Page 106 - Journal of Special Operations Medicine - Summer 2015

John F. Kragh Jr, MD; Donald L. Parsons, PA-C;
Russ S. Kotwal, MD; Bijan S. Kheirabadi, PhD; James K. Aden 3d, PhD;
Robert T. Gerhardt, MD; David G. Baer, PhD; Michael A. Dubick, PhD

e thank Dr Schwartz and colleagues, The Journal, us was their reference 3, which is nearly identical to our
Wand the operational medicine community for the reference 11, which we cited correctly. We acknowledge
opportunity to increase awareness of junctional hem- and remain aware of the studies Dr Schwartz and col-
orrhage control in replying to a letter of Dr Schwartz leagues cited, two of which were associated with more
and colleagues about our publication in the Fall 2014 tolerance of discomfort than as we reported. One of the
issue titled, “Testing of Junctional Tourniquets by Mili- references we did not cite had a different design, different
tary Medics to Control Simulated Groin Hemorrhage.” 1 methods, and different placement, so it was only tangen-
The letter tries to make the following points about our tially related to points made. We selected only references
study: methods were not followed, previous works were that were directly relevant to points we made.
not cited, and the tourniquet was approved for groin
placement at the time of the study. By its design, testing was to compare tourniquets in a
head-to-head manner at a time when there was only one
The methods were followed. The tourniquet in ques- way to do so. That way was executed and reported. The
tion was tested as applied to the umbilicus. As we un- ethical oversight body mentioned in the original publi-
derstand the relevant public documents, the tourniquet cation could not, and cannot, permit testing other than
when tested was not approved for placement on the in accordance with the IFU. To assess a medical device
groin. The tourniquet was approved for an indication contrary to its IFU would be a research experiment,
of inguinal (i.e., groin, hemorrhage), but its instructions not a customer assessment of user preference. The IFU
for use (IFU) only instructed application to the umbili- for a medical device is the responsibility of the device’s
cus, the surface landmark of aortic compression. IFU, sponsor, which in this case was a company. The com-
also known as a product insert, is regulated as part of pany holds its regulatory filings as does the regulatory
the labeling of a medical device. The first way umbilical administration. Portions of filings may be made public
application was expressed was in the listed steps of use. if or when the sponsor so discloses. We are aware of
The second step of use was “2. Position bladder over no disclosure of why the IFU was limited to umbilicus
umbilicus.” Nothing in the IFU mentioned the groin, in- placement. The letter of Dr Schwartz and colleagues is
guinal, or any other site as a place of application. The opaque on this matter. A review article on the medical
second way umbilical application was described in the device may provide a platform to clarify the potential of
IFU was by the mechanism of aortic compression. this tourniquet to the operational medicine community.
The IFU stated in part to begin the second paragraph of In the past, we asked the sponsor to consider such a clar-
the indication section: “Proximal compression of vessels ification. We look forward to learning more about the
is still the most effective way of hemorrhage control. potential risk and benefit of the junctional tourniquet.
The abdominal aortic tourniquet does this by compress-
ing the descending aorta at or near its bifurcation.” No References
other mechanism is mentioned in the IFU. The original
publication again repeated the restricted application to 1. Kragh JF Jr, Parsons DL, Kotwal RS, et al. Testing of junctional
the umbilicus with elaboration of: “The AAJT was ap- tourniquets by military medics to control simulated groin hem-
orrhage. J Spec Oper Med. 2014;14:58–63.
plied to the umbilicus; other models were applied to the 2. Kragh JF, Kotwal RS, Cap AP, et al. Performance of junctional
groin.” Methods and findings of the original publication tourniquets in normal human volunteers. Prehosp Emerg Care.
were similar to those of another study we published. 2 2014 Dec 12. [Epub ahead of print]

Directly relevant references were cited. One reference
mentioned by Dr Schwartz and colleagues as not cited by

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