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This presentation explains the technical basis for high- efficiency filtration and then explores the fundamentals of Pulmonary Function Testing, the procedure for which our PFT Filters are used, and also describes the technical details of the Westmed BlockAide™ PFT filters. by Michael McPeck, RRT FAARC Director, Clinical Educa1on Westmed, Inc. [email protected] 516.729.9989 BASIC TRAINING Copyright © 2014 Westmed, Inc. All Rights Reserved

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Page 1: This presentation explains the technical basis for high ... · This presentation explains the technical basis for high-efficiency filtration and then explores the fundamentals of

This presentation explains the technical basis for high-efficiency filtration and then explores the fundamentals of Pulmonary Function Testing, the procedure for which our

PFT Filters are used, and also describes the technical details of the Westmed BlockAide™ PFT filters.

by  Michael  McPeck,  RRT  FAARC      Director,  Clinical  Educa1on      Westmed,  Inc.      [email protected]      516.729.9989  

BASIC TRAINING

Copyright © 2014 Westmed, Inc. All Rights Reserved

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Copyright © 2014 Westmed, Inc. All Rights Reserved

What  is  a  filter?

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Copyright © 2014 Westmed, Inc. All Rights Reserved

Filter  defined

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Copyright © 2014 Westmed, Inc. All Rights Reserved

Filtration …the  process  of  separating  the  components  of  a  fluid  “stream.”    The  components  may  be  the  ingredients  of  the  stream  or    accidental  contaminants  that  need  to  be  removed  to  purify  the  stream.     The  fluid  “stream”  can  be  a  liquid  or  a  gas. The  two  main  types  of  filtration  are:

•  particulate •  gas  phase

In  most  medical  applications,  we  are  concerned  with particulates  or  “patient  droplets.”

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Copyright © 2014 Westmed, Inc. All Rights Reserved

What  is  efficiency?

Efficiency  is  the  expression  of  a  filter’s  ability  to to  perform  filtration,  or  to  trap  and  remove   components  of  a  certain  size  from  the  stream.  

Efficiency  is  expressed  mathematically  as  … Output  divided  by  Input:

 Efficiency    =    Output  

Input  

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Mechanisms  of  particle  capture There  are  five  primary  mechanisms  by  which  filtration  of  particles  occurs  …

Inertial impaction – the particle’s forward inertia slams it into the filter media.

Diffusion – exceptionally small particles “drift” into the media by Brownian motion.

Interception – the particle has too little forward inertia for impaction but not enough to completely bypass the media.

Sieving – the most commonly perceived mechanism; the particle is too large to pass through “pores” in the media.

Electrostatic attraction – differences in electric charge create attraction of the particle to the media. This may be used in conjunction with the other mechanisms to enhance them.

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Copyright © 2014 Westmed, Inc. All Rights Reserved

How  is  filter  efficiency  determined? Filters  are  challenged  with  0.3  µμM  (micron)  particles  in  order  to  analyze  the  percentage  of  particles  that  have  been  retained.                    Why  0.3  µμM  ?

For a variety of physical reasons, the 0.2 to 0.3 µM diameter particle is the most difficult to filter. For that reason, 0.3 µM has been termed the “MPPS,” Most Penetrable Particle Size and has become the standard by which filters are tested for efficiency.

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Copyright © 2014 Westmed, Inc. All Rights Reserved

What  does  HEPA  mean?

HEPA  is  the  acronym  for  …

High  Efficiency  Particulate  Air So,  going  back  to  the  definitions,  we  see  that  a  HEPA  filter  is  concerned  with  particulates  and  a  gas  stream  (air)  …                                            …  and  it  is  especially  concerned  with  efficiency.

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HEPA  defined

HEPA  is  a  type  of  air  filter.  Filters  meeting  the  HEPA  standard  have  many  applications,  including  use  in  medical  facilities  and  equipment,  automobiles,  aircraft,  and  homes.   The  filter  must  satisfy  certain  standards  of  efficiency  such  as  those  set  by  the  United  States  Department  of  Energy  (DOE).   To  qualify  as  HEPA  by  US  government  standards,  an  air  filter  must  remove  (from  the  air  that  passes  through)  99.97%  of  particles  that  have  a  size  of  0.3  µμM  or  larger.  A  filter  that  is  qualified  as  HEPA  is  also  subject  to  interior  classifications.

