CP-PCD-064-00.txt

                             IHE Change Proposal

                            Tracking information:
|IHE Domain                          |Patient Care Devices                |
|Change Proposal ID:                 |CP-PCD-064                          |
|Change Proposal Status:             |Submitted                           |
|Date of last update:                |20122-05-22                         |
|Person assigned:                    |John Rhoads                         |

                    Change Proposal Summary information:
|Editorial Update – Implantable, Manufacturer                              |
|Submitter’s Name(s) and e-mail      |Stephen Swanson (sswanson@sjm.com)  |
|address(es):                        |Gene Hageman                        |
|                                    |(gene.hageman@medtronic.com)        |
|                                    |Alexander Kraus                     |
|                                    |(alexander.kraus@biotronik.com)     |
|                                    |Ken Hoyme (ken.hoyme@bsci.com)      |
|Submission Date:                    |April 05, 2012                      |
|Integration Profile(s) affected:    |Implantable Device – Cardiac –      |
|                                    |Observation                         |
|Actor(s) affected:                  |None                                |
|IHE Technical Framework or          |IHE Patient Care Device (PCD)       |
|Supplement modified:                |Technical Framework; Volume 1;      |
|                                    |Revision 1.0; August 12, 2011       |
|Volume(s) and Section(s) affected:  |Volume 1 (PCD TF-1); Section 6,     |
|                                    |Section 6.5                         |
|Rationale for Change:                                                     |
|This change request is to update wording in this section by adding the    |
|word “implantable” to be more specific that this profile deals with       |
|implantable devices only and not similar surface-mounted systems.         |
|Also changing the word “vendor” to “manufacturer” to be specific about who|
|is the IDC-Reporter providing this data to IDC-Consumers.                 |


Proposed Changes:

Replace Section 6 by the following:

6 Implantable Device – Cardiac – Observation (IDCO)


Cardiac physicians follow patients with implantable cardiac devices from
multiple vendor manufacturers. These devices are categorized as implantable
pacemakers, cardioverter defibrillators, cardiac resynchronization therapy,
and implantable cardiac monitor devices. As part of patient follow-up an
interrogation of an implanted cardiac device is performed (either in-clinic
or remotely from a patient’s residence). These initial device
interrogations (solicited or unsolicited) are typically performed by
manufacturer provided interrogation vendor proprietary equipment using
manufacturer specific protocol. Information is collected regarding the
system (attributes, settings and status), the patient (demographics and
observations) and therapy (delivery and results).

To improve workflow efficiencies cardiology and electrophysiology practices
require the management of “key” information in a central system such as an
EHR or a device clinic management system.

To address this requirement, the Implantable Device – Cardiac – Observation
(IDCO) Profile defines a standard-based translation and transfer of summary
device interrogation information from the manufacturer provided
interrogation system equipment to the information management system.

The IDCO profile specifies a mechanism for the translation, transmission,
processing, and storage of discrete data elements and report attachments
associated with cardiac device interrogations (observations).





Replace Section 6.5 by the following:

6.5 IDCO Patient Identification Considerations


This profile assumes a pre-coordinated association of identifiers across
the two Patient Identifier Domains: the device vendor manufacturer systems
providing the observations and the clinics receiving the observations.

Depending on local regulations each implantable cardiac device vendor
manufacturer may be obligated to maintain a registry that maps a unique
device identifier with the patient in which it is implanted.  In some
locales this mapping is the strict responsibility of the implanting or
other organization.  Specific patient identification information is
typically not stored in the device but is made available in the registry or
by other means.  Consequently the Implantable Device – Cardiac – Reporter
is only required to send this identifier which represents the patient to
device relationship for an implanted device as part of the [PCD-09]
transaction.  This identifier by normative convention is the concatenation
of a unique industry wide manufacturer id, unique manufacturer model
number, and unique manufacturer serial number.

This profile specifies one actor, the Implantable Device – Cardiac –
Consumer, as the endpoint for observation messages. The Implantable Device
– Cardiac – Consumer will have pre-coordinated a cross-reference of patient
identifiers across the two Patient Identifier Domains.  This will be done
by storing the unique device identifier within the patient’s record.  This
will typically be the patient’s unique identity but could be the patient’s
location in emergency situations.

In some cases the Implantable Device – Cardiac – Reporter will have
detailed patient identification information like name, address, etc.  In
these cases the Implantable Device – Cardiac – Reporter can send this
information as part of the [PCD-09] transaction.