Presentation given at the 2012 NPAG Conference in Rugby UK. Some suggestions as to how we can better develop our 'technical talk' and what has already been developed and available.

1. Esperanto for Engineers
“Tools for Technical Talk”
Paul A Blackett
Medical Engineering Operations Manager
Lancashire Teaching Hospitals NHS Foundation Trust

2. Paul A Blackett: NPAG Clinical Engineering Conference 2012

3. Paul A Blackett: NPAG Clinical Engineering Conference 2012
In Windows…

4. Paul A Blackett: NPAG Clinical Engineering Conference 2012
At the Polling Station

5. Paul A Blackett: NPAG Clinical Engineering Conference 2012
Overview
• GMDN
• UDI
• GS1 coding
• Technical Nomenclature
• Failure Codes
• Risk
• KPIs
• The way ahead

6. Paul A Blackett: NPAG Clinical Engineering Conference 2012
GMDN
• Equipment Databases held locally
• Naming of devices
• ECG Monitor, Cardiac monitor, vital signs monitor,
multiparameter monitor?
• a common naming convention
– Brings together 6 previous nomenclatures [1]
– GMDN [2] (Global Medical Device Nomenclature) From
ISO 15225:2010 part of Global Harmonization
– Used by Manufacturers and EUDAMED (European Database on
Medical Devices)
– Maintained by GMDN Agency
– Accessible at a cost to pay for administration
– Term: Centrifuge, general-purpose laboratory (Code: 36465)
What
What
What
What’’’’s in a name?
s in a name?
s in a name?
s in a name?

7. Paul A Blackett: NPAG Clinical Engineering Conference 2012
GMDN Data

8. Paul A Blackett: NPAG Clinical Engineering Conference 2012
GMDN Data
The device category is the broadest level of the GMDN data. It divides the
entire medical device product market into highest-level groups based on
device application, technology, or other common characteristics. The
standard (ISO 15225) allocates codes for 20 categories. These are:
Category Description
01 Active implantable devices
02 Anaesthetic and respiratory devices
03 Dental devices
04 Electro mechanical medical devices
05 Hospital hardware
06 In vitro diagnostic devices
07 Non-active implantable devices
08 Ophthalmic and optical devices
09 Reusable devices
10 Single use devices
11 Assistive products for persons with disability
12 Diagnostic and therapeutic radiation devices
13 Complementary therapy devices
14 Biological-derived devices
15 Healthcare facility products and adaptations
16 Laboratory equipment
17 Vacant
18 Vacant
19 Vacant
20 Vacant

9. Paul A Blackett: NPAG Clinical Engineering Conference 2012
GMDN Data
Collective terms are high-level device terms used to aggregate medical
device groups that have common features within the GMDN. Collective terms
may be device names (e.g., Stents, Catheters, Pacemakers) or device
attributes (e.g., Electrophysiology, Absorbable, Home-use); the device name
collective terms are especially used to create hierarchical constructs in the
GMDN.

10. Paul A Blackett: NPAG Clinical Engineering Conference 2012
GMDN Data
Preferred terms with their unique 5 digit codes are the only terms available for product identification.
The preferred term is the optimal name selected to represent a group of devices (a collection of device types)
that have the same or similar intended use or commonality of technology allowing them to be grouped in a
generic manner, typically without reflecting specialized characteristics such as brand or trade names.
Other Terms exist such as Template, which is used as a root for more specific terms and Synonym which is
used as a navigational toot to find the Preferred Term.

11. Paul A Blackett: NPAG Clinical Engineering Conference 2012
GMDN Data
Sample data
Sample data
Sample data
Sample data…………

12. Paul A Blackett: NPAG Clinical Engineering Conference 2012
GMDN Data
What it looks like in real life
What it looks like in real life
What it looks like in real life
What it looks like in real life…………
•Long Term names!
•Term ID added to the end of the Device Type?
•Could possibly use the Term ID as part of the Equipment Code?

