There has recently been an issue with recertification of Disetronic insulin pumps when they run out of calendar time. I have prepared this information sheet to try and explain the situation to users of the H-Tron, H-Tron Plus and D-Dtron series of pumps which have a fixed calendar life.
Fixed Calender Life:
The H-Tron and D-Tron pumps when sold each had a fixed calendar life, usually of two years, after which time the pump would stop functioning. I as a prescriber of the pumps and the pump users were told that this was a quality control measure and that the pumps had to be sent back for inspection and recertification, after which they would be returned to the user with the clock reset to allow another 2 years of use. We were under the impression that this process would go on until the pump was uneconomic to recertify. There was a 4 year warranty on the pump but a 2 year calendar life. In the case of the H-Tron, this was a 2 pump system and when the first pump ran out of time it would be sent back for recertification while the second pump was used, then when the second pump had run out of its 2 year life it would be returned and recertified for another 2 years. Potentially one could therefore get up to 6 years of calendar life with a pump purchase and it was assumed that this recertification process could go on as long as the pump could be economically recertified.
In the case of the D-tron pump, since this is a one pump system, the user had to notify Disetronic when the time was about to expire and they would send a replacement pump, while presumably refurbishing the original pump. It was understood that at the time of refurbishment, the calendar would be reset for another 2 years. None of the other pump manufacturers had a fixed calendar life but it was felt that the Disetronic inspection and recertification program was a good safety factor.
What has changed?
In 2007, when the new Accu-Chek Spirit came on the market, Disetronic refused to do any more inspection or recertification of pumps that had run out of calendar time. This caused quite an outcry with Disetronic Pump users because they felt that the terms of their original purchase had been violated and that they were being unjustly forced to purchase a new pump when they had a perfectly good functioning pump. In addition many D-Tron users preferred this pump model to the new Accu-Chek Spirit.
What is really happening?
Some word of explanation is needed as to what is really going on with Disetronic. When the original H-Tron Pump was developed, it was anticipated that there would be an inspection, software updating and recertification process in place by the time the pump’s 2 year life was up. The pump components had been built and tested for a 4 year life span and therefore the pumps should be able to be recertified at least once and with experience this period might be prolonged. The inspection and recertification process was to be contracted to a third party but in fact this never came to pass. When a Disetronic pump that had run out of calendar time was returned to the manufacturer it was destroyed and a new pump sent out. If a pump failed and was replaced under warranty, the replacement was programmed to have the same calendar life as the pump it replaced so the replacement did not prolong the period of functioning. Obviously this pump replacement program cannot go on for ever so Disetronic is now refusing to exchange the old pumps and is requiring users to upgrade to a current model pump. The new Accu-Chek Spirit has a 6 year calendar life. After 6 years the pump expires and will no longer function. If it malfunctions after the 4 year warranty period, there is no advertised out of warranty service agreement so you may also have to buy a new pump..
You don’t buy a Disetronic Pump, you rent it!
From the financial point of view you should consider that you are renting the pump with a fixed term lease. The cost of a new pump is $6395 so over the 48 month life of the pump (under warranty) the cost is $133 per month. In the best case scenario, if the pump lasts the full calendar life of 72 months, the cost is $88:00 per month.
What about other manufacturers?
Although other manufacturers offer refurbished pumps under certain circumstances, There is no such thing!
There is no service department or mechanism for opening the sealed cases of any of the brands of pumps. A refurbished pump is simply a new pump shipped without the packaging of the new pump and a more limited warranty. (Medtronic Mini-Med offers a 6 month warranty on “Refurbished” pumps).
What do you do?
Firstly, a pump from any manufacturer guarantees to give you 4 years of use, if you negotiate it before you purchase a pump, you can generally extend this warranty for an additional year though there may be a cost for this. Animas will provide a replacement for $500.00 if the pump fails in the fifth year or $500.00 off the price of a new pump. Mini-Med has an extended service plan, the price varies according to when you buy it. They will also sell a current pump user a “refurbished” pump with a 6 month warranty for $1900.00.