There may be some additional software issues here creating problems. The FDA is studying reports to find out why, it is the software or perhaps an easier user interface needed, or maybe a combination of both.
One more time we can address the fact that the FDA has no way of recalling devices in an efficient manner. So if this happens to be the case here it would be a lot easier if a system were put in place for recalls. People die because they use or are implanted with recalled and faulty devices that miss getting off the shelf.
With a cell phone, we have no shortage of scanners that the manufacturer could put on the packaging as well as an online data base on the internet. Soon I will be adding another post on how the Microsoft Tags can be encrypted and used for adding information to Personal Health Records too.
We have another case of tech denial here it seems and the fear of the word “change”. Look at the Becton Dickinson recall with catheters and something like this would have made it simple and lowered the chance that someone would die due to the fact that a product was missed and not pulled from use.
Tags for Use in Healthcare – Medical Stents, Medications - One Scan Away From Safety Information in Real Time
There’s a new video out on Windows Tags. Watch the video and pretend that box with Windows Vista is a stent ready to be used in surgery, get the hint here, take that phone out and scan the box!
If it has been recalled, one scan would let your know. Medical device companies can use this to ensure recalls are not missed. I wrote a post about one man who died because the doctors and hospitals missed the implant recall and it malfunctioned.
You can read the entire article at the link above. Sure makes sense to me. BD
WASHINGTON—The Food and Drug Administration said Wednesday it has seen an increasing number of hardware and software problems with insulin pumps, tiny devices worn by thousands of diabetics to deliver insulin.
"Device problems critical to insulin pumps exist across manufacturers," the agency said, noting there have been 18 recalls of devices over a five-year period, including recalls by a Roche Holding AG unit and Medtronic Inc.
The FDA is convening an advisory panel of outside medical experts on Friday to discuss what actions might be taken to "minimize risks associated with the devices in these recall situations." Background materials for the meeting were posted on the FDA's Web site Wednesday.
The agency didn't single out specific manufacturers, which also include a Johnson & Johnson unit.
Insulin pumps are primarily used by people with Type I diabetes, a condition in which the pancreas produces little or no insulin, a hormone needed to help the body properly use sugars from foods. People with Type 1 diabetes need to administer insulin daily whether through a pump or other methods like shots.
The more common form of diabetes, Type 2, which is often associated with obesity and typically develops later in life, is managed with oral medications designed to help the body properly use insulin, although some cases do require insulin.
However, in 41 death reports, a device problem wasn't identified but the circumstances involving the death involved diabetic coma and problems associated with blood-sugar levels being too high or too low, suggesting the device may not have been working properly.