2011-18369. Unique Device Identification for Postmarket Surveillance and Enforcement; Public Workshop

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop; request for comments.

SUMMARY:

The Food and Drug Administration (FDA) is announcing a public workshop on the adoption, implementation, and use of unique device identifiers (UDIs) in various health-related electronic data systems. The purpose of this workshop is to engage multiple stakeholders to obtain information and comments on issues confronting the effective and efficient incorporation of UDIs into appropriate data sets, to identify barriers and incentives to their adoption and use, and to understand the best solutions and practices to resolve open issues.

Dates and Times: The public workshop will be held on September 12, 2011, from 1 to 5 p.m. and on September 13, 2011, from 9 a.m. to 5 p.m. Submit electronic and written comments by October 13, 2011.

Location: The public workshop will be held at the Bethesda North Marriott Hotel and Conference Center, 5701 Marinelli Road, Bethesda, MD 20852; 301-822-9200.

Contact Person: Jay Crowley, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903, 301-980-1936, e-mail: [e-mail]

Registration: Registration is free and will be on a first-come, first-served basis. To register for the public workshop—whether attending in person or for the Web cast—please visit http://www.fda.gov/​UDI (or go the FDA Medical Devices News & Events—Workshops & Conferences calendar and select this public workshop from the posted events list). Please provide complete contact information for each attendee, including name, title, affiliation, address, e-mail, and telephone number. For those without Internet access, please contact Jay Crowley (see Contact Person) to register. Registration requests should be received by 5 p.m. on September 5, 2011. Early registration is recommended because seating is limited and, therefore, FDA may limit the number of participants from each organization. If time and space permit, onsite registration on the day of the public workshop will be provided beginning at 11 a.m.

Hotel reservations can be made by calling the hotel and requesting the group rate for the “FDA UDI Public Workshop” room block.

If you need special accommodations due to a disability, please contact Jay Crowley ([e-mail]) at least 7 days in advance.

The meeting will also be Web cast. Persons interested in participating by Web cast must register online by 5 p.m. on September 5, 2011. Web cast participants will be sent connection requirements. More information on the Web cast can be found on our Web site at http://www.fda.gov/​UDI.

By August 12, 2011, and then as available, FDA will post the workshop agenda and discussion topics, registration information, information about lodging, and other relevant information on the Internet at http://www.fda.gov/​UDI.

Comments: Regardless of attendance at the public workshop, interested persons may submit either electronic or written comments by October 13, 2011. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

SUPPLEMENTARY INFORMATION:

I. Background

Section 226 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) directs FDA to issue regulations establishing a UDI system for medical devices. FDA is developing proposed regulations to establish this UDI system to strengthen and improve FDA's enforcement of other statutory authorities and improve the identification of devices through distribution and use. This workshop will not address the FDA's UDI regulatory framework. However, UDI systems have been under development for some years by the U.S. and global device industry and some device manufacturers have been incorporating UDI into their product labeling and packaging. See http://www.fda.gov/​UDI for more information about UDI.

FDA is also leading an effort to develop and implement a national strategy for the best public health use of health-related electronic data related to devices that incorporates UDIs, including registries, and leverages existing processes and systems. Health-related data (from large data sources such as health insurers and integrated health systems, and others) contains a wealth of public health information that could be harnessed to contribute to understanding device safety and effectiveness. Currently, however, these data generally cannot be used to identify specific device exposures in patients. This is not the case for drug exposure, where the regular documentation of NDC numbers allows for robust analysis of pharmaceutical safety and effectiveness. Absent such information for devices, a vast amount of potentially useful data regarding patient safety and outcomes remains untapped.

The incorporation of UDI into various health-related databases will greatly facilitate many important public health-related activities including:

• Reducing medical errors,
• Reporting and assessing device-related adverse events and product problems,
• Tracking of recalls,
• Assessing patient-centered outcomes and the risk/benefit profile of medical devices in large segments of the U.S. population,
• Providing an easily accessible source of device identification information to patients and health care professionals.

