Presentation given to ISO TC 215, WG 6, Hangzhou, China

1. MYRON FINSETH
IDMP: PERSPECTIVE
FROM A MEDICAL
DEVICE GLOBAL
MANUFACTURER
ISO TC 215 MEETING
HANGZHOU, CHINA
18 APRIL 2017

2. 2 IDMP: Perspective from a Medical Device Global Manufacturer | ISO TC 215 meeting, Hangzhou, China | 18 April 2017
ISO IDMP standard for drugs and biologics
and IMDRF UDI system for medical devices
can help establish a global information model for
regulated products.

3. 3 Structured Product Labeling | February 25, 2016 | Confidential, for Internal Use Only

4. 4 Structured Product Labeling | February 25, 2016 | Confidential, for Internal Use Only
The fundamental concepts of a globally harmonized UDI
System include:
a. UDI and UDI Carrier (AIDC and HRI) are based on
standards,
b. UDI applied to a medical device anywhere in the
world should be able to be used globally and to meet
the UDI requirements of its regulatory authority,
c. national or local identification numbers should NOT
be a substitute for UDI,
d. regulatory authorities should not specify the
procedure for modifying these UDI standards
e. UDI databases (UDID) core elements should not be
modified,
f. UDID should use the Health Level Seven
International (HL7) Structured Product Label
(SPL) and web based interface for data
submission,
g. every medical device needs to be identified by a
UDI, unless it is exempted.

5. 5 Structured Product Labeling | February 25, 2016 | Confidential, for Internal Use Only
GLOBAL UDI ADOPTION

6. 6 Structured Product Labeling | February 25, 2016 | Confidential, for Internal Use Only
IDMP INCORPORATES THE SET OF DATA ELEMENTS SPECIFIED BY IMDRF FOR UDI SYSTEMS

7. 7 UDI in EHRs | September 27, 2016 | National Library of Medicine
GLOBAL UDI ADOPTION
UDI adoption and Global UDI Databases
Country UDI standard Data exchange Nomenclature Data system Schedule
U.S. Yes SPL/CPM GMDN UDI database Class III, II
implemented
EU Yes TBD TBD Eudamed
database
Soon
China TBD TBD GMDN CFDA database N.A.
Japan GS1/HIBCC TBD JMDM MEDIS database. N.A.
Canada Yes TBD GMDN UDI database N.A.
Turkey Not official UDI TBD GMDN UTS June 2017
India GS1 TBD TBD N.A. N.A.
Brazil Yes TBD GMDN N.A. N.A.
Argentina GS1 (non UDI) GMDN Track and trace N.A.
Saudi Arabia Yes SPL/CPM GMDN UDI database
Taiwan Yes TBD TBD TBD Voluntary

8. 8 IDMP: Perspective from a Medical Device Global Manufacturer | ISO TC 215 meeting, Hangzhou, China | 18 April 2017
HL7 STRUCTURED PRODUCT LABELING (SPL) STANDARD
Structured Product Labeling (SPL) message
✓Common Product Model (CPM) = data elements
✓Content of labeling = human-readable text
US FDA and the US National Library of Medicine:
✓DailyMed website provides 95,569 drug listings as
submitted to the Food and Drug Administration (FDA)
in SPL format or through the FDA’s web portal.
✓AccessGUDID (medical devices) website currently has
1,356,569 device records.
✓New FDA Proposed Rule for Patient Labeling (device
manuals) requires use of the SPL format.

9. 9 IDMP: Perspective from a Medical Device Global Manufacturer | ISO TC 215 meeting, Hangzhou, China | 18 April 2017
ISO AND 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)
✓HL7 / ISO Electronic Health Record (EHR)
✓HL7 / ISO Personal Health Record (PMR)

10. 10 IDMP: Perspective from a Medical Device Global Manufacturer | ISO TC 215 meeting, Hangzhou, China | 18 April 2017
HL7 HEALTH INFORMATICS – ELECTRONIC HEALTH RECORD
COMBINATION PRODUCTS
DI
Data elements from
SPL/CPM identify the
specific drug in EHR.

11. 11 IDMP: Perspective from a Medical Device Global Manufacturer | ISO TC 215 meeting, Hangzhou, China | 18 April 2017
HL7 HEALTH INFORMATICS – ELECTRONIC HEALTH RECORD
COMBINATION PRODUCTS
DI
Content of labeling is
made available in the
EHR.

12. 12
HL7 HEALTH INFORMATICS – ELECTRONIC HEALTH RECORD
COMBINATION PRODUCTS
DI
IDMP: Perspective from a Medical Device Global Manufacturer | ISO TC 215 meeting, Hangzhou, China | 18 April 2017
Data elements from
SPL/CPM identify the
devices in EHR.

13. 13
HL7 HEALTH INFORMATICS – ELECTRONIC HEALTH RECORD
COMBINATION PRODUCTS
DI
IDMP: Perspective from a Medical Device Global Manufacturer | ISO TC 215 meeting, Hangzhou, China | 18 April 2017
Possible mechanism for
making the content of
labeling available through
the EHR.

14. 14 IDMP: Perspective from a Medical Device Global Manufacturer | ISO TC 215 meeting, Hangzhou, China | 18 April 2017
HL7 HEALTH INFORMATICS – ELECTRONIC HEALTH RECORD
§ INVITRO DEVICE DIAGNOSTICS
InVitro diagnostic device (lab)
InVivo (implanted device)
Description of the actions. i.e., observations and
interventions (procedures), that a device performs when
it operates. This model is based on use cases from
implantable cardiac devices, including pacemakers,
implantable cardioverter defibrillators (ICDs), cardiac
resynchronization therapy (CRT) devices, and
implantable sensors. In addition to providing pacing and
cardioversion or defibrillation therapy (Procedure), and
keeping a retrievable record about some of the
interventions delivered by the device, these devices also
produce observations about the patient (e.g. heart rate,
arrythmia episodes) and about the device itself (e.g.,
battery status).
From the HL7 CPM R3 specification

15. 15 IDMP: Perspective from a Medical Device Global Manufacturer | ISO TC 215 meeting, Hangzhou, China | 18 April 2017
HL7 HEALTH INFORMATICS – ELECTRONIC HEALTH RECORD
§ INVITRO DEVICE DIAGNOSTICS

16. 16 IDMP: Perspective from a Medical Device Global Manufacturer | ISO TC 215 meeting, Hangzhou, China | 18 April 2017
CLOSING COMMENTS
The ISO IDMP standard can help establish international
harmonization of UDI databases.
✓Possible international standard that regulators can point to for
implementation.
✓Drive alignment of device data elements for consistency in
regulatory submissions and healthcare information systems.
✓Allows greater access to diagnostic information for medical
devices, drugs, biologics, and patient health.
✓Adoption of the HL7 SPL/CPM data exchange standards for all
regulated products (devices, biologics, and drugs) allows
interoperability between national healthcare systems and
between international geographies.