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Safety	
  of	
  Intraosseous	
  Vascular	
  
  Access	
  in	
  the	
  21st	
  Century	
  


    John	
  J.	
  Rogers,	
  MD,	
  FACS,FACEP	
  
                  ED	
  Medical	
  Director	
  
   Coliseum	
  Health	
  System,	
  Macon,	
  Georgia,	
  USA	
  

                   Board	
  of	
  Directors	
  
     American	
  College	
  of	
  Emergency	
  Physicians	
  
Disclosures	
  



 Travel	
  Related	
  Expenses	
  	
  
to	
  AKend	
  this	
  Conference	
  	
  
Disclaimer	
  



Opinions	
  and	
  Statements	
  are	
  My	
  Own	
  

   Not	
  Policies	
  or	
  Opinions	
  of	
  ACEP	
  	
  
The	
  Dream	
  
The	
  Reality	
  
The	
  Problem	
  	
  

IV	
  Cannot	
  Be	
  Started	
  in	
  over	
  5	
  Million	
  
IV	
  Extremely	
  Difficult	
  in	
  over	
  7	
  Million	
  
             Anxiety	
  and	
  Panic	
  

     Thousands	
  Die	
  Every	
  Year	
  
Current	
  SoluTons	
  to	
  IV	
  Failure	
  

                          EMS	
  
         ET,	
  SQ,	
  IM,	
  Rectal,	
  Oral,	
  Nasal,	
  
   	
  InhalaTon,	
  Sublingual,	
  Transdermal	
  



Drive	
  FASTER	
  
Current	
  SoluTons	
  to	
  IV	
  Failure	
  
      Emergency Department
        Central Venous Lines
                  Time to Insert
      Resources – Staff and Equipment (US)
                     Training
        400,000 complications/year (FDA)
      $2,300 or more per complication (CDC)
            More than 10 % mortality
Central Venous Line Challenges
 –  5 million central lines placed annually
 –  500,000 strictly for rapid vascular access
 –  Complications in up to 26%
 –  Infections cost $50,000+ per episode
 –  Safe placement up to 20 minutes

Initiatives to decrease complications
 –  Medicare will not pay for complications
 –  Aim for Zero Campaign
 –  National Patient Safety Goals
NPSG	
  07.04.01	
  
 Implement	
  evidence	
  based	
  
precauTons	
  to	
  prevent	
  central	
  
  line	
  associate	
  bloodstream	
  
              infecTons.	
  

      Avoid	
  Central	
  Lines	
  
Alternative Methods of
Vascular Access in the ED	
  
       ACEP Clinical Policy
    Board of Directors June 2011
Current	
  SoluTons	
  to	
  IV	
  Failure	
  

Alternative – Intraosseous Access (IO)

       Standard of care in pediatrics and adults
  Recommended if no IV can be established rapidly
   Safety and efficacy proven in thousands of cases
            Has Saved Hundreds of Lives
Thousands of small veins lead from the medullary space to the central circulation
The	
  Ideal	
  IO	
  	
  
        Easy	
  

        Safe	
  

     EffecTve	
  

        Fast	
  
Intraosseous	
  (IO)	
  Vascular	
  Access	
  
•  Inside the bone is a huge non-collapsible vein
•  All drugs reach the circulation the same as IV
•  Volume of up to 9 Liters per hour (EZ-IO)
•  Pain of insertion equivalent to peripheral (EZ-IO)
•  Lab studies, Blood Type
•  Lytic therapy, SVT with Adenosine, RSI
•  Can be learned easily (EZ-IO)
•  Can be inserted quickly (EZ-IO)
•  Technology was possible in kids because their bones are soft
ComplicaTons	
  –	
  Commonly	
  Reported	
  
                             Central	
  Venous	
  Catheters	
  
       Severity	
          Frequent	
              Occasional	
                                 Rare	
  

       Serious	
          DVT(30%*)	
         InfecTon	
  (5-­‐9%)	
              Death	
  InfecTon	
  (1%)	
  	
  	
  	
  
                                               DVT	
  (8	
  –	
  26%)	
           Air	
  Embolism	
  (0.5%)	
  
                                                 PE	
  (15	
  %*)	
              Bleed/Pneumo	
  (1-­‐3%)	
  
