William,
You quoted the following:
"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."
Actually, I'm not at all reading too much into the question since I had
direct involvement in some of the tracking/reporting processes during the
2-decades plus that I worked in the health care industry. The act of
reporting is inherent in the act of tracking. Tracking and reporting is
addressed by the Safe Medical Devices Act. Here are excerpts from the FDA's
guidance re tracking:
"Manufacturers are required to track certain devices from their manufacture
through the distribution chain when they receive an order from the agency to
implement a tracking system for a certain type of device. Permanently
implanted devices and life-sustaining or life-supporting devices that are
intended for use by a single patient over the life of the device must be
tracked to the patient using the device. Life sustaining or life supporting
tracked devices used outside a user facility that are intended to be used by
more than one patient must be tracked to the multiple distributor level and,
if the information is available, the patient.
Tracking information may be used to facilitate notifications and recalls
ordered by FDA in the case of serious risks to health presented by the
devices.
By law, the agency may require tracking for a class II or class III device:
(A) the failure of which would be reasonably likely to have serious adverse
health consequences; or
(B) which is intended to be implanted in the human body for more than one
year;
or
(C) which is a life sustaining or life supporting device used outside a
device user facility.
FDA has discretion about whether to order tracking for devices that meet the
statutory requirements or to release devices from tracking based on
additional guidance factors and other relevant information that comes to the
agency�s attention. The following additional guidance factors, in addition
to the statutory criteria, may be considered to determine whether a tracking
order should be issued:
(A) likelihood of sudden, catastrophic failure;
(B) likelihood of significant adverse clinical outcome; and
(C) the need for prompt professional intervention.
Final Distributor:
(21 CFR 821.30(b)) The person or institution who owns the device, e.g., a
doctor or hospital, is considered the final distributor. Final distributors
must report to the manufacturer the name of the patient to whom it
distributed the device and other required information.
Patient Information name and address of the final distributor;
lot, batch, model, or serial number of the device or other identifier
necessary to track the device;
name, address, telephone number, and social security number (if available)
of the patient receiving the device;
date that the device was provided to the patient;
name, mailing address, and telephone number of the prescribing physician;
name, mailing address, and telephone number of the physician who regularly
follows the patient; and
(when applicable) the date the device was --
- explanted, with the name, mailing address, and telephone number of the
explanting physician;
- out of use due to patient death (date of death);
- returned to the manufacturer;
- permanently retired from use, or permanently disposed of.
Multiple Distributor
Information: Multiple distributors must keep tracking records each time that
a life-sustaining or life-supporting tracked device intended for use outside
a user facility is received.
(21 CFR 821.30(c)) The manufacturer does not need to be advised of the
patient(s) using the device until the information is requested.
Records
(21 CFR 821.30(c)(1)) A multiple distributor must keep the following written
records:
lot, batch, or serial number of the device or other identifier necessary to
provide for effective tracking of the device;
name, address, telephone number, and social security number (if available)
of the patient using the device;
location of the device;
date the device was provided to the patient using the device;
name, address, and telephone number of the prescribing physician;
name, address, and telephone number of the physician who regularly follows
the patient; and
(if and when applicable) the date the device was:
- returned to the manufacturer;
- permanently retired from use, or otherwise disposed of permanently.
Time Frame to Report
(21 CFR 821.30(c)(2)) The multiple distributor must provide this information
to a manufacturer within 5 days of a request and to FDA within 10 days of a
request from FDA.
Reporting Format There is no obligation to use a particular reporting
format, but the required information must be provided to the manufacturer.
Whenever possible, hospitals should consider using the manufacturer�s format
to increase the ease of tracking.
Patient Confidentiality
(21 CFR 821.55(b)) The tracking regulation requires that the names of
patients or other identifiers be provided to manufacturers or other persons
subject to the tracking requirements or to a physician, when the health or
safety of a patient requires such disclosure and the information will not be
further disclosed, pursuant to agreement."
It was not common in my experience at the world's leading medical products
manufacturer and distributor,
to see all of the detail required for tracking to be on a purchase order
from the provider to the manufacturer, since the full scope of tracking data
includes the date/time of implantation, the name of the physician performing
the implant, the name of the instution as well as patient information.
Furthermore, it was also not common for these types of devices to even be
ordered electronically, and I believe that's still the situation. Most often
the manufacturer's sales rep works very closely with the health care
provider for the acquisition of these types of devices, and in many
situations, the sales rep may even be present in the OR during the implant
procedure.
Again, during my 2-decade plus tenure in the health care supply chain a
product recall never was issued electronically. It's an extremely rare (if
one exists at all) health care provider instution that can even accept
product recall data electronically, let alone do anything intelligent with
it once received. Depending on the nature of the product being recalled and
the reason for the recall, such product recall notification can be
accomplished via many modes: phone call, fax, mail, etc.
Further to response to your assertion that it's the product being registed
not the patient, you're somewhat incorrect in this assumption. It's both the
specific instance of a product that has been implanted into a specific
patient that's being registered, thus uniquely tying a given instance of the
product to a specific person. Again, the reason for this is not solely to
register the product but to have the association between a specific instance
of the product and a specific person established for the purpose of
documenting, tracking and reporting any adverse events that occured while
the product was in use in that specific person and to further tracking when
and if that specific instance of the product was explanted, when and why.
The FDA regulations controlling this process and the required procedures are
not covered under HIPAA, which is Public Law 104-191, and for which final
enabling rules covering transaction sets and codes were published last
August in the Federal Register. The U.S. Department of Health & Human
Services is charged with the responsibility for developing and publishing
rules required under PL 104-191. The FDA does not have any regulatory or
oversight authority regarding HIPAA. The primary role of the FDA is to
assure the safety of foods and cosmetics, and the safety and efficacy of
pharmaceuticals, biological products and medical devices. HCFA is the
primary agency involved under DHHS regarding HIPAA and its primary role is
to administer the Medicare and Medicaid programs, which provide health care
to America's aged and indigent populations, about one in every four
Americans, including nearly 18 million children and and nursing home
coverage for low-income elderly. HCFA also administers the new Children's
Health Insurance Program through approved state plans that cover more than
2.2 million children.
Hope this clarifies the issue of HIPAA and FDA requirements for medical
device tracking. For those wishing more detailed information regarding the
FDA requirements for medical device tracking required under the Safe Medical
Devices Act follow this link: http://www.fda.gov/cdrh/modact/tracking.html
Rachel
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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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