Safety	  of	  Intraosseous	  Vascular	    Access	  in	  the	  21st	  Century	      John	  J.	  Rogers,	  MD,	  FACS,FACEP	...
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	  Milli...
Current	  SoluTons	  to	  IV	  Failure	                            EMS	           ET,	  SQ,	  IM,	  Rectal,	  Oral,	  Nasa...
Current	  SoluTons	  to	  IV	  Failure	        Emergency Department        Central Venous Lines                  Time to I...
Central Venous Line Challenges –  5 million central lines placed annually –  500,000 strictly for rapid vascular access – ...
NPSG	  07.04.01	   Implement	  evidence	  based	  precauTons	  to	  prevent	  central	    line	  associate	  bloodstream	 ...
Alternative Methods ofVascular 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 a...
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 circulat...
ComplicaTons	  –	  Commonly	  Reported	                               Central	  Venous	  Catheters	         Severity	     ...
Landmark	  Study	                        Rosef	  et	  al	  1985	  Meta-­‐analysis	  of	  30	  studies	  involving	  4,270	...
Needed:	  Update	  of	  Rosef’s	  Numbers	   27	  years	  later,	  Rosef’s	  0.6%	  sTll	  quoted	  But…IO	  has	  drasTca...
Methods	  Literature	  search	      –  Pub	  Med	      –  Google	      –  Vidacare’s	  IO	  access	  bibliography	  	     ...
Intraosseous	  Vascular	  Access	  Serious	  ComplicaTons	  Found	  in	  the	  Literature:	  Osteomyeli*s	              Si...
Intraosseous	  Vascular	  Access	  Serious	  ComplicaTons	  Found	  in	  the	  Literature:	  Other	                   Case...
Compartment	  Syndrome 	  	                  Atanda	  2008,	  Am	  J	  Ortho:	  “With	   proper	   aKenTon	   to	   detail...
Compartment	  Syndrome 	  	                    Taylor	  and	  Clark,	  2011	  BMJ	   Compartment	  syndrome	  leading	  to...
Compartment	  Syndrome	              Waltzman,	  Harvard	  Medical	  School:	  “To	   aKribute	   the	   rare	   complicaT...
Compartment	  Syndrome	            Waltzman,	  Harvard	  Medical	  School:	  Hand	   driven	   placement	   of	   IO	   ne...
Compartment	  Syndrome	             Moen	  and	  Sarwark	  2008,	  Orthopedics	             1	  case	  following	  difficult...
EZ-­‐IO	  Intraosseous	  Vascular	  Access	              Serious	  ComplicaTons	  	        Found	  on	  the	  FDA	  Websit...
A	  Myth	  That	  Lives	  On	      Example	  from	  2005	  
Summary	  •  Simple	   extravasaTon	                most	                                       prevalent	     complicaTon...
Difficult	  Vascular	  Access	  OpTons	                          Intraosseous	                         Central	             ...
Conclusions	  With	  new	  devices	  and	  techniques	                  	  IO	  is	  SAFE	  	              IO	  is	  EFFEC...
jrogers@acep.org	  
17.15 17.30 john rogers - publiceren
17.15 17.30 john rogers - publiceren
17.15 17.30 john rogers - publiceren
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17.15 17.30 john rogers - publiceren

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17.15 17.30 john rogers - publiceren

  1. 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. 2. Disclosures   Travel  Related  Expenses    to  AKend  this  Conference    
  3. 3. Disclaimer  Opinions  and  Statements  are  My  Own   Not  Policies  or  Opinions  of  ACEP    
  4. 4. The  Dream  
  5. 5. The  Reality  
  6. 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. 7. Current  SoluTons  to  IV  Failure   EMS   ET,  SQ,  IM,  Rectal,  Oral,  Nasal,    InhalaTon,  Sublingual,  Transdermal  Drive  FASTER  
  8. 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. 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 minutesInitiatives to decrease complications –  Medicare will not pay for complications –  Aim for Zero Campaign –  National Patient Safety Goals
  10. 10. NPSG  07.04.01   Implement  evidence  based  precauTons  to  prevent  central   line  associate  bloodstream   infecTons.   Avoid  Central  Lines  
  11. 11. Alternative Methods ofVascular Access in the ED   ACEP Clinical Policy Board of Directors June 2011
  12. 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. 13. Thousands of small veins lead from the medullary space to the central circulation
  14. 14. The  Ideal  IO     Easy   Safe   EffecTve   Fast  
  15. 15. 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
  16. 16. 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%)  
  17. 17. 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  
  18. 18. 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  
  19. 19. 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  
  20. 20. 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  
  21. 21. 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  
  22. 22. 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.”  
  23. 23. 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.”  
  24. 24. 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.”  
  25. 25. 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.”  
  26. 26. 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.  
  27. 27. 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  
  28. 28. A  Myth  That  Lives  On   Example  from  2005  
  29. 29. 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  
  30. 30. 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  
  31. 31. Conclusions  With  new  devices  and  techniques    IO  is  SAFE     IO  is  EFFECTIVE     IO  is  EASY   IO  is  FAST   Why  not  IO?  
  32. 32. jrogers@acep.org  

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