WE L COME AND I NT RODUCT I ONS Ja me s T c he ng , M.D. Jo - - PowerPoint PPT Presentation

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S.M.A.R.T. Medical Device Informatics Think Tank Specific, Measurable, Achievable, Results-Oriented, Time Bound Collaboration WE L COME AND I NT RODUCT I ONS Ja me s T c he ng , M.D. Jo se ph P. Dro zda , Jr., M.D. T e rrie L . Re e

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SLIDE 1

WE L COME AND I NT RODUCT I ONS

Ja me s T c he ng , M.D. Jo se ph P. Dro zda , Jr., M.D. T e rrie L . Re e d, M.S.

S.M.A.R.T. Medical Device Informatics Think Tank Specific, Measurable, Achievable, Results-Oriented, Time Bound Collaboration

JO IN th e C o n v e rs a tio n o n Tw itte r @ M D e p iN e t_ p p p # M D Ep iN e t_ M TG fo r m e e tin g q u e s tio n s / c o m m e n ts

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SLIDE 2

SMART INF ORMAT ICS T HINK T ANK PL ANNING

MDE PiNe t

 E

xe c utive Pa rtne rs

 Da nic a Ma rina c -Da b ic  Mitc he ll K

ruc o ff

 Art Se dra kya n  Sha ro n-L

ise No rma nd

 E

xe c utive Co mmitte e

 Pub lic a tio ns Co mmitte e  We b site T

e a m

 Ab b y I

sa a c s

 Ma tthe w Cio ffi  Swa ti Cha kra b o rty  Sa ndi Mc Da ne l

DCRI Coor dinating Ce nte r

 Britt Ba rha m  Mic he lle Sme re k  Princ e ss Grime s  Re b e c c a Wilg us  We nd y Sprintz

F DA CDRH Se nior L e ade r ship T hink T ank Planning T e am (>50) Pr e se nte r s/ Br e akout L e ade r s/ Sc r ibe s/ F loate r s AHRQ

 E

lise Be rline r

 Ja me s Nie b e rding

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SLIDE 3

Pe o ple who re c e ive c a re o r suppo rt the c a re o f o the rs*

* F r

  • m “ONC Conne c ting He alth and Car

e for the Nation A Shar e d Nationwide Inte r

  • pe r

ability Roadmap” Dr aft v.1

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SLIDE 4

Pe o ple a nd

  • rg a niza tio ns tha t

de live r c a re a nd se rvic e s

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SLIDE 5

Org a niza tio ns tha t pa y fo r c a re

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SLIDE 6

Pe o ple a nd

  • rg a niza tio ns tha t

suppo rt the pub lic g o o d

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SLIDE 7

Pe o ple a nd

  • rg a niza tio ns tha t

g e ne ra te ne w kno wle dg e , whe the r re se a rc h o r q ua lity impro ve me nt

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SLIDE 8

Pe o ple a nd

  • rg a niza tio ns tha t

pro vide He a lth I T c a pa b ility

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SLIDE 9

Pe o ple a nd

  • rg a niza tio ns tha t

suppo rt the pro duc tio n a nd distrib utio n o f me dic a l pro duc ts

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SLIDE 10

Pe o ple a nd

  • rg a niza tio ns tha t

de ve lo p a nd ma inta in sta nda rds

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SLIDE 11

8:45-10:00 – Plenary Session: Building a SMART Medical Device Data Capture Infrastructure

Purpose of this Session: To highlight key National initiatives that will inform prioritization of Think Tank projects and set a common vision and goals for expected outcomes over the two-day session

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SLIDE 12

8:45-10:00 – Plenary Session:

  • T

he impo rta nc e o f hig h q ua lity da ta to the suc c e ss o f F DA’ s Na tio na l Po stma rke t Surve illa nc e Pla n: Je ffr

e y Shur e n

  • De ve lo pme nt a nd inno va tive use o f struc ture d da ta c a pture a sse ts: links to MDE

piNe t visio n a nd g o a ls: Danic a Mar

inac - Dabic

  • Ma jo r F

DA-spo nso re d initia tive s

  • L

inks to Na tio na l Pla nning Bo a rd: Mar

k Mc Cle llan

  • UDI

Ro a dma p fo r Ado ptio n in E le c tro nic He a lth I nfo rma tio n: Mar

k Mc Cle llan

  • De vic e I

de ntific a tio n a s pa rt o f a n o ve ra ll He a lth I T Pla n: Ste ve n Posnac k

  • PE

W-ONC-F DA Pub lic Me e ting o n Re a lizing the Be ne fits o f UDI I n He a lth Ca re : Josh

Rising

  • Visio n a nd Go a ls fo r T

he T wo -Da y T hink T a nk: Jose ph Dr

  • zda
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SLIDE 13

USE CASE ONE : CAPT URI NG DE VI CE AT T RI BUT E S

10:00-11:00 – Use Case One - Captur ing de vic e attr ibute s Se ssion L e ade r : Mike Sc hille r

De sc riptio n o f Use Ca se : Ca pture a nd e xc ha ng e o f c o re de vic e ide ntific a tio n info rma tio n within the he a lthc a re pro vide r e nviro nme nt fo r use a s a ma ste r so urc e to c o nsiste ntly ide ntify the de vic e in a ll do wnstre a m syste ms a nd pro c e sse s. Using the Da ta in the F DA Glo b a l Uniq ue De vic e I de ntific a tio n Da ta b a se (GUDI D): Indir

a Kondur i

Ma nufa c ture r Pe rspe c tive o n c a pturing de vic e info rma tio n: Cor

win He e

Sta nda rds De ve lo pme nt Org a niza tio n wo rk o n de vic e ide ntific a tio n: Paul Knapp De vic e le sso ns to b e le a rne d fro m me dic a tio n da ta c a pture : Julie Suko

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SLIDE 14

USE CASE T WO: L I NK I NG PAT I E NT AND DE VI CE

11:00-12:15 – Use Case T wo - Making the link be twe e n the patie nt and de vic e Se ssion L e ade r : Natalia Wilson/ Jose ph Dr

  • zda

De sc riptio n o f Use Ca se : L ink o f struc ture d de vic e a nd pa tie nt da ta during a pro c e dure into a pa tie nt-de vic e da ta c a pture syste m inc luding a b ility to e xc ha ng e da ta with o the r syste ms tha t suppo rt linka g e b e twe e n pro c e dure , de vic e a nd pa tie nt.

