Pyng receives results of military study
Pyng Technologies Corp PYT
Shares issued 9,788,905 May 19 close $1.55
Wed 19 May 99 News Release
Mr. Michael Jacobs reports
The long-awaited Walter Reed Army Institute of Research study has been
released. It compared the F.A.S.T. 1 (designed for adult emergency vascular
access through the sternum), to the B.I.G. Bone Injection Gun (designed for
in-hospital bone anesthesia), the SurFast (designed for pediatric emergency
vascular access through the lower leg), and the Jamshidi needle (designed
for bone marrow biopsy).
The purpose of the Walter Reed evaluation was to determine the
appropriateness of intraosseous infusion in a battlefield environment.
In the study, 31 special operations medics got a general lecture on I.O.
devices, and viewed videos on the F.A.S.T. 1 and B.I.G., followed by a
short hands on session with the devices. Each medic used each device once
in a cadaver, then rated the devices for successful access, adequate fluid
flow, security of the needle, weight and size, and overall preference.
The military medics using the devices rated the F.A.S.T. 1 and the Jamshidi
needle as tied for first choice. We assume that medics who ranked the
Jamshidi first liked its very low weight in a combat backpack (less than
one-10th of the F.A.S.T. 1), while those who ranked the F.A.S.T. 1 first
preferred its superior performance. The authors note the Jamshidi, while
lightweight and simple to use, protrudes at least two inches above the
insertion site, making dislodgement likely during transport. The B.I.G.
device was the medics' second choice.
Each of the devices was successfully placed by 29 or 30 of the 31 medics
using it. Only the F.A.S.T. 1 had good flow rate in all cases. Only the
F.A.S.T. 1 infusion site was rated very secure in all cases. The other
devices showed slight to "a fair amount" of leakage, at infusion sites
where leakage might cause compartment syndrome, a severe medical
complication. The F.A.S.T. 1 showed slight leakage in two cases, not
clinically significant because compartment syndrome which is a risk at the
competitors' sites, does not occur at the sternal site. The two
unsuccessful F.A.S.T. 1 attempts were due to operator. Products other than
the F.A.S.T. 1 showed design failures (stuck stylet, needle falling out
before use, inadequate provision for landmarking the correct site, bent
needles). A significant operator safety issue was noted with one of the
other devices.
All four I.O. devices studied were found easy to use, easy to place and
could be adequately used by military combat medics. The study included
information which will lead civilian paramedics to conclude that the
F.A.S.T. 1 is clearly the device of choice based on speed, effectiveness,
and operator safety in the prehospital environment.
The most contentious finding, and a significant flaw in the study, related
to speed of use. The study reported average times to place the devices
ranging from 70 to 114 seconds, with the F.A.S.T. 1, ironically, being
least fast. However, the F.A.S.T. 1 system includes all components needed
to achieve an accurately located, clean, and securely protected infusion
site. None of the other devices contain such features. To quote from the
study, "... the F.A.S.T. 1 time included everything from unwrapping the
package through securing the insertion site. Dressing the site would simply
include an additional one to two seconds to place the plastic dome.... The
other I.O. devices would have had increased insertion times if securing and
dressing were also included. ... For this reason, times to secure and dress
each device were not included as that would have made placement times
extremely variable." In other words, the investigators chose not to include
securing and dressing the site in the study. All other devices (B.I.G.,
Jamshidi and SurFast) required dressing after insertion in order to
maintain a secure sight. In addition, the investigators used non-clothed
cadavers. The time taken to remove clothing and footwear is not included.
One of the advantages of the F.A.S.T. 1 is the ease of accessing the
sternal site. Paramedics will recognize accessing the site, and securing
and dressing the site as critical parts of the procedure, which require
another one to two seconds for the F.A.S.T. 1 and up to several minutes for
other devices.
The study also stated, "The FAST's plastic infusion tube, Velcro patch and
plastic dome cover make it the most secure and easily dressed of the units
tested. In an environment where the casualty may be carried over the
shoulder or in makeshift stretchers, where possible dislodgement is a
significant concern, the FAST seems to have the best design. This system is
probably more secure than a peripheral IV."
In final summary the study states that "if weight and volume are not of
significant concern, the F.A.S.T. 1 appears to offer the appropriate
option, due to combined package with excellent protection of insertion
site."
(c) Copyright 1999 Canjex Publishing Ltd. canada-stockwatch.com
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