The document discusses a proposal for a standardized system to provide up-to-date medical device information to patients and clinicians using structured product labeling (SPL). SPL would allow device manufacturers to submit standardized electronic product labels to the FDA that could then be accessed through the DailyMed website and integrated into electronic health records and patient health records using the unique device identifier. This would help ensure patients and clinicians always have access to the most current information for a specific medical device.

1. Medtronic Confidential
 Industry-wide web sites will allow users to use the new unique
device identifier (UDI) to quickly find essential medical device
information.
 Patients, clinicians, and physicians will know with certainty that
they have the most up-to-date information for a specific device.
 Device information will be instantly accessible through web site(s),
Electronic Health Records and Patient Health Records.
 The industry and FDA will have a format and process to review and
update device information through the lifecycle of a device.
Health informatics: delivering medical product information to the point of patient care
Myron Finseth, CRDM Technical Communications, HL7 SPL Working Group, October 17, 2011
Problems with medical device documentation
 No universal method for patients or clinicians to quickly find
device information.
o Web site designs are company-specific. No consistent
organization or search mechanisms.
o No consistent document type exists for device documentation.
Table of contents are company-specific and change from device
to device.
 No industry-wide system for document distribution.
o No central source for patients or clinicians to go to to find
medical device information.
 No standard process for updating documentation through the
lifecycle.
o No industry-wide mechanism for patients, clinicians, and
physicians to know that they have the most up-to-date product
information.
 Patients and clinicians rely heavily on company call centers for
basic information.
o Clinicians don’t always have time to find phone numbers or to
make calls to each device manufacturer.
 No sure way to know if you have the right manual for a specific
device model.
Background
The FDA soon will begin requiring medical device manufacturers to
submit device information into its proposed Unique Device Identification
(UDI) database. The Center will use an electronic UDI submission that
populates the database with device information that identifies and
describes each device type. This submission will be formatted in the Health
Level Seven (HL7) Structured Product Labeling (SPL) information
exchange standard.
CDRH could also begin accepting the content of labeling submissions for
certain types of devices. The content of labeling could represent the current
instructions for use or other manual types that provide essential device
information (e.g., indications, contraindications, warnings and precautions,
or the basic operating instructions). When implemented, all device
manufacturers will use the same document type, same electronic format,
and same submission process – the same format and similar process
currently in place for drug and biologic products.
What is Structured Product Labeling (SPL)?
SPL defines the content of regulated product labeling in an XML format.
This format is defined within the HL7 SPL schema and is displayed in a
web browser using the SPL style sheet. The schema has been adopted by
the FDA as a mechanism for exchanging regulated product information.
The SPL standard specifies that certain information is coded using FDA
and other code systems. SPL documents contain both the content of
labeling (text, tables, and figures) for a product along with additional data
elements (machine and human-readable information). The data elements
include information about the company that manufacturer the product,
description of the product, and package labeling.
Flow of SPL information
If the FDA adopts SPL for medical devices in the same capacity as drugs and
biologics, medical device companies will submit a core set of device labeling
to the FDA for approval and for placement in the Agency’s centralized
information systems. The labeling is then sent to the National Library of
Medicine where the content is made available on a public website such as
DailyMed.
Conclusion
The device industry needs structured product labeling
The SPL standard will provide the medical device industry with a
mechanism for device identification and product information. It will also
provide a standard process for FDA labeling reviews and for making that
information available to patients, clinicians, or physicians – the same
format and process used with other medical products that are regulated by
the FDA.
The intent of the FDA is not to replace existing manufacturers’ document
support systems, but to provide an electronic source of FDA-approved
labeling and to make that labeling available to the public and healthcare
professionals.
The use of electronic labeling for medical devices is a step forward for
Medtronic, FDA, and for our National Health Information Technology
infrastructure.
Healthcare information systems
The National Library of Medicine makes all SPL submissions available for
download on the DailyMed Web site. These are not static PDF files but SPL
submissions in the XML format. These files allow third party developers to
build databases or information systems that integrate Electronic Health
Records and Patient Health Records in hospitals, clinics, or doctors’ offices.
These information systems will use the UDI to identify the specific medical
device and provide a connection to the appropriate FDA-approved labeling.
The DailyMed Web site provides health information providers and the
public with a standard, comprehensive, up-to-date, resource for
medical product labeling. As of October 2011, there were over 26,000
labels posted. The site gets over 10 million visits per month.
For more information, contact: myron.finseth@medtronic.com
Key words:
Regulatory, Human Factors,
Tech Comm, eManuals, Packaging
FDA
Hospitals, clinics, etc.
Healthcare
information system
Electronic
Health Record
Patient Health
Record
National Library of
Medicine
Medical product industry General public
Patients
Pharmacies
Healthcare professionals
IT developers
Insurance companies
Government agencies (US and Int’l)
Research centers
Education
Drug companies
Device companies
Law enforcement
Borders
U.S. Department of Health and Human Services
Center for Medicare
and Medicaid (CMS)
SPL label for
drug product
SPL label for
device product
SPL label for
biologic product
SPL label for
combination product
FDA information
systems
DailyMed
website
CDER
CBER
CDRH
UDI
database
CMS information
systems
3rd party
developers
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