  • Struc ture d de vic e re po rting a s pa rt o f pa tie nt c a re : Jame s T

c he ng

  • Ca pturing struc ture d de vic e da ta a t the VA: Paul Var
  • sy
  • L

inking de vic e da ta to K a ise r E HR: Re be c c a L

  • ve
  • L

inking de vic e da ta to Me rc y Ca th L a b : Cur

tis Dudle y/ Jose ph Dr

  • zda
  • I

mpla nt tra c king a t Ma yo Clinic Arizo na – Natalia Wilson

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SLIDE 15

USE CASE T HRE E : DAT A F ROM I MPL ANT ABL E DE VI CE OUT PUT

12:45-1:30 – Use Case T hr e e : Obtaining str uc tur e d de vic e data fr

  • m implantable de vic e
  • utput

Se ssion L e ade r : T e r r ie Re e d

De sc riptio n o f Use Ca se : E xc ha ng e o f de vic e info rma tio n fro m de vic e itse lf to / fro m pa tie nt- de vic e da ta c a pture syste ms

  • Ba c kg ro und o f I

HE I DCO I mple me nta tio ns: David Slotwine r

  • Use fo r impla nta b le c a rdia c de vic e s: Manish Wadhwa
  • Use in pe rso na l he a lth re c o rd: Mic hae l Mir

r

  • L

e sso ns L e a rne d fro m Me dic a l De vic e Plug n Pla y (MDPnP) a t Pa rtne rs He a lthc a re : Julian

Goldman

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SLIDE 16

USE CASE F OUR: DOWNST RE AM USE

1:30-2:30 – Use Case F

  • ur

: E xtr ac ting str uc tur e d de vic e data c olle c te d in pr e vious use s c ase s for downstr e am syste m use Se ssion L e ade r : Mar c Ove r hage

De sc riptio n o f Use Ca se : I nput a nd e xc ha ng e o f pa tie nt a nd de vic e info rma tio n fro m so urc e syste ms to a se c o nda ry so urc e (e .g . Re g istry, AE Re po rt o r Clinic a l T ria l). T his ma y/ ma y no t inc lude a dditio n o f supple me nta l da ta fo r purpo se o f po pula ting se c o nda ry so urc e .

  • ONC Struc ture d Da ta Ca pture : E

ve lyn Galle go

  • Co o k Me dic a l – E

HR Re g istry Da ta : Ne al F

e ar not/ T e d He ise

  • ACC Pro je c t to pull da ta to I

CD Re g istry: Dino Damale s/ Kathle e n He witt/ Gane san

Sr inivasan

  • AJRR – da ta pulle d fro m E

HR to this re g istry: Car

yn E tkin

  • F

ORCE T JR: Patr

ic ia F r anklin

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SLIDE 17

E NVI RONME NT AL RE VI E W

2:45- 3:45 – E nvir

  • nme ntal Re vie w: Oppor

tunitie s for de vic e data e ngage me nt Se ssion L e ade r : E d Hammond

Purpo se o f this Se ssio n: T

  • pro vide o ve rvie ws o f re la te d he a lth da ta c a pture a nd do wnstre a m a na lysis

initia tive s a nd e xplo re o ppo rtunitie s fo r e ng a g e me nt o f de vic e sta ke ho lde rs a nd use c a se s in the se e ffo rts

  • He a lth Se rvic e s Pla tfo rm Co nso rtium: Stan Huff
  • Use o f So urc e Da ta in Do wnstre a m E

ffo rts

  • Se ntine l/ PCORNE

T : L

e sle y Cur tis

  • DE

L T A: F

r e d Re snic / Mike Mathe ny

  • I

nte rna tio na l Co nso rtium o f Ortho pe dic Re g istrie s (Da ta L ib ra ry): Re be c c a L

  • ve
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SLIDE 18

PANE L DI SCUSSI ON – DAY 2 PRE P

3:45-4:30 – Pane l disc ussion of obstac le s/ le ssons le ar ne d; Pr e par ation for day 2 Se ssion L e ade r : Jame s T c he ng

Purpo se o f this Se ssio n: T

  • summa rize c o mmo n the me s he a rd in pro je c t summa rie s a nd he lp

se t prio ritie s o n the mo st impo rta nt issue s to a ddre ss in Da y 2 b re a ko ut se ssio ns. Se t e xpe c ta tio ns fo r Da y 2 o utc o me s a nd ide a s fo r pa th to suc c e ss inc luding e nvisio ning the e nd to e nd e nviro nme nt

  • Ob sta c le s to Struc ture d De vic e Da ta Ca pture : De br

a Dor e

  • A c linic ia n vie w o f impa c t o n wo rkflo w: De nise Downing
  • I

ssue s with De vic e Da ta Sta nda rds Ado ptio n: Hans Buite ndijk

  • Wha t’ s in it fo r the C-Suite ? : Jose ph Dr
  • zda
  • Oppo rtunitie s fo r c o lla b o ra tio n with o the r initia tive s: L

e sle y Cur tis