Dave Frenkel wrote: "Does anybody have any suggestions for a transaction
to do patient registration for tracking medical devices. The FDA
requires medical devices like pacemakers to be tracked by the
manufacturers for things like recalls. It is common for patient
information to be on hospital purchase orders (850) but under HIPAA
privacy regulations this will probably not be allowed, accounting has no
need to know patient info since it is the hospital usually being
billed."
Rachel Foerster "[doesn't] believe there is a requirement to
track/report to the FDA UNLESS there is an adverse event or the device
is explanted. Thus, again I don't believe there is a standard
transactions for this purpose." She suggests that Dave "...may wish to
look at the 275 Patient Information transaction to see if it will meet
your needs."
Dear Rachel:
Dave said that the "FDA requires medical devices like pacemakers to be
tracked by the manufacturers," not anything about reporting to the FDA -
you're reading far too much into the question.
Thus, somehow the hospital - which was responsible for implanting the
device - needs to tell the manufacturer who the thing was stuck into.
Presumably the manufacturer would like to capture not only the patient
details, but also record stuff like the surgeon and hospital, so it can
get in contact with the relevant parties if a ticker is later determined
to have a likelihood of a problem. This doesn't sound too much
different from product recalls of automobiles or tires - it's the
manufacturer that collects the information, not some government
authority.
It's a product being registered in this case, not the patient, and
something like the X12 140 - Product Registration - transaction set
might be more appropriate than your suggestion of the 275 Patient
Information transaction set. And when the product is recalled, its
sister transaction - the X12 143 Product Service Notification - can be
sent to the hospitals (or the surgeons) who then would notify the
individual patients in a discreet, expeditious and sensitive manner:
"Hey pal, you're dead meat unless you get your ass in here, pronto."
Though the 140 and 143 are not HIPAA standard transactions, there's no
law that says they couldn't be used in this context, assuming the
transactions are securely transferred between hospitals and
manufacturers.
William J. Kammerer
FORESIGHT Corp.
4950 Blazer Pkwy.
Dublin, OH USA 43017-3305
+1 614 791-1600
Visit FORESIGHT Corp. at http://www.foresightcorp.com/
"accelerating time-to-trade"
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