly. Not like we need to conduct a survey of insulin pump patients but given the choice between safety and way cool whiz bang we have a pretty good sense over 95% would chose safety. Sure way cool whiz bang is nice, and it will get here but there is no need for it to get here at the expense of patient safety.
Let’s be very clear here we too want smartphone control and are all for systems that take away much of the heavy lifting performed by patients following intensive insulin management. However we are bigger fans of living and while we know that no system will ever be perfect or error free the standards for a true closed loop system should be set at the highest level, the same goes for smartphone control.
Not to talk up Tyler even more but it’s recalls such as these that are another feather in Tyler’s cap. Tyler can tell the patient how much and when to dose but he does not perform the dosing that’s the patient’s job. We have never been strong advocates of insulin delivery systems that take the patient fully out of the loop. Again we are all for eliminating as many steps as possible, but our experience tells us that the patient must play a role. As we said before 95% of a flight may be on auto pilot but we’re not sure we’d want to board a plane that has no humans in the cockpit.
As the Medtronic recall points out something as inconsequential as a retainer ring, something no patient thinks about can cause serious damage. What most seem to forget is that a closed loop insulin delivery system is a collection of interconnected devices designed to work together. Should any of the devices fail or malfunction the entire system fails.
We have made and are making great strides towards making insulin therapy easier for the patient. However it would be foolish to ignore the role the patient plays, remember it is THEIR diabetes they are managing. These patients should be able to choose what role they play. Given what we know about the patient population there will be a small percentage completely comfortable with being on autopilot 100% of the time. Yet there is a greater percentage who will choose to play a more active role and the needs of these patients should not be ignored.
As Spock said; “The needs of the many outweigh the needs of the few or the one.”