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THE VALUE OF UNIQUE DEVICE IDENTIFIERS IN ORTHOPEDIC SURGERY
Daniel J. Berry, MD
2nd Vice President2nd Vice President
American Academy of Orthopaedic Surgeons
LZ Gund Professor and Chairman
Department of Orthopedic Surgery
Mayo Clinic, Rochester, MN
UDI IN ORTHOPEDICSIntroduction
Orthopedic Patients Receive Many Implantable Devices:
Examples:• Examples:
- total joint replacement
- fracture fixation devices
- spine instrumentation
UDI IN ORTHOPEDICSIntroduction
• We need a standardized unique device identifier in orthopedic surgery
• A world wide standard would be best
UDI IN ORTHOPEDICSIntroduction
Value of a UDI:
• To individual patient (and his/her • To individual patient (and his/her surgeon)
• To patients collectively: facilitates systematic implant tracking (registries)
UDI IN ORTHOPEDICSIntroduction
Value of a UDI:
• To individual patient (and his/her surgeon)his/her surgeon)
• To patients collectively: facilitates systematic implant tracking (registries)
UDI IN ORTHOPEDICSIndividual Patient
What Implant is in a Patient?
• The surgeon needs to know
• It helps the patient
• Right now is often difficult to find out
UDI IN ORTHOPEDICSIndividual Patient
What Implant is in a Patient?Patient?
• Ambiguous hospital records and operative reports
• Ambiguous or incomplete implant naming
UDI IN ORTHOPEDICSIndividual Patient
Value of UDI:
• Implant • Implant removal
• Implant compatibility
UDI IN ORTHOPEDICSExample
66 yo man with instability after instability after total knee replacement:
• Implant revision required
UDI IN ORTHOPEDICSExample
Value of UDI:
• Allows surgeon • Allows surgeon to know what instruments needed for implant removal
UDI IN ORTHOPEDICSExample
55 yo woman with with failed hip replacement:
• Socket revision required
UDI IN ORTHOPEDICSExample
• Which implants are present?
Manufacturer• Manufacturer
• Exact model
• Implant sizes
UDI IN ORTHOPEDICSExample
• Implant compatibilitycompatibility
UDI IN ORTHOPEDICSSystematic Following of Implants
Value of UDI to individual patients:
• A UDI also will help alert patients if a recall occurs
UDI IN ORTHOPEDICSIntroduction
Value of a UDI:
• To individual patient (and his/her • To individual patient (and his/her surgeon)
• To patients collectively: facilitates systematic implant tracking (registries)
UDI IN ORTHOPEDICSSystematic Following of Implants
Implant Registries:
• Follow outcome of implants in large populationspopulations
• Successful models for joint replacement –Scandinavia, Australia
• Goal:
- trip-wire for problem implants
- improve all results
UDI IN ORTHOPEDICSSystematic Following of Implants
Implant Registries:
• Goal: trip-wire for • Goal: trip-wire for problem implants
UDI IN ORTHOPEDICSImplant Registries
UDI IN ORTHOPEDICSSystematic Following of Implants
Implant Registries:
• Goal: improve • Goal: improve care of all patients
-better implants
-better surgery
-less cost
UDI IN ORTHOPEDICSImplant Registries
American Joint Replacement $400,000,000
$500,000,000
$600,000,000
Ye
arl
y S
av
ing
s
1%
2%Replacement Registry:
• Huge potential cost savings
$0
$100,000,000
$200,000,000
$300,000,000
$400,000,000
2005 2010 2020 2030
Year
Ye
arl
y S
av
ing
s
3%
4%
5%
10%
UDI IN ORTHOPEDICSImplant Registries
Value of UDI:
• Unambiguous • Unambiguous tracking of every implant
UDI IN ORTHOPEDICSImplant Registries
Value of UDI: Registry can track:track:
• Implant In
• Implant Out
UDI IN ORTHOPEDICSCase Example
• Is hip resurfacing as resurfacing as good or better than conventional hip replacement?
UDI IN ORTHOPEDICSImplant Registries
Registry with UDI:
• Implant performance
UDI IN ORTHOPEDICSImplant Registries
Hospital Hospital
UDI UDI
National JointRegistry
HospitalHospital
UDI
UDI UDI
UDI
UDI IN ORTHOPEDICSImplant Registries
Value of UDI:
• Rapid, cost effective entry of data from point of care…..data from point of care…..
• Into key databases (example: National Joint Registry)
50 yo woman:Dislocated hip since birth
UDI: did this method work?UDI: Compatible implants for
future surgeries