13. Paul A Blackett: NPAG Clinical Engineering Conference 2012
GMDN Data
•Integration with SNOMED CT
WhatWhatWhatWhat’’’’s next?s next?s next?s next?
'Systematized Nomenclature of Medicine Clinical Terms'
The Integration of
GMDNS into Clinical
Terminology and
health records. [5]

14. Paul A Blackett: NPAG Clinical Engineering Conference 2012
Unique Device Identification
• Unique Device Identification [9][10]
– A global number for each model by 2013
– Traceable
– Product Part
– Producer Part

15. Paul A Blackett: NPAG Clinical Engineering Conference 2012
UDI
What the UDI includes…
• Unique for each version or model
• Permanently marked on device
• The trade or brand name
(as shown on the device)
• Lot No / Serial No. (some ambiguity here)
• Version or model

16. Paul A Blackett: NPAG Clinical Engineering Conference 2012
UDI
• Sterile or non-sterile
• Contains latex or not
• Size and unit of measure (if relevant)
• GMDN code
• Packing quantity
UDI
Code

17. Paul A Blackett: NPAG Clinical Engineering Conference 2012
GS1 Coding
• Common data structures - Coding for Success [6]
– GS1 coding of labels for patient… and
equipment (300+ trusts reg’d)
– Recommended by the NAO [7] and Lord Hunt
[8]
– Choice of data carrier…

18. Paul A Blackett: NPAG Clinical Engineering Conference 2012
GS1 Coding
• Patient wrist band identification
• Drugs
• Medical Equipment
• Staff

19. Paul A Blackett: NPAG Clinical Engineering Conference 2012
[F1]8004505521790000023672
GIAI
Global Individual Asset Identifier Site code
Local number
GS1 identifier

20. Paul A Blackett: NPAG Clinical Engineering Conference 2012
Technical Nomenclature
Q1 A Nurse arrives at your department and says
her infusion pump needs maintaining.
Do you…
a) Presume it needs a repair
b) Presume it needs a service
c) Presume nothing
d) Do something different!

21. Paul A Blackett: NPAG Clinical Engineering Conference 2012
Technical Nomenclature
Q2 An Engineer asks you if the ECG monitor on
Ward 1 needs a service, PVP, an inspection or
PPM.
Do you…
a) Say Yes
b) Pretend not to hear
c) Tell him he should know by now
d) Move onto the next slide to find out…..

22. Paul A Blackett: NPAG Clinical Engineering Conference 2012
Technical Nomenclature
Corrective Maintenance, repair, PM, PVP, Maintained,
Serviced, inspection , Tested, PPM, checked ok! FixedFixedFixedFixed
Acceptance testedAcceptance testedAcceptance testedAcceptance tested,,,, Commissioned, Received, Scrapped, Retired,
Removed from service
• We need to speak the same technical language
• ECRI Publication:
– “Clear Talk About Service” [3] ECRI publication for
unifying and defining terms we use in our profession

23. Paul A Blackett: NPAG Clinical Engineering Conference 2012
Technical Nomenclature
ECRI’s Universal Medical Technical Service
Nomenclature (UMTSN).
Definitions provided for 24 common phrases used in the
management of health care technology
Inspection. A procedure used to verify that the
physical integrity, safety, and performance
of a device meet the necessary requirements.
Preventive maintenance. A routine procedure
used to minimize a device’s risk of
FAILURE and to ensure its continued proper
operation. Examples of preventive maintenance
tasks are lubricating, adjusting,
and replacing parts as recommended by
the manufacturer (e.g., batteries, O-rings).

24. Paul A Blackett: NPAG Clinical Engineering Conference 2012
Technical Nomenclature
Calibration. A procedure used to
determine a device’s accuracy using test
equipment whose own accuracy is appropriate
and has been verified; and then, as
needed, adjusting that medical device to
meet the manufacturer’s specifications.
Acceptance inspection. A detailed INSPECTION
performed before a device is put into use either
after initial receipt (i.e., the incoming inspection
of new equipment) or following other service
activities (e.g., a major REPAIR, MODIFICATION, or
OVERHAUL) as appropriate.
Downtime. The time that a device is not
available for clinical use because of the
need to perform activities such as INSPECTIONS,
PREVENTIVE MAINTENANCE, and
REPAIRS. Downtime is specified in hours
or as a percentage.
Repair. A process used to restore the
physical integrity, safety, and/or performance
of a device after a FAILURE.