The incorporation of UDI into various health-related databases would also greatly expand Sentinel Initiative capabilities to conduct active device surveillance given that Sentinel device data sources are currently limited to a few registries capturing short-term patient outcomes. FDA's Sentinel Initiative, on the Internet at http://www.fda.gov/​Safety/​FDAsSentinelInitiative/​default.htm,, seeks to establish “a national electronic system that will transform FDA's ability to track the safety of drugs, biologics, medical devices—and ultimately all FDA-regulated products once they reach the market” and “aims to develop and implement a proactive system that will complement existing systems that the Agency has in place to track reports of adverse events linked to the use of its regulated products.” (Please note that this workshop will NOT address FDA's oversight of EHRs.)

II. Topics for Discussion at the Public Workshop

This public workshop is intended to engage multiple stakeholders to inform FDA's efforts to promote and facilitate incorporation of UDIs into healthcare systems, obtain actionable information on the issues surrounding effective and efficient incorporation of UDIs into health-related electronic records, and understand best solutions and practices. To that end, we will focus on the following issues:

A. Documenting Device Use Using UDIs in Electronic Health Records

1. The current state of documentation of device use in health-related databases, including EHRs.

2. The barriers to, and various possible incentives for, the development, implementation and use of UDI in EHR systems.

3. The possible roles and activities of various government stakeholders (including FDA, CMS, ONC, and NLM) necessary to drive the adoption and use of UDIs in EHRs and other health-related databases.

4. Any other issues or concerns that would affect the efficient and effective incorporation of UDIs in EHRs and other health-related data.

B. The Role of UDI in Device Registries

5. The current state of documentation of device use in registries.

6. The future vision for device registries using UDI.

7. How EHRs and other, similar population-based databases can be used to provide registries or registry-like data.

8. Any technical issues confronting the effective and efficient incorporation of UDIs into appropriate data sets.

C. UDI's Role in National and Local Data Standards

9. The current state of Health IT data standards in EHRs.

10. The future vision for use of standards in EHRs to improve data quality and data exchange.

11. The activities of the Health IT Standards Panel and its relationship to Meaningful Use.

12. The relationship of data standards to UDI integration in hospital systems.

D. Integrating UDI Throughout Hospital Systems

13. The particular issues associated with networked devices that need to be considered.

14. The issues and challenges with device interoperability.

15. The current and future state of MMIS and RTLS systems to support safe device use.

16. How other information systems are adopting and implementing UDI and how these systems are integrating with other clinical information systems to transmit the appropriate data.

E. The Role of UDI in Postmarket Surveillance and Compliance

17. How we can use UDIs in health-related electronic data systems to improve post-approval studies.

18. How the documentation of UDIs can be used to improve the conduct of recalls.

19. The issues associated with the use of UDI in claims data sources.

20. How adverse event reporting can be improved.

21. Other postmarket surveillance and enforcement activities that can be improved through the documentation of UDIs in these databases.

F. UDIs in Personal Health Records

22. The device information currently being transmitted from the EHR to a patient's PHR.

23. Any lessons learned that can be applied from documenting medication use.

24. How the documentation of UDI in patients' PHRs can be used for postmarket surveillance, enforcement activities and to improve device use.

25. Any differences in documentation and tracking of device use needed for different care settings (e.g., hospital, outpatient clinic, and home) and different device types (e.g., implants, home/patient use) that need to be considered.

III. Transcripts

Please be advised that as soon as a transcript is available, it will be accessible at http://www.regulations.gov. It may be viewed at the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. Written requests are to be sent to Division of Freedom of Information (HFI-35), Office of Management Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857. A link to the transcripts will also be available on the Internet at http://www.fda.gov/​MedicalDevices/​NewsEvents/​WorkshopsConferences/​ucm257194.htm (or go to http://www.fda.gov and select this public workshop from the posted events list), approximately 45 days after the public workshop.

Dated: July 15, 2011.

Nancy K. Stade,

Deputy Director for Policy, Center for Devices and Radiological Health.