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.

BackgroundThe 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 informationIf 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.

ConclusionThe device industry needs structured product labelingThe 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 systemsThe 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.

Healthcareinformation system

ElectronicHealth Record

Patient HealthRecord

National Library ofMedicine

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 Medicareand Medicaid (CMS)

SPL label fordrug product

SPL label fordevice product

SPL label forbiologic product

SPL label forcombination product

FDA informationsystems

DailyMedwebsite

CDERCBERCDRH

UDIdatabase

CMS informationsystems

3rd partydevelopers

<UDI>

<UDI >