David,
Many years ago I had to dig into this when I was employed by a major global
medical product/technology manufacturer that manufactured implantable
devices identified by the FDA as requiring tracking. I worked for this
company for more than 20 years, with over 10 of those years directly
supporting its EDI efforts with customers (i.e. hospitals). It was not at
all common nor routine for any specific patient information to be included
on electronic purchase orders received from a provider for such items.
However, when the FDA tightened the tracking and reporting requirements I
did look into a standard EDI transaction. At that time there was no standard
EDI transaction to support the tracking and adverse event reporting. I even
communicated directly with the appropriate staff at the FDA on this. The FDA
(and HIMA...the Health Industry Manufacturers Association) both supported
and published specifications for a proprietary flat file format.
As an active member of the X12 Committee and its Technical Assessment
Committee for over a decade, no such transaction was brought forward for
this specific purpose.
Regarding Patient Registration, which by your query I'm assuming is the
capture of patient information when a trackable device is implanted, to the
best of my knowledge this information is captured directly by the
professional staff during the implantation procedure, most often the OR.
Unless the FDA regs have changed over the years, I don'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.
As a last resort you may wish to look at the 275 Patient Information
transaction to see if it will meet your needs.
Rachel
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. Thanks
Dave Frenkel
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