Comment Re:Source code access for medical devices (Score 2) 38
That would be nice, but you are probably not going to have the chance to shop around. The ICD (defib + pacemaker) that gets implanted is going to be selected by your doctor, or their practice. It is going to come from the vendor they selected. The lead(s) that connect the device to your heart are going to come from the same vendor. You did want them to be compatible with your device, didn't you? You know, have the proper connectors to connect to the device, rather than have the doctor or someone in the room cut off the connections and solder on the correct ones for your device before they implant it. Yes, I'm sure they can solder coax in a sterile environment.
My ICD was strongly suggested because my ejection fraction (how much your heart pumps out when it beats) was such that there was a high probability that I could fall over dead at some point. I didn't go car shopping to see which one got the best gas mileage, had XM radio, 4WD, etc. I didn't ask for the source code, as I didn't when we bought our last car - you did get the source code to your cars' computer, didn't you? I went with the device the doctor had selected. Later I found out other cardiologist groups in the area used several different manufacturers and were not familiar with mine.
BTW - communications with all ICDs is wireless - you do not have a bunch of wires and a connector hanging out of your chest (usual location is upper left on chest). The programming and monitoring is performed over the air so to say. I have been able to communicate with my device up to about 10 M. It does make a rather loud noise whenever I place a magnet over it to disable it temporarily (there are times when I did not want it to fire unexpectedly). Some devices, not mine, have the ability to communicate with a local device / base station that collects data sensed by the device and relays that data to a remote server so someone can monitor your device. The base station could be sitting on a night stand next to your bed and collect data while you sleep, others collect the data when you enter the room.
RE: battery life and repeated surgery - when I last looked, the batteries in these devices are expected to last 5 to 7 years. That said, my device is on a watch list where the battery life may be shorter than expected.
As a comment to a post above regarding 'over-regulation' - take a look at the FDA web site and the approval process. It is difficult to get the first one approved. When you produce the second / next generation, all you have to do is say that it is 'like' the first one and the approval process is a lot less difficult.
My ICD was strongly suggested because my ejection fraction (how much your heart pumps out when it beats) was such that there was a high probability that I could fall over dead at some point. I didn't go car shopping to see which one got the best gas mileage, had XM radio, 4WD, etc. I didn't ask for the source code, as I didn't when we bought our last car - you did get the source code to your cars' computer, didn't you? I went with the device the doctor had selected. Later I found out other cardiologist groups in the area used several different manufacturers and were not familiar with mine.
BTW - communications with all ICDs is wireless - you do not have a bunch of wires and a connector hanging out of your chest (usual location is upper left on chest). The programming and monitoring is performed over the air so to say. I have been able to communicate with my device up to about 10 M. It does make a rather loud noise whenever I place a magnet over it to disable it temporarily (there are times when I did not want it to fire unexpectedly). Some devices, not mine, have the ability to communicate with a local device / base station that collects data sensed by the device and relays that data to a remote server so someone can monitor your device. The base station could be sitting on a night stand next to your bed and collect data while you sleep, others collect the data when you enter the room.
RE: battery life and repeated surgery - when I last looked, the batteries in these devices are expected to last 5 to 7 years. That said, my device is on a watch list where the battery life may be shorter than expected.
As a comment to a post above regarding 'over-regulation' - take a look at the FDA web site and the approval process. It is difficult to get the first one approved. When you produce the second / next generation, all you have to do is say that it is 'like' the first one and the approval process is a lot less difficult.