Examine the HL7 Structured Product Labeling (SPL) format. Better understand how: UDI data elements relate to the IFU label; and how regulated product information flows to downstream uses of SPL labeling

1. Investigating future prospects
of electronic labeling
Marcus Evans
Medical Device Global Labeling Strategies
July 24 and 25, 2013
Myron Finseth
Principal Technical Writer
Medtronic, Inc.
Cardiac Rhythm Disease Management
myron.finseth@medtronic.com

2. Objectives
• Review the 2011 and 2013 FDA CDRH labeling
initiatives
• Examine the HL7 Structured Product Labeling (SPL)
format. Better understand how:
– UDI data elements relate to the IFU label
– Regulated product information flows to downstream uses of SPL
labeling
• Look at the pros and cons of a government-sponsored
IFU labeling repository
– Review considerations for future labeling strategies
2

3. FDA CDRH LABELING
INITIATIVES

4. What’s the problem?
4

5. FDA CDRH Labeling Initiative, 2011
What is the problem?
• Labeling
– Has no single centralized source for devices
– Is easily separated from the device
• Devices
– Have many components and accessories are used by different
types of people and in different environments
• Can be in service for years
• Are sold or distributed to more than one person
5
Source: Mary Brady, Senior Policy Analyst, CDRH 510(k) Implementation Meeting on Device
Labeling. April 7, 2011.

6. FDA CDRH Labeling Initiative, 2011
What is the problem?
• People
– Want to know about available devices and choices they have
– Need an easier way to find out what is cleared or approved by
the FDA
– Want the instructions for use
• Manufacturers
– Claim substantial equivalence to older products and the FDA
does not have the current labeling to substantiate the claim
– FDA does not always keep labeling for all of the supported
devices on manufacturers' websites
6
Source: Mary Brady, Senior Policy Analyst, CDRH 510(k) Implementation Meeting on Device
Labeling. April 7, 2011.

7. Problems with medical device
information
• No universal method for patients or clinicians to quickly
find device information.
– Web site designs are company-specific. No consistent
organization or search mechanisms.
– No consistent document type exists for device documentation.
Table of contents are company-specific and frequently change
from device to device over time.
• No industry-wide system for document distribution.
– No central location for patients or clinicians to find medical
device information.
7

8. FDA CDRH Labeling Initiative, 2013
• Possible implementation of standardized content and
format of medical device labeling:
– List of required sections in addition to an abbreviated list of
required sections.
– Labeling would possibly be structured in the Health Level Seven
(HL7) Structured Product Labeling (SPL) standard, similar to
what the agency has implemented for drug and biologic
products.
• Electronic format for web viewing
• PDF format for printed paper format
• Possible implementation of a centralized repository for
medical device labeling, similar to drugs and biologics
• Use of the UDI to link device labeling to specific device
models.
8

9. HL7 STRUCTURED PRODUCT
LABELING (SPL) FORMAT

10. Standardized content in
a standardized format
10
Instructions for use
Troubleshooting
Warnings
Precautions
Contraindications
Adverse events
Manufacturer's contact information
Lot and serial number
Health Level Seven (HL7)
Structured Product Labeling (SPL)
• XML document markup standard
adopted by FDA as a mechanism for
exchanging labeling information for
regulated products.
• Allows for a public website for
regulated products. For
pharmaceutical drugs:
www.dailymed.com
Recommended sections were identified in Medical Device Labeling for Health Care Practitioners
Focus Group Study, Final Report. Presented to the FDA. RTI International. May 6, 2011.

11. Instructions for use
Troubleshooting
Warnings
Precautions
Contraindications
Adverse events
Manufacturer's contact information
Lot and serial number
<?xml version="1.0" encoding="UTF-8?>
<setId root="560e1287-1fb3-4e77-9250-6b0e4fa7ffdf"/>
<versionNumber value="1"/>
<author>
HL7 SPL R5 data model
Content of labeling
(IFU)
Header

12. Instructions for use
Troubleshooting
Warnings
Precautions
Contraindications
Adverse events
Manufacturer's contact information
Lot 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
<?xml version="1.0" encoding="UTF-8?>
<setId root="560e1287-1fb3-4e77-9250-6b0e4fa7ffdf"/>
<versionNumber value="1"/>
<author>
HL7 SPL R5 data model
Content of labeling
(text from manuals)
Data elements
Header

13. Instructions for use
Troubleshooting
Warnings
Precautions
Contraindications
Adverse events
Manufacturer's contact information
Lot 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
<?xml version="1.0" encoding="UTF-8?>
<setId root="560e1287-1fb3-4e77-9250-6b0e4fa7ffdf"/>
<versionNumber value="1"/>
<author>
HL7 SPL R5 data model
Electronic IFU
Metadata for the IFU
(could be used effectively
to track labeling through
its lifecycle)

