Investigating future prospects of electronic medical device labeling

Investigating future prospectsof electronic labelingMarcus EvansMedical Device Global Labeling StrategiesJuly 24 and 25, 2013

Myron FinsethPrincipal Technical WriterMedtronic, Inc.Cardiac Rhythm Disease Managementmyron.finseth@medtronic.com

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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

FDA CDRH LABELING INITIATIVES

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What’s the problem?

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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

Source: Mary Brady, Senior Policy Analyst, CDRH 510(k) Implementation Meeting on Device Labeling. April 7, 2011.

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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

Source: Mary Brady, Senior Policy Analyst, CDRH 510(k) Implementation Meeting on Device Labeling. April 7, 2011.

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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.

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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.

HL7 STRUCTURED PRODUCT LABELING (SPL) FORMAT

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Standardized content in a standardized format

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.

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

Instructions for use

Troubleshooting

Warnings

Precautions

Contraindications

Adverse events

Manufacturer's contact information

Lot and serial number

Special storage conditionsSterilizationContains latexContain human tissueControlled by lot / serial #KitCombo productControlled byProduct exempt from DPMPackage sterile?

UDICompany name /addressContact informationBrand nameModel / version #GMDNUnit of useDevice countLabeler companyStorage 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

Instructions for use

Troubleshooting

Warnings

Precautions

Contraindications

Adverse events

Manufacturer's contact information

Lot and serial number

Special storage conditionsSterilizationContains latexContain human tissueControlled by lot / serial #KitCombo productControlled byProduct exempt from DPMPackage sterile?

UDICompany name /addressContact informationBrand nameModel / version #GMDNUnit of useDevice countLabeler companyStorage 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 effectivelyto track labeling through

its lifecycle)

Instructions for use

Troubleshooting

Warnings

Precautions

Contraindications

Adverse events

Manufacturer's contact information

Lot and serial number

Special storage conditionsSterilizationContains latexContain human tissueControlled by lot / serial #KitCombo productControlled byProduct exempt from DPMPackage sterile?

UDICompany name /addressContact informationBrand nameModel / version #GMDNUnit of useDevice countLabeler companyStorage 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

Instructions for use

Troubleshooting

Warnings

Precautions

Contraindications

Adverse events

Manufacturer's contact information

Lot and serial number

Special storage conditionsSterilizationContains latexContain human tissueControlled by lot / serial #KitCombo productControlled byProduct exempt from DPMPackage sterile?

UDICompany name /addressContact informationBrand nameModel / version #GMDNUnit of useDevice countLabeler companyStorage 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 labelingSubmission

The content is in coded, XML structure and stored in

databases. Content can be modeled and distributed for

use in downstream applications.

Instructions for use

Troubleshooting

Warnings

Precautions

Contraindications

Adverse events

Manufacturer's contact information

Lot and serial number

Special storage conditionsSterilizationContains latexContain human tissueControlled by lot / serial #KitCombo productControlled byProduct exempt from DPMPackage sterile?

UDICompany name /addressContact informationBrand nameModel / version #GMDNUnit of useDevice countLabeler companyStorage 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

Instructions for use

Troubleshooting

Warnings

Precautions

Contraindications

Adverse events

Manufacturer's contact information

Lot and serial number

Special storage conditionsSterilizationContains latexContain human tissueControlled by lot / serial #KitCombo productControlled byProduct exempt from DPMPackage sterile?

UDICompany name /addressContact informationBrand nameModel / version #GMDNUnit of useDevice countLabeler companyStorage 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

Instructions for use

Troubleshooting

Warnings

Precautions

Contraindications

Adverse events

Manufacturer's contact information

Lot and serial number

Special storage conditionsSterilizationContains latexContain human tissueControlled by lot / serial #KitCombo productControlled byProduct exempt from DPMPackage sterile?

UDICompany name /addressContact informationBrand nameModel / version #GMDNUnit of useDevice countLabeler companyStorage 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

Instructions for use

Troubleshooting

Warnings

Precautions

Contraindications

Adverse events

Manufacturer's contact information

Lot and serial number

Special storage conditionsSterilizationContains latexContain human tissueControlled by lot / serial #KitCombo productControlled byProduct exempt from DPMPackage sterile?

UDICompany name /addressContact informationBrand nameModel / version #GMDNUnit of useDevice countLabeler companyStorage 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

Flow of SPL information

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Flow of SPL information

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Flow of SPL information

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

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

Tracking changes through product lifecycle

Flow of SPL information

PROS AND CONS OF A GOVERNMENT-SPONSORED IFU LABELING REPOSITORY

Considerations for future labeling strategies

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Possible concerns

• 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.

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Possible advantages for device companies

• 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.

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Considerations for future labeling

• 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.

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Myron FinsethPrincipal Technical Writer

Medtronic, Inc.Cardiac Rhythm Disease Management

myron.finseth@medtronic.com