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Investigating future prospects of electronic medical device labeling

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Myron Finseth, MSc
Myron Finseth, MSc

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

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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
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
FDA CDRH LABELING INITIATIVES
What’s the problem? 4
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.
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.
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
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
HL7 STRUCTURED PRODUCT LABELING (SPL) FORMAT
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.
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 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
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)
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
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.
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
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
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
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
Flow of SPL information
Flow of SPL information 21
Flow of SPL information 22
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
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.
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.
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 Myron Finseth Principal Technical Writer Medtronic, Inc. Cardiac Rhythm Disease Management myron.finseth@medtronic.com

More Related Content

Investigating future prospects of electronic medical device 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
  • 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
  • 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