25. Paul A Blackett: NPAG Clinical Engineering Conference 2012
Failure Codes
What is a Failure Code?
Why are they used?
• Most Databases have
some ability to record
events or observations
against work activity.
Failure codes provide
a convenient method
of getting statistics
about equipment
failures or breakdowns
Failure codes are
used to illustrate why
an asset failed or the
reason that the asset
failed.

26. Paul A Blackett: NPAG Clinical Engineering Conference 2012
Failure Codes
Standardising failure Codes [4]
– Journal of Clinical Engineering: Measuring
Maintenance Effectiveness with Failure
Codes.
– Range of codes suggested to make
comparing failures easier between
organisations.

27. Paul A Blackett: NPAG Clinical Engineering Conference 2012
Failure Codes
• NPF – No Problem Found
• ACC – Accessory Failure
• BATT – Battery Failure
• USE – User damage /abuse
• PPF – Preventable or Predictable Failure
• SIF – Service Induced Fault
• UPF – Unpredictable Failure
• (FFPM – Failure Found in PM)
Repair Codes

28. Paul A Blackett: NPAG Clinical Engineering Conference 2012
Failure Codes
• NPF – No Problem Found
• EF – Evident Failure (Could have been reported but wasn’t)
• HF - Hidden Failure (Failure not detectable by User)
• PF – Potential Failure (eg frayed power cord)
Close PM job with code and open
Repair job (use code FFPM)
Scheduled
Maintenance Codes

29. Paul A Blackett: NPAG Clinical Engineering Conference 2012
Failure Codes
• Annual Failure Probability
• Use as evidence for maintenance
• Target specific failures eg,
ACC, BATT, EF
• Purchase devices with a lower UPF
Analysis and Action

30. Paul A Blackett: NPAG Clinical Engineering Conference 2012
Risk
• Standardising Risk Models
Swedish Model of Prioritising Maintenance
Risk calculated between 1 and 5 (greatest)
Maintenance needs between 1 and 5 (greatest)
Mission Critical function between 1 and 10 (most severe)
Score = 2*Risk + 2*Maintenance + Mission Critical

31. Paul A Blackett: NPAG Clinical Engineering Conference 2012
KPIs
Service User Internal Management
Continuous Improvement Financial
• Response Time - from
requesting phone call to first
action.
• Time to Completion – from
requesting phone call to
completed job.
• Scheduled maintenance
completion – percentage
attempted in a 12 month
period.
• Repair jobs open for more
than 3 months.
• Annual Customer
Satisfaction survey
• Time spent on Engineer
training – hrs per year
• Annual cost per device
• Annual cost per bed

32. Paul A Blackett: NPAG Clinical Engineering Conference 2012
The way ahead…
• GMDN – FDA will adopt as part of UDI
– Already adopted by some UK hospitals
• UDI – Adopting by 2013
• GS1 – Already here.
• UMTSN – Published, easy to adopt.
• Failure Codes – new.
• Risk Models – A lot of reticence.
• KPIs – NPAG lead the pack.

33. Paul A Blackett: NPAG Clinical Engineering Conference 2012
Finally…
Perhaps our next
Conference could be
in Esperanto?
NPAG
Kliniko Inĝenierio
Konferenco
2013

34. Paul A Blackett: NPAG Clinical Engineering Conference 2012
References and suggestions
for further study
[1] http://www.gmdnagency.org/Downloads/GMDN_Agency_User_Guide_v120810.pdf
[2] http://www.gmdnagency.com/
[3] Clear Talk about Service. 2009 ECRI Health Devices, April https://www.ecri.org/umtsn
[4] Wang B. et al. 2010 Evidence Based Maintenance pt 1 Journal of Clinical Engineering Vol 35, No. 3 July/Sep
[5] http://www.ihtsdo.org/news/article/article/ihtsdo-and-gmdna-signs-cooperation-agreement/
[6] DH 2007 Coding for Success.
http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_066082
[7] GS1-uk 2010 http://www.gs1uk.org/news/Pages/GS1UKNewsDetails.aspx?NewsID=445
[8] http://www.connectingforhealth.nhs.uk/systemsandservices/aidc/background
[9] GHTF 2010 Unique Device Information for Medical Devices
http://www.ghtf.org/documents/ahwg/AHWG-PD2-N2R2.pdf
[10] http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm310505.htm
Thank you for your attention Paul.Blackett@lthtr.nhs.uk