This is something I’m sure that goes through the mind of everyone who has one. The FDA is taking a closer look and as well as durability of the device, the software also needs to be scrutinized as well, as these devices are doing more than just sustaining life, they now report data.
FDA Wants Data on Older Medical Devices – Hip joints, dental implants and spinal surgery screws
Medtronic – 1000s of the Sprint Fidelis Defibrillator Cables May Stop working in the next few years
St. Jude has one that send the information right to an EMR or PHR that is FDA approved. Biotronik has one that sends text messages, somewhat of an eerie feeling knowing you might be a walking/talking text message machine inside.(grin)
Biotronik Home Monitoring – Cardio Implant that sends email, SMS or faxes
In the US, Clinical Trials are still being conducted, more information available here. So now we have a device that has a mind of it’s own, well sort of. Biotronik is located in Europe and now with the home monitoring features, the devices will alert your physician, and again, earlier notification will hopefully save a few lives. All in all the FDA has a much bigger job ahead with devices and might need to hire some real time programmers too to make sure the software works as designed too as devices get more complicated with additional features for them to disperse as they all start sending to your PHR in the very near future. BD
In a recent follow-up letter, FDA scientists pleaded with president Obama to revisit the approval of medical devices that involved questionable judgment. An FDA-wide email in March promised the new FDA commissioner will revitalize the agency and work hard to support scientific integrity.
Safety concerns over life sustaining medical devices. - WQAD
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