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(g)(1) The Secretary shall establish a national medical device registry (in this subsection referred to as the ‘registry’) to facilitate analysis of postmarket safety and outcomes data on each device that—
(A) is or has been used in or on a patient; and
(B) is—
(i) a class III device; or
(ii) a class II device that is implantable, life-supporting, or life-sustaining.
Yes, you heard it...implantable record keeping device. Joy.
(g)(1) The Secretary shall establish a national medical device registry (in this subsection referred to as the ‘registry’) to facilitate analysis of postmarket safety and outcomes data on each device that—
(A) is or has been used in or on a patient; and
(B) is—
(i) a class III device; or
(ii) a class II device that is implantable, life-supporting, or life-sustaining.
Yes, you heard it...implantable record keeping device. Joy.
It describes a national registry, then goes on to mention the means in which to store this information. No context lost there. If you would be so kind as to explain where the misunderstanding lie?
If you read it carefully, it says it's a registry for implanted medical devices. Medical devices implanted into a patient included artificial hips, artificial hearts, and pace makers for example. This is so that if there is a failure of a particular device that is found from manufactor defects, they can have a data base of patients they need to contact.
Yes, you heard it...implantable record keeping device. Joy.
Or rather the reverse: Record keeping on implantable devices. You know, things like those awful pacemakers and such.
Oh noes, government wants to keep track of the postmarket safety of medical devices that are used by millions. And they want... this AWFUL list of patients and model numbers so they can contact people in case of recalls. THE SHEER HUMANITY OF IT ALL.
(g)(1) The Secretary shall establish a national medical device registry (in this subsection referred to as the ‘registry’) to facilitate analysis of postmarket safety and outcomes data on each device that—
(A) is or has been used in or on a patient; and
(B) is—
(i) a class III device; or
(ii) a class II device that is implantable, life-supporting, or life-sustaining.
Yes, you heard it...implantable record keeping device. Joy.
OK I'm not for this bill out all, but I think they are saying they need to keep a national registry of all devices implanted in people. For example the serial number on someone hip replacement. They want data on how well it works, and if there were any issues with the device.
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