High-Efficiency Particulate Air or High-Efficiency Particulate Absorption

99.97% Efficient @ 0.3 µM

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HEPA  defined

HEPA  media   is   similar   to  blo[ing   paper,   and  made  of   a   matrix   of   very   thin,  r a n d om l y   a r r a n g e d  overlapping   fibers   that  create  a  tortuous  pathway.        The   airflow   pathway   is  made  even  more  tortuous  by  pleating  the  media.    

High-Efficiency Particulate Air or High-Efficiency Particulate Absorption

polyester  glass  fibers  

plea1ng  

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Electrostatic  Filters In  electrostatic  filters,  50%  of  the  fibers  are  positively  charged,  and  50%  negatively  charged.    Particles  and  droplets  tend  to  carry  either  a  positive  or  negative  electrostatic  charge.    So,  roughly  half  of  the  negative  particles  will  be  a[racted  to  positive  fibers  and  vice  versa.    Upon  reaching  the  fibers  particles  are  held  in  place  by  the  electrostatic  charge.    The  electrostatic  mechanism  is  utilized  to  enhance  the  fundamental  physical  particle  capture  mechanisms.

Electrosta1c  par1cle  aFrac1on  mechanism  

Nega1ve  (  -­‐  )    Par1cle  

Posi1ve  (  +  )    Fiber  

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Copyright © 2014 Westmed, Inc. All Rights Reserved

Electrostatic  Filters Electrostatic  filters  are  nearly  as  good  as  HEPA  filters  and  are  used  in  some  similar  applications  where  airflow  resistance  and  resistance  to  we[ing  may  be  critical  factors. Features: •  Open  structure •  Larger  pore  size •  Electrostatically  charged  polypropylene  fibers •  Lower  airflow  resistance •  Lower  weight •  Failsafe  hydrophobic  mechanism  

(does  not  absorb  water) •  Tend  to  be  sold  at  lower  price  than  HEPA •  Media  of  choice  in  global  market  for  respiratory  

applications   99.9% Efficient @ 0.3 µM

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Copyright © 2014 Westmed, Inc. All Rights Reserved

Electrostatic  vs  HEPA

Electrosta?c   HEPA  

10,000   10,000  

10   3  

99.9  %  Efficient 99.97  %  Efficient

Theoretical  mean  efficiencies  predicted  for  electrostatic  and  HEPA  filters  based  upon  challenge  with  0.3  µμM  test  particles.  

10  particles  /  10,000 3  particles  /  10,000

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How  small/large  is  a  micron  (µμM)? Can  you  really  appreciate  how  small  1  micron  actually  is?  

Human Hair

1  micron  (µμM)

2.5  microns  (µμM)  (average  aerosol  particle  created  by  nebulizer)  

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Copyright © 2014 Westmed, Inc. All Rights Reserved

How  small/large  is  a  micron  (µμM)? Can  you  really  appreciate  how  small  1  micron  actually  is?  

Human Hair

1  micron  (µμM)

Relative  Sizes •  Filters  are  challenged  with  

0.3  µμM  spherical  particles.

•  P.  aeruginosa  is  a  rod,  ~1  to  5    X    0.5  to  1  µμM.

•  M.  tuberculosis  is  a  rod,  ~2  to  4    X    0.2  to  0.4  µμM.  

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Copyright © 2014 Westmed, Inc. All Rights Reserved

Purpose  of  the  PFT  filter PFT  filters  serve  one  purpose:  to  protect  the  patient  from  inhaling  micro-­‐‑organisms  and  aerosols  from  the  PFT  equipment,  and  to  keep  aerosols  and  droplets  containing  micro-­‐‑organisms  from  entering  the  PFT  equipment.

However, they must do their job without inhibiting flowrates or causing high resistance or creating a gas leak in the PFT system.

