Here a Reuters story siting an FDA panel study release this week concluding that most issue with insulin pumps are due do errors by the patient, not failure by the pump. http://www.reuters.com/article/idUSN059270720100305
"...The Food and Drug Administration said problems with insulin pumps have occurred across the industry and asked the panel of outside experts for ways to minimize risks from malfunctions. Makers of the pumps include Medtronic Inc (MDT.N), Roche Holding AG (ROG.VX) and Johnson & Johnson (JNJ.N).
Panel members said they felt user errors were more likely than defects with the tiny devices worn by tens of thousands of diabetics who need insulin injections to control blood sugar. ..."
I did read that… and though I am not a Type 1, nor a pumper, I felt mixed feelings about it… Sure, maybe in the beginning, people might make mistakes… but I doubt veteran pumpers are going to have many of these issues. I guess, after a while, if they focus so much more on ‘pump use education,’ they won’t be able to blame it so much on that anymore… Kind of a double edged sword.
I think the same applies to nearly all human/machine interactions.
Off hand, I can’t think of a good example of a machine that is operated by a person where the machine caused more malfunctions than the person. I am sure there are some edge cases.
I just had a pod on that either wasn’t giving me all my insulin or none at all. No alarm no nothing. I shot up to 328, took 5 units by injection and changed the pod. Insulet was great replaced the pod and asked for the malfunctioning one back. So, what I’m trying to say was how was this my fault? I pinched up and pushed down like is suggested…have plenty of meat where it was placed. So I can see where sometimes it’s the wearer but sometimes it’s the pump.
Maybe it is just me but the term ‘felt’ seems odd if this is an investigation.
Lamont Weide was quoted ‘the failure rate to all of us seems extremely, extremely low.’ This is good news but again I read the word ‘seems’. So what is the rate of incidents with pumps? They had 17,000 reports of health problems in pump users and this alone seems to be a very low rate for health problems. I mean health problems is a very broad term here. How did they try to make the connection between health problem and device problem? This approach seems questionable because pumpers with a malfunctioning device will most likely fix the problem quickly by contacting the manufacturer.
So the rate of pump exchanges carried out by the pump manufacturer would reveal some significant insights into quality problems of manufacturer or pump model. This would be worth to be examined by an FDA panel.
What about the rare deaths that happened? How is the association between model and number of deaths? Again worth to be investigated.
It may be true that the fault is mostly on the pumpers side. Still such an investigation should be carried out with much more willingness to find something and not rely on ‘feelings’ of panel members.
This relaxed replacement policy is a good thing. I did not think of the impact an FDA inquiry could have on that. To restrict access to replacements could be more hurtful to patients than the benefits of having exact numbers of malfunctions can compensate for.
The UL for the pump is the FDA, but there still are no specific requirements other than proving that the pump will safely do the job…w/o the human factor figured in.
From another perspective, related to the outcome of the study, when using a coffee pot, people still need learn how to use it to make a good cup of coffee.
It will be interesting to see where this may lead the pump manufactures and the FDS… Is the need for better user interface, education requirements, standards or tight specifications?
I disagree. I’ve had 2 pumps replaced because of mechanical malfunctions, they just stopped working. I sent both of my malfunctioning pumps back to Minimed, but I never heard back from them about what happened.
Sure, I’ve screwed up some stuff with my pumps, but I’m not 100% at fault all the time.
We are the people who have to hold them accountable. Diabetes are consumers. Ive read anywhere from 34-174 billions dollars anually in the USA alone. If they dont do a good job… good bye, I’ll go somewhere else. If their customer service is poor… good bye, I’ll go somewhere else… If we all unite in this and said if we’re spending billions of dollars of our hard earned money this is what we want. We will get it.
On the flip side, they are machines made by man. There will be problems. All the literature you read with your pumps says if a problem occurs remove your infusion site… and start over. If you wear a pump with problems for hours or days and know something is wrong, thats your fault. If your catheter kinks on insertion, thats an accident, not realy anybodys fault. If your pump primes while your sleeping, thats a pump problem and should be addresed by the pump maker, patient, and FDA…
Ive had 8 Minimed pumps alarm and die on me. Once while I was on a 3 day hike in the Grand Canyon. I was scared and could have very well died. But, I brought syringes and extra insulin incase of an emergency and hiked out 2 days later. So, fault doesnt really mater, your common sense and health do. If you think and plan and rethink and plan you will stay healthy.
I agree, it is up to me to make the pump and me work correctly. In 14 years on the pump, I’ve only had one go bad, but that was with a Disetronic when they provide two and you could just switch out the pumps and on you went. I’ve never had a MM go bad so I feel lucky, but I never totally trust it, so when anything is not going right I make sure I can rule out the pump as the cause ASAP, site, insulin, infusion set of some thing else. Just like carrp I always have enough extra insulin and a syringe to get bu. I even spent the time to learn how to do multiple shots with regular to simulate a basal dose to get by until the pump issue is fixed.