14. Instructions for use
Troubleshooting
Warnings
Precautions
Contraindications
Adverse events
Manufacturer's contact information
Lot 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
<?xml version="1.0" encoding="UTF-8?>
<setId root="560e1287-1fb3-4e77-9250-6b0e4fa7ffdf"/>
<versionNumber value="1"/>
<author>
HL7 SPL R5 data model
UDI submission

15. Instructions for use
Troubleshooting
Warnings
Precautions
Contraindications
Adverse events
Manufacturer's contact information
Lot 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
<?xml version="1.0" encoding="UTF-8?>
<setId root="560e1287-1fb3-4e77-9250-6b0e4fa7ffdf"/>
<versionNumber value="1"/>
<author>
HL7 SPL R5 data model
Content of labeling
Submission
The content is in coded, XML
structure and stored in
databases. Content can be
modeled and distributed for
use in downstream
applications.

16. Instructions for use
Troubleshooting
Warnings
Precautions
Contraindications
Adverse events
Manufacturer's contact information
Lot 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
<?xml version="1.0" encoding="UTF-8?>
<setId root="560e1287-1fb3-4e77-9250-6b0e4fa7ffdf"/>
<versionNumber value="1"/>
<author>
HL7 SPL R5 data model
Multiple submissions from a
single SPL file:
• UDI submission
• Establishment Registration
• Product Listing
• Content of labeling

17. Instructions for use
Troubleshooting
Warnings
Precautions
Contraindications
Adverse events
Manufacturer's contact information
Lot 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
<?xml version="1.0" encoding="UTF-8?>
<setId root="560e1287-1fb3-4e77-9250-6b0e4fa7ffdf"/>
<versionNumber value="1"/>
<author>
HL7 SPL R5 data model
As content changes over
time, change indicators can
identify applicable
content.
setID remains constant
over the lifecycle
Version number increments
with each submission

18. Instructions for use
Troubleshooting
Warnings
Precautions
Contraindications
Adverse events
Manufacturer's contact information
Lot 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
<?xml version="1.0" encoding="UTF-8?>
<setId root="560e1287-1fb3-4e77-9250-6b0e4fa7ffdf"/>
<versionNumber value="1"/>
<author>
HL7 SPL R5 data model
As content changes over
time, change indicators can
identify applicable
content.
setID remains constant
over the lifecycle
Version number increments
with each submission

19. Instructions for use
Troubleshooting
Warnings
Precautions
Contraindications
Adverse events
Manufacturer's contact information
Lot 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
<?xml version="1.0" encoding="UTF-8?>
<setId root="560e1287-1fb3-4e77-9250-6b0e4fa7ffdf"/>
<versionNumber value="1"/>
<author>
HL7 SPL R5 data model
As content changes over
time, change indicators can
identify applicable
content.
setID remains constant
over the lifecycle
Version number increments
with each submission

20. Flow of SPL information

21. Flow of SPL information
21

22. Flow of SPL information
22

23. DailyMed website
• Searching by Names or Codes
• Search Archive for Old Labels
• Notify of Changes (RSS)
• Archive of Labels
• Forward (e-mail) Label
• Preview Labels
• Product Identification
• Download Product Labels
• Print Product Labels

24. http://dailymed.nlm.nih.gov/dailymed/about.cfm
• 10 million visits per month (09 / 2012)
• Over 52,000 drug labels (07 / 2013)
• 8 Minutes Per Page View

25. Tracking changes through product
lifecycle

26. Flow of SPL information

27. PROS AND CONS OF A
GOVERNMENT-SPONSORED
IFU LABELING REPOSITORY
Considerations for future labeling strategies

28. Possible concerns
28
• The effort to submit SPL labeling would be redundant to
existing labeling requirements.
– Redundancy adds risks and costs
• There are already too many regulatory requirements. We
don’t need to add any more.
• Centralized website doesn’t allow manufacturer’s to
differentiate product information from competitor
information.
• The new required sections don’t apply to their products.

29. Possible advantages for device
companies
29
• Opens new opportunities for IFU distribution:
– Centralized website could make IFUs easier to find.
• The implementation of a mandated National device
labeling repository could reduce operating costs of the
company’s existing website.
• Reduce the risks of errors in validating PDF files for the
company website.
• Makes IFU information available at the point of patient
care.

30. Considerations for future labeling
30
• When planning and implementing UDI through the
organization, consider the publishing group (technical
writers) a major stakeholder.
• Follow or engage in the discussion of health informatics
standards for medical product labeling.
• Keep in mind that SPL is an FDA initiative. At this point,
SPL is not part of the global plans for UDI.
• Portable Document Format (PDF) files will continue to be
a standard for sharing documents for many more years.

31. 31
Myron Finseth
Principal Technical Writer
Medtronic, Inc.
Cardiac Rhythm Disease Management
myron.finseth@medtronic.com