                                          Arterial	
  puncture	
  (3.5%)	
  


    Less	
  Serious	
                         Hematoma	
  (4.5%)	
  


        Minor	
                               MalposiTon	
  (9%)	
  

                          Intraosseous	
  Access	
  	
  Catheters	
  
      Severity	
           Frequent	
              Occasional	
                                 Rare	
  

       Serious	
                                                                  OsteomyeliTs	
  (0.6%)	
  




    Less	
  Serious	
                                                             ExtravasaTon	
  (0.8%)	
  
                                                                                   SQ	
  abscess	
  (0.1%)	
  


        Minor	
                                                                    Leakage	
  (0.4%)	
  
                                                                               Removal	
  problems	
  (0.2%)	
  
Landmark	
  Study	
  
                      Rosef	
  et	
  al	
  1985	
  




Meta-­‐analysis	
  of	
  30	
  studies	
  involving	
  4,270	
  paTents	
  
           Only	
  37	
  complicaTons	
  reported	
  
  OsteomyeliTs	
  most	
  prevalent	
  (n=27)	
  at	
  0.6%	
  
       Device	
  leh	
  in	
  place	
  many	
  days	
  –	
  weeks	
  
Needed:	
  Update	
  of	
  Rosef’s	
  Numbers	
  
 27	
  years	
  later,	
  Rosef’s	
  0.6%	
  sTll	
  quoted	
  

But…IO	
  has	
  drasTcally	
  changed	
  since	
  1985	
  
                          BeKer	
  devices	
  
                          Greater	
  uTlity	
  	
  
                      BeKer	
  Guidelines	
  for	
  use	
  	
  
    dwell-­‐Tme	
  ≤	
  24	
  hours	
  (USA)	
  up	
  to	
  72	
  hours	
  in	
  Europe	
  	
  
                              frequent	
  site	
  checks	
  
                                contraindicaTons	
  
Methods	
  
Literature	
  search	
  
    –  Pub	
  Med	
  
    –  Google	
  
    –  Vidacare’s	
  IO	
  access	
  bibliography	
  	
  
         •  Available	
  at	
  vidacare.com	
  
Checked	
  FDA’s	
  Manufacturer	
  and	
  User	
  Facility	
  
Device	
  	
  Experience	
  (MAUDE)	
  database	
  for	
  Medical	
  
Device	
  Reports	
  (MDRs)	
  from	
  manufacturers	
  
    –  Available	
  at	
  accessdata.fda.gov	
  
Intraosseous	
  Vascular	
  Access	
  
Serious	
  ComplicaTons	
  Found	
  in	
  the	
  Literature:	
  Osteomyeli*s	
  

            Since	
  Rosef	
  (1985),	
  only	
  single	
  cases	
  cited	
  in	
  literature	
  

  •  PlaK	
   et	
   al	
   (1993):	
   2-­‐1/2	
   month	
   old	
   with	
   IO	
   needle	
   leh	
   in	
   place	
   3	
   days,	
  
     resulted	
  in	
  fungal	
  osteomyeliTs;	
  treated/recovered	
  
  •  Rosovsky	
  et	
  al	
  (1994):	
  14	
  month	
  old	
  with	
  bilateral	
  femoral	
  osteomyeliTs	
  
  •  Barron	
  (1994):	
  20	
  month	
  old	
  with	
  Tbial	
  osteomyeliTs;	
  treated/recovered	
  
  •  Stoll	
   et	
   al	
   (2001):	
   3	
   month	
   old	
   with	
   Tbial	
   osteomyeleTs	
   aher	
   adrenalin	
  
     infusion;	
  required	
  orthopedic	
  stabilizaTon	
  surgery	
  for	
  recovery	
  
  •  Dogan	
   et	
   al	
   (2004):	
   5	
   month	
   old	
   with	
   Tbial	
   osteomyeliTs;	
   treated/
     recovered	
  
  •  Henson	
  (2010):	
  62	
  year	
  old	
  with	
  co-­‐morbidiTes	
  including	
  diabetes,	
  MRSA	
  
     colonizaTon;	
  had	
  Tbial	
  IO;	
  presented	
  6	
  months	
  later	
  with	
  osteomyeliTs	
  
