1. The document assesses how the recommendations of an FDA-commissioned study on medical device labeling align with Medtronic's labeling for its Reveal implantable heart monitor for home use. 2. It finds that Medtronic's existing clinician manual is well-aligned with the study's recommended labeling sections. Including universal device identification data elements along with the manual's content would better represent the existing information. 3. The document also considers options for structuring and distributing device labeling using the HL7 Structured Product Labeling format to sites like electronic health records and patient portals.

1. 1
Structured labeling for home use devices
– assessment of the SPL format
Myron Finseth
Principal Technical Writer
Medtronic Cardiac Rhythm and Disease Management (CRDM)
Technical Communications
FDA Workshop, April 30, 2013
Accessible Medical Device Labeling in a Standard Content and Format

2. 2
Structured labeling for home use devices
• Overview:
– About Medtronic CRDM
– HL7 Structured Product Labeling (SPL) format
– SPL for home use devices – analysis
– Considerations

3. 3
About Medtronic CRDM
Cardiac Rhythm and Disease Management (CRDM)
• Cardiac resynchronization therapy
• Implantable cardiac defibrillators
• Pacemakers
• Heart monitors

4. 4
CRDM home use device labeling
• Document types:
– Clinician manual
– Patient manual
• Audiences:
– Physicians, clinicians
– Home healthcare nurses and aides
– Patients
– Regulatory authorities (US and International)

5. 5
HL7 Structured Product Labeling (SPL) format
Data elements
Content of labeling
(text from manuals)
HL7 SPL R5 data model
Instructions for use
Troubleshooting
Warnings
Precautions
Contraindications
Adverse events
Manufacturer’s contact information
Lot number /and serial number
Special storage conditions
Sterilization
Contains latex
Contain human tissue
Controlled by lot / serial #
Kit
Combo product
Controlled by
Product exempt from DPM
Package sterile?
UDI
Company name /address
Contact information
Brand name
Model / version #
GMDN
Unit of use
Device count
Labeler company
Storage and handling
HL7 Health Informatics
include data standards
for Electronic Health
Records, Patient Health
Records, and mobile
health information.

6. 6
• Reveal XT Patient Assistant
– Patients use the device to mark points of
time when they experience fainting spells.
– Clinicians or home healthcare
professionals train patients on how to use
the device.
– Medtronic REVEAL Patient Assistant
9538/9539 Clinician Manual used for
training.
Reveal XT
Patient Assistant
Reveal XT
implantable heart monitor
SPL for home use devices - analysis

7. 7
SPL for home use devices - analysis
• Objectives:
– Assess how the RTI study(1)
recommendations align with Reveal
Clinician manual.
– Assess how the proposed UDI data
elements support the text from the Reveal
Clinician manual.
– Better understand how a standardized
labeling submission could impact device
labeling.
1 Medical Device Labeling for Health Care Practitioners Focus Group
Study, Final Report. Presented to Food and Drug Administration.
Research Triangle Institute (RTI) International. 2011.

8. 8
Alignment with the RTI study
• Reveal Clinician manual aligns
well with the RTI study.
• Some rearranging of sections
and editing were necessary.
• Tables and graphics appeared
as they do in the printed
manual.
• “Indications” should be
included as part of the required
sections.
• Lot and serial number should
be in the data elements section
only.
Recommended sections Existing content
sufficient?
Instructions for use Yes
Troubleshooting Yes
Warnings Yes
Precautions Yes
Contraindications Yes
Adverse events Yes
Contact information Yes
Lot and serial number* Yes

9. 9
Alignment with UDI data elements
• The UDI data element
connects the specific device to
the correct labeling.
• Including the data elements
along with the content of
labeling better represents
content from existing manuals.
• Makes sense to use device
data elements in a similar way
as drug and biologic products.
– Support combination products
– Maintain continuity in labeling
for all regulated products.
Highlighted data elements represent content
from the existing Reveal manual.

10. 10
Implantable CRT device - patient manual
• Patient manual is largely informational.
Rather than “how to operate” a device,
this manual informs “how to live” with
their device.
– Implant procedure and recovery
– Registration, follow-up care, contact
information
– Precautions, medical procedures, EMI
• Can be aligned closely to RTI sections
and UDI data elements.
• Possible use for distribution to electronic
patient health record, including mobile
device delivery.
Active implantable devices represent the
majority of CRDM products.

11. 11
Considerations
• The RTI recommended sections do not add new content. The
effort to implement would involve restructuring and editing
existing content.
• The HL7 SPL data model allows new opportunities for
labeling distribution (dedicated website for devices, Health
Information Systems, Patient Health Records, and mobile
devices).
• The required format needs to be a global solution. We
recommend adoption through IMDRF (International Medical
Device Regulators Forum) UDI Guidance.

12. 12
Considerations
• Make the Labeling submission separate from the UDI
submission and Device Listing submission. Perhaps, include
SPL as part of the final labeling submission for PMA products
and something similar for 510(k) submissions.
• Industry needs the ability to choose or develop their own
software to implement the requirement and sufficient time for
deployment.
• Some data elements lack clear definition (e.g., model / brand).
Implementation of any solution requires that better definitions
be developed and harmonized across all agency uses of
those terms.