Monday, March 5, 2007
For Want of a Screw...
Filed under: Regulation
A medicine professor at Duke University, named Kevin Schulman, wrote a nice piece recently about the need for better record-keeping for medical devices and parts. This was prompted by an unwelcome post-op discovery: a new screw in his knee:
Like a growing number of aging baby boomers, I recently had knee surgery. During a follow-up visit, my doctor showed me an x-ray of my knee, and I saw that a metal screw had been implanted during the surgery. I didn't know the screw was being placed there, and I knew nothing about who had made it, how well these devices had performed in long-term studies or whom I would tell if I had a problem with the device.
When I buy an appliance these days, the manufacturer asks me to register the product so it can match me with the product details. In health care, we don't do this. If there is a product recall, I won't know whether to be concerned about the screw in my knee because I don't know its make, model or lot number...
Active monitoring would match product with patient. If a patient has a problem but does not see the original physician or visit the same hospital, the new clinical team would have access to all of the information on the patient's device and other medical history. Moreover, the medical staff could report concerns back through the system to the FDA and the manufacturer.
Such a system also could notify patients about product recalls and other developments, or it could be used to survey patients to study questions about medical devices.
He's right, and the technology to do this is readily available. Let's shake a leg and hop to it.
More writing from Prof. Kevin Schulman...
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examples: <b>Bold</b> <i>Italic</i>