Intraosseous	
  Vascular	
  Access	
  
Serious	
  ComplicaTons	
  Found	
  in	
  the	
  Literature:	
  Other	
  

                 Cases	
  since	
  Rosef	
  (1985)	
  

               Compartment	
  syndrome:	
  18	
  
                       Fracture:	
  3	
  
                     Skin	
  necrosis:	
  2	
  
                Suspected	
  air	
  embolism:	
  2	
  
Compartment	
  Syndrome 	
  	
  
                Atanda	
  2008,	
  Am	
  J	
  Ortho:	
  

“With	
   proper	
   aKenTon	
   to	
   detail	
   and	
   serial	
  
monitoring	
   of	
   the	
   involved	
   limb,	
   compartment	
  
syndrome	
   and	
   other	
   potenTal	
   complicaTons	
   of	
  
IO	
  line	
  placement	
  can	
  be	
  avoided.”	
  
Compartment	
  Syndrome 	
  	
  
                  Taylor	
  and	
  Clark,	
  2011	
  BMJ	
  

 Compartment	
  syndrome	
  leading	
  to	
  amputaTon	
  

“by	
   day	
   7	
   the	
   right	
   limb	
   was	
   perfused	
   but	
   the	
  
leh	
   had	
   become	
   demarcated	
   to	
   the	
   mid	
   calf	
  
level.”	
  
Compartment	
  Syndrome	
  
            Waltzman,	
  Harvard	
  Medical	
  School:	
  
“To	
   aKribute	
   the	
   rare	
   complicaTon	
   of	
  	
  
compartment	
   syndrome	
   	
   to	
   these	
   devices	
   and	
  
not	
   to	
   either	
   the	
   technique	
   of	
   inserTon	
   or	
   lack	
  
of	
   careful	
   monitoring	
   is	
   unfortunate.	
   	
   These	
  
devices	
   have	
   been	
   shown	
   to	
   decrease	
   the	
   Tme	
  
needed	
  to	
  obtain	
  vascular	
  access	
  and	
  speed	
  the	
  
delivery	
   	
   of	
   fluids	
   and	
   medicaTons,	
   thereby	
  
saving	
  the	
  lives	
  of	
  many	
  children.”	
  
Compartment	
  Syndrome	
  
          Waltzman,	
  Harvard	
  Medical	
  School:	
  
Hand	
   driven	
   placement	
   of	
   IO	
   needles	
   are	
   also	
  
misplaced	
   either	
   due	
   to	
   incomplete	
   placement	
  
in	
  the	
  marrow	
  space	
  or	
  penetraTon	
  through	
  the	
  
posterior	
   cortex….it	
   is	
   not	
   the	
   needle	
   type	
   that	
  
results	
   in	
   extravasaTon,	
   but	
   the	
   difficulty	
   with	
  
inserTon	
   and	
   penetraTon	
   of	
   both	
   corTces	
  
during	
  stressful	
  emergency	
  situa*ons.”	
  
Compartment	
  Syndrome	
  
           Moen	
  and	
  Sarwark	
  2008,	
  Orthopedics	
  

           1	
  case	
  following	
  difficult	
  resuscitaTon	
  	
  
                        recognized	
  immediately	
  

                               Lesson	
  
Use	
  correct	
  needle	
  size,	
  don’t	
  force	
  the	
  drill,	
  watch	
  
for	
  extravasaTon	
  early	
  especially	
  when	
  giving	
  large	
  
fluid	
  volumes,	
  parTcularly	
  in	
  children.	
  
EZ-­‐IO	
  Intraosseous	
  Vascular	
  Access	
  
            Serious	
  ComplicaTons	
  	
  
      Found	
  on	
  the	
  FDA	
  Website*	
  


           Compartment	
  Syndrome:	
  4	
  
              OsteomyeliTs: 	
  1	
  


       In	
  over	
  1	
  million	
  inserTons	
  
*Source:	
  www.accessdata.fda.gov/scripts/cdrh/cfdocs/dfMAUDE/search.cfm	
  
A	
  Myth	
  That	
  Lives	
  On	
  
    Example	
  from	
  2005	
  
Summary	
  
•  Simple	
   extravasaTon	
                most	
                                       prevalent	
  
   complicaTon:	
  <5%	
  of	
  IO	
  placements	
  
•  OsteomyeliTs	
  not	
  a	
  great	
  concern	
  
    –  6	
  cases	
  reported	
  in	
  literature	
  
    –  1	
  case	
  reported	
  to	
  FDA	
  by	
  MDR	
  (EZ-­‐IO)	
  	
