Explanation of how medical device information in the AccessGUDID web site will be used in Electronic Health Records NLM device manufacturers submit to the FDA is made available at the National from the National Library of Medicine.

1. MYRON FINSETH
UDI in Electronic
Health Records
NATIONAL LIBRARY OF MEDICINE
September 27, 2016
9/27/2016

2. 2 UDI in Electronic Health Records | September 27, 2016 | National Library of Medicine
AGENDA
UDI in Electronic Health Records
 NLM AccessGUDID website
 ONC Regulations: list of implanted devices in Electronic Health Records (EHR).
 HL7 Health Informatics: CPM, EHR, PHR, CDS
 Flow of structured, regulated, product information

3. 3 UDI in Electronic Health Records | September 27, 2016 | National Library of Medicine
NLM ACCESSGUDID WEBSITE
Offers quick access to specific device
information.
 Search for a specific medical device.
 Download the entire set of UDI files.
 Similar in design and function as DailyMed
website for drug products.
 Currently has ~691,00 device records.
Medical devices, combination products
https://accessgudid.nlm.nih.gov/

4. 4 UDI in Electronic Health Records | September 27, 2016 | National Library of Medicine
NLM ACCESSGUDID WEBSITE
Offers quick access to specific device
information.
 Offers RSS feeds and APIs to provide a direct
connection to the data.
 Under ONC EHR incentive programs,
Electronic Health Records will include a list of
patient’s implantable devices.
 OpenFDA also allows direct download of
device data.

5. 5 Structured Product Labeling | February 25, 2016 | Confidential, for Internal Use Only
ONC REGULATIONS
Information to be parsed from UDI:
 Device Identifier
 Batch/lot number
 Expiration date
 Manufacturing date
 Serial number
 Distinct Identification Code (for an HCT/P regulated
as a device)
Collected from AccessGUDID web service:
 GMDN PT Name (or SNOMED CT)
 Brand Name
 Version or model
 Company name
 What MRI safety information does the labeling
contain?
 Device required to be labeled as containing natural
rubber latex or dry natural rubber.

6. 6 Structured Product Labeling | February 25, 2016 | Confidential, for Internal Use Only
FDA GUDID DATA ELEMENTS
Identification
Pri DI Issuing Agency
Primary DI #
Brand Name
Version/Model #
Catalog #
Device Description
Sec DI Issuing Agency
Secondary DI #
DM Exempt (Y/N)
DM DI Different (Y/N)
DM DI #
Labeler
Labeler DUNS #
Labeler Name*
Labeler Address*
Contact Phone
Contact Email
Regulatory
Publish Date
Distribution End Date
Distribution Status*
Premrkt Exempt (Y/N)
Premrkt Submission #
Supplement #
FDA Listing #
Product Code
Product Code Name*
GMDN Code
GMDN Name*
GMDN Definition*
Rx (Y/N)
OTC (Y/N)
Packaging
Device Count
Unit of Use DI #
Kit (Y/N)
Pkg DI #
Pkg Quantity
Pkg Contains DI #
Pkg Type
Pkg Discontinue Date
Pkg Status*
Production Control
Lot/Batch (Y/N)
Serial # (Y/N)
Mfg Date (Y/N)
Expiration Date (Y/N)
Donation Id # (Y/N)
Characteristics
Single Use (Y/N)
Combo Product (Y/N)
HCT/P (Y/N)
Contains Rubber (Y/N)
Not Made with Rubber
(Y/N)
MRI Safety Info
Size Type
Size Value
Size Unit
Size Text
Storage & Handling Type
S&H Low value
S&H High Value
S&H Unit
Storage Conditions
Sterile Pkg (Y/N)
Sterile Req'd
Sterile Method
55 Attributes Submitted by Labeler (some can have multiple values)
7 Additional Attributes Populated by FDA GUDID System (*)

7. 7 UDI in Electronic Health Records | September 27, 2016 | National Library of Medicine
HL7 HEALTH INFORMATICS – ELECTRONIC HEALTH RECORD
ONC Certification Criteria: § 170.315(a)(20)
Implantable Device List
1. Record a minimum set of data elements for
each UDI in a patient's implantable device list.
2. Accept electronic UDI data via automatic
identification and data capture (AIDC) or via
human readable format.
3. Use the device identifier portion of the UDI to
obtain and incorporate GUDID device
identification attributes in the patient’s
implantable device list.
• Will likely see implementation in 2017 in many EMR systems
• Full implementation will be required in 2018.

8. 8 UDI in Electronic Health Records | September 27, 2016 | National Library of Medicine
HL7 HEALTH INFORMATICS – ELECTRONIC HEALTH RECORD
§ 170.315(A)(20) IMPLANTABLE DEVICE LIST
DI
MR information:
o MR Unsafe
o MR Conditional
o MR Safe
o Labeling does not contain
MRI Safety Information

9. 9 UDI in Electronic Health Records | September 27, 2016 | National Library of Medicine
HL7 HEALTH INFORMATICS – ELECTRONIC HEALTH RECORD
ONC Certification Criteria: § 170.315(a)(20)
Implantable Device List
1. Record a minimum set of data elements for
each UDI in a patient's implantable device list.
2. Accept electronic UDI data via automatic
identification and data capture (AIDC) or via
human readable format.
3. Use the device identifier portion of the UDI to
obtain and incorporate GUDID device
identification attributes in the patient’s
implantable device list.
 List created or updated during implant or
explant.
 Updated if not previously recorded.

10. 10 UDI in Electronic Health Records | September 27, 2016 | National Library of Medicine
HL7 HEALTH INFORMATICS – ELECTRONIC HEALTH RECORD
§ 170.315(A)(20) IMPLANTABLE DEVICE LIST
The physician has specific
information for each implanted
device.
Specific information for
previously implanted (explanted
or abandoned devices).
Specific MRI safety information.
Capability to find additional
device information.
• Possible safety issues
regarding MRI scans?
• Position or movement in
body cavity over time?
EHR is updated over patient’s
lifetime.
EHR is shared between
providers.
Abandoned
00643169102101 199940 Medtronic CareLink Monitor 2490H9 Device communicator
Unknown
00567880009128 188895 Medtronic CAPSUREFIX MRI 5086 Low power lead MR Conditional
DI

11. 11 UDI in Electronic Health Records | September 27, 2016 | National Library of Medicine
HL7 HEALTH INFORMATICS – FLOW OF STRUCTURED, REGULATED PRODUCT
INFORMATION
Health Informatics standards used to deliver medical
product information to clinicians and patients:
 Structured Product Labeling (SPL)
 Common Product Model (CPM)
 Clinical Decision Support (CDS)
 HL7 / ISO Electronic Health Record (EHR)
 HL7 / ISO Personal Health Record (PMR)

12. 12
Health Informatics – interoperability of Electronic Health
Records between healthcare systems

13. 13 UDI in Electronic Health Records | September 27, 2016 | National Library of Medicine
SUMMARY
 Close to 700,000 medical device records have been submitted to the
AccessGUDID.
RSS feeds and APIs allow organizations (hospitals and clinics) to establish
direct connections to the data and feed that data into electronic health
records.
 Electronic Health Records will soon include a list of patient’s
implantable devices.
Physicians are given specific information for implanted or explanted devices.
EHR records the medical devices that are implanted and explanted over the
life of a patient.
 The list of UDIs provides a way for physicians to learn about device recalls or
other important information.
 Health Informatics standards provide a consistent format and delivery
mechanisms to make medical device information available at the point
of patient care.