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Paul A BlackettMedical Engineering Operations Manager
Lancashire Teaching Hospitals NHS Foundation Trust
Preparing for Preparing for future future
compliance compliance requirementsrequirements
Paul A Blackett: SBK Compliance Conference 2013
What’s Changin
g?
What we call our medical devices!
Where we get
our data from...
How medical devices
are tracked
GMDN
AIDCUDI
Paul A Blackett: SBK Compliance Conference 2013
C arm
Mobile Image Intensifier
Screening Unit
Mobile x-ray machine
Intensifier, Mobile
Paul A Blackett: SBK Compliance Conference 2013
Introducing GMDNIntroducing GMDN
The Global Medical Device Nomenclature The Global Medical Device Nomenclature (GMDN) is a system of internationally (GMDN) is a system of internationally agreed descriptors used to identify agreed descriptors used to identify medical device products. medical device products. [1][1]
““
””
Paul A Blackett: SBK Compliance Conference 2013
Introducing GMDN
Brings together 6 previous nomenclatures [2]
From ISO 15225:2010 (part of Global Harmonization)
Used by Manufacturers and EUDAMED (European Database on Medical Devices)
Maintained by GMDN Agency [1]
Accessible at a low cost to pay for administration Device type = Preferred Term
Paul A Blackett: SBK Compliance Conference 2013
GMDN DataThe device category is the broadest level of the GMDN data. It divides theentire medical device product market into highest-level groups based ondevice application, technology, or other common characteristics. The standard (ISO 15225) allocates codes for 20 categories. These are:
Category Description01 Active implantable devices02 Anaesthetic and respiratory devices03 Dental devices04 Electro mechanical medical devices05 Hospital hardware06 In vitro diagnostic devices07 Non-active implantable devices08 Ophthalmic and optical devices09 Reusable devices10 Single use devices11 Assistive products for persons with disability12 Diagnostic and therapeutic radiation devices13 Complementary therapy devices14 Biological-derived devices15 Healthcare facility products and adaptations16 Laboratory equipment17 Vacant18 Vacant19 Vacant20 Vacant
Paul A Blackett: SBK Compliance Conference 2013
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.
Paul A Blackett: SBK Compliance Conference 2013
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.
Paul A Blackett: SBK Compliance Conference 2013
GMDN DataWhat it looks like in real life…
•Longer Device Type names!•Use the Term ID as the Equipment Code?
Paul A Blackett: SBK Compliance Conference 2013
GMDN Data
•Integration with SNOMED CT
'Systematized Nomenclature of Medicine Clinical Terms'
The Integration of GMDNS into Clinical Terminology and health records. [3]
Paul A Blackett: SBK Compliance Conference 2013
Unique Device Identification [4][5]
A unique code combination that identifies the attributes of an individual medical device.
“”
Paul A Blackett: SBK Compliance Conference 2013
Unique Device Identification• Been around for 20+ years• GHTF Proposal in 2010• The FDA progressing in US• Reusable and single use • Permanent markings
New guidance due 14 Nov 13
Paul A Blackett: SBK Compliance Conference 2013
Unique Device Identification
Made up of 2 parts
The Production Identifier
The Device Identifier
(possible location in use…)
Paul A Blackett: SBK Compliance Conference 2013
Unique Device Identification
The Production Identifier
This code specifies the particular production unit.•Serial Number•Expiry Date and/or Lot Number
Paul A Blackett: SBK Compliance Conference 2013
Unique Device Identification
The Device Identifier
This code identifies a specific product (model variant) and acts as a key to access the Unique Device Identifier Database (UDID)
Paul A Blackett: SBK Compliance Conference 2013
Unique Device Identification
+ = UDI
The Production Identifier The Device Identifier
Already stored on our databases
Something new to store!
Paul A Blackett: SBK Compliance Conference 2013
UDI Database
•Data submitted by Manufacturers
•Single database or possibly a network of national ones that update each other.
•Publicly and internationally accessible - free of charge.
Paul A Blackett: SBK Compliance Conference 2013
Unlocking the UDI• Manufacturers name• Manufacturers address• Contact name (if different)
• GMDN code• Any Trade or Brand name • Device Model number• Controlled by…
(serial/batch/lot)
• and…
Paul A Blackett: SBK Compliance Conference 2013
Unlocking the UDI• Sterile or non-sterile• Contains latex or not• Size and unit of
measure (if relevant)• Packing quantity
Paul A Blackett: SBK Compliance Conference 2013
Practical Uses of the UDI
• Tracking and tracing
• MHRA alerts
• Adverse Incident reports
• Recalls of implants
• Counterfeit control
• Populating databases with correct data
• Procurement improvements
Paul A Blackett: SBK Compliance Conference 2013
Formats• UDI should be readable in human and digital form
• Any digital formats can be used that conform to an ISO format
Paul A Blackett: SBK Compliance Conference 2013
Coding
• DH encouraging common data structures - Coding for Success in 2007 [7] – GS1 coding for patient and equipment use– Register with GS1uk (300+ trusts reg’d)
– Recommended by the NAO [8] and Lord Hunt [9]
• Considered by Parliament – DH to progress implementation [10]
Paul A Blackett: SBK Compliance Conference 2013
GS1 Coding
• Patient wrist band identification
• Drugs
• Medical Equipment
• Staff
Paul A Blackett: SBK Compliance Conference 2013
[F1]8004505521790000023672
GIAIGlobal Individual Asset Identifier Site code
Local number
GS1 identifier
Format and coding in practice
Paul A Blackett: SBK Compliance Conference 2013
In Summary…
• GMDN – FDA will adopt as part of UDI
– Some UK hospitals already registered
• UDI Mentioned in EU Medical Devices Regulations revision [11]
• UDI-US adopting this year
• UDI-MHRA acknowledged [12]
• GS1 – Already here.
Paul A Blackett: SBK Compliance Conference 2013
1 Register with the GMDN AgencyLook into changing to GMDN
2 Contact your database support and ask if they are ready for UDI
3 If your Trust hasn’t already done so, register with GS1uk and think
about labelling integration
Paul A Blackett: SBK Compliance Conference 2013
References and suggestions for further study[1] http://www.gmdnagency.com/[2] http://www.gmdnagency.org/Downloads/GMDN_Agency_User_Guide_v120810.pdf[3] http://www.ihtsdo.org/news/article/article/ihtsdo-and-gmdna-signs-cooperation-agreement/[4] GHTF 2010 Unique Device Information for Medical Devices
http://www.ghtf.org/documents/ahwg/AHWG-PD2-N2R2.pdf no longer available see instead:http://www.imdrf.org/docs/imdrf/final/work-items/imdrf-wi-120923-presentation-udi.pdf#search="revised udi guidance“
[5] http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm310505.htm[6] http://www.udiconference.com[7] DH 2007 Coding for Success.
http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_066082[8] GS1-uk 2010 http://www.gs1uk.org/news/Pages/GS1UKNewsDetails.aspx?NewsID=445 [9] http://www.connectingforhealth.nhs.uk/systemsandservices/aidc/background[10] http://www.publications.parliament.uk/pa/cm200809/cmselect/cmhealth/151/15110.htm[11] Revision of Medical Device Directive
http://www.mhra.gov.uk/Publications/Consultations/Deviceconsultations/CON205361 page 20 #15.4
[12] MHRA Draft 2013-2018 corporate plan http://www.mhra.gov.uk/home/groups/comms-ic/documents/publication/con216948.pdf see page9 for UDI information
Thank you for your attention Paul.Blackett@lthtr.nhs.uk
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