  
         •  1	
  case	
  out	
  of	
  >1	
  million	
  placements	
  =	
  <0.0001%	
  
•  Compartment	
  syndrome	
  is	
  greater	
  concern	
  
    –  18	
  cases	
  reported	
  in	
  literature	
  since	
  1985	
  
    –  Most	
  cases	
  secondary	
  to	
  undetected	
  extravasaTon	
  
    –  Indicates	
  need	
  for	
  closer	
  monitoring	
  of	
  IO	
  site	
  
•  Other	
   serious	
   complicaTons	
   (e.g.	
   air	
   embolism,	
  
   fracture)	
  excep*onally	
  rare	
  
Difficult	
  Vascular	
  Access	
  OpTons	
  
                        Intraosseous	
                         Central	
                      Peripheral	
  
     Time	
             6	
  –	
  30	
  seconds	
       10	
  –	
  26	
  minutes	
         20	
  -­‐39	
  minutes	
  
ComplicaDons	
                   <	
  1%	
                        15	
  %	
                      32-­‐70	
  %	
  
   Success	
                90	
  –	
  98	
  %	
             60	
  –	
  89	
  %	
              33	
  –	
  77	
  %	
  
First	
  AKempt	
           90	
  –	
  97	
  %	
             22	
  –	
  86	
  %	
              49	
  –	
  71	
  %	
  
      Staff	
                   Nurse	
                Dr	
  /APP	
  +	
  Assistant	
               Nurse	
  
 Equipment	
          IO	
  Needle/Device	
            Kit,	
  Mask/Gown/                       Catheter	
  
                                                              Drape/US	
  
  Flow	
  Rate	
      Moderate	
  to	
  High	
                  High	
                   Depends	
  on	
  gauge	
  
      Cost	
                    $	
  100	
                        $290	
                     $	
  32	
  /aKempt	
  
                                                                                         $	
  96	
  /	
  3	
  aKempts	
  
Conclusions	
  
With	
  new	
  devices	
  and	
  techniques	
  

                	
  IO	
  is	
  SAFE	
  	
  

            IO	
  is	
  EFFECTIVE	
  	
  

                IO	
  is	
  EASY	
  

                IO	
  is	
  FAST	
  

              Why	
  not	
  IO?	
  
jrogers@acep.org	
  

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17.15 17.30 john rogers - publiceren

