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  

Severity   Frequent   Occasional   Rare  

Serious   DVT(30%*)   InfecTon  (5-­‐9%)  DVT  (8  –  26%)  PE  (15  %*)  

Arterial  puncture  (3.5%)  

Death  InfecTon  (1%)        Air  Embolism  (0.5%)  Bleed/Pneumo  (1-­‐3%)  

Less  Serious   Hematoma  (4.5%)  

Minor   MalposiTon  (9%)  

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%)  

Central  Venous  Catheters  

Intraosseous  Access    Catheters  

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/Drape/US  

Catheter  

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