Morgan  PFT  filter  shown

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Copyright © 2014 Westmed, Inc. All Rights Reserved

For  Pulmonary  Function  Testing,  electrostatic  filters  are  preferred  for  the  3  principle  reasons:

•  Lower  resistance  than  HEPA  filters •  Be[er  moisture  resistance •  Lower  cost  than  HEPA  filters.  

Use  of  an  electrostatic  filter  instead  of  a  HEPA  filter  allows  for  the    manufacture  of  an  effective  filter,  with  airflow  resistance  as  low  as  possible,  at  a  cost  acceptable  to  the  market. Use  of  an  electrostatic  filter  instead  of  a  HEPA  filter  does  not  increase  either  the  machine  contamination  risk  or  the  patient  infection  risk because:   (1)  the  theoretical  efficiencies  between  the  devices  are  statistically  similar,  and   (2)  particles  encountered  in  pulmonary  function  testing  are  almost  always  

large  “patient  droplets,”  many  microns  in  size,  not  individual  microorganisms.*

Electrostatic  vs  HEPA  for  PFTs

*  Microorganisms  do  not  exist  in  free  form,  they  are  aFached  to,  or  a  part  of,        some  suitable  substrate  that  tends  to  form  larger  droplets  or  par1cles.  

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Westmed  BlockAide™  PFT  Filters

The  sales  flyer  is  very  important  because,  in  addition  to  describing  the  product,  it  also  contains  important  specifications  to  help  match  the  correct  filter  to  the  wide  variety  of  PFT  devices  currently  in  use.

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Elliptical  vs  Round Pulmonary  function  labs  often  like  to  have  different  shapes  of  mouthpieces  available  to  accommodate  patient  preferences.    Some  patients,  particularly  children,  have  small  mouths  and  therefore  tend  to  do  be[er  with  the  elliptical  mouthpiece.    

Studies where high expiratory flowrates are anticipated (spirometry and flow/volume loops) require filter mouthpieces with large inside diameters that do not impose high resistance or impede the flow.

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Flanged  vs  Straight Rubber  flanged  mouthpieces  that  fit  in  the  mouth  with  the  flange  situated  between  the  lips  and  the  gums  tend  to  do  a  be[er  job  of  making  a  gas-­‐‑tight  seal  for  tests  that  require  a  long  breathing  period,  such  as  gas  dilution  lung  volumes  and  diffusing  capacity.    They  are  also  useful  for  plethysmography  where  the  flange  helps  hold  the  mouthpiece  in  place  during  the  panting  breathing  technique.    Straight  mouthpieces  are  more  frequently  used  for  spirometry  procedures  where  forced  expiratory  flowrates  are  very  high.

Be aware that our mouthpieces are cost-effective substitutes for OEM filters (shown here) and can be used either with or without a flanged rubber mouthpiece.

Morgan  PFT  filter  shown

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Copyright © 2014 Westmed, Inc. All Rights Reserved

Basic  Specifications

Common customer questions might include:

• What is the filter efficiency? •  What is the filter resistance to flow? •  What is the filter deadspace?

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Copyright © 2014 Westmed, Inc. All Rights Reserved

Filter  Efficiency A  common  customer  question  might  be:      What  is  the  filter  efficiency?

Efficiency  is  the  expression  of  a  filter’s  ability  to  perform  filtration,  or  to  trap  and  remove  components  of  a  certain  size  from  the  stream.  Efficiency  is  expressed  mathematically  as  …

Output  divided  by  Input: Efficiency    =    Output                                                Input

The Westmed BlockAide™ PFT Filter has an bacterial/viral efficiency of 99.9% of particles 0.3 µM in size. 0.3 µM is the industry standard test size for filters because 0.3 µM represents the MPPS, or Most Penetrable Particle Size.

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Resistance  to  Flow A  common  customer  question  might  be:      What  is  the  filter  resistance  to  flow?

How  is  filter  resistance  determined?    Very  simply,  a  number  of  samples  of  filters  are  tested  to  determine  their  pressure  drop  (△P)  at  many  different  flowrates  across  their  expected  range  of  use.    One  way  of  doing  this  would  be  to  subject  the  filter  to  increasing  flowrates  at  1  L/sec  increments,  up  to  a  maximum  of  14  L/sec,  and  then  measuring  the  △P  at  each  flowrate.    The  resulting  data  set  might  look  like  the  table  on  the  left  below.    Next,  the  data  would  be  plo[ed  in  a  spreadsheet  to  create  a  graph  showing  the  data  points  on  the  chart  on  the  right,  below.    

Finally, the equation for the slope of the △P /Flowrate line is solved by linear regression to reveal the filter resistance (y); in this case, 0.46 cmH2O/L/sec.

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Copyright © 2014 Westmed, Inc. All Rights Reserved

Resistance  to  Flow A  common  customer  question  might  be:      What  is  the  filter  resistance  to  flow?

Our  filter  resistance  specification,  0.46  cmH2O/L/sec  indicates  that,  for  every  1  L/sec  of  increasing  flowrate,  the  pressure  drop  (△P)  across  the  filter  increases  by  0.46  cmH2O.      The  spec  also  indicates  that  the  filter  was  tested  up  to  a  maximum  flowrate  of  14  L/sec  which  is  slightly  more  than  we  would  expect  even  the  healthiest  patient  to  achieve.

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Deadspace A  common  customer  question  might  be:      What  is  the  filter  deadspace?

“Deadspace”  is  simply  the  amount  of  gas-­‐‑containing  volume  enclosed  within  the  body  of  the  filter.    Obviously,  the  larger  the  filter,  the  greater  the  deadspace.    Deadspace  is  important  because  it  often  represents  the  amount  of  exhaled  CO2-­‐‑containing    “rebreathed  volume”  that  a  patient  may  have  to  inhale  when  a[ached  to  an  apparatus  through  a  filter.    The  smaller  the  patient,  the  smaller  the  tidal  volume  and,  hence,  the  more  critical  that  deadspace  becomes.

S o m e d e g r e e o f d e a d s p a c e i s unavoidable because of the large diameters that are required to reduce airflow resistance. However, the shape of our PFT filter is designed specifically to reduce deadspace as much as possible while maintain the requisite diameter for low flow resistance.

Round  =  54  mL   Ellip?cal  =  51  mL  

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Connector  Sizes

One way of selecting the correct filter would be to match the inside and outside diameter of the PFT machine-side of the filter to the actual diameter on the mouthpiece port of the PFT machine or device.

Inside (ID) &Outside (OD) Filter Diameters in millimeters (mm)

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Connector  Sizes

Another way of selecting the correct filter would be to look up the brand and model of the PFT device on the chart on the flyer. Sizes given are in millimeters (mm).

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Conclusion •  The  American  Thoracic  Society  (ATS),  issues  clinical  practice  guidelines  

that  are  widely  accepted  by  pulmonary  practitioners  and  manufacturers  of  pulmonary  diagnostic  equipment.    ATS  has  specified  a  maximum  allowable  PFT  filter  resistance  of  1.5  cmH2O/L/sec.    Obviously,  the  Westmed  Blockaide™  PFT  Filters,  at  0.46  cmH2O/L/sec,  are  well  below  that  maximum.  

•  Statements  by  other  manufacturers  of  filters,  especially  by  the  companies  that  make  the  PFT  equipment,  that  suggest  our  filter  resistance  is  too  high,  or  that  the  high  limit  is  impractical  for  pediatric  patients,  are  merely  sales  tactics  that  are  designed  to  confuse  the  customer  and  cast  doubt  on  the  quality  of  our  filter.    They  are  trying  to  sell  their  filters,  with  a  high  markup,  but  which  are  no  be[er  than  ours.

•  The  fact  is  the  Westmed  Blockaide™  PFT  filters  are  high  quality  filters  that  are  well  within  the  maximum  resistance  specified  by  the  ATS.    The  high  testing  limit  of  14  L/sec  is  assurance  that  the  filter  resistance  is  linear  up  to  that  value;  it  does  not  affect  whether  or  not  the  filter  can  be  used  on  pediatric  patients.    It  can.