  • 1. Safety  of  Intraosseous  Vascular   Access  in  the  21st  Century   John  J.  Rogers,  MD,  FACS,FACEP   ED  Medical  Director   Coliseum  Health  System,  Macon,  Georgia,  USA   Board  of  Directors   American  College  of  Emergency  Physicians  
  • 2. Disclosures   Travel  Related  Expenses     to  AKend  this  Conference    
  • 3. Disclaimer   Opinions  and  Statements  are  My  Own   Not  Policies  or  Opinions  of  ACEP    
  • 6. The  Problem     IV  Cannot  Be  Started  in  over  5  Million   IV  Extremely  Difficult  in  over  7  Million   Anxiety  and  Panic   Thousands  Die  Every  Year  
  • 7. Current  SoluTons  to  IV  Failure   EMS   ET,  SQ,  IM,  Rectal,  Oral,  Nasal,    InhalaTon,  Sublingual,  Transdermal   Drive  FASTER  
  • 8. Current  SoluTons  to  IV  Failure   Emergency Department Central Venous Lines Time to Insert Resources – Staff and Equipment (US) Training 400,000 complications/year (FDA) $2,300 or more per complication (CDC) More than 10 % mortality
  • 9. Central Venous Line Challenges –  5 million central lines placed annually –  500,000 strictly for rapid vascular access –  Complications in up to 26% –  Infections cost $50,000+ per episode –  Safe placement up to 20 minutes Initiatives to decrease complications –  Medicare will not pay for complications –  Aim for Zero Campaign –  National Patient Safety Goals
  • 10. NPSG  07.04.01   Implement  evidence  based   precauTons  to  prevent  central   line  associate  bloodstream   infecTons.   Avoid  Central  Lines  
  • 11. Alternative Methods of Vascular Access in the ED   ACEP Clinical Policy Board of Directors June 2011
  • 12. Current  SoluTons  to  IV  Failure   Alternative – Intraosseous Access (IO) Standard of care in pediatrics and adults Recommended if no IV can be established rapidly Safety and efficacy proven in thousands of cases Has Saved Hundreds of Lives
  • 13.
  • 14. Thousands of small veins lead from the medullary space to the central circulation
  • 15.
  • 16. The  Ideal  IO     Easy   Safe   EffecTve   Fast  
  • 17.
  • 18. Intraosseous  (IO)  Vascular  Access   •  Inside the bone is a huge non-collapsible vein •  All drugs reach the circulation the same as IV •  Volume of up to 9 Liters per hour (EZ-IO) •  Pain of insertion equivalent to peripheral (EZ-IO) •  Lab studies, Blood Type •  Lytic therapy, SVT with Adenosine, RSI •  Can be learned easily (EZ-IO) •  Can be inserted quickly (EZ-IO) •  Technology was possible in kids because their bones are soft
  • 19. ComplicaTons  –  Commonly  Reported   Central  Venous  Catheters   Severity   Frequent   Occasional   Rare   Serious   DVT(30%*)   InfecTon  (5-­‐9%)   Death  InfecTon  (1%)         DVT  (8  –  26%)   Air  Embolism  (0.5%)   PE  (15  %*)   Bleed/Pneumo  (1-­‐3%)   Arterial  puncture  (3.5%)   Less  Serious   Hematoma  (4.5%)   Minor   MalposiTon  (9%)   Intraosseous  Access    Catheters   Severity   Frequent   Occasional   Rare   Serious   OsteomyeliTs  (0.6%)   Less  Serious   ExtravasaTon  (0.8%)   SQ  abscess  (0.1%)   Minor   Leakage  (0.4%)   Removal  problems  (0.2%)  
  • 20. Landmark  Study   Rosef  et  al  1985   Meta-­‐analysis  of  30  studies  involving  4,270  paTents   Only  37  complicaTons  reported   OsteomyeliTs  most  prevalent  (n=27)  at  0.6%   Device  leh  in  place  many  days  –  weeks  
  • 21. Needed:  Update  of  Rosef’s  Numbers   27  years  later,  Rosef’s  0.6%  sTll  quoted   But…IO  has  drasTcally  changed  since  1985   BeKer  devices   Greater  uTlity     BeKer  Guidelines  for  use     dwell-­‐Tme  ≤  24  hours  (USA)  up  to  72  hours  in  Europe     frequent  site  checks   contraindicaTons  
  • 22. Methods   Literature  search   –  Pub  Med   –  Google   –  Vidacare’s  IO  access  bibliography     •  Available  at  vidacare.com   Checked  FDA’s  Manufacturer  and  User  Facility   Device    Experience  (MAUDE)  database  for  Medical   Device  Reports  (MDRs)  from  manufacturers   –  Available  at  accessdata.fda.gov  
  • 23. Intraosseous  Vascular  Access   Serious  ComplicaTons  Found  in  the  Literature:  Osteomyeli*s   Since  Rosef  (1985),  only  single  cases  cited  in  literature   •  PlaK   et   al   (1993):   2-­‐1/2   month   old   with   IO   needle   leh   in   place   3   days,   resulted  in  fungal  osteomyeliTs;  treated/recovered   •  Rosovsky  et  al  (1994):  14  month  old  with  bilateral  femoral  osteomyeliTs   •  Barron  (1994):  20  month  old  with  Tbial  osteomyeliTs;  treated/recovered   •  Stoll   et   al   (2001):   3   month   old   with   Tbial   osteomyeleTs   aher   adrenalin   infusion;  required  orthopedic  stabilizaTon  surgery  for  recovery   •  Dogan   et   al   (2004):   5   month   old   with   Tbial   osteomyeliTs;   treated/ recovered   •  Henson  (2010):  62  year  old  with  co-­‐morbidiTes  including  diabetes,  MRSA   colonizaTon;  had  Tbial  IO;  presented  6  months  later  with  osteomyeliTs  
  • 24. Intraosseous  Vascular  Access   Serious  ComplicaTons  Found  in  the  Literature:  Other   Cases  since  Rosef  (1985)   Compartment  syndrome:  18   Fracture:  3   Skin  necrosis:  2   Suspected  air  embolism:  2  
  • 25. Compartment  Syndrome     Atanda  2008,  Am  J  Ortho:   “With   proper   aKenTon   to   detail   and   serial   monitoring   of   the   involved   limb,   compartment   syndrome   and   other   potenTal   complicaTons   of   IO  line  placement  can  be  avoided.”  
  • 26. Compartment  Syndrome     Taylor  and  Clark,  2011  BMJ   Compartment  syndrome  leading  to  amputaTon   “by   day   7   the   right   limb   was   perfused   but   the   leh   had   become   demarcated   to   the   mid   calf   level.”  
  • 27. Compartment  Syndrome   Waltzman,  Harvard  Medical  School:   “To   aKribute   the   rare   complicaTon   of     compartment   syndrome     to   these   devices   and   not   to   either   the   technique   of   inserTon   or   lack   of   careful   monitoring   is   unfortunate.     These   devices   have   been   shown   to   decrease   the   Tme   needed  to  obtain  vascular  access  and  speed  the   delivery     of   fluids   and   medicaTons,   thereby   saving  the  lives  of  many  children.”  
  • 28. Compartment  Syndrome   Waltzman,  Harvard  Medical  School:   Hand   driven   placement   of   IO   needles   are   also   misplaced   either   due   to   incomplete   placement   in  the  marrow  space  or  penetraTon  through  the   posterior   cortex….it   is   not   the   needle   type   that   results   in   extravasaTon,   but   the   difficulty   with   inserTon   and   penetraTon   of   both   corTces   during  stressful  emergency  situa*ons.”  
  • 29. Compartment  Syndrome   Moen  and  Sarwark  2008,  Orthopedics   1  case  following  difficult  resuscitaTon     recognized  immediately   Lesson   Use  correct  needle  size,  don’t  force  the  drill,  watch   for  extravasaTon  early  especially  when  giving  large   fluid  volumes,  parTcularly  in  children.  
  • 30. EZ-­‐IO  Intraosseous  Vascular  Access   Serious  ComplicaTons     Found  on  the  FDA  Website*   Compartment  Syndrome:  4   OsteomyeliTs:  1   In  over  1  million  inserTons   *Source:  www.accessdata.fda.gov/scripts/cdrh/cfdocs/dfMAUDE/search.cfm  
  • 31. A  Myth  That  Lives  On   Example  from  2005  
  • 32. Summary   •  Simple   extravasaTon   most   prevalent   complicaTon:  <5%  of  IO  placements   •  OsteomyeliTs  not  a  great  concern   –  6  cases  reported  in  literature   –  1  case  reported  to  FDA  by  MDR  (EZ-­‐IO)     •  1  case  out  of  >1  million  placements  =  <0.0001%   •  Compartment  syndrome  is  greater  concern   –  18  cases  reported  in  literature  since  1985   –  Most  cases  secondary  to  undetected  extravasaTon   –  Indicates  need  for  closer  monitoring  of  IO  site   •  Other   serious   complicaTons   (e.g.   air   embolism,   fracture)  excep*onally  rare  
  • 33. Difficult  Vascular  Access  OpTons   Intraosseous   Central   Peripheral   Time   6  –  30  seconds   10  –  26  minutes   20  -­‐39  minutes   ComplicaDons   <  1%   15  %   32-­‐70  %   Success   90  –  98  %   60  –  89  %   33  –  77  %   First  AKempt   90  –  97  %   22  –  86  %   49  –  71  %   Staff   Nurse   Dr  /APP  +  Assistant   Nurse   Equipment   IO  Needle/Device   Kit,  Mask/Gown/ Catheter   Drape/US   Flow  Rate   Moderate  to  High   High   Depends  on  gauge   Cost   $  100   $290   $  32  /aKempt   $  96  /  3  aKempts  
  • 34. Conclusions   With  new  devices  and  techniques    IO  is  SAFE     IO  is  EFFECTIVE     IO  is  EASY   IO  is  FAST   Why  not  IO?