Esperanto for Engineers, Technical Talk for Medical Engineers

Esperanto for Engineers

“Tools for Technical Talk”

Paul A Blackett

Medical Engineering Operations Manager

Lancashire Teaching Hospitals NHS Foundation Trust

Paul A Blackett: NPAG Clinical Engineering Conference 2012


In Windows…


At the Polling Station


Overview

• GMDN

• UDI

• GS1 coding

• Technical Nomenclature

• Failure Codes

• Risk

• KPIs

• The way ahead


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)

WhatWhatWhatWhat’’’’s in

a name?

s in a nam

e?s in a

name?

s in a nam

e?


GMDN Data


GMDN DataThe device category is the broadest level of the GMDN data. It divides theentire 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 Description01 Active implantable devices

02 Anaesthetic and respiratory devices

03 Dental devices

04 Electro mechanical medical devices

05 Hospital hardware06 In vitro diagnostic devices

07 Non-active implantable devices

08 Ophthalmic and optical devices

09 Reusable devices

10 Single use devices11 Assistive products for persons with disability

12 Diagnostic and therapeutic radiation devices

13 Complementary therapy devices

14 Biological-derived devices15 Healthcare facility products and adaptations

16 Laboratory equipment

17 Vacant

18 Vacant

19 Vacant20 Vacant


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.


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.


GMDN Data

Sample dat

aSamp

le data

Sample dat

aSamp

le data…………


GMDN DataWhat it looks

like in real lifeWhat it looks

like in real lifeWhat it looks

like in real lifeWhat 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?


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]


Unique Device Identification

• Unique Device Identification [9][10]

– A global number for each model by 2013

– Traceable

– Product Part

– Producer Part


UDIWhat 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


UDI

• Sterile or non-sterile

• Contains latex or not

• Size and unit of measure (if relevant)

• GMDN code

• Packing quantity

UDI

Code


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…


GS1 Coding

• Patient wrist band identification

• Drugs

• Medical Equipment

• Staff


[F1]8004505521790000023672

GIAIGlobal Individual Asset Identifier Site code

Local number

GS1 identifier


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!



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…..


Technical NomenclatureCorrective Maintenance, repair, PM, PVP, Maintained,

Serviced, inspection , Tested, PPM, checked ok! FixedFixedFixedFixedAcceptance 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



ECRI’s Universal Medical Technical Service Nomenclature (UMTSN).

Definitions provided for 24 common phrases used in the

management of health care technologyInspection. 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 properoperation. Examples of preventive maintenance

tasks are lubricating, adjusting,

and replacing parts as recommended by

the manufacturer (e.g., batteries, O-rings).



Calibration. A procedure used todetermine 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 eitherafter 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, andREPAIRS. Downtime is specified in hours

or as a percentage.

Repair. A process used to restore thephysical integrity, safety, and/or performance

of a device after a FAILURE.


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.


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.


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


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


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


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


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


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.


Finally…

Perhaps our next Conference could be

in Esperanto?

NPAG

Kliniko Inĝenierio

Konferenco

2013


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 [email protected]

Technology

Esperanto for Engineers, Technical Talk for